ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01994837
Conditions: Acute Myelogenous Leukemia AML Acute Myeloid Leukemia
Keywords: GDC-0199 Acute Myelogenous Leukemia AML ABT-199 Acute Myeloid Leukemia Myeloid Leukemia
Sponsor: AbbVie
Start date: 2013-11-01; Completion date: 2014-12-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a Phase 2, open-label, multicenter study evaluating the preliminary efficacy and safety of venetoclax (ABT-199) administered orally in participants with acute myelogenous leukemia (AML).

Detailed description:
The primary objective was to evaluate the preliminary efficacy of venetoclax administered orally in participants with relapsed and/or refractory (R/R) acute myelogenous leukemia (AML) or frontline therapy in patients with AML who were unfit for intensive therapy. The secondary objective was to evaluate the preliminary safety of venetoclax administered orally in patients with AML. The first portion of the study was to consist of 19 participants with the objective of evaluating anti-tumor effects and confirming the safety of the regimen. The second portion (expansion) was to consist of 35 additional subjects to evaluate anti-tumor effects and safety and was to commence if an adequate efficacy signal (i.e., ≥ 5/19 achieved complete remission \[CR\], CR with incomplete bone marrow recovery \[CRi\] or partial remission \[PR\]) had been observed in the first portion of the study. The criterion for success would have been met if ≥ 16 of 54 participants achieved remission. The efficacy signal from first portion of the study was deemed insufficient for enrollment into the second portion of the study, as 4 of the 19 subjects achieved CR/CRi. During the trial, a number of participants were in screening at the point of the interim analysis. Given the early signs of clinical activity of venetoclax, disease severity, and prognosis of these participants without available options for therapy, they were allowed to initiate treatment ahead of completion of the interim analysis. Therefore, 32 participants were enrolled. No additional participants were screened or treated after the interim analysis was completed.

Arms: arm 1: Continuous dosing of venetoclax (ABT-199) QD (once daily) beginning with dose-escalation on Week 1 Day 1. Participants received a dose of 20 mg of ABT-199 on Week 1 Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5, 800 mg on Day 6 and QD thereafter.
Interventions: intervention 1: ABT-199
Intervention descriptions: intervention 1: Tablet

Protocol documents:
Clinical trial NCT02000531
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small-cell lung cancer (NSCLC)
Sponsor: Hoffmann-La Roche
Start date: 2014-01-01; Completion date: 2014-12-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).

Detailed description:

Arms: arm 1: Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment arm 2: Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Interventions: intervention 1: Erlotinib intervention 2: Chemotherapy
Intervention descriptions: intervention 1: 150 mg oral dose of erlotinib given once daily intervention 2: Cisplatin (75 mg/m\^2 intravenously \[IV\]) on Day 1 and gemcitabine (1250 mg/m\^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)

Protocol documents:
Clinical trial NCT02002936
Conditions: Myelodysplastic Syndrome
Sponsor: SymBio Pharmaceuticals
Start date: 2013-08-01; Completion date: 2014-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an extension study to investigate long term safety and efficacy of SyB C-1101 when orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who have completed 6 cycles in the study 2012002 whose purpose is to investigate tolerability of SyB C-1101 when administered orally in patients with recurrent/relapsed or refractory myelodysplastic syndrome.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SyB C-1101
Intervention descriptions: intervention 1: SyB C-1101（rigosertib sodium） will be administered orally twice daily for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days (14 days of administration + 7 days of observation) constitutes 1 cycle.

The dose at cycle 6 in the study 2012002 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 7).

From cycle 8 on, the dose of SyB C-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle.

Protocol documents:
Clinical trial NCT02010632
Conditions: Pharmacodynamics
Keywords: Clopidogrel Platelet inhibition Platelet aggregation
Sponsor: Khon Kaen University
Start date: 2013-08-01; Completion date: 2014-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid metabolite between generic and reference clopidogrel products in Thai healthy volunteers

Detailed description:
Platelet aggregation (ex vivo) were measured by using Whole blood impedence aggregometry (Chrono-log®) and VerifyNow® P2Y12 assay. Plasma concentration of clopidogrel carboxylic acid metabolite were measured by High performance liquid chromatography (HPLC).

Arms: arm 1: Apolets® 75 mg tablet arm 2: Plavix® 75mg tablet
Interventions: intervention 1: Generic clopidogrel product Apolets® intervention 2: Original clopidogrel product Plavix®
Intervention descriptions: intervention 1: * Clopidogrel 75 mg once daily for 7 days
* Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 intervention 2: * Clopidogrel 75 mg once daily for 7 days
* Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Protocol documents:
Clinical trial NCT02015663
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis CF
Sponsor: Novartis Pharmaceuticals
Start date: 2014-01-01; Completion date: 2014-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis.

Detailed description:

Arms: arm 1: Tobramycin Inhalation Powder (112 mg) once daily during 168 days arm 2: Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
Interventions: intervention 1: Tobramycin Inhalation Powder
Intervention descriptions: intervention 1: Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm

Protocol documents:
Clinical trial NCT02023164
Conditions: Acute Urticaria
Keywords: urticaria allergic reaction cetirizine JDP-205
Sponsor: JDP Therapeutics, Inc.
Start date: 2013-07-01; Completion date: 2014-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.

Detailed description:
Multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics. This study will be conducted in 33 patient who either present themselves to the hospital emergency department, allergy clinic or urgent care centers with acute urticaria or developed acute urticaria following a allergen challenge at an allergy clinic.

Following informed consent, eligibility will be established, capturing baseline data including vitals, age, medical history, and medications taken prior to coming to the clinical study site. Following data collection, study subjects will be randomized in a 1:1 ratio to receive study drug of either cetirizine 10 mg IV or diphenhydramine, 50 mg IV. Baseline data including vital signs, the extent of urticaria and erythema, the severity of pruritus, and the level of sedation will be recorded prior to and at 1 hour and 2 hours post study drug administration, and at the time of "Readiness for Discharge". The actual time at which the investigator determines that the subject is ready for discharge (physically and mentally fit) from the study site will also be recorded. At these same time intervals, subjects will be asked to self-rate (recorded by study staff) severity of their pruritus and level of sedation (recorded by study staff).

Twenty-four hours following discharge from the study site, study staff will call the subject to ask them a few short questions to follow-up on the treatment of their acute urticaria. All adverse and serious adverse events experienced by the subjects following informed consent, and all data captured will be recorded in the source documents and/or case report forms.

Arms: arm 1: JDP-205 Injection, 10 mg/mL, 1 mL arm 2: Diphenhydramine Injection, 50 mg/mL, 1 mL
Interventions: intervention 1: JDP-205 Injection intervention 2: Diphenhydramine
Intervention descriptions: intervention 1: Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes intervention 2: Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of \~2 minutes

Protocol documents:
Clinical trial NCT02031640
Conditions: Asthma
Keywords: asthma breath-actuated inhaler metered-dose inhaler
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-12-01; Completion date: 2014-12-01
Enrollment: 1113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.

Detailed description:

Arms: arm 1: Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily. arm 2: Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily. arm 3: Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. arm 4: Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. arm 5: Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Interventions: intervention 1: Beclomethasone dipropionate intervention 2: Placebo intervention 3: Albuterol/salbutamol
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.

Protocol documents:
Clinical trial NCT02032901
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2014-01-01; Completion date: 2014-12-01
Enrollment: 173 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection

Detailed description:

Arms: arm 1: Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks arm 2: Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Interventions: intervention 1: Daclatasvir intervention 2: Sofosbuvir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02037347
Conditions: Toxic Epidermal Necrolysis Stevens-Johnson Syndrome
Sponsor: Brett King
Start date: 2010-10-01; Completion date: 2014-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.

Detailed description:

Arms: arm 1: Palifermin 60 micrograms/kg/day IV for 3 consecutive days
Interventions: intervention 1: Palifermin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02041195
Conditions: Overweight and Obesity
Keywords: Overweight
Sponsor: Rhythm Pharmaceuticals, Inc.
Start date: 2014-01-01; Completion date: 2014-12-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK) profile. The study is designed to evaluate the efficacy and tolerability of setmelanotide administered once or twice daily. The study drug (setmelanotide and placebo) will be administered in a blinded fashion.

Detailed description:

Arms: arm 1: Once daily in the morning, equivalent placebo in evening. arm 2: Split dose, one half in the morning and one half in the evening. arm 3: Placebo in the morning, placebo in the evening.
Interventions: intervention 1: Setmelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02069184
Conditions: Post-operative Pain
Keywords: opioid usage requirements pain IV acetaminophen opioid usage c-section
Sponsor: Montefiore Medical Center
Start date: 2013-11-01; Completion date: 2014-12-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.

Detailed description:
Most of the opioids used are centrally acting drugs like morphine or its derivatives. The most common adverse reactions related to systemic administration of opioids are sedation, itching, constipation and less commonly, respiratory depression. One of the other management strategies for the pain control is the use of non-steroidal anti-inflammatory drugs (NSAIDS). Frequent use of NSAIDS is also associated with complications, such as gastric ulcer and platelet dysfunction. When compared to other non-NSAIDS, IV acetaminophen is a relatively safer drug with quicker onset of action. In an earlier conducted study, the onset of action of analgesia for a bolus dose of IV acetaminophen is 3 minutes. IV acetaminophen is FDA approved for management of mild to moderate pain. An adverse reaction associated with the prolonged usage of IV acetaminophen is hepatic injury. The most common adverse events encountered during previous clinical trials were nausea, vomiting, headache and insomnia.

Arms: arm 1: IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. arm 2: IV form, total 4 units, each given every 6th hourly in 24 hours.
Interventions: intervention 1: IV Acetaminophen intervention 2: Saline as placebo
Intervention descriptions: intervention 1: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly intervention 2: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.

Protocol documents:
Clinical trial NCT02083783
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Tris Pharma, Inc.
Start date: 2014-03-01; Completion date: 2014-12-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether TRI102 is effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.

Detailed description:
A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is taken once daily and subjects undergo dose optimization activities for 5 weeks.

Arms: arm 1: Active, amphetamine extended-release oral suspension arm 2: Placebo
Interventions: intervention 1: TRI102 intervention 2: Placebo
Intervention descriptions: intervention 1: formulation containing active moiety (amphetamine) intervention 2: formulation without active moiety

Protocol documents:
Clinical trial NCT02094716
Conditions: Scabies
Keywords: Sarcoptes Scabiei Scabies ectoparasite parasite infestation Renaissance
Sponsor: Mylan Inc.
Start date: 2014-04-01; Completion date: 2014-12-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.

Detailed description:
It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.

Arms: arm 1: First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. arm 2: First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. arm 3: First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary. arm 4: First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.
Interventions: intervention 1: Permethrin Foam 4% intervention 2: Permethrin Foam 5% intervention 3: Vehicle Foam
Intervention descriptions: intervention 1: Topical application, whole-body treatment intervention 2: Topical application, whole-body treatment intervention 3: Topical application, whole-body treatment

Protocol documents:
Clinical trial NCT02096718
Conditions: Renal Insufficiency
Sponsor: Boehringer Ingelheim
Start date: 2014-05-01; Completion date: 2014-12-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal function.

The assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.

Detailed description:

Arms: arm 1: Single Dose Afatinib in moderate renal impaired subjects arm 2: Single Dose Afatinib in severe renal impaired subjects arm 3: Single Dose Afatinib in healthy subjects matched by gender, race, age and BMI to moderate and severe renal impaired subjects
Interventions: intervention 1: Afatinib healthy intervention 2: Afatinib severe renally impaired intervention 3: Afatinib moderate renally impaired
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02097719
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2014-05-01; Completion date: 2014-12-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Detailed description:

Arms: arm 1: Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. arm 2: Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Interventions: intervention 1: bimatoprost 0.01% intervention 2: travoprost 0.004% intervention 3: timolol 0.5% intervention 4: hypromellose 0.3%
Intervention descriptions: intervention 1: Bimatoprost 0.01% administered to both eyes once daily for 12 weeks. intervention 2: Travoprost 0.004% administered to both eyes once daily for 12 weeks. intervention 3: Timolol 0.5% administered to both eyes once daily for 12 weeks. intervention 4: Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Protocol documents:
Clinical trial NCT02100839
Conditions: Hypercholesterolemia Hyperlipoproteinemia Type II
Keywords: hypercholesterolemia apolipoprotein E First in Human Apolipoprotein E (ApoE) Apolipoprotein E Mimetic (AEM)
Sponsor: LipimetiX Development, LLC
Start date: 2014-03-01; Completion date: 2014-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated.

The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia.

AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia.

Detailed description:

Arms: arm 1: Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL

Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg. arm 2: Single Ascending Dose: Single IV dose for each cohort.

Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Interventions: intervention 1: AEM-28 intervention 2: Normal Saline
Intervention descriptions: intervention 1: Solution for injection intervention 2: 0.9% saline for injection

Protocol documents: