ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01636947
Conditions: Nausea Vomiting
Keywords: chemotherapy nausea vomiting emetogenic cancer antiemetics tumor
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-12-12; Completion date: 2014-08-04
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors. MECs include a number of commonly used cancer chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based regimens.

The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.

Detailed description:

Arms: arm 1: Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3. arm 2: Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
Interventions: intervention 1: Aprepitant intervention 2: Aprepitant Placebo intervention 3: Ondansetron intervention 4: Dexamethasone intervention 5: Ondansetron Placebo intervention 6: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).
Intervention descriptions: intervention 1: Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3 intervention 2: Aprepitant Placebo (PO, QD) on Days 1, 2, and 3 intervention 3: Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3 intervention 4: Dexamethasone (20 mg or 12 mg, PO) on Day 1 intervention 5: Ondansetron Placebo (PO, BID) on Days 2 and 3 intervention 6: Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).

Protocol documents:
Clinical trial NCT01833494
Conditions: Hemodialysis Patients With Hyperphosphatemia
Keywords: Hemodialysis Hyperphosphatemia
Sponsor: Kissei Pharmaceutical Co., Ltd.
Start date: 2013-03-18; Completion date: 2014-08-04
Enrollment: 161 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PA21
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02019719
Conditions: Anaemia
Keywords: Hemodialysis GSK1278863 Pharmacokinetics Erythropoiesis Stimulating Agents Chronic Kidney Disease Hemoglobin Recombinant Erythropoietin Prolyl Hydroxylase Inhibitor Anemia
Sponsor: GlaxoSmithKline
Start date: 2013-11-05; Completion date: 2014-08-06
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD). It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials. This study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a follow-up visit approximately 4 weeks after completing treatment.

Detailed description:

Arms: arm 1: Subjects will receive GSK1278863 4 mg once daily for 4 weeks arm 2: Subjects will receive GSK1278863 6 mg once daily for 4 weeks arm 3: Subjects will receive GSK1278863 8 mg once daily for 4 weeks arm 4: Subjects will receive GSK1278863 10 mg once daily for 4 weeks arm 5: Subjects will receive placebo once daily for 4 weeks
Interventions: intervention 1: GSK1278863 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK1278863 will be supplied as film coated tablets for oral administration containing 1 mg, 2 mg, or 5 mg of GSK1278863. intervention 2: Film coated tablets of GSK1278863 matching placebo for oral administration.

Protocol documents:
Clinical trial NCT01874431
Conditions: Diabetic Nephropathies
Sponsor: Bayer
Start date: 2013-06-12; Completion date: 2014-08-07
Enrollment: 823 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

Detailed description:

Arms: arm 1: 1.25 mg dose oral once daily for 90 days arm 2: 2.5 mg dose oral once daily for 90 days arm 3: 5 mg dose oral once daily for 90 days arm 4: 7.5 mg dose oral once daily for 90 days arm 5: 10 mg dose oral once daily for 90 days arm 6: 15 mg dose oral once daily for 90 days arm 7: 20 mg dose oral once daily for 90 days arm 8: Placebo oral dose once daily for 90 days
Interventions: intervention 1: Finerenone (BAY94-8862) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00748215
Conditions: Chemotherapeutic Agent Toxicity Colorectal Cancer Diarrhea
Keywords: diarrhea chemotherapeutic agent toxicity recurrent colon cancer recurrent rectal cancer stage IV colon cancer stage IV rectal cancer
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-02-04; Completion date: 2014-08-12
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Calcium aluminosilicate anti-diarrheal (CASAD) may help treat and prevent diarrhea caused by irinotecan. It is not yet known whether CASAD is more effective than a placebo in treating and preventing diarrhea in patients receiving irinotecan.

PURPOSE: This randomized phase II trial is studying CASAD to see how well it works compared with a placebo in treating and preventing diarrhea in patients with metastatic colorectal cancer receiving irinotecan.

Detailed description:
OBJECTIVES:

Primary

* To compare the efficacy of calcium aluminosilicate anti-diarrheal (CASAD) versus placebo in reducing the incidence of grade 3 or 4 diarrhea in patients with metastatic colorectal cancer receiving an irinotecan-based chemotherapy regimen.

Secondary

* To compare stools per day in patients treated with these drugs.
* To compare chemotherapy dose reductions and delays due to diarrhea in patients treated with these drugs.
* To compare quality of life of patients treated with these drugs.
* To compare the safety of these drugs in these patients.
* To compare the incidence of grade 3 or 4 diarrhea in patients treated with these drugs.

OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy regimen (irinotecan hydrochloride in combination with fluorouracil and/or biologic therapy vs irinotecan hydrochloride alone). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who develop grade 3 or 4 diarrhea and are removed from the study may receive CASAD for an additional 6 weeks.
* Arm II: Patients receive oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who develop grade 3 or 4 diarrhea and are removed from the study may then receive CASAD for 6 weeks.

Patients undergo quality-of-life assessment at baseline and at weeks 3, 5, and 6.

After completion of study treatment, patients are followed for 30 days.

Arms: arm 1: Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks. arm 2: Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks.
Interventions: intervention 1: calcium aluminosilicate anti-diarrheal intervention 2: placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT01506271
Conditions: Intra-abdominal Infections
Keywords: Complicated Intra-abdominal Infections
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-06-01; Completion date: 2014-08-12
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of relebactam (MK-7655) to imipenem/cilastatin in adults 18 years or older with Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the relebactam + imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin alone with respect to the percentage of participants with a favorable clinical response at completion of intravenous (IV) study therapy.

Detailed description:

Arms: arm 1: Participants randomized to receive relebactam 250 mg will be administered 250 mg doses of relebactam IV in a blinded fashion once every 6 hours with each dose infused over a 30-minute interval. A 500 mg dose of imipenem/cilastatin will be administered in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval. arm 2: Participants randomized to receive relebactam 125 mg will be administered 125 mg doses of relebactam IV, in a blinded-treatment fashion once every 6 hours with each dose infused over a 30-minute interval. A 500 mg dose of imipenem/cilastatin will be administered IV in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval. arm 3: Participants randomized to receive placebo for relebactam will receive a placebo-matching infusion of IV normal saline (0.9%) once every 6 hours. A 500 mg dose of imipenem/cilastatin will be administered IV in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval.
Interventions: intervention 1: Relebactam 250 mg intervention 2: Relebactam 125 mg intervention 3: Imipenem/cilastatin intervention 4: Matching placebo to relebactam
Intervention descriptions: intervention 1: Relebactam 250 mg IV every 6 hours for a minimum of 96 hours intervention 2: Relebactam 125 mg IV every 6 hours for a minimum of 96 hours intervention 3: A 500 mg dose of imipenem/cilastatin will be administered IV in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval. intervention 4: Placebo-matching infusion of IV normal saline (0.9%) once every 6 hours.

Protocol documents:
Clinical trial NCT01285557
Conditions: Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
Keywords: Gastric Cancer , S-1, Phase 3
Sponsor: Taiho Oncology, Inc.
Start date: 2011-04-14; Completion date: 2014-08-15
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

Detailed description:
This is an open-label, international, Phase 3 study evaluating the efficacy and safety of the S-1/cisplatin regimen versus the 5-FU/cisplatin regimen in chemotherapy-naïve patients with metastatic diffuse gastric carcinoma including carcinoma of the gastro-esophageal junction. Patients will be randomly assigned to S-1/cisplatin (experimental regimen, Arm A) or 5-FU/cisplatin (control regimen, Arm B).

Arms: arm 1: Participants received S-1 25 milligrams per meter square (mg/m\^2) orally twice daily (BID) every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m\^2 as a 1- to 3-hour intravenous (IV) infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until progression of disease (PD), adverse event (AE), withdrawal of consent, or other reason for discontinuation, whichever happened earlier. arm 2: Participants received 5-Fluorouracil (5-FU) 800 mg/m\^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m\^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
Interventions: intervention 1: S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm) intervention 2: Fluorouracil/cisplatin (control arm)
Intervention descriptions: intervention 1: 25 mg/m² body surface area (BSA) orally 2 times daily from Days 1 through 21 followed by a 7 day rest period, plus cisplatin 75 mg/m2 BSA on Day 1 each 28 day cycle Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles. intervention 2: 5-FU: 800 mg/m2 BSA/24 hours by continuous intravenous infusion (CIV) from Days 1 through 5 plus cisplatin 80 mg/m2 BSA on Day 1 each 21 day cycle.

Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.

Protocol documents:
Clinical trial NCT01808313
Conditions: Vascular Disease
Sponsor: GlaxoSmithKline
Start date: 2012-12-01; Completion date: 2014-08-15
Enrollment: 134 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open label, single-arm, non-controlled, multicentre study will determine the effect of ambrisentan on exercise capacity (6MWT) in Chinese subjects with PAH. The study consists of a screening period of 4 weeks, a 12-week primary evaluation period (PEP) and a 12-week dose-adjustment period (DAP). Ambrisentan 5 mg will be administered to eligible subjects for 12 weeks (PEP).

Detailed description:
Pulmonary arterial hypertension (PAH) consists of a group of progressive and incurable diseases of the pulmonary vasculature. These are characterised by profound vasoconstriction and abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries, which leads to a progressive increase in pulmonary vascular resistance (PVR) and sustained elevations in pulmonary artery pressure (PAP). A variety of drug classes have been used to treat PAH but no single compound has yet been shown to be effective in treating all patients with the disease. Three widely used treatment options are calcium channel blockers (CCBs), diuretics and anticoagulants but all have varying responses.There is a lack of clinical data on ambrisentan among the Chinese population,Ambrisentan is conditionally approved for the treatment of PAH in China.A clinical trial with a minimum of 100 patients in the ambrisentan arm was requested by SFDA.Several PAH medications have been approved in China, so a placebo-controlled study is not ethically appropriate while an active control non-inferiority design is unfeasible due to sample size requirements and inconsistency in indications.

Arms: arm 1: ambrisentan 5 mg will be administered to eligible subjects for 12 weeks
Interventions: intervention 1: ambrisentan
Intervention descriptions: intervention 1: Ambrisentan 5 mg will be administered to eligible subjects for 12 weeks

Protocol documents:
Clinical trial NCT02054572
Conditions: Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis
Keywords: AMG 416, ESRD, hemodialysis
Sponsor: Amgen
Start date: 2014-02-07; Completion date: 2014-08-15
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of \[¹⁴C\]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole blood and plasma over time.

Detailed description:
Six adult male or female patients with end stage renal disease requiring hemodialysis will be enrolled to receive 750 nCi of \[¹⁴C\]-labeled etelcalcetide formulated in 10 mg etelcalcetide administered as a single 2 mL intravenous dose at the end of hemodialysis.

Participants will spend the first approximately 12 days in confinement at the clinic (day -1 until completion of day 11 study procedures). Blood samples, and complete collections of dialysate, dialysis membrane (as necessary), urine (as available), and feces will be analyzed for radioactivity content by accelerator mass spectrometry (AMS). Following the confinement period, participants will return to the site on an outpatient basis in accordance to their routine dialysis sessions up to day 39. Blood and dialysate samples and dialysis membranes will be collected at specified times during the outpatient visit period.

Participants may be asked to return so the site for the Extended Pharmacokinetic Collection Period. During the Extended Pharmacokinetic Collection Period, participants will return to the site for 3 consecutive hemodialysis sessions (Collection Period 1) and then again approximately one month later, for an additional 3 consecutive hemodialysis sessions (Collection Period 2).

Arms: arm 1: Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
Interventions: intervention 1: [¹⁴C]Etelcalcetide
Intervention descriptions: intervention 1: 750 nCi of \[¹⁴C\]etelcalcetide formulated as a single 10 mg dose of etelcaletide in 2 mL liquid solution for bolus intravenous (IV) administration at the end of hemodialysis.

Protocol documents:
Clinical trial NCT01886690
Conditions: Bilateral LASIK Surgery
Sponsor: Allergan
Start date: 2013-08-20; Completion date: 2014-08-18
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.

Detailed description:

Arms: arm 1: 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days. arm 2: 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Interventions: intervention 1: carboxymethylcellulose sodium based new eye drop formulation intervention 2: carboxymethylcellulose sodium based eye drops
Intervention descriptions: intervention 1: 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days. intervention 2: 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.

Protocol documents:
Clinical trial NCT01797536
Conditions: Hepatic Insufficiency
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-03-06; Completion date: 2014-08-20
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.

Detailed description:

Arms: arm 1: Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale arm 2: Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale arm 3: Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale arm 4: Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
Interventions: intervention 1: Elbasvir
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01100775
Conditions: Schizophrenia
Keywords: Galantamine Schizophrenia working memory cognitive
Sponsor: University of Maryland, Baltimore
Start date: 2010-05-01; Completion date: 2014-08-21
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early twenties, with cognitive impairments and negative symptoms frequently emerging much earlier. Such cognitive impairments and negative symptoms but much milder are also observed in high-risk groups (such as relatives of schizophrenia patients), who may or may not develop the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test the effects of galantamine on clinical/physiological/cognitive measures. This study serves several goals: If a drug is found effective in treating subtle deficits, then it will provide treatment strategy in individuals with schizophrenia spectrum personality disorders and for early intervention in schizophrenia. In addition, one of the difficulties of testing a drug on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can change the effects of the test drug. The proposed study will be in subjects who will not be taking antipsychotic medications. Our study will be carried out in two sessions, at least one month apart. Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. We will administer a battery of clinical/cognitive/neurophysiological tests after the 8 mg drug dose.

Detailed description:

Arms: arm 1: Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. arm 2: Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing.
Interventions: intervention 1: Galantamine intervention 2: Placebo
Intervention descriptions: intervention 1: A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. intervention 2: Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.

Protocol documents: