ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01429987
Conditions: Chronic Idiopathic Constipation
Keywords: Chronic Idiopathic Constipation Constipation Sign and Symptoms: Digestive
Sponsor: Bausch Health Americas, Inc.
Start date: 2011-10-01; Completion date: 2012-12-01
Enrollment: 951 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).

Detailed description:
This is a Phase IIb/III, randomized, double-blind, placebo-controlled, 12-Week, Repeat, Oral Dose Ranging, study to determine the safety and efficacy of plecanatide in patients with chronic idiopathic constipation (CIC). Subjects diagnosed with CIC via modified Rome III criteria will be screened against the inclusion and exclusion criteria for the study and enter a 2 Week pre treatment screening. During this phase patients will be required to call in their bowel movements (BM diary) as they occur, and call at least once daily to complete a patient diary of questions on their symptoms (Symptom Diary) associated with CC, as they will throughout the trial. Patients who complete at least 5 days of dosing per week, 6 of each 7 day period of BM diary calls, and continue to have less than 3 complete spontaneous movements per week (as well as meeting other inclusion and exclusion criteria) will be enrolled and randomized to one of three plecanatide doses 0.3 mg, 1.0 mg, and 3.0 mg or placebo. 880 patients will be randomized with the intent of having 200 patients per treatment group (each group the same size) included in efficacy analyses. All subjects receiving at least one dose of plecanatide or matching placebo will be included in the safety analyses.

Arms: arm 1: Subjects receive plecanatide 0.3 mg for 12 consecutive weeks arm 2: Subjects receive plecanatide 1.0 mg for 12 consecutive weeks arm 3: Subjects receive plecanatide 3.0 mg for 12 consecutive weeks arm 4: Subjects receive placebo for 12 consecutive weeks
Interventions: intervention 1: plecanatide intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects receive experimental study drug for 12 weeks. intervention 2: Subjects receive experimental study drug for 12 weeks.

Protocol documents:
Clinical trial NCT01430585
Conditions: Early Breast Cancer (Phase 2) Advanced Breast Cancer (Phase 1b)
Keywords: Ki-67 postmenopausal early breast cancer ER positive/HER2 negative early breast cancer
Sponsor: Pfizer
Start date: 2012-03-01; Completion date: 2012-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high Ki-67) patient population of hormone-sensitive breast cancers. In addition, Ki-67, a marker of cellular proliferation, could be used to select those patients who benefit from treatment with a PI3K-pathway inhibitor.

Detailed description:
The study was prematurely discontinued on 09Oct2012 due to the tolerability findings in 2 clinical studies testing PF-04691502 that have prompted the Sponsor to re-evaluate the strategic goals of the program. In the study B1271003 an unexpected frequency of severe skin toxicity was observed and in the study B1271004 5 cases of drug induced pneumonitis were reported.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: PF-04691502 intervention 2: PF-04691502 in combination with Letrozole intervention 3: Letrozole
Intervention descriptions: intervention 1: PF-04691502 administered as single agent for 2 weeks. After this period, patients in this arm will take PF-04691502 in combination with Letrozole until Week 6. Beyond Week 6, if considered appropriate, patients can be treated with the combination for up to 10 additional weeks until breast surgery. intervention 2: PF-04691502 in combination with Letrozole will be administered for 6 weeks. Beyond Week 6, if considered appropriate, patients can be treated for up to 10 additional weeks until breast surgery. intervention 3: Letrozole will be administered for 6 weeks. Beyond Week 6, if considered appropriate, patients can be treated for up to 10 additional weeks until breast surgery.

Protocol documents:
Clinical trial NCT01431339
Conditions: Abscess Wound Infection Surgical Site Infection Cellulitis
Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
Start date: 2011-07-01; Completion date: 2012-12-01
Enrollment: 739 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: IV Dalbavancin intervention 2: Vancomycin/Linezolid
Intervention descriptions: intervention 1: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 intervention 2: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days

Protocol documents:
Clinical trial NCT01440881
Conditions: Renal Failure
Keywords: renal failure cardiopulmonary bypass
Sponsor: University of Florida
Start date: 2010-04-01; Completion date: 2012-12-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.

Detailed description:
This will be a randomized, prospective blinded pilot study comparing nesiritide to placebo in patients undergoing aortic arch, ascending aorta, aortic valve or mitral valve surgery with baseline GFR 30-90ml/min. Patients were randomized to either placebo or nesiritide (administered prophylactically starting in the operating room prior to incision at 0.01 mcg/kg /minute with no bolus and continued for 48 hours).

Arms: arm 1: infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours arm 2: infuses at 0.01MCG/KG/min for 48 hours
Interventions: intervention 1: Nesiritide intervention 2: Placebo
Intervention descriptions: intervention 1: infuses at 0.01MCG/KG/min for 48 hours intervention 2: infuses at 0.01MCG/KG/min for 48 hours

Protocol documents:
Clinical trial NCT01443442
Conditions: Allergic Conjunctivitis
Keywords: Conjunctivitis Allergic Bepotastine besilate Loteprednol etabonate
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Start date: 2011-10-01; Completion date: 2012-12-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically, patients manifest symptoms in the spring, summer and fall, when airborne allergens are at their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and burning.

This is a randomized clinical study to evaluate the efficacy of Bepreve® (bepotastine besilate 1.5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0.2%) in the treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years. The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms (itching) will be monitored as outcome variables.

Detailed description:
Investigator and Study Center:

Judy Tong, OD Eye Care Center Southern California College of Optometry

Test Product, Dose and Mode of Administration:

Bepreve (bepotastine besilate ophthalmic solution) 1.5% bid ou vs. Alrex (loteprednol etabonate ophthalmic suspension) 0.2% qid ou

Study Title:

A Single-Center, Masked, Randomized Study Comparing Bepreve (bepotastine besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (loteprednol etabonate) 0.2% - Corticosteroid in Subjects with Moderate to Severe Allergic Conjunctivitis

Primary Objective(s):

The primary objective of this study is to compare the efficacy of Bepreve (bepotastine besilate) 1.5% ophthalmic solution compared to Alrex (loteprednol etabonate) 0.2% in the treatment of moderate to severe allergic conjunctivitis in patients over the age of 18 years of age

Study Design:

Interventional, Randomized, Parallel Arm, Investigator Masked

Study Population:

Subjects over the age of 18 years of age with moderate to severe allergic conjunctivitis.

Duration of Treatment: 14 days

Efficacy Assessments: Itching, Bulbar conjunctival injection, Bulbar conjunctival chemosis

Safety Assessments: N/A

Arms: arm 1: 1.5% bepotastine besilate, drops, twice per day, for two weeks arm 2: treatment with 0.2 % loteprednol etabonate, drops, four times per day
Interventions: intervention 1: bepotastine besilate, 1.5% intervention 2: Loteprednol etabonate
Intervention descriptions: intervention 1: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days intervention 2: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days

Protocol documents:
Clinical trial NCT01451541
Conditions: Perennial Allergic Rhinitis PAR
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-10-01; Completion date: 2012-12-01
Enrollment: 848 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

Detailed description:
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. This study will consist of the following periods/visits: Screening , Single-blind Placebo Run-in period, Double-blind Treatment period , Follow-up. The total duration of subject participation will be approximately 5 months.

Arms: arm 1: ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily arm 2: ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily arm 3: None
Interventions: intervention 1: Ciclesonide nasal aerosol 37 mcg intervention 2: ciclesonide nasal aerosol 74 mcg intervention 3: Placebo
Intervention descriptions: intervention 1: ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 intervention 2: ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg intervention 3: Placebo - one dose per nostril

Protocol documents:
Clinical trial NCT01451996
Conditions: Healthy
Keywords: direct-to-consumer advertising
Sponsor: University of Chicago
Start date: 2011-10-01; Completion date: 2012-12-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary goal of this study is to examine determinants of the efficacy of Claritin.

Detailed description:
Subjects will be given Claritin 10mg tablet. Subjects will be challenged with histamine via skin prick prior to Claritin administration and at 1 and 2 hours post administration. We will measure and record wheal and flare area 10 minutes following each challenge.

Arms: arm 1: Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin. arm 2: Subject will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.
Interventions: intervention 1: Claritin
Intervention descriptions: intervention 1: Subject will be given 10mg Claritin tablet.

Protocol documents:
Clinical trial NCT01457521
Conditions: Pain
Keywords: pain medical abortion
Sponsor: Gynuity Health Projects
Start date: 2011-10-01; Completion date: 2012-12-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain.

Detailed description:
This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain. Secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, overall satisfaction with the abortion procedure.

Arms: arm 1: Ibuprofen arm 2: Ibuprofen
Interventions: intervention 1: Ibuprofen
Intervention descriptions: intervention 1: Ibuprofen

Protocol documents:
Clinical trial NCT01475136
Conditions: Hepatic Insufficiency
Sponsor: Denovo Biopharma LLC
Start date: 2011-11-01; Completion date: 2012-12-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039).

Detailed description:
The study included 4 groups, based on the Child-Pugh classification of hepatic impairment as follows:

Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment (Child-Pugh class C).

Arms: arm 1: A single oral dose of 80 milligrams (mg) LY2140023 administered on Day 1.
Interventions: intervention 1: LY2140023
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01475253
Conditions: Interstitial Cystitis
Sponsor: Allergan
Start date: 2011-11-01; Completion date: 2012-12-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

Detailed description:
The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham).

All patients who complete part 1 of the study have the option to enter the extension.

Arms: arm 1: Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period. arm 2: LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14. arm 3: No intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder.
Interventions: intervention 1: Lidocaine Releasing Intravesical System - LiRIS® intervention 2: LiRIS Placebo intervention 3: Sham Cystoscopy Procedure
Intervention descriptions: intervention 1: Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period. intervention 2: LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14. intervention 3: Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.

Protocol documents:
Clinical trial NCT01476475
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2011-11-01; Completion date: 2012-12-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.

Secondary Objectives:

* To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:

  * Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
  * Percentage of participants reaching HbA1c \<7% or ≤6.5%;
  * 7-point Self-Monitored Plasma Glucose (SMPG) profile;
  * Body weight;
  * Insulin glargine dose
  * Fasting Plasma Glucose (FPG);
  * Percentage of participants requiring rescue therapy during the 24-week open label treatment period;
* To assess safety and tolerability of insulin glargine/lixisenatide FRC.

Detailed description:
Approximately 27 weeks including a 24-week treatment period.

Arms: arm 1: FRC injected once daily (QD) for 24 weeks. Dose individually adjusted. arm 2: Insulin glargine QD for 24 weeks. Dose individually adjusted.
Interventions: intervention 1: Insulin glargine /lixisenatide Fixed Ratio Combination intervention 2: Insulin glargine intervention 3: Metformin (Background drug)
Intervention descriptions: intervention 1: FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using pen-type injector (Tactipen®): 100 U/ml insulin glargine and 50 mcg Lixisenatide (ratio of 2 U/1 mcg). The initial dose was 10 U/5 mcg and then dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L. intervention 2: Insulin glargine (100 U/ml) was self-administered by SC injection before breakfast using pen-type injector (Lantus® Solostar®). The initial daily dose of insulin glargine was 10 U and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). intervention 3: Pharmaceutical form: Tablet; Route of administration: oral administration. To be kept at stable dose (≥1.5 g/day) throughout the study.

Protocol documents:
Clinical trial NCT01483625
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2011-11-01; Completion date: 2012-12-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.

Detailed description:

Arms: arm 1: active arm 2: placebo
Interventions: intervention 1: tiotropium intervention 2: Placebo
Intervention descriptions: intervention 1: 18mcg intervention 2: placebo

Protocol documents:
Clinical trial NCT01493180
Conditions: Keratoconjunctival Epithelial Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2011-12-01; Completion date: 2012-12-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.

Detailed description:

Arms: arm 1: OPC-12759 ophthalmic suspension arm 2: Sodium hyaluronate ophthalmic solution
Interventions: intervention 1: OPC-12759 ophthalmic suspension intervention 2: Sodium hyaluronate ophthalmic solution
Intervention descriptions: intervention 1: OPC-12759 ophthalmic suspension 2% intervention 2: Sodium hyaluronate ophthalmic solution 0.1%

Protocol documents:
Clinical trial NCT01529632
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease COPD QVA149 QAB149 NVA237 indacaterol glycopyrronium bromide
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-01; Completion date: 2012-12-01
Enrollment: 193 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

Arms: arm 1: QVA149 plus placebo once daily for 28 days. arm 2: Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
Interventions: intervention 1: QVA149 intervention 2: NVA237 intervention 3: QAB149 intervention 4: Placebo
Intervention descriptions: intervention 1: QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily intervention 2: NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily intervention 3: QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily intervention 4: Placebo capsules provided in blister packs for inhalation via SDDPI, once daily

Protocol documents:
Clinical trial NCT01539538
Conditions: Post-Operative Pain
Keywords: Adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery or hip/knee replacement surgery
Sponsor: Talphera, Inc
Start date: 2012-04-01; Completion date: 2012-12-01
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sufentanil NanoTab PCA System/15 mcg intervention 2: morphine IV PCA
Intervention descriptions: intervention 1: 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours intervention 2: 1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours

Protocol documents: