ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00689078
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Sponsor: ORA, Inc.
Start date: 2008-05-01; Completion date: 2008-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.

Detailed description:
Structure:

Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:

1. Prednisolone Acetate 1% ophthalmic suspension
2. Prednisolone Acetate 0.12% ophthalmic suspension
3. Loteprednol Etabonate 0.2% ophthalmic suspension
4. Tears Naturale® II

Duration:

Approximately four (4) weeks

Controls:

Artificial Tears (Tears Naturale® II)

Arms: arm 1: Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. arm 2: Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. arm 3: Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. arm 4: Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Interventions: intervention 1: Prednisolone Acetate 1% intervention 2: Prednisolone Acetate 0.12% intervention 3: Loteprednol Etabonate 0.2% intervention 4: Placebo
Intervention descriptions: intervention 1: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. intervention 2: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. intervention 3: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. intervention 4: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

Protocol documents:
Clinical trial NCT00695435
Conditions: Dry Eye
Keywords: normal volunteers anti-infective tobramycin
Sponsor: Alcon Research
Start date: 2008-06-01; Completion date: 2008-06-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.

Detailed description:

Arms: arm 1: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension arm 2: TOBREX® Ophthalmic Solution arm 3: TOBRADEX® Ophthalmic Suspension
Interventions: intervention 1: TOBRADEX Ophthalmic Suspension intervention 2: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension intervention 3: TOBREX Ophthalmic Solution
Intervention descriptions: intervention 1: TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline intervention 2: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline intervention 3: TOBREX Ophthalmic Solution 1 drop each eye at baseline

Protocol documents:
Clinical trial NCT00749125
Conditions: Depression
Keywords: Emotional Circuitry fMRI
Sponsor: Washington University School of Medicine
Start date: 2001-07-01; Completion date: 2008-06-01
Enrollment: 99 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine activation of a brain circuit that regulates emotion in depressed patients before and after treatment to see which areas of the brain are involved in chronic depression.

Detailed description:
Major depressive disorder can be a recurrent problem for many people, interfering with their ability to function normally in day-to-day life. Although research shows that activation in certain brain areas corresponds to certain emotional functions, it is not well known which specific changes in brain functioning are related to or caused by depression. A proposed theory holds that depression is related to abnormal regulation of emotions and thoughts. This study will focus particularly on a brain circuit involved in emotional regulation, which includes the amygdala, the affective division of the anterior cingulate (ACad), and dorsolateral prefrontal cortex (DLPFC). The amygdala detects critical emotional information, especially threats; the ACad judges relevance of motivational cues, detects conflict, and regulates emotional responses; and the DLPFC has a critical role in supporting a wide range of cognitive control functions. This study will compare brain scans from people with and without depression to attempt to clarify which changes in brain functioning are related to depression.

Participation in this study will last 8 weeks. All participants will undergo initial screening in a telephone interview, then a diagnostic interview and brief physical examination. After passing through screening, participants will schedule a functional magnetic resonance imaging (fMRI) scan. The fMRI scan, lasting approximately 2 hours, will take pictures of both brain structure and brain functioning during different tasks. Also at this visit but outside the fMRI scanner, participants will be asked to complete an additional 2 hours of tasks on a computer. Depressed participants will then be given Lexapro, an approved drug for the treatment of depression. Participants taking Lexapro will go to scheduled doctor's visits after 2, 4, and 6 weeks of treatment to assess health, effectiveness of the drug, and side effects. On the eighth week, all participants will again undergo fMRI scanning and computer testing. At both the initial and follow-up fMRI study visits, images of brain function and anatomy will be recorded, heart rate will be monitored, and anxiety and arousal will be measured in the computer tests.

Arms: arm 1: The depressed participants in this arm will be given Lexapro. arm 2: The nondepressed participants in this arm will not be given any intervention for depression.
Interventions: intervention 1: Lexapro
Intervention descriptions: intervention 1: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day

Protocol documents:
Clinical trial NCT00758160
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Disorder With Hyperactivity Methylphenidate Concerta
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2008-03-01; Completion date: 2008-06-01
Enrollment: 296 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).

Detailed description:
This is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH. Clinicians will adjust the dose of each participant according to participant's clinical responses and/or side effects. During the study period, participants will be assessed on Week 2, 4, and 8. Efficacy will be evaluated primarily based on change from baseline in Chinese version of the 26-item Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) rating scale assessed by parents and Chinese Health Questionnaire (CHQ). Safety will be monitored throughout the study.

Arms: arm 1: Participants willl receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.
Interventions: intervention 1: OROS Methylphenidate
Intervention descriptions: intervention 1: Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.

Protocol documents:
Clinical trial NCT00761202
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2007-08-01; Completion date: 2008-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.

Detailed description:

Arms: arm 1: Optive Eyedrops arm 2: Hylocomod Eyedrops
Interventions: intervention 1: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® intervention 2: Sodium hyaluronate
Intervention descriptions: intervention 1: Eyedrops as required, but at least 3 times per day intervention 2: Eyedrops as required, but at least 3 times per day

Protocol documents:
Clinical trial NCT00761930
Conditions: Gingival Diseases
Sponsor: Colgate Palmolive
Start date: 2008-03-01; Completion date: 2008-06-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Detailed description:

Arms: arm 1: commercially available Fluoride toothpaste arm 2: fluoride/triclosan/copolymer toothpaste arm 3: fluoride/herbal toothpaste
Interventions: intervention 1: Fluoride intervention 2: Triclosan and fluoride intervention 3: Herbal Ingredient and fluoride
Intervention descriptions: intervention 1: Brush twice daily intervention 2: Brush twice daily intervention 3: Brush twice daily

Protocol documents:
Clinical trial NCT00762853
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Start date: 2008-05-01; Completion date: 2008-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective is to develop a method to determine active ingredient uptake in oral care products.

Detailed description:

Arms: arm 1: fluoride toothpaste from Thailand arm 2: fluoride/triclosan/copolymer toothpaste
Interventions: intervention 1: Fluoride intervention 2: Fluoride and triclosan
Intervention descriptions: intervention 1: Brush half mouth once with assigned study treatment intervention 2: Brush half mouth once with assigned study treatment

Protocol documents:
Clinical trial NCT00775658
Conditions: Allergic Rhinitis Allergic Conjunctivitis
Keywords: allergy skin testing eye drops antihistamines
Sponsor: Vanderbilt University Medical Center
Start date: 2008-01-01; Completion date: 2008-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.

Detailed description:

Arms: arm 1: participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days arm 2: participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
Interventions: intervention 1: olopatadine intervention 2: placebo
Intervention descriptions: intervention 1: olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day intervention 2: placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day

Protocol documents:
Clinical trial NCT00957372
Conditions: Partial Epilepsy
Keywords: epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2004-12-01; Completion date: 2008-06-01
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.

Detailed description:
This was a phase III, 2-part multicenter study. Part I was an 26-week parallel-group, randomized, placebo-controlled design consisting of an 8 week baseline period, a 2 week double-blinded titration period, 12 week maintenance period, and a 4 week tapering-off period. After completing the baseline period, patients were randomized in a 1:1:1 ratio to 1 of the 2 ESL daily dose levels (1200 or 800 mg) or placebo.

Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day. Patients who completed Part II could participate in a study extension and continue treatment with ESL until marketing authorization is obtained or clinical development is discontinued, with visits scheduled at the discretion of the investigator but at least every 6 months.

Results from Part I \& II were presented in two separate reports.

Arms: arm 1: ESL 800mg daily arm 2: ESL 1200mg daily arm 3: placebo arm 4: All patients were treated with only ESL during Part II.
Interventions: intervention 1: eslicarbazepine acetate intervention 2: placebo (Part I) intervention 3: ESL - Open-label Extension (Part II)
Intervention descriptions: intervention 1: oral tablet, 800 mg or 1200 mg once daily intervention 2: once daily placebo comparator intervention 3: Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day

Protocol documents:
Clinical trial NCT01062971
Conditions: Primary Open Angle Glaucoma Ocular Hypertension
Keywords: Open-angle glaucoma Ocular hypertension POAG Treatment
Sponsor: Laboratorios Sophia S.A de C.V.
Start date: 2006-02-01; Completion date: 2008-06-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.

Detailed description:
This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination.

Arms: arm 1: IOP Dorzolamide-Timolol-Brimonidine group arm 2: IOP dorzolamide-timolol group
Interventions: intervention 1: dorzolamide-timolol-brimonidine
Intervention descriptions: intervention 1: Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will received 1 drop twice a day of either formulations.

Protocol documents:
Clinical trial NCT01211769
Conditions: Alcohol Dependence
Keywords: PUFAs Alcoholism Treatment Effectiveness
Sponsor: Federal University of São Paulo
Start date: 2006-02-01; Completion date: 2008-06-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.

Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients.

Detailed description:

Arms: arm 1: Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA; arm 2: Naltrexone chlorhydrate 50 mg arm 3: Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;

Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil. arm 4: Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;

Naltrexone chlorhydrate 50 mg
Interventions: intervention 1: Naltrexone intervention 2: PUFAs intervention 3: Placebo intervention 4: Naltrexone + Placebo
Intervention descriptions: intervention 1: A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil. intervention 2: Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone. intervention 3: A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil). intervention 4: A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.

Protocol documents:
Clinical trial NCT01365650
Conditions: Allergic Rhinitis
Sponsor: Egalet Ltd
Start date: 2007-12-01; Completion date: 2008-06-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was an open label, three way study in participants with symptomatic allergic rhinitis. The following 3 treatments were administered to each subject during dosing periods 1, 2 and 3, respectively:

* Treatment A: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 1.
* Treatment B: Single intranasal dose of oxymetazoline hydrochloride followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
* Treatment C: Seven days of treatment with intranasal fluticasone propionate (between Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 3.

Subjects remained resident in the Clinical Unit from Day 1 until the morning of Day 2 in each period and there was a washout period of 2 to 7 days between periods. A post study medical was performed within 7 days of Period 3.

The objectives of this study were:

* To assess the pharmacokinetics (PK) of intranasal ketorolac in participants with symptomatic allergic rhinitis.
* To assess the effects of a single dose of intranasal oxymetazoline hydrochloride on the pharmacokinetics and tolerability of intranasal ketorolac in participants with symptomatic allergic rhinitis.
* To assess the effects of chronic administration of fluticasone propionate on the bioavailability and tolerability of intranasal ketorolac in participants with symptomatic allergic rhinitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ketorolac Tromethamine intervention 2: Oxymetazoline Hydrochloride intervention 3: Fluticasone Propionate
Intervention descriptions: intervention 1: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 1 intervention 2: Single intranasal dose of oxymetazoline hydrochloride followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2 intervention 3: Seven days of treatment with intranasal fluticasone propionate (between Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 3

Protocol documents:
Clinical trial NCT01388543
Conditions: HIV
Keywords: Pharmacokinetics Clinical Pharmacology Pharmacogenomics HIV
Sponsor: University of Colorado, Denver
Start date: 2006-09-01; Completion date: 2008-06-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5 (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to people with the normal metabolizing genotype.

Detailed description:

Arms: arm 1: A pre-screening genetic test determines CYP3A5 expressor status arm 2: A pre-screening genetic test determines CYP3A5 non-expressor status
Interventions: intervention 1: Atazanavir
Intervention descriptions: intervention 1: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days

Protocol documents: