ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01851720
Conditions: Headaches Associated With Subarachnoid Hemorrhage (SAH)
Sponsor: Johns Hopkins University
Start date: 2012-07-01; Completion date: 2014-09-15
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. Most critically, all narcotics can result in respiratory depression and sedation. For patients who present without neurological defects but debilitating pain, management is particularly challenging. The sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. Pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. In order to control the pain associated with SAH headaches, the use of narcotics is often required despite the risks. This standard therapy involves an IV bolus dose delivered by the provider regularly as needed for pain control. A common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that this approach to pain relief for SAH headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment.

Detailed description:

Arms: arm 1: * IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain
* (Bolus dose can be titrated up in 25 mcg increments if necessary)
* Maximum dose of 100 mcg/hr arm 2: * Initially: 10 mcg demand dose every 12 minutes
* No initial bolus and no continuous infusion
* Demand dose increased 10 mcg every 12 minutes if necessary
* Maximum dose of 100 mcg/hr
Interventions: intervention 1: Low dose fentanyl PCA intervention 2: Standard IV fentanyl bolus
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00202878
Conditions: Hypercholesterolemia Myocardial Infarction
Keywords: hypercholesterolemia myocardial infarction cholesterol randomized controlled trials acute coronary syndrome angina
Sponsor: Organon and Co
Start date: 2005-10-17; Completion date: 2014-09-18
Enrollment: 18144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.

Detailed description:

Arms: arm 1: One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day. arm 2: One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
Interventions: intervention 1: ezetimibe/simvastatin intervention 2: simvastatin intervention 3: Placebo for simvastatin 40 mg intervention 4: Placebo for ezetimibe 10 mg/simvastatin 40 mg combination
Intervention descriptions: intervention 1: Ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). intervention 2: Simvastatin 40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). intervention 3: one or two tablets orally daily intervention 4: one tablet orally daily.

Protocol documents:
Clinical trial NCT01502631
Conditions: Acute Spinal Cord Injury
Keywords: ASCI SUN13837 Acute traumatic cervical spinal cord injury
Sponsor: Daiichi Sankyo
Start date: 2012-08-08; Completion date: 2014-09-21
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to gather scientific information about the effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive substance) in participants with acute spinal cord injury.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SUN13837 injection intervention 2: Placebo
Intervention descriptions: intervention 1: SUN13837 injection, injection 1 x daily for 28 doses intervention 2: Matching placebo, volume equivalent to injection 1 x daily for 28 doses

Protocol documents:
Clinical trial NCT00545688
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-06-26; Completion date: 2014-09-22
Enrollment: 417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Herceptin intervention 2: Docetaxel intervention 3: Pertuzumab
Intervention descriptions: intervention 1: 8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly intervention 2: 75mg/m2 iv escalating to 100mg/m2 iv 3-weekly intervention 3: 840mg iv loading dose, followed by 420mg iv 3-weekly

Protocol documents:
Clinical trial NCT01826448
Conditions: V600-mutated BRAF Unresectable Melanoma V600-mutated BRAF Metastatic Melanoma Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
Sponsor: Daiichi Sankyo
Start date: 2013-11-05; Completion date: 2014-09-22
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.

Detailed description:

Arms: arm 1: Patients will take PLX3397 and vemurafenib at the recommended phase 2 dose. This will be determined by the tolerability and safety of these drugs in the previous 3 cohorts. arm 2: Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib arm 3: Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib arm 4: Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib
Interventions: intervention 1: PLX3397 intervention 2: vemurafenib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02121847
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2014-04-03; Completion date: 2014-09-23
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.

Detailed description:

Arms: arm 1: Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
Interventions: intervention 1: cyclosporine 0.05% ophthalmic emulsion intervention 2: carboxymethylcellulose-based lubricant eye drops
Intervention descriptions: intervention 1: Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months. intervention 2: Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Protocol documents:
Clinical trial NCT01369498
Conditions: Myelofibrosis
Keywords: Hematology Myelofibrosis Thrombocythemia Myelofibrosis Bone Marrow Diseases Hematologic Diseases Blood Diseases Leukemia Blood Disorders
Sponsor: Gilead Sciences
Start date: 2011-06-30; Completion date: 2014-09-24
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF).

The study is designed as a two-stage trial. In the stage 1, participants will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, participants on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.

Detailed description:

Arms: arm 1: Participants in Stage 1 of study will receive simtuzumab 200 mg for up to 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician. arm 2: Participants in Stage 1 of study will receive simtuzumab 700 mg for up to 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician. arm 3: In Stage 2, participants on stable doses of ruxolitinib will receive simtuzumab 200 mg for at least 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician. arm 4: In Stage 2, participants on stable doses of ruxolitinib will receive simtuzumab 700 mg for at least 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.
Interventions: intervention 1: Simtuzumab intervention 2: Ruxolitinib
Intervention descriptions: intervention 1: Simtuzumab administered intravenously over approximately 30 minutes every 2 weeks intervention 2: In Stage 2, participants will be on a stable dose of ruxolitinib

Protocol documents:
Clinical trial NCT01563029
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2012-03-28; Completion date: 2014-09-24
Enrollment: 597 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy, parallel-group, placebo and active controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period during which time they will continue their current medications. Visit 2 will occur two weeks into the run-in period to allow a review of compliance with daily diary and run-in medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility criteria who remain uncontrolled despite baseline therapy will be stratified based on pre screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to the treatment phase of the study where they will receive one of five treatments for 12 weeks. Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of 115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be performed one week after completing study medication. All subjects must attempt spirometry measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2 and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and 7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, urinary cortisol, and vital signs.

Detailed description:

Arms: arm 1: Fluticasone Furoate 100mcg inhalation powder once daily in the evening ICS powder arm 2: Fluticasone Furoate 50mcg inhalation powder once daily in the evening ICS powder arm 3: Fluticasone Furoate 25mcg inhalation powder once daily in the evening ics powder arm 4: Fluticasone Propionate 100mcg inhalation powder twice daily ICS powder arm 5: Placebo inhalation powder once daily in the evening Placebo powder
Interventions: intervention 1: Fluticasone Furoate intervention 2: Fluticasone Propionate intervention 3: Placebo
Intervention descriptions: intervention 1: current asthma medicine intervention 2: Fluticasone propionate intervention 3: placebo

Protocol documents:
Clinical trial NCT00766116
Conditions: Acute Myeloid Leukemia
Keywords: AML
Sponsor: University of California, San Diego
Start date: 2005-07-01; Completion date: 2014-09-26
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.

Detailed description:
In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks

In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.

A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.

Arms: arm 1: 5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m\^2 5-Aza 2 days then GO at 3 mg/m\^2 arm 2: 5-Azacitidine, Gemtuzumab ozogamicin

75mg/m\^2 5-Aza for 4 days then GO at 6 mg/m\^2 arm 3: 5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2 arm 4: 5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2
Interventions: intervention 1: 5-Azacitidine intervention 2: Gemtuzumab ozogamicin
Intervention descriptions: intervention 1: Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit. intervention 2: Mylotarg given 2 times over 2 weeks

Protocol documents:
Clinical trial NCT00948935
Conditions: Biliary Cancer Cholangiocarcinoma
Keywords: Biliary Cancer Cholangiocarcinoma Panitumumab
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2009-04-01; Completion date: 2014-09-26
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.

Detailed description:

Arms: arm 1: Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
Interventions: intervention 1: Gemcitabine, Irinotecan, Panitumumab
Intervention descriptions: intervention 1: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Protocol documents:
Clinical trial NCT00922207
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2010-05-07; Completion date: 2014-09-29
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Adefovir intervention 2: Entecavir intervention 3: Placebo intervention 4: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: From week -4 to week 2 intervention 2: From week -4 to week 2 intervention 3: From week -4 to week 2 intervention 4: 180 micrograms sc weekly, from week 1-48

Protocol documents:
Clinical trial NCT01259089
Conditions: Adenocarcinoma of the Lung Non-small Cell Lung Cancer
Keywords: Adenocarcinoma of the Lung Non-small Cell Lung Cancer
Sponsor: Northwestern University
Start date: 2011-04-27; Completion date: 2014-09-29
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hsp90 inhibitor AUY922 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of Hsp90 inhibitor AUY922 when given together with erlotinib hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer.

Detailed description:
This is a phase I, dose-escalation study of Hsp90 inhibitor AUY922 followed by a phase II study. Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: erlotinib hydrochloride intervention 2: Hsp90 inhibitor AUY922 intervention 3: laboratory biomarker analysis intervention 4: needle biopsy intervention 5: mutation analysis intervention 6: pharmacological study
Intervention descriptions: intervention 1: Given orally intervention 2: Given IV intervention 3: Correlative studies intervention 4: Undergo image-guided needle biopsy (correlative studies) intervention 5: Correlative studies intervention 6: Correlative studies

Protocol documents:
Clinical trial NCT01328756
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
Sponsor: Shire
Start date: 2011-07-07; Completion date: 2014-09-30
Enrollment: 314 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks.

A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population.

In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404.

Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lisdexamfetamine dimesylate
Intervention descriptions: intervention 1: Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years

Protocol documents:
Clinical trial NCT00785785
Conditions: Gastrointestinal Stromal Tumor (GIST)
Keywords: Unresectable GIST metastatic GIST nilotinib AMN107 imatinib STI571
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2014-10-01
Enrollment: 644 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Detailed description:

Arms: arm 1: nilotinib 400 mg twice a day arm 2: imatinib 400 mg once daily
Interventions: intervention 1: Nilotinib (AMN107) intervention 2: imatinib (STI571)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00789828
Conditions: Tuberous Sclerosis Subependymal Giant Cell Astrocytoma
Keywords: SEGA Tuberous Sclerosis Subependymal Giant Cell Astrocytoma mTOR RAD001 Mamalian Target Rapamycin Everolimus TSC
Sponsor: Novartis Pharmaceuticals
Start date: 2009-08-01; Completion date: 2014-10-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.

Detailed description:

Arms: arm 1: Everolimus was administered orally at a starting dose of 4.5mg/m\^2 daily and subsequently titrated to attain whole blood trough concentration of 5 to 15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations. arm 2: Matching Placebo administered orally.
Interventions: intervention 1: Everolimus intervention 2: Placebo
Intervention descriptions: intervention 1: Everolimus was formulated as tablets of 1.0-mg strength and was blisterpacked under aluminum foil in units of 10 tablets. intervention 2: Placebo was provided as a matching tablet and was blisterpacked under aluminum foil in units of 10.

Protocol documents: