ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01131585
Conditions: Visual Impairment Due to Diabetic Macular Edema
Keywords: Diabetic macular edema DME Proliferative diabetic retinopathy PDR ranibizumab laser
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-01; Completion date: 2011-07-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.

Detailed description:

Arms: arm 1: Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. arm 2: Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Interventions: intervention 1: Active laser photocoagulation intervention 2: Sham injections intervention 3: Ranibizumab 0.5 mg
Intervention descriptions: intervention 1: Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. intervention 2: Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. intervention 3: Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Protocol documents:
Clinical trial NCT01147848
Conditions: Asthma
Keywords: Salmeterol fluticasone furoate Vilanterol fluticasone propionate GW642444
Sponsor: GlaxoSmithKline
Start date: 2010-06-01; Completion date: 2011-07-01
Enrollment: 810 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Detailed description:

Arms: arm 1: Fluticasone furoate/vilanterol inhalation powder once daily + placebo inhalation powder twice daily for 24 weeks arm 2: Fluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks
Interventions: intervention 1: Fluticasone furoate/Vilanterol Inhalation Powder intervention 2: Fluticasone propionate/salmeterol Inhalation Powder intervention 3: Placebo (1) intervention 4: Placebo (2)
Intervention descriptions: intervention 1: Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks intervention 2: Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks intervention 3: Inhalation powder inhaled orally once daily for 24 weeks intervention 4: Inhalation powder inhaled orally twice daily for 24 weeks

Protocol documents:
Clinical trial NCT01153321
Conditions: Chronic Obstructive Pulmonary Disease Lung Disease
Keywords: Respiratory disease chronic obstructive pulmonary disease
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2011-07-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.

Detailed description:

Arms: arm 1: Oral treatment arm 2: Oral treatment
Interventions: intervention 1: AZD2423 intervention 2: AZD2423 Placebo
Intervention descriptions: intervention 1: 100mg Oral dose od intervention 2: Oral dose od

Protocol documents:
Clinical trial NCT01160822
Conditions: Osteoarthritis
Keywords: Osteo arthritis pain control intra- articular injections Knee OA
Sponsor: Novartis Pharmaceuticals
Start date: 2010-04-01; Completion date: 2011-07-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.

Detailed description:
This is a randomized, double-blind, parallel group, placebo controlled 18 weeks study, consisting of two parts:

1. Part A: an ascending single dose part in which the safety and tolerability of up to 4 different canakinumab doses are studied (starting dose 150 mg, maximum dose 600 mg).
2. Part B: a double-dummy, active-controlled, parallel design part in which the pain reduction of the canakinumab dose selected from part A is studied in comparison to Placebo and Naproxen.

Arms: arm 1: In this ascending dose part, participants received a single intra-articular injection of canakinumab. The beginning dose was 150 mg, escalating to the 300 mg dose and then to 600 mg. arm 2: Participants received a single intra-articular injection of canakinumab-matching placebo. arm 3: Participants received a single intra-articular injection of canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. arm 4: Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. arm 5: Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Interventions: intervention 1: Canakinumab intervention 2: Placebo to canakinumab intervention 3: Naproxen intervention 4: Placebo to Naproxen
Intervention descriptions: intervention 1: Intra-articular injection intervention 2: Intra-articular injection intervention 3: Tablets for oral administration intervention 4: Tablets for oral administration

Protocol documents:
Clinical trial NCT01163643
Conditions: Dry Eye Syndrome
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-07-01; Completion date: 2011-07-01
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.

Detailed description:

Arms: arm 1: 0.3% BOL-303242-X ophthalmic suspension arm 2: 2% BOL-303242-X ophthalmic suspension arm 3: Vehicle twice daily (BID) arm 4: 1% BOL-303242-X ophthalmic suspension arm 5: 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) arm 6: Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
Interventions: intervention 1: 0.3% BOL-303242-X ophthalmic suspension intervention 2: 2% BOL-303242-X ophthalmic suspension intervention 3: Placebo Comparator: Vehicle intervention 4: 1% BOL-303242-X ophthalmic suspension intervention 5: 2% BOL-303242-X ophthalmic suspension AM intervention 6: 2% BOL-303242-X ophthalmic suspension PM
Intervention descriptions: intervention 1: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 2: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 3: Placebo Comparator: Vehicle BID for 12 weeks. intervention 4: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 5: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks. intervention 6: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

Protocol documents:
Clinical trial NCT01166646
Conditions: Plaque Psoriasis
Sponsor: Therapeutics, Inc.
Start date: 2010-07-01; Completion date: 2011-07-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the investigational lotion is an effective treatment of moderate to severe plaque psoriasis in comparison to an approved cream.

Detailed description:

Arms: arm 1: Subjects randomized to receive lotion arm 2: Subjects randomized to receive cream
Interventions: intervention 1: Halobetasol Proprionate Lotion 0.05% intervention 2: Halobetasol Proprionate Cream 0.05%
Intervention descriptions: intervention 1: Apply 3.5 grams twice daily for 1-2 weeks intervention 2: Apply 3.5 grams twice daily for 1-2 weeks

Protocol documents:
Clinical trial NCT01189747
Conditions: Lateral Canthus Rhytides Crow's Feet Lines
Sponsor: Allergan
Start date: 2010-10-01; Completion date: 2011-07-01
Enrollment: 446 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).

Detailed description:

Arms: arm 1: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1. arm 2: normal saline injected into bilateral Crow's Feet Line areas on Day 1.
Interventions: intervention 1: onabotulinumtoxinA intervention 2: normal saline
Intervention descriptions: intervention 1: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1 intervention 2: Injected into bilateral Crow's Feet Line areas on Day 1

Protocol documents:
Clinical trial NCT01199055
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: PPAR gamma agonist Tumor Cancer Antineoplastic Agent Respiratory Tract Neoplasms Carboplatin Paclitaxel Neoplasms
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2010-03-01; Completion date: 2011-07-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.

Detailed description:

Arms: arm 1: Drug: CS-7017 from 0.25 mg twice a day (BID) to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks)

Drug: Carboplatin IV, Area under the curve (AUC) of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)
Interventions: intervention 1: CS-7017 intervention 2: Carboplatin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks) intervention 2: Drug: Carboplatin IV, AUC of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) intervention 3: Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

Protocol documents:
Clinical trial NCT01204398
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2010-11-01; Completion date: 2011-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension

Detailed description:

Arms: arm 1: Patients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
Interventions: intervention 1: telmisartan+amlodipine fixed dose combination
Intervention descriptions: intervention 1: after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.

Protocol documents:
Clinical trial NCT01205685
Conditions: Hormone-sensitive Metastatic Breast Cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2010-05-01; Completion date: 2011-07-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human beings show that this drug can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that helps them live and grow. Studies done in the laboratory show that OSI-906 can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers.

Detailed description:
The safety run component of this trial is to determine the safety profile of the OSI-906, erlotinib and anti-endocrine treatment combination. The phase II component evaluates the antitumor activity of the combination OSI-906, erlotinib and endocrine therapy.

Arms: arm 1: * OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
Interventions: intervention 1: OSI-906 intervention 2: Erlotinib intervention 3: Letrozole intervention 4: Goserelin
Intervention descriptions: intervention 1: In a pill form by mouth, twice a day (12 hours apart)

During the safety run portion of the study"

* Dose level 2 = 150 mg twice a day
* Dose level 1 = 100 mg twice a day
* Dose level -1 = 100 mg twice a day
* Dose level -2 = 100 mg twice a day intervention 2: During the safety run phase of the study:

* Dose Level 2 = 100 mg/d
* Dose Level 1 = 100 mg/d
* Dose Level -1= 75 mg/d
* Dose Level -2 = 50 mg/d intervention 3: In a pill form, by mouth, once per day at 2.5 mg/d. intervention 4: For pre-menopausal patients only. Given as an injection once a month at 3.6 mg/month.

Protocol documents:
Clinical trial NCT01207752
Conditions: Meibomian Gland Dysfunction
Keywords: dry eye, MGD, tear film break up time
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Start date: 2010-09-01; Completion date: 2011-07-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study will be to determine the efficacy of this novel, lipid-containing artificial tear on the signs and symptoms of meibomian gland disease.

Detailed description:
This investigation will involve approximately 90 MGD subjects, randomly assigned to either the Systane Balance treatment group or a control group using Optive™ Lubricant Eyedrops (Allergan), a low-viscosity artificial tear. Both arms will dose the drops four times per day and the treatment trial will be conducted for 6 months. The age range will be 18 years and older, with no upper age limit. Standard diagnostic tests for dry eye, as recommended by the NEI-Industry Workshop report,8 but with updated criteria in some instances, will be used to define clinical dry eye of the MGD sub-type. The three major tests will be: symptoms using a validated questionnaire (Schein), evidence of ocular surface damage, and demonstration of tear instability. The subjects will be enrolled if they consent and are confirmed as MGD subjects using the established clinical criteria used at SCCO of gland dropout Grade 1 per lower eyelid using meiboscopy,6, 9 or secretion quality Grade 1 in any of the three sectors (temporal, central, nasal) upon gland expression9, 10 using the recently developed Korb device.11 The principal outcome measure will be the tear film breakup time (TBUT), in seconds, at two hours post drop instillation. The two-hour TBUT value will be used to compare the control and test formulation at baseline and visits 3, 5 and 7. TBUT will be measured using 2.0 l of 1.0% NaFl. Exploratory outcome measures will include TBUT (seconds; change over time), corneal staining (change over time; 0 - 20 scale), symptoms (Schein and MGD-specific preliminary questionnaire score), drop comfort, Surface Regularity Index (a measure of surface disruption), lipid layer grade (1 - 5 Yokoi scale), meibum excreta quality, gland drop out and lid margin appearance all monitored as the change over time from baseline. Treatment comparisons will be made at each timepoint

Arms: arm 1: Artificial tear emulsion arm 2: Artificial tear
Interventions: intervention 1: Systane Balance intervention 2: Optive Lubricant Eye Drops
Intervention descriptions: intervention 1: Artificial tear emulsion drop intervention 2: Artificial tear eye drop

Protocol documents:
Clinical trial NCT01215968
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2010-09-01; Completion date: 2011-07-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this Study is to help answer the following research question(s).

* How does LY2189265 affect gastric emptying (the speed at which food and drink leaves the stomach) in patients with Type 2 diabetes?
* How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2 diabetes)?
* Is LY2189265 safe and are any side effects associated with it?

The study will be participant-blind in Week 1, and participant- and investigator-blind from Week 2 through Week 5.

Each participant will receive placebo on Week 1 and once-weekly doses of LY2189265 or Placebo on Weeks 2 to 5. Participants taking metformin for the treatment of Type 2 Diabetes Mellitus (T2DM) will continue taking metformin as part of the study.

Detailed description:

Arms: arm 1: Each participant will receive placebo on Week 1. Participants randomized to placebo will receive once-weekly doses of placebo on Weeks 2 to 5.

Placebo will be administered by single subcutaneous injection into the skin of the abdominal wall.

Participants regularly taking metformin will continue their normal dosing regimen throughout the study. arm 2: Participants randomized to LY2189265 will receive once-weekly doses of LY2189265 on Weeks 2 to 5.

1.5 milligram (mg) LY2189265 will be administered by single subcutaneous injection into the skin of the abdominal wall.

Participants regularly taking metformin will continue their normal dosing regimen throughout the study.
Interventions: intervention 1: LY2189265 intervention 2: Placebo
Intervention descriptions: intervention 1: 1.5 mg administered subcutaneously intervention 2: Administered subcutaneously

Protocol documents:
Clinical trial NCT01219959
Conditions: End Stage Renal Disease (ESRD) Diabetes CAPD
Keywords: ESRD Diabetes CAPD
Sponsor: Vantive Health LLC
Start date: 2010-10-01; Completion date: 2011-07-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.

Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.

Detailed description:

Arms: arm 1: Dianeal only arm 2: Dianeal, Extraneal, Nutrineal
Interventions: intervention 1: Dianeal intervention 2: Dianeal, Extraneal, Nutrineal
Intervention descriptions: intervention 1: Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose intervention 2: Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin

Protocol documents:
Clinical trial NCT01221727
Conditions: Postmenopausal Osteoporosis
Keywords: Amgen Phase 1 Postmenopausal Osteoporosis
Sponsor: Amgen
Start date: 2010-11-01; Completion date: 2011-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.

Detailed description:
Approximately 27 subjects (Group A: 18; Group B: 9) will receive a 2 mg oral dose of midazolam on day 1 followed by a 24 hour PK collection. Subjects randomized to Group A will receive a single 60 mg subcutaneous (SC) dose of denosumab on day 2 administered in the abdomen. On study day 16, another 2 mg oral dose of midazolam will be administered to all subjects (Groups A and B) followed by a 24 hour PK collection. The primary analysis to determine the effect of denosumab on the PK of midazolam will be based on data from subjects in Group A only.

Arms: arm 1: All 27 subjects will receive midazolam. arm 2: Eighteen (18) subjects will receive denosumab.
Interventions: intervention 1: Denosumab intervention 2: Midazolam
Intervention descriptions: intervention 1: Eighteen (18) subjects will receive 1 fixed dose administration of denosumab. intervention 2: All subjects will receive two oral dose administrations of midazolam.

Protocol documents:
Clinical trial NCT01223001
Conditions: Traumatic Brain Injury Depression
Keywords: Depression Traumatic brain injury Duloxetine Cymbalta impaired cognitive function
Sponsor: Rehabilitation Hospital of Indiana
Start date: 1996-09-01; Completion date: 2011-07-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.

Detailed description:
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function. Research exploring the use of selective serotonin reuptake inhibitors in the treatment of post-traumatic depression generally validates this approach (Horsfield et al., 2002). However, the literature suggests that serotonin/norepinephrine reuptake inhibitors such as duloxetine may be more effective in the treatment of depression.

Arms: arm 1: Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. arm 2: Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
Interventions: intervention 1: Duloxetine intervention 2: Sugar pill
Intervention descriptions: intervention 1: Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. intervention 2: Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.

Protocol documents: