ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01882985
Conditions: Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer
Keywords: docetaxel lycopene prostate cancer
Sponsor: University of California, Irvine
Start date: 2010-12-01; Completion date: 2016-10-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial evaluated the impact of giving docetaxel together with lycopene supplements in treating patients with hormone-resistant prostate cancer not previously treated with chemotherapy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprevention is the use of certain drugs, such as lycopene, to keep cancer from forming. Giving docetaxel together with lycopene may be an effective treatment for prostate cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. (\>50% reduction from baseline) in subjects treated with a combination of docetaxel and lycopene.

SECONDARY OBJECTIVES:

I.To determine the objective response rate (ORR) according to modified RECIST criteria in patients with measurable disease, following treatment with docetaxel and lycopene.

II. To define the time to PSA progression, according to the response criteria of Scher, et al., in subjects treated with docetaxel and lycopene.

III. To determine the safety and tolerability of lycopene in combination with docetaxel.

IV. To determine the effects of docetaxel + lycopene therapy on the functioning of the IGFR-I, selected biomarkers, and docetaxel blood levels in plasma and peripheral blood mononuclear cells (correlative studies).

OUTLINE:

Patients receive 75 mg/m2 docetaxel intravenously (IV) over 1 hour q 21 days and lycopene 30 mg capsules orally (PO) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Docetaxel intervention 2: Lycopene
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO

Protocol documents:
Clinical trial NCT01884688
Conditions: Asymptomatic Multiple Myeloma
Keywords: Asymptomatic Multiple Myeloma Auto-ENK Cell Therapy Natural Killer Cells
Sponsor: University of Arkansas
Start date: 2013-04-01; Completion date: 2016-10-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and in vivo persistence and expansion of autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.

Detailed description:
To determine whether significant in vivo expansion of auto-ENK cells occurs, defined as a \> 4 fold increase in absolute cluster of differentiation 3(CD3)-cluster of differentiation 56 (CD56+) NK cell count/blood 7 days after infusion over the pre-study baseline level and the safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple myeloma (AMM) defined as gene expression profile (GEP) 70 gene score\>-0.26.

Arms: arm 1: Expanded Natural Killer Cell Infusion
Interventions: intervention 1: ENK Cell Infusion
Intervention descriptions: intervention 1: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU

Protocol documents:
Clinical trial NCT01968031
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's disease Moderate to Severe Parkinson's Disease
Sponsor: Kyowa Kirin Co., Ltd.
Start date: 2013-10-01; Completion date: 2016-10-01
Enrollment: 613 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.

Detailed description:

Arms: arm 1: Istradefylline 20 mg and placebo to match istradefylline 40 mg:

A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. arm 2: Istradefylline 40 mg and placebo to match istradefylline 20 mg:

A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. arm 3: Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:

A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Interventions: intervention 1: Istradefylline 40 mg intervention 2: Istradefylline 20 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Istradefylline 40 mg and placebo intervention 2: Istradefylline 20 mg and placebo intervention 3: Placebo

Protocol documents:
Clinical trial NCT01974752
Conditions: Metastatic Uveal Melanoma
Keywords: uveal melanoma
Sponsor: AstraZeneca
Start date: 2014-04-01; Completion date: 2016-10-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Selumetinib therapy in patients with metastatic uveal melanoma.

Detailed description:
A randomised double-blind study to assess the efficacy of selumetinib (AZD6244, Hyd-Sulfate) in combination with Dacarbazine compared with placebo in combination with Dacarbazine as first systemic therapy in patients with metastatic uveal melanoma (SUMIT)

Arms: arm 1: selumetinib 75mg twice daily in combination with dacarbazine. arm 2: placebo twice daily in combination with dacarbazine.
Interventions: intervention 1: 75mg selumetinib intervention 2: placebo intervention 3: Dacarbazine
Intervention descriptions: intervention 1: selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle. intervention 2: placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle. intervention 3: dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.

Protocol documents:
Clinical trial NCT01979276
Conditions: Multiple Myeloma
Sponsor: Weill Medical College of Cornell University
Start date: 2013-11-01; Completion date: 2016-10-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is for subjects with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory). The study is in two parts, Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the effectiveness of combining romidepsin with pomalidomide and dexamethasone. The hypothesis is that overall response in a cohort of patients treated with romidepsin + pomalidomide + dexamethasone will be 60 percent.

Detailed description:
This phase I/II study is a treatment program for patients with relapsed or refractory multiple myeloma. Up to 48 patients will be enrolled. Phase I will follow a 3+3 dose escalation design to find the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone.

In Phase I, subjects will receive:

* Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
* Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
* Romidepsin intravenously (9 mg/m2, 12 mg/m2, 15 mg/m2 or 18 mg/m2) on days 1 and 15 of a 28-day cycle.

Phase II will expand the number of subjects in the MTD arm of the trial until 48 subjects are enrolled. In Phase II, subjects subjects will receive:

* Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
* Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
* Romidepsin intravenously on days 1 and 15 of a 28-day cycle at the Maximum Tolerated Dose determined by Phase I

Arms: arm 1: Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined Dexamethasone
Interventions: intervention 1: Romidepsin intervention 2: pomalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Romidepsin intravenously on days 1 and 15 of a 28-day cycle intervention 2: Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle intervention 3: Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle

Protocol documents:
Clinical trial NCT02023866
Conditions: Inherited Mitochondrial Disease, Including Leigh Syndrome
Keywords: Leigh Syndrome Leber's hereditary optic neuropathy myoclonic epilepsy mitochondrial encephalomyopathy Kearn-Sayre syndrome POLG-related disorders Neurogastrointestinal encephalopathy
Sponsor: Amgen
Start date: 2014-05-01; Completion date: 2016-10-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) administered at a target maintenance dose of 1.3 g/m²/day in two divided doses, every 12 hours, for up to 6 months in patients with inherited mitochondrial disease.

Detailed description:
This is an open-label, dose-escalation study to assess the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of cysteamine bitartrate delayed-release capsules (RP103) for treatment of children with inherited mitochondrial disease.

Prior to treatment, patients will undergo a Screening Visit. If eligible, each participant will return for the Day 1 study visit and begin dosing. Every 2 weeks over the subsequent 8 weeks, participants will alternate between returning to the clinic for detailed assessments (Weeks 4 and 8) and receiving a telephone call from the Investigator team to assess safety and RP103 dose (Weeks 2 and 6) and the potential need for an immediate unscheduled study visit. Thereafter, participants will continue to return to the clinic every 4 weeks for detailed assessments at Weeks 12, 16, 20, and 24 (the Study Exit visit).

The Study Exit visit will occur at Week 24, and participants will be offered the opportunity to continue on to an extension study (RP103-MITO-002 \[NCT02473445\]) until results of the present study are known.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Cysteamine bitartrate delayed-release capsules were administered twice daily following a dose-escalation design with a progressive weekly dose increase over the first 6 weeks. The starting dose was 0.2 g/m²/day, up to a maximum dose of 1.3 g/m²/day. Participants remained on their highest tolerated dose until Week 24.
Interventions: intervention 1: Cysteamine Bitartrate
Intervention descriptions: intervention 1: Cysteamine Bitartrate Delayed-release capsules

Protocol documents:
Clinical trial NCT02025751
Conditions: Diabetic Gastroparesis
Keywords: Diabetes Gastroparesis Delayed gastric emptying Nausea Vomiting Bloating Abdominal pain Early Satiety Gastric stasis Gastropathy
Sponsor: Evoke Pharma
Start date: 2014-04-01; Completion date: 2016-10-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.

Detailed description:
Diabetic men with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.

Arms: arm 1: Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks arm 2: Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Interventions: intervention 1: Metoclopramide Nasal Spray intervention 2: Placebo Nasal Spray
Intervention descriptions: intervention 1: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) intervention 2: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)

Protocol documents:
Clinical trial NCT02028325
Conditions: Adult Intracranial Neoplasm Vascular: Intracranial
Sponsor: Indiana University
Start date: 2013-12-01; Completion date: 2016-10-01
Enrollment: 136 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.

Detailed description:
The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions. The objectives of this study aim to investigate the use of Fluorescein in assisting with evaluating complete tumor removal and thorough treatment of intracranial vascular lesions as well as tumor biopsy procedures. The hypothesis is that Fluorescein Sodium will help surgeons better identify residual tumor and vascular lesions and its use will allow surgeons to obtain better surgical results and prognostic outcomes.

Arms: arm 1: All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
Interventions: intervention 1: Fluorescein Sodium
Intervention descriptions: intervention 1: All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

Protocol documents:
Clinical trial NCT02046369
Conditions: Bipolar I Depression
Keywords: Lurasidone, Latuda, Bipolar Depression
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2014-03-01; Completion date: 2016-10-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression

Detailed description:
This is a randomized, parallel, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of flexibly dosed lurasidone (20 - 80 mg/day) for 6 weeks compared with placebo in children and adolescent subjects with depression associated with Bipolar I Disorder (bipolar depression).

Arms: arm 1: Luradisone 20- 80 mg administered once daily arm 2: Placebo administered once daily
Interventions: intervention 1: Lurasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Lurasidone flexibly dosed 20-80 mg once daily intervention 2: Placebo Comparator once daily

Protocol documents:
Clinical trial NCT02055872
Conditions: Edema Hypoproteinemia
Keywords: Edema Hypoproteinemia Albumin Diuresis Critical illness
Sponsor: Hamilton Health Sciences Corporation
Start date: 2014-09-01; Completion date: 2016-10-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Critically ill patients usually require intravenous fluids to correct low blood pressure and improve blood flow to vital organs. However, once the patient's blood pressure has improved, these fluids can leak out into various organs, including the lung, kidneys, and skin. Excess fluid in these tissues, called edema, has been associated with longer ICU stays and higher mortality. Thus removing excess fluid is an important goal. The simplest way to treat edema is to use diuretics, such as furosemide, which increase urine output.

To further improve urine output, patients are sometimes given albumin, a protein which helps to suck fluid out from the tissues, and keep it in the blood vessel, where it can be filtered in the kidney and removed in the urine. Although albumin is often used for this purpose, there is little evidence to support it. A large randomized controlled trial is needed to determine if albumin plus furosemide is truly more effective than furosemide alone in critically ill patients with low levels of blood albumin. We will perform a pilot study to assess the feasibility of such a trial.

Detailed description:

Arms: arm 1: Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments) arm 2: Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments)
Interventions: intervention 1: Intravenous albumin intervention 2: Normal saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02104583
Conditions: Ventricular Arrhythmia
Keywords: VT VF Ventricular Tachycardia Ventricular Fibrillation shock ATP
Sponsor: Gilead Sciences
Start date: 2014-09-01; Completion date: 2016-10-01
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing \[ATP\] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).

Detailed description:

Arms: arm 1: Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months. arm 2: Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months. arm 3: Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
Interventions: intervention 1: Eleclazine intervention 2: Placebo to match eleclazine
Intervention descriptions: intervention 1: Eleclazine tablets administered orally intervention 2: Placebo to match eleclazine tablets administered orally

Protocol documents:
Clinical trial NCT02113436
Conditions: Asthma
Keywords: FP/SLM Asthma Infant Efficacy Safety
Sponsor: GlaxoSmithKline
Start date: 2014-05-01; Completion date: 2016-10-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period. The study is designed to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg one or two BID for 16 weeks.

The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in period. The subjects who meet the eligibility criteria for randomization will be stratified according to their age (\<2 or \>=2 year-old) at Visit 1 and randomized to one of the two treatment groups.

The total duration of participation in the study will be 10 weeks for a comparison period completion and 27 weeks for a completion.

Detailed description:

Arms: arm 1: Subject will receive 1 or 2 inhalation of SLM 25mcg plus FP 50mcg twice daily in the first treatment period for 8 weeks and will continue to receive SLM 25mcg plus FP 50mcg one or two inhalation twice daily for 16 weeks in the second treatment period. arm 2: Subject will receive 1 or 2 inhalation of FP 50mcg twice daily in the first treatment period for 8 weeks and will receive SLM 25mcg plus FP 50mcg one or two inhalation twice daily for 16 weeks in the second treatment period.
Interventions: intervention 1: FP/ SLM HFA MDI 50/25 mcg intervention 2: FP HFA MDI 50 mcg
Intervention descriptions: intervention 1: Metered-dose aerosol product containing 50 mcg of fluticasone propionate and 25 mcg of salmeterol per inhalation intervention 2: Metered-dose aerosol product containing 50 mcg of fluticasone propionate per inhalation

Protocol documents:
Clinical trial NCT02119663
Conditions: Pancreatic Cancer
Keywords: Metastatic pancreatic cancer
Sponsor: Incyte Corporation
Start date: 2014-06-01; Completion date: 2016-10-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.

Detailed description:
This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 270 participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were to be randomized (1:1) to one of the following treatment groups:

* Treatment A (N = 135): Capecitabine + ruxolitinib
* Treatment B (N = 135): Capecitabine + placebo

Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered during the entire cycle. Treatment for all participants was to continue as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued treatment continued to be followed for subsequent anticancer treatments and survival.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ruxolitinib intervention 2: Placebo intervention 3: Capecitabine
Intervention descriptions: intervention 1: 5 mg tablets to be administered by mouth twice daily (BID) intervention 2: 5 mg matching placebo tablets to be administered by mouth twice daily (BID) intervention 3: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID)

Protocol documents: