ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01337245
Conditions: Coral Snake Bite Toxic Effect of Coral Snake Venom
Keywords: Envenomation Coral Snake Antivenom Micrurus fulvius
Sponsor: University of Arizona
Start date: 2012-05-01; Completion date: 2016-11-11
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and death from the bite of a coral snake.

Funding Source - FDA OOPD.

Detailed description:
Coral snake bites may be trivial in effect, or they may cause profound and life-threatening respiratory paralysis, depending on the severity of the envenomation. Venom toxins target the neuromuscular junction, where effects typically become apparent hours following the bite, by which time the clinical syndrome may be irreversible. Unless neurotoxicity is prevented, ventilatory paralysis may cause death or require intensive care for weeks after the bite. Prevention of paralysis, historically, has involved treating all bite victims with antivenom.

This protocol will enable the therapeutic use of a new F(ab')2 antivenom in the management of coral snake envenomation.

Following a coral snake bite, patients who meet inclusion/exclusion criteria and who provide informed consent will receive 5 vials of antivenom intravenously over no less than 30 minutes. Blood assays for venom levels and clinical assessments of neurologic status before and after treatment will be conducted and patients will be followed for 22 days for safety and survival endpoints.

The primary endpoint of this Phase 3 trial will be survival, for comparison with a historical mortality rate of 15%.

Arms: arm 1: For comparison with historical mortality rate, all patients prospectively enrolled will receive antivenom (Snake \[Micrurus\] North American immune F(ab')2 Equine) for treatment of coral snake bite.
Interventions: intervention 1: Snake (Micrurus) North American immune F(ab')2 Equine
Intervention descriptions: intervention 1: 5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.

Protocol documents:
Clinical trial NCT02063698
Conditions: Pain
Sponsor: Mayo Clinic
Start date: 2014-02-19; Completion date: 2016-11-11
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized pilot clinical trial studies whether auranofin will relieve pain following paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being studied to see if it will decrease pain following paclitaxel.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine whether one dose of auranofin given the day following administration of paclitaxel decreases pain as assessed by daily completion of the Modified Brief Pain Inventory scale for seven days.

SECONDARY OBJECTIVES:

I. Assess whether auranofin is well tolerated in this setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive auranofin orally (PO) on day 2.

ARM II: Patients receive placebo PO on day 2.

After completion of study treatment, patients are followed up at 21-28 days.

Arms: arm 1: Patients receive auranofin PO on day 2. arm 2: Patients receive placebo PO on day 2.
Interventions: intervention 1: auranofin intervention 2: placebo intervention 3: questionnaire administration
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Ancillary studies

Protocol documents:
Clinical trial NCT02134015
Conditions: Lung Cancer Non-small Cell Lung Cancer
Keywords: Carcinoma Non-Small-Cell Lung Lung Neoplasms Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Erlotinib Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action
Sponsor: Daiichi Sankyo
Start date: 2014-03-01; Completion date: 2016-11-11
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin.
2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.

Detailed description:

Arms: arm 1: Placebo infusion every 3 weeks and oral erlotinib 150 mg/day arm 2: Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
Interventions: intervention 1: Patritumab intervention 2: Erlotinib intervention 3: Placebo
Intervention descriptions: intervention 1: Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) intervention 2: Oral erlotinib 150 mg/day intervention 3: Placebo infusion every 3 weeks

Protocol documents:
Clinical trial NCT02906618
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-10-04; Completion date: 2016-11-11
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:

* How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
* How long it takes the body to remove the study drug
* The safety of LY3039478 and any side effects that might be associated with it

Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.

Detailed description:

Arms: arm 1: LY3039478 given once, orally arm 2: 13C 15N 2H-LY3039478 given once, IV
Interventions: intervention 1: LY3039478 intervention 2: 13C 15N 2H-LY3039478 IV
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered IV

Protocol documents:
Clinical trial NCT01687712
Conditions: Infertility
Keywords: IVF In vitro fertilization Controlled ovarian stimulation Follitropin AFOLIA Finox
Sponsor: Fertility Biotech AG
Start date: 2013-11-25; Completion date: 2016-11-14
Enrollment: 1100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF.

Detailed description:
Comparison of the clinical pregnancy rate in the AFOLIA group compared to the US approved Gonal-f® RFF Redi-ject group as the primary endpoint. Comparison of the number and size of follicles, the number of cycle cancellation, the hormone parameters and adverse events in the AFOLIA group compared to the Gonal-f® RFF group as secondary endpoints.

Arms: arm 1: One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU. arm 2: One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
Interventions: intervention 1: AFOLIA intervention 2: Gonal-f® RFF
Intervention descriptions: intervention 1: 225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached intervention 2: 225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached

Protocol documents:
Clinical trial NCT02346370
Conditions: Non-small Cell Lung Cancer
Keywords: Recurrent, previously treated, locally advanced or metastatic NSCLC (non small cell lung cancer)
Sponsor: Halozyme Therapeutics
Start date: 2015-02-10; Completion date: 2016-11-14
Enrollment: 16 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
A Phase 1b study for participants with Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) to participate in 1 of 2 portions of this study. The first portion is Dose Escalation in which participants are tested with PEGPH20 at various doses (1.6, 3.0, 2.2 and 2.8 micrograms/kilogram (ug/kg)) in addition to dosing with the standard dose of docetaxel (PDoc) of 75 milligrams/meter squared (mg/m\^2) once every 21-day cycle. Based on observations on the safety and tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0 ug/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 ug/kg. Up to 30 additional participants may be enrolled to test these dose levels. The second portion of Phase 1b is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in dose escalation is administered every 21 days to approximately 50 participants with high hyaluronan (HA-high) prospectively measured in their tumor tissue.

Detailed description:

Arms: arm 1: PEGylated recombinant human hyaluronidase PH20 (PEGPH20) (1.6, 3.0, or 2.2 micrograms per kilogram (ug/kg)) was administered on Day 1 of each 21-day cycle (every 3 weeks) as an intravenous (IV)-infusion over 10 minutes, approximately 1 milliliter/minute (mL/min) (a window of +2 minutes allowed, i.e., infusion could be 10 to 12 minutes). Docetaxel (75 milligrams/meter squared (mg/m\^2)) was administered on Day 2 of each 21-day cycle.
Interventions: intervention 1: PEGylated recombinant human hyaluronidase PH20 intervention 2: Docetaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02348723
Conditions: Atrial Fibrillation
Sponsor: Boehringer Ingelheim
Start date: 2015-04-28; Completion date: 2016-11-14
Enrollment: 678 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.

Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.

It is not intended to assess confirmatory hypothesis, this is an exploratory study.

Detailed description:

Arms: arm 1: Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID) arm 2: Patients receiving Warfarin to keep International Normalized Ratio (INR) between 2.0 - 3.0
Interventions: intervention 1: Warfarin intervention 2: Dabigatran Etexilate 150mg
Intervention descriptions: intervention 1: Patients receiving Warfarin to keep International Normalized Ratio (INR)between 2.0 - 3.0 intervention 2: Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)

Protocol documents:
Clinical trial NCT02462122
Conditions: Plaque Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2015-08-19; Completion date: 2016-11-14
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis

Detailed description:
A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Arms: arm 1: Lotion arm 2: Vehicle Lotion
Interventions: intervention 1: IDP-118 Lotion intervention 2: IDP-118 Vehicle Lotion
Intervention descriptions: intervention 1: Lotion intervention 2: Lotion

Protocol documents:
Clinical trial NCT02720107
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: fingolimod Biomarker Multiple sclerosis Relapsing-remitting multiple sclerosis
Sponsor: Novartis Pharmaceuticals
Start date: 2016-05-12; Completion date: 2016-11-14
Enrollment: 133 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this single visit extension study is to explore immune status in RRMS patients treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be compared to short-term changes in immune status (baseline to month 6) after treatment start with fingolimod as assessed in the original Biobank study (CFTY720DDE01).

Detailed description:

Arms: arm 1: Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm).
Interventions: intervention 1: fingolimod
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00501059
Conditions: Moderate Risk of CVD
Keywords: Primary prevention of coronary heart disease Stroke and cardiovascular death Aspirin
Sponsor: Bayer
Start date: 2007-07-05; Completion date: 2016-11-15
Enrollment: 12546 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

Detailed description:
Summary of substantial Protocol amendments

Amendment #2 from 09-APR-2008:

* Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria
* Exclusion of patients currently taking anticoagulant medication
* A longer interval between the daily dose of study drug and ibuprofen
* Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): "To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%."

Amendment #3 from 02-JAN-2009

• Increase in the number of allowed risk factors for males, age is no longer a risk factor

Amendment #4 from 02-OCT-2013

* The primary endpoint is changed to include confirmed UA and TIA.
* The estimated event rate is changed to 1.5% per year due to new information.
* Effect size (risk reduction) changed from 14.9% to 17 to 18%.
* Achieving 60,000 person-years instead of 1488 primary endpoint events
* Additional treatment and follow-up for a maximum of another 12 months.
* Change to reduced adverse event and concomitant therapy reporting

Arms: arm 1: Participants received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily. arm 2: Participants received 1 tablets of matching placebo orally once daily.
Interventions: intervention 1: Aspirin (Acetylsalicylic acid, BAYE4465) intervention 2: Placebo
Intervention descriptions: intervention 1: 100mg enteric coated Aspirin, taken daily intervention 2: Placebo, taken daily

Protocol documents:
Clinical trial NCT02586077
Conditions: Ankle Arthrodesis Hindfoot Arthrodesis Tibitalocalceal Arthrodesis
Sponsor: OrthoCarolina Research Institute, Inc.
Start date: 2014-02-01; Completion date: 2016-11-15
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.

Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.

Detailed description:

Arms: arm 1: Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Interventions: intervention 1: Exparel
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02985840
Conditions: Nausea Abdominal Pain
Keywords: ondansetron dexamethasone
Sponsor: OhioHealth
Start date: 2014-01-28; Completion date: 2016-11-15
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.

Previous studies in patients undergoing surgical procedures have shown that when IV dexamethasone is given with IV ondansetron to post-operative patients they have less nausea and vomiting than ondansetron alone, and were even found to show decreased post-operative pain associated with nausea. It has also been shown to decrease the need to re-dose antiemetic medication. Although this combination has not been tested in the emergency department it is believed by these investigators that the additional use of dexamethasone may decrease the need to use repeated doses of ondansetron.

The investigators believe this may change the way physicians currently approach the nauseated patient in regards to treatment. That rather than possibly giving multiple doses of one medication over and over to reduce a patient's nausea, physicians can give two medications together at one time. The investigators hope to demonstrate that by giving intravenous dexamethasone and ondansetron together, it may be possible to reduce the number of patients who need additional doses of nausea medication.

Detailed description:
Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.

Arms: arm 1: Ondansetron (4 mg) followed by two 5 ml normal saline flush arm 2: Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush
Interventions: intervention 1: Ondansetron intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes intervention 2: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush

Protocol documents:
Clinical trial NCT02057692
Conditions: Alagille Syndrome
Sponsor: Mirum Pharmaceuticals, Inc.
Start date: 2014-11-24; Completion date: 2016-11-16
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.

Detailed description:

Arms: arm 1: LUM001 for oral administration arm 2: Placebo administered orally once each day
Interventions: intervention 1: LUM001 intervention 2: Placebo
Intervention descriptions: intervention 1: LUM001 administered orally intervention 2: Placebo administered orally

Protocol documents: