ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01762982
Conditions: Wound Healing
Sponsor: GlaxoSmithKline
Start date: 2012-02-01; Completion date: 2012-02-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to evaluate the irritation potential of benzalkonium chloride disinfectant spray when placed in contact with normal human skin.

Detailed description:
Benzalkonium chloride is recognized as safe and effective for short term use as first aid antiseptic drug products. In this study, benzalkonium chloride disinfectant spray will be compared to a positive control, and two negative control for irritancy potential on normal skin according to Chinese Patch Test Guideline (China Health Authority 2002). The skin irritation assessment will characterize the test products individually in terms of symptomatology using a 5-point categorical scale ranging from 0 (no visible reaction) to 4 (Erythema,edema˛ extreme blistering).

Arms: arm 1: Benzalkonium chloride (0.13%) Disinfectant Spray water arm 2: Sodium lauryl sulfate (SLS) (0.3% weight by weight \[w/w\]) water solution arm 3: Normal saline water (0.9% weight by volume \[w/v\]) arm 4: Empty Finn Chamber
Interventions: intervention 1: 0.13% Benzalkonium Chloride intervention 2: SLS Solution intervention 3: Normal Saline Water intervention 4: Empty Finn Chamber
Intervention descriptions: intervention 1: Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution intervention 2: Finn Chamber filled with SLS (0.3% w/v) water solution intervention 3: Finn Chamber filled with Normal Saline water (0.9% w/v) intervention 4: Empty Finn Chamber

Protocol documents:
Clinical trial NCT01777763
Conditions: Fungal Infections
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-06-01; Completion date: 2012-02-01
Enrollment: 230 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to collect pharmacokinetic (PK) information related to how well posaconazole tablet is distributed in the body and to determine the safety of this new formulation. The study consists of a Phase 1B study that includes participants with neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant (HSCT).

Detailed description:
Participants with a blood disease or cancer that can affect their infection-fighting white blood cells and those who have undergone a hematopoietic stem cell transplant (HSCT) and are receiving immunosuppressive therapy and have or are at risk of graft-vs-host disease (GVHD) are eligible for the study. These blood diseases and their treatments can weaken the immune system and may put individuals at high risk for a serious fungal infection of their internal organs or blood (invasive fungal infection). As these infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection.

Enrollment into this study will take place in several stages (parts). The determination of which part a participant will be in is based on which part is open at the site at the time of enrollment.

Arms: arm 1: Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days arm 2: Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
Interventions: intervention 1: Posaconazole 200 mg intervention 2: Posaconazole 300 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00838565
Conditions: Rheumatoid Arthritis
Keywords: Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921
Sponsor: Pfizer
Start date: 2009-05-20; Completion date: 2012-02-02
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Blood tests will be performed to measure the amount of drug and changes in measures of inflammation.

Detailed description:
Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: dose level 1 intervention 3: dose level 2 intervention 4: dose level 3 intervention 5: dose level 4
Intervention descriptions: intervention 1: intravenous infusion on three consecutive months intervention 2: intravenous infusion on three consecutive months intervention 3: intravenous infusion on three consecutive months intervention 4: intravenous infusion on three consecutive months intervention 5: intravenous infusion on 3 consecutive months

Protocol documents:
Clinical trial NCT03035955
Conditions: Rosacea
Keywords: Rosacea Wake Forest Demodex Finacea Gel
Sponsor: Wake Forest University
Start date: 2010-12-01; Completion date: 2012-02-02
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum counts and disease condition via a split face design in approximately twenty patients with mild to moderate rosacea. The investigators hypothesize that treatment of rosacea with azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement in lesion count and redness.

Detailed description:
This is a split face, randomized, single blind, single center study. Male and female (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular facial rosacea, with bilateral facial involvement, and no more than two nodules will be enrolled. Subjects will be randomized 1:1 by the study coordinator using a standard randomization table to receive azelaic acid twice daily on either the left side or the right side of the face and no treatment on the other side of the face. Subjects must have a positive Demodex folliculorum standardized skin surface biopsy, defined at \>5 mites cm at Screening/Baseline on at least one of two different SSSB specimens on bilateral sides of the face. The SSSB test location will ideally be on the cheek, but may be done in the most disease involved area. Subjects will be seen at Screening/Baseline, Week 1 and Week 4. Standard topical washout periods will be observed. At each visit, rosacea will be evaluated by lesion count, IGA and two Demodex SSSB tests done on each side of the face. Safety will be monitored at each visit using the Investigator Skin Irritation Assessment.

Arms: arm 1: azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face arm 2: no treatment on the other side of the face
Interventions: intervention 1: Azelaic acid
Intervention descriptions: intervention 1: 15% gel twice daily for four weeks to one side of face

Protocol documents:
Clinical trial NCT00545129
Conditions: Neoplasm Metastasis Palliative Care
Sponsor: Pfizer
Start date: 2009-04-29; Completion date: 2012-02-07
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

Detailed description:

Arms: arm 1: None arm 2: Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
Interventions: intervention 1: Tanezumab 10 mg IV intervention 2: IV Placebo for tanezumab
Intervention descriptions: intervention 1: Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen. intervention 2: Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.

Protocol documents:
Clinical trial NCT01307046
Conditions: Hypertension
Keywords: Essential hypertension Uncontrolled hypertension Antihypertensive agents Blood pressure
Sponsor: Organon and Co
Start date: 2011-03-29; Completion date: 2012-02-07
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.

Detailed description:

Arms: arm 1: Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks. arm 2: Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Interventions: intervention 1: MK-0954A intervention 2: Losartan intervention 3: Placebo to MK-0954A intervention 4: Placebo to losartan 100 mg intervention 5: Placebo to losartan 50 mg
Intervention descriptions: intervention 1: Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily intervention 2: Tablet containing losartan potassium (100 mg), once daily intervention 3: Placebo tablet to match MK-0954A, once daily intervention 4: Placebo tablet to match losartan 100 mg, once daily intervention 5: Placebo tablet to match losartan 50 mg, once daily

Protocol documents:
Clinical trial NCT01226797
Conditions: Hepatitis C, Chronic
Keywords: Chronic HCV infection raised ALT transaminitis HCV infection
Sponsor: Pfizer
Start date: 2011-01-17; Completion date: 2012-02-09
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus infection and abnormal liver enzymes.

Detailed description:
Study recruitment was stopped on Dec 15, 2011 due to difficulty in enrolling the targeted number of patients. Subjects currently enrolled into the study will complete the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The new anticipated Last Subject Last Visit (LSLV) is February 2012.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: PF-04136309
Intervention descriptions: intervention 1: Take 4 capsules twice daily 12 hours apart with water. Swallow whole. intervention 2: Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Protocol documents:
Clinical trial NCT01243567
Conditions: Glaucoma, Open-Angle
Sponsor: Allergan
Start date: 2010-06-01; Completion date: 2012-02-14
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.

Detailed description:

Arms: arm 1: Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. arm 2: Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Interventions: intervention 1: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution intervention 2: latanoprost 0.005% ophthalmic solution
Intervention descriptions: intervention 1: Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. intervention 2: Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.

Protocol documents:
Clinical trial NCT01459588
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2011-10-01; Completion date: 2012-02-15
Enrollment: 315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

Detailed description:

Arms: arm 1: Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. arm 2: Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. arm 3: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. arm 4: Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Interventions: intervention 1: Carboxymethylcellulose Based Eye Drop Formulation A intervention 2: Carboxymethylcellulose Based Eye Drop Formulation B intervention 3: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops intervention 4: Carboxymethylcellulose Based Lubricant Eye Drops
Intervention descriptions: intervention 1: Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. intervention 2: Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. intervention 3: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. intervention 4: Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Protocol documents:
Clinical trial NCT01381094
Conditions: Anemia Kidney Disease
Keywords: anemia chronic kidney disease CKD chronic renal insufficiency renal impairment erythropoietin safety efficacy tolerability pharmacokinetics
Sponsor: Akebia Therapeutics
Start date: 2011-06-15; Completion date: 2012-02-16
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: AKB-6548 intervention 2: Placebo
Intervention descriptions: intervention 1: oral dose administered once daily for 42 days intervention 2: oral Placebo administered once daily for 42 days

Protocol documents:
Clinical trial NCT00504751
Conditions: Non-Hodgkin's Lymphoma
Keywords: diffuse large b cell
Sponsor: Weill Medical College of Cornell University
Start date: 2007-05-01; Completion date: 2012-02-17
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives

The primary objective of this study is to:

• determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma

The secondary objectives of this study are to:

* assess event free survival and overall survival
* assess conversion of chemo-resistant to chemo-sensitive disease
* assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation
* perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity

Detailed description:
Single arm phase II trial of combination therapy bortezomib, DICE, and Rituximab in patients with relapsed and refractory diffuse large B-cell non-Hodgkin's lymphoma (NHL)

VIPER chemotherapy will be administered every 28 days at the following doses:

* Dexamethasone 40 mg IV days 1-4
* Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
* Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
* Cisplatin 25 mg IV days 1-4
* Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
* Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
* VELCADE 1.5 mg/m2 on days 2 and 5

Arms: arm 1: This is a single arm study
Interventions: intervention 1: bortezomib, dexamethasone, ifosfamide intervention 2: mesna, cisplatin, etoposide, rituximab
Intervention descriptions: intervention 1: VIPER chemotherapy will be administered every 28 days at the following doses:

* Dexamethasone 40 mg IV days 1-4
* Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
* Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
* Cisplatin 25 mg IV days 1-4
* Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
* Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
* VELCADE 1.5 mg/m2 on days 2 and 5 intervention 2: VIPER chemotherapy will be administered every 28 days at the following doses:

* Dexamethasone 40 mg IV days 1-4
* Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
* Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
* Cisplatin 25 mg IV days 1-4
* Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
* Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
* VELCADE 1.5 mg/m2 on days 2 and 5

Protocol documents:
Clinical trial NCT03062605
Conditions: Caries, Dental Cariostatic Agents
Sponsor: University of California, Los Angeles
Start date: 2011-05-21; Completion date: 2012-02-17
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the effect of a two-step mouth rinsing procedure on reducing the germs (mutans Streptococci) that cause tooth decay. We hope that the two-step mouth rinse (0.3% NaOCl followed by 10% Povidone Iodine) decreases the tooth causing germs better than the one-step mouth rinse (10% Povidone Iodine). The mouth rinse for both treatment groups is done only once at the beginning of the study after the initial saliva samples are taken, and before a detailed examination of the teeth and gums. It is hypothesized that the treatment group receiving the NaOCl and Povidone iodine will have significantly lower microbial counts than the control group (Povidone iodine) because the NaOCl will disrupt the microbial biofilm and make the Povidone iodine more effective in decreasing the microbes in the biofilm. Microbial counts are made from Salivary samples taken from participants at baseline, one week, one month, two months and three months. The samples are tested by two commercial methods for determining microbial counts. The CariScreen Test is a rapid bioluminescence assay that quantitates the total number of all of the organisms present. The CRT test requires a culture media that is specific for the two germs (S. mutans and Lactobacillus) strongly associated with tooth decay. The results of the CRT Test are read after three days of incubation.

Detailed description:

Arms: arm 1: . Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute arm 2: . Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute. The CT group was a positive control. Both of these treatments were done only once at the baseline. The reminder of the three-month study was to obtain saliva samples at specific times to determining microbial levels.
Interventions: intervention 1: Iodine (Betadine) intervention 2: NaOCL
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01493570
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-12-01; Completion date: 2012-02-21
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Due to the exploratory nature of this trial, there is no primary objective in a confirmatory sense. The study aims

\- to evaluate the effect of different doses of BI 409306 on biomarker and to assess the exposure of BI 409306

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: BI 409306 intervention 2: Placebo
Intervention descriptions: intervention 1: Film-coated tablet intervention 2: Film-coated tablet

Protocol documents:
Clinical trial NCT01293006
Conditions: Insomnia
Keywords: Pulmonary Disease, Chronic Obstructive
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-03-25; Completion date: 2012-02-22
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease (COPD). This is a crossover study, so all participants will receive both suvorexant and placebo while on study. The primary hypothesis of this study is that multiple doses of suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2) during total sleep time in participants with COPD, as compared to placebo.

Detailed description:

Arms: arm 1: During Period 1, participants \<65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening and participants ≥65 years of age were administered a 30-mg oral dose of

suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. arm 2: During Period 1, participants \<65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening and participants ≥65 years of age received one placebo tablet matching

suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
Interventions: intervention 1: suvorexant intervention 2: Placebo
Intervention descriptions: intervention 1: one tablet (30 or 40 mg suvorexant depending on participant age: 40 mg for participants \<65 years of age and 30 mg for participants ≥65 years of age), orally, once daily, for 4 consecutive days intervention 2: one tablet matching suvorexant, orally, once daily, for 4 consecutive days

Protocol documents: