ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01296152
Conditions: HIV-1 Infection
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2011-05-01; Completion date: 2012-10-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was done to look at the level of Depo-Provera, an injectable birth control, in the blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir \[LPV/r\]). It is not known whether taking Depo-Provera together with Kaletra changes the amount of Kaletra in blood. Therefore, this study also looked at the levels of HIV and Kaletra before and after receiving a shot of Depo-Provera. This study evaluated the safety of Depo-Provera and Kaletra when they are used together. In addition to what is stated above, this study also explored any effect of Depo-Provera on the immune system.

Detailed description:
The primary study objective was addressed by calculating the Area Under the Concentration-Time Curve (AUC) from week 0 (prior to DMPA injection) to week 12 (twelve weeks after DMPA injection) in our study participants.

DMPA was supplied and administered as part of the protocol, however Kaletra was not. It was required that participants already be on a Kaletra based regimen prior to entering the study, as described in the eligibility criteria.

Arm A of AIDS Clinical Trial Group (ACTG) A5093, which consisted of 14 participants who were administered DMPA without Kaletra, was used as reference data.

Arms: arm 1: At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
Interventions: intervention 1: depo-medroxyprogesterone acetate
Intervention descriptions: intervention 1: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.

Protocol documents:
Clinical trial NCT01297244
Conditions: Renal Cell Carcinoma
Keywords: AV-951 Tivozanib RCC Biomarkers Advanced Renal Cell Carcinoma
Sponsor: AVEO Pharmaceuticals, Inc.
Start date: 2011-01-01; Completion date: 2012-10-01
Enrollment: 105 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single arm, multicenter study. Subjects will be stratified by histology (clear cell versus non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤ 30% of the entire study population.

Detailed description:
This is a Phase 2, open-label, single arm, multi-center, study of orally administered tivozanib to approximately 100 subjects with advanced renal cell carcinoma (RCC). This study is designed to evaluate biomarkers in blood and archived tissue samples, and their correlation with clinical activity and/or treatment-related toxicity in subjects with advanced RCC, and estimate the percentage of tivozanib-treated subjects who are progression-free at 6 months, overall response rate (ORR), progression free survival (PFS), safety and tolerability, and pharmacokinetics (PK). Subjects will be stratified by histology (clear cell vs. non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤ 30% of the entire study population.

Study enrollment is anticipated to complete in approximately 9 months. Treatment duration is estimated to last approximately 6 months from the subject's first dose of tivozanib with a follow-up period of 30 days. After 6 months, treatment with tivozanib may continue by participation in a rollover protocol (AV-951-09-901). Maximum duration of subject participation in this Phase 2 study is approximately 8 months.

Arms: arm 1: Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
Interventions: intervention 1: Tivozanib
Intervention descriptions: intervention 1: Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.

Protocol documents:
Clinical trial NCT01306617
Conditions: Chronic Hepatitis C Infection Hepatitis C Hepatitis C Virus
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-02-01; Completion date: 2012-10-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Detailed description:
This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment.

Arms: arm 1: ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants. arm 2: ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants. arm 3: ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Interventions: intervention 1: ABT-450 intervention 2: ABT-333 intervention 3: ribavirin intervention 4: ritonavir
Intervention descriptions: intervention 1: tablets intervention 2: tablets intervention 3: tablets intervention 4: capsules

Protocol documents:
Clinical trial NCT01309828
Conditions: Safety
Keywords: Renal Insufficiency Kidney Diseases Hypertension Drug Therapy
Sponsor: Takeda
Start date: 2011-03-01; Completion date: 2012-10-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate long term safety and tolerability of azilsartan medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and hydrochlorothiazide in hypertensive participants with moderate renal impairment.

Detailed description:
A major component of blood pressure regulation is the renin-angiotensin-aldosterone system (RAAS). Drugs that modulate the RAAS are used commonly worldwide for the treatment of hypertension. TAK-491 (azilsartan medoxomil) is a prodrug of TAK-536 (azilsartan), an angiotensin II receptor blocker (ARB). Azilsartan medoxomil is being evaluated by Takeda to treat participants with essential hypertension.

Chlorthalidone is an orally administered thiazide-like diuretic agent, and long-term outcomes trials show blood pressure reductions associated with chlorthalidone treatment reduce risk of cardiovascular morbidity and mortality.

Hypertensive patients with moderate renal impairment are a relatively more severe and resistant hypertension population, and may benefit from effective fixed-dose combination treatments such as an ARB plus a diuretic for blood pressure control.

Participants will be randomized to receive azilsartan medoxomil and chlorthalidone or olmesartan medoxomil and hydrochlorothiazide for up to 52 weeks to evaluate long term safety of azilsartan medoxomil and chlorthalidone. A titration-to-target blood pressure approach will be used to guide the titration of study medication in this trial.

Arms: arm 1: United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets, titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks. arm 2: United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
Interventions: intervention 1: Azilsartan medoxomil and chlorthalidone intervention 2: Olmesartan medoxomil and hydrochlorothiazide
Intervention descriptions: intervention 1: Fixed-dose combination tablets. intervention 2: Fixed-dose combination tablets.

Protocol documents:
Clinical trial NCT01312961
Conditions: Asthma
Sponsor: Sanofi
Start date: 2011-03-01; Completion date: 2012-10-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma.

Secondary Objectives:

* To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
* To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.

Detailed description:
The total duration of the study period per participant was 20-22 weeks broken down as follows:

* Screening period: up to 14 days,
* Treatment period: 12 weeks,
* Follow-up period: 6-8 weeks.

Arms: arm 1: Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication. arm 2: Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Interventions: intervention 1: Dupilumab intervention 2: Placebo (for Dupilumab) intervention 3: Fluticasone/Salmeterol combination therapy intervention 4: Fluticasone monotherapy intervention 5: Albuterol intervention 6: Levalbuterol
Intervention descriptions: intervention 1: Solution for injection, one subcutaneous injection. intervention 2: Solution for injection, one subcutaneous injection. intervention 3: Oral inhalation twice daily. intervention 4: Oral inhalation twice daily. intervention 5: Oral inhalation as needed. intervention 6: Oral inhalation as needed.

Protocol documents:
Clinical trial NCT01324518
Conditions: Alzheimer's Disease
Sponsor: Orion Corporation, Orion Pharma
Start date: 2011-04-01; Completion date: 2012-10-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.

Detailed description:
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of cognitive and behavioral symptoms in patients with Alzheimer's disease.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: ORM-12741 intervention 2: ORM-12741 intervention 3: Placebo for ORM-12741
Intervention descriptions: intervention 1: 60mg twice a day intervention 2: 200mg twice a day intervention 3: Placebo twice a day

Protocol documents:
Clinical trial NCT01329549
Conditions: Ovarian Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2012-10-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression is observed.

Detailed description:

Arms: arm 1: BIBF 1120 (low dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2) arm 2: BIBF 1120 (medium dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2) arm 3: BIBF 1120 (high dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)
Interventions: intervention 1: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min intervention 2: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min intervention 3: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Intervention descriptions: intervention 1: BIBF 1120 twice daily along with standard therapy of PLD + CBDCA intervention 2: BIBF 1120 twice daily along with standard therapy of PLD + CBDCA intervention 3: BIBF 1120 twice daily along with standard therapy of PLD + CBDCA

Protocol documents:
Clinical trial NCT01334944
Conditions: Pain Fever
Keywords: Pain Fever
Sponsor: Cumberland Pharmaceuticals
Start date: 2011-06-01; Completion date: 2012-10-01
Enrollment: 150 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting.

Detailed description:

Arms: arm 1: Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
Interventions: intervention 1: Intravenous ibuprofen
Intervention descriptions: intervention 1: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Protocol documents:
Clinical trial NCT01340014
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Glaucoma Intraocular pressure Tonometry, ocular
Sponsor: Alcon Research
Start date: 2011-09-01; Completion date: 2012-10-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

Detailed description:
At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.

Arms: arm 1: 1 drop AZARGA instilled in each eye twice a day for 7 days, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods. arm 2: 1 drop COSOPT instilled in each eye twice a day for 7 days, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.
Interventions: intervention 1: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension intervention 2: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01350115
Conditions: Basal Cell Carcinoma Gorlin Syndrome Nevoid Basal Cell Carcinoma Syndrome
Keywords: Basal Cell Carcinoma Gorlin Syndrome, Gorlin-Goltz Syndrome, Basal Cell Nevus Syndrome, Nevoid Basal Cell Carcinoma Syndrome, Basal Cell Carcinoma Nevus Syndrome Smo inhibitor, Hedgehog pathway inhibitor BCCs
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-01; Completion date: 2012-10-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult patients with NBCCS. This was an exploratory study designed to demonstrate preliminary efficacy of LDE225 in this indication. This study included a Screening period of approximately 4 weeks, treatment period duration of 12 weeks with initial follow-up of approximately 6-8 weeks followed by a long-term follow-up period.

Detailed description:

Arms: arm 1: Participants received 400 mg once daily. arm 2: Participants received matching placebo.
Interventions: intervention 1: LDE225 intervention 2: Placebo
Intervention descriptions: intervention 1: supplied as 100 mg capsules intervention 2: supplied in capsules

Protocol documents:
Clinical trial NCT01386879
Conditions: Secretion Removal Above ETT Cuff
Keywords: suction aspiration general anesthesia intubation endotracheal tube respiratory complications
Sponsor: Thomas Jefferson University
Start date: 2011-07-01; Completion date: 2012-10-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation, amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia in the operating room (OR). Studies in the intensive care unit (ICU) have demonstrated a significant reduction in the incidence of ventilator acquired pneumonia when a ETT with suction above the cuff is used to remove secretions that accumulate above the inflated cuff. This will be the first study to evaluate the efficacy of above the cuff suctioning during general anesthesia and surgery.

One hundred and ten adult patients undergoing elective abdominal surgery (general, colorectal or gynecological) requiring general anesthesia with an endotracheal tube and mechanical ventilation will be randomized into 3 groups to receive one of the following three endotracheal tubes:

1. Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port Endotracheal Tube (Teleflex ISIS ETT).
2. Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT).
3. Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT)

The first two groups will be compared to standard ETT (third group) regarding easy of tracheal intubation, efficacy of suctioning of secretions, efficacy of sealing the trachea with an inflated ETT cuff by preventing the movement of test dye (methylene blue) from the pharynx into the trachea and incidence of post-operative respiratory complications.

Detailed description:

Arms: arm 1: Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff arm 2: Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff arm 3: Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)
Interventions: intervention 1: methylene blue
Intervention descriptions: intervention 1: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.

Protocol documents:
Clinical trial NCT01391559
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: breathing difficulty
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2011-07-01; Completion date: 2012-10-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One possible explanation is that the patient is unable to inhale the dry powder bronchodilator medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A PIFR \< 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device. The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured at two hours after inhalation of the study medication will be higher with arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from the Diskus.

Detailed description:

Arms: arm 1: beta-2 agonist bronchodilator arm 2: beta-2 agonist bronchodilator
Interventions: intervention 1: arformoterol intervention 2: salmeterol
Intervention descriptions: intervention 1: 15 mcg administered via nebulizer intervention 2: 50 mcg delivered vis Diskus

Protocol documents:
Clinical trial NCT01417936
Conditions: Carcinoma, Squamous Cell of Head and Neck
Sponsor: Symphogen A/S
Start date: 2011-07-01; Completion date: 2012-10-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.

Symphogen was the sponsor for planning/conducting and reporting results for this trial.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sym004
Intervention descriptions: intervention 1: Sym004 will be administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.

Protocol documents: