ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02525536
Conditions: Neoplasms, Advanced Solid
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2009-06-01; Completion date: 2014-05-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profile of trebananib (AMG 386) after intravenous administration in adult Japanese participants with advanced solid tumors.

Detailed description:
The drug being tested in this study is called trebananib (AMG 386). Trebananib (AMG 386) is being tested to treat people with advanced solid tumors.

This study will look at the safety, tolerability and pharmacokinetic (PK) profile of trebananib and response to treatment.

The study will enroll approximately 18 participants. Once enrolled, participants will be assigned sequentially into 1 of the 3 cohorts:

* Trebananib 3 milligram/kilogram (mg/kg),
* Trebananib 10 mg/kg,
* Trebananib 30 mg/kg.

All participants will receive trebananib via 60 minute intravenous infusion. This study will be conducted in Japan. The overall time to participate in this study is 14 weeks or more. Participants will attend the end-of-treatment visit 28 days after the last dose of study drug.

Arms: arm 1: Trebananib (AMG 386) 3 milligram/kilogram (mg/kg), 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks). arm 2: Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks). arm 3: Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
Interventions: intervention 1: Trebananib 3 mg/kg intervention 2: Trebananib 10 mg/kg intervention 3: Trebananib 30 mg/kg
Intervention descriptions: intervention 1: Trebananib (AMG 386) 3 mg/kg, intravenous infusion. intervention 2: Trebananib (AMG 386) 10 mg/kg, intravenous infusion. intervention 3: Trebananib (AMG 386) 30 mg/kg, intravenous infusion.

Protocol documents:
Clinical trial NCT02020304
Conditions: Pain
Keywords: Combined spinal epidural duration labor pain
Sponsor: Wake Forest University Health Sciences
Start date: 2013-08-29; Completion date: 2014-05-04
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.

Detailed description:
Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator (\~\<43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.

Arms: arm 1: room temperature combined spinal epidural dose (60-75 degrees F) arm 2: refrigerated temperature combined spinal epidural dose (\~\<43 degrees F)
Interventions: intervention 1: combined spinal epidural
Intervention descriptions: intervention 1: Combined Spinal Epidural

Protocol documents:
Clinical trial NCT01624974
Conditions: Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-08-09; Completion date: 2014-05-05
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effect of MK-1029 on lung function in the treatment of adults who have persistent asthma that is uncontrolled with the use of montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for two separate 4-week treatment periods. All participants will also use ML during the treatment periods. The primary hypothesis is that MK-1029 is superior to placebo in change from baseline in forced expiratory volume in one second (FEV1) at the end of the 4-week treatment period.

Detailed description:

Arms: arm 1: Participants received 4 weeks treatment with MK-1029 150 mg once daily (QD) + ML 10 mg QD in Period III and Placebo QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD. arm 2: Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III and MK-1029 150 mg QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.
Interventions: intervention 1: MK-1029 intervention 2: Placebo intervention 3: Montelukast (ML)
Intervention descriptions: intervention 1: MK-1029 150 mg tablets taken QD intervention 2: Placebo tablets (matching the MK-1029 150 mg tablets) QD intervention 3: ML 10 mg tablets QD

Protocol documents:
Clinical trial NCT01930058
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-02; Completion date: 2014-05-05
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This adaptive design study will evaluate the safety, pharmacokinetics, and effect on hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV infection. The study will consist of 4 parts evaluating participants infected with specific hepatitis C virus genotypes and up to 10 panels allowing for additional participants to enroll in each panel as specified in the study analysis. The hypothesis evaluated in the study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple dose administration of MK-8876 in participants with HCV infection.

Detailed description:

Arms: arm 1: Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days. arm 2: Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days. arm 3: Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
Interventions: intervention 1: MK-8876
Intervention descriptions: intervention 1: MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.

Protocol documents:
Clinical trial NCT01723072
Conditions: Chronic Spontaneous Urticaria Angioedema
Keywords: Chronic spontanous urticaria, refractory CSU, Angioedema
Sponsor: Novartis Pharmaceuticals
Start date: 2013-01-23; Completion date: 2014-05-09
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

Detailed description:
This study will be conducted using a double-blind, placebo-controlled, randomized, multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or inhibiting the occurrence, time-course and severity of angioedema episodes.

Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed by an 8-week follow-up. The study aims to enroll approximately 70 patients.

The study is divided into a 2-week screening period, a 28-week double-blind treatment phase with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.

Arms: arm 1: omalizumab once a month via subcutaneous injection. arm 2: placebo of omalizumab once a month via subcutaneous injection
Interventions: intervention 1: Omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Humanized monoclonal antibody against human IgE intervention 2: Placebo to omalizumab

Protocol documents:
Clinical trial NCT01788046
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Sponsor: Amgen
Start date: 2013-03-12; Completion date: 2014-05-09
Enrollment: 515 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

Detailed description:

Arms: arm 1: Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. arm 2: Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
Interventions: intervention 1: Etelcalcetide intervention 2: Placebo
Intervention descriptions: intervention 1: Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (4-week intervals) by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg. intervention 2: Administered intravenously (IV) three times per week.

Protocol documents:
Clinical trial NCT02089659
Conditions: HIV-1 Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-03-26; Completion date: 2014-05-12
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate hepatic insufficiency was compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 was to evaluate PK of doravirine in participants with mild hepatic insufficiency.

Detailed description:

Arms: arm 1: Participants with moderate hepatic insufficiency receive a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have moderate hepatic insufficiency based on the Child-Pugh scale. arm 2: Healthy participants matched for age and weight receive a single oral dose of 100 mg doravirine on Day 1 of Part 1. arm 3: Participants with mild hepatic insufficiency receive a single oral dose of 100 mg doravirine on Day 1 of Part 1. All participants in this arm were to have mild hepatic insufficiency based on the Child-Pugh scale. This arm was to be enrolled and investigated only if a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1.
Interventions: intervention 1: Doravirine
Intervention descriptions: intervention 1: Following an overnight fast, a single tablet of 100 mg doravirine was be administered orally

Protocol documents:
Clinical trial NCT00609154
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes Insulin biosynthesis Non diabetic control
Sponsor: Albert Einstein College of Medicine
Start date: 2010-08-12; Completion date: 2014-05-13
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood.

Detailed description:
We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.

Arms: arm 1: Participants with Type 2 diabetes arm 2: Participants who are non-diabetic will serve as control. treatment is matched to experimental group
Interventions: intervention 1: glucagon like peptide-1 intervention 2: glucose control
Intervention descriptions: intervention 1: GLP-1 1 pmole/kg/min intervention 2: glucose without GLP-1

Protocol documents:
Clinical trial NCT01363908
Conditions: Transfusional Iron Overload Beta-Thalassemia
Keywords: Beta-Thalassemia Sickle Cell Anemia Transfusional iron overload Iron Overload Iron Chelation
Sponsor: Shire
Start date: 2011-08-10; Completion date: 2014-05-13
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the chronic dosing phase, during which patients will receive an additional 48 weeks of SSP-004184AQ dosing. Two age groups will be studied: 6-\<12, and 12-\<18 years old. The study is designed to initially assess the pharmacokinetics and safety of SSP-004184AQ in older children (adolescents, 12-\<18 years old) and then if deemed safe, in younger children (6-\<12 years old).

Detailed description:
Pharmacokinetic Phase: Patients will receive a single 16 mg/kg dose of SSP-004184AQ in capsule form.

Chronic Dosing Phase: Patients will receive SSP-004184AQ capsules daily for 48 weeks. Doses may range from 8-60 mg/kg/d.

Arms: arm 1: Oral SSP-004184AQ taken once daily for 48 weeks arm 2: Oral SSP-004184AQ taken once daily for 48 weeks. Starting dose based on transfusion burden and iron overload status. Doses may range from 8-60mg/kg/day depending on clinical response. arm 3: A single dose given in the initial pharmacokinetic phase.
Interventions: intervention 1: SPD602
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01569438
Conditions: Bladder Pain Syndrome
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2012-04-13; Completion date: 2014-05-14
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of gefapixant (AF-219/MK-7264) in female participants with moderate to severe pain associated with interstitial cystitis/bladder pain syndrome (IC/BPS) after 4 weeks of treatment.

Detailed description:
This study is a double-blind, placebo-controlled, randomized trial designed to assess the efficacy and safety of gefapixant in female participants with moderate to severe pain associated with IC/BPS. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up.

Arms: arm 1: Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred. arm 2: Female participants receive dose matched placebo tablets, BID, orally, with food for 4 weeks.
Interventions: intervention 1: Gefapixant intervention 2: Placebo
Intervention descriptions: intervention 1: 50 or 300 mg tablets for a total daily dose of 50, 100, 150, 200, 250 or 300 mg BID, orally with food for 4 weeks intervention 2: Dose matched placebo tablets, BID, orally, with food for 4 weeks

Protocol documents:
Clinical trial NCT01917916
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-08-05; Completion date: 2014-05-14
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: BI 655064
Intervention descriptions: intervention 1: Solution for subcutaneous (s.c.) injection. intervention 2: Solution for subcutaneous (s.c.) injection.

Protocol documents:
Clinical trial NCT01999322
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2013-11-19; Completion date: 2014-05-14
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.

Detailed description:

Arms: arm 1: The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period arm 2: The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period
Interventions: intervention 1: Faster-acting insulin aspart intervention 2: insulin aspart
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin). Dose individually adjusted. intervention 2: Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Protocol documents:
Clinical trial NCT00723125
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: William Sikov MD
Start date: 2008-09-01; Completion date: 2014-05-15
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.

Detailed description:
See above brief summary

Arms: arm 1: Avastin 10 mg/kg IV over 90 minutes day -14

Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10

Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2\* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles

Definitive surgery

Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks arm 2: Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7

Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7

Definitive surgery

Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2\* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
Interventions: intervention 1: Abraxane intervention 2: Carboplatin intervention 3: Avastin
Intervention descriptions: intervention 1: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks intervention 2: Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10 intervention 3: Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)

Protocol documents:
Clinical trial NCT01348347
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2011-04-25; Completion date: 2014-05-15
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label phase I dose escalation trial, 1230.15, is the first trial with Volasertib in Japanese advanced cancer patients. The trial will investigate the maximum tolerated dose (MTD), safety, tolerability, and preliminary efficacy of this specific polo-like kinase 1 (Plk1) inhibitor in advanced cancer patients.

Detailed description:

Arms: arm 1: Patient to receive low, middle and high doses of Volasertib IV
Interventions: intervention 1: Volasertib, low dose, d1q3w intervention 2: Volasertib, middle dose, d1q3w intervention 3: Volasertib, high dose, d1q3w
Intervention descriptions: intervention 1: Patient to receive low dose of Volasertib IV intervention 2: Patient to receive middle dose of Volasertib IV intervention 3: Patient to receive high dose of Volasertib IV

Protocol documents:
Clinical trial NCT01849289
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-06-02; Completion date: 2014-05-15
Enrollment: 833 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Insulin Degludec intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency. intervention 2: Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Protocol documents: