ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00669071
Conditions: Melasma
Sponsor: Galderma R&D
Start date: 2008-01-01; Completion date: 2008-10-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.

Detailed description:
Same as above.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% intervention 2: Cetaphil® Moisturizing Cream as Inactive Control
Intervention descriptions: intervention 1: Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face. intervention 2: Applied once daily at bedtime on the opposite side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.

Protocol documents:
Clinical trial NCT00676676
Conditions: Depression
Keywords: Depression Major Depressive Disorder
Sponsor: Massachusetts General Hospital
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine whether adding a low dose of testosterone to current antidepressant therapy improves depression and fatigue in women who remain depressed despite necessary adequate doses of anti-depressants. Testosterone will be given over an 8-week period.

Testosterone is a hormone that occurs naturally in the body. In women it comes from the ovaries and adrenal glands and is found in amounts that are ten to twenty times lower than in men.

In early research studies, testosterone has been shown to have some antidepressant effects in the following groups of subjects:

* Women with anorexia nervosa
* Women who have low testosterone levels because their pituitary glands do not work
* Men with Selective Serotonin Reuptake Inhibitor (SSRI)-resistant depression.

However, testosterone administration in women with SSRI or Serotonin-norepinephrine reuptake inhibitor (SNRI) -resistant depression has not been studied.

Detailed description:

Arms: arm 1: Testosterone patch delivering 300mcg daily for 8-weeks.
Interventions: intervention 1: Testosterone
Intervention descriptions: intervention 1: Testosterone atch delivering 300mcg daily for 8-weeks

Protocol documents:
Clinical trial NCT00683930
Conditions: Pemphigus Vulgaris (PV)
Sponsor: Hoffmann-La Roche
Start date: 2004-05-01; Completion date: 2008-10-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients had their corticosteroid dose gradually reduced if they responded to treatment. The anticipated time on study treatment was 12 months, and the target sample size was \<100 individuals.

Detailed description:

Arms: arm 1: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks arm 2: Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks arm 3: None
Interventions: intervention 1: Mycophenolate Mofetil 2 g/Day intervention 2: Mycophenolate Mofetil (MMF) 3 g/Day intervention 3: Placebo
Intervention descriptions: intervention 1: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks intervention 2: Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks intervention 3: Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks

Protocol documents:
Clinical trial NCT00689481
Conditions: Psoriasis
Keywords: Plaque-type Psoriasis psoriasis
Sponsor: Stiefel, a GSK Company
Start date: 2008-03-01; Completion date: 2008-10-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.

Detailed description:

Arms: arm 1: U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. arm 2: Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Interventions: intervention 1: U0267 Foam intervention 2: Vehicle foam
Intervention descriptions: intervention 1: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). intervention 2: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

Protocol documents:
Clinical trial NCT00691808
Conditions: Age-Related Memory Disorders
Sponsor: Lexicon Pharmaceuticals
Start date: 2008-02-01; Completion date: 2008-10-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: LX6171 High Dose intervention 2: LX6171 Low Dose intervention 3: Placebo
Intervention descriptions: intervention 1: A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. intervention 2: A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. intervention 3: Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.

Protocol documents:
Clinical trial NCT00692341
Conditions: Hepatic Insufficiency
Keywords: hepatic impairment
Sponsor: Pfizer
Start date: 2008-05-01; Completion date: 2008-10-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.

Detailed description:

Arms: arm 1: Subjects with mild hepatic impairment (Child Pugh class A, score 5-6) arm 2: Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9) arm 3: Group 1

1\) subjects with normal hepatic function
Interventions: intervention 1: AG-013736 intervention 2: AG-013736 intervention 3: AG-013736
Intervention descriptions: intervention 1: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet. intervention 2: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet. intervention 3: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Protocol documents:
Clinical trial NCT00693654
Conditions: Pruritis
Keywords: Uremic Pruritis
Sponsor: Wake Forest University
Start date: 2006-11-01; Completion date: 2008-10-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled comparative trial.

Detailed description:
This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil lotion). A target lesion limited to one anatomic site, excluding face and genitals, was selected at baseline. Each subject was instructed to apply lotion twice daily to all affected areas of pruritus for four weeks. The use of any other topical or systemic medication to treat uremic pruritus was not permitted while participating in the study. Subjects were clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline, week 1, and week 4 (end of study)

Arms: arm 1: 1% pramoxine Sarna lotion arm 2: Placebo Cetaphil lotion
Interventions: intervention 1: Sarna intervention 2: Cetaphil
Intervention descriptions: intervention 1: Active Ingredient: Pramoxine Hydrochloride Inactive ingredients:Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate (\&) PEG-100 Stearate, Isopropyl Myristate, Petrolatum, PEG 8 Stearate, Purified Water, Stearic Acid, Sodium Hydroxide intervention 2: Purified Water, Glycerin, Hydrogenated Polyisobutene, Cetearyl Alcohol, Ceteareth 20, Macadamia Nut Oil, Dimethicone, Tocopheryl Acetate, Stearoxytrimethylsilane, Stearyl Alcohol, Panthenol, Farnesol, Benzyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Citric Acid

Protocol documents:
Clinical trial NCT00696488
Conditions: Actinic Keratosis
Sponsor: Wake Forest University
Start date: 2007-04-01; Completion date: 2008-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.

Detailed description:
The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System

Arms: arm 1: each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions
Interventions: intervention 1: Fluorouracil 0.5%
Intervention descriptions: intervention 1: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions

Protocol documents:
Clinical trial NCT00699608
Conditions: Healthy Subjects Sleep Initiation and Maintenance Disorders
Keywords: Zopiclone Hypnotic Residual effects Eszopiclone
Sponsor: GlaxoSmithKline
Start date: 2008-07-01; Completion date: 2008-10-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.

Detailed description:

Arms: arm 1: All subjects received all three treatments in a randomised order
Interventions: intervention 1: GSK1755165; placebo; zopiclone
Intervention descriptions: intervention 1: Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone

Protocol documents:
Clinical trial NCT00700063
Conditions: Actinic Keratosis
Keywords: Peplin Actinic keratosis PEP005
Sponsor: Peplin
Start date: 2008-06-01; Completion date: 2008-10-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: PEP005 Topical Gel intervention 2: PEP005 Topical Gel intervention 3: PEP005 Topical Gel intervention 4: Vehicle gel intervention 5: PEP005 Topical Gel intervention 6: PEP005 Topical Gel intervention 7: PEP005 Topical Gel intervention 8: Vehicle gel
Intervention descriptions: intervention 1: 0.005%, two days treatment intervention 2: 0.01%, two days treatment intervention 3: 0.015%, two days treatment intervention 4: two days treatment intervention 5: 0.005%, three days treatment intervention 6: 0.01%, three days treatment intervention 7: 0.015%, three days treatment intervention 8: three days treatment

Protocol documents:
Clinical trial NCT00707057
Conditions: Pain Post-Operative Pain Third Molar Extraction
Sponsor: SCOLR Pharma, Inc.
Start date: 2008-06-01; Completion date: 2008-10-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.

Detailed description:
This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded, parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. The surgery will consist of surgical extraction of 1-2 impacted third molars, of which one must be a mandibular impaction that is partially impacted in either tissue or bone. Subjects will be stratified according to baseline pain intensity, as rated on an 11-point pain intensity numerical rating scale (PI-NRS)and gender.

Arms: arm 1: One-hundred and sixty subjects will be randomly assigned to the Ibuprofen 600 mg ER treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain). arm 2: Eighty subjects will be randomly assigned to the Placebo treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain).
Interventions: intervention 1: Ibuprofen 600 mg Extended-Release Tablets intervention 2: Placebo
Intervention descriptions: intervention 1: Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36. intervention 2: Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.

Protocol documents:
Clinical trial NCT00708305
Conditions: Dental Caries
Keywords: toothpaste plaque fluid fluoride
Sponsor: GlaxoSmithKline
Start date: 2008-06-01; Completion date: 2008-10-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF) containing toothpastes in prevention of dental caries. Change from baseline fluoride data at various time points up to four hours after a single brushing with NaF containing toothpastes will be evaluated.

Detailed description:
Topical fluorides in a wide variety of delivery systems have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that fluoride has its anti-caries effect mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. There is a general consensus that level of fluoride in plaque fluid, may be directly related to the anti caries effects of fluoride. Also, fluoride levels in the oral fluids decrease rapidly after topical fluoride application, mainly due to the diluting and washing effect of saliva followed by periodic swallowing. To evaluate fluoride content, plaque samples will be collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride will be calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis.

Arms: arm 1: Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. arm 2: Participants brushed for one timed minute with 1.6g of NaF toothpaste containing 1400ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. arm 3: Participants brushed for one timed minute with 1.6g of NaMFP/NaF toothpaste containing 1450ppmF from NaMFP and NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. arm 4: Participants brushed for one timed minute with 1.6g of fluoride free toothpaste. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Interventions: intervention 1: Sodium Fluoride (NaF) intervention 2: Placebo
Intervention descriptions: intervention 1: Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF intervention 2: Fluoride free toothpaste (0ppmF)

Protocol documents:
Clinical trial NCT00719810
Conditions: Skin Structure Infections Bacterial Skin Diseases Staphylococcal Skin Infections
Keywords: complicated skin
Sponsor: Melinta Therapeutics, Inc.
Start date: 2008-06-01; Completion date: 2008-10-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: delafloxacin intervention 2: delafloxacin intervention 3: tigecycline
Intervention descriptions: intervention 1: 300 mg intravenous every 12 hours intervention 2: 450 mg intravenous every 12 hours intervention 3: 100 mg then 50 mg intravenous tigecycline every 12 hours

Protocol documents:
Clinical trial NCT00721955
Conditions: Bipolar I Disorder
Keywords: Bipolar 1 disorder, agitation, acute, treatment
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2008-07-01; Completion date: 2008-10-01
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

Detailed description:
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Arms: arm 1: Inhaled Staccato Placebo, may repeat after 2 hours x 2 arm 2: Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2 arm 3: Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled loxapine 5 mg intervention 3: Inhaled loxapine 10 mg
Intervention descriptions: intervention 1: Inhaled loxapine Placebo, may repeat after 2 hours x 2 intervention 2: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2 intervention 3: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

Protocol documents:
Clinical trial NCT00728416
Conditions: Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2008-08-01; Completion date: 2008-10-01
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray
Interventions: intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray
Intervention descriptions: intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Protocol documents:
Clinical trial NCT00728689
Conditions: Orthopoxviral Disease Smallpox Monkey Pox
Keywords: Orthopoxviral Smallpox Monkey pox
Sponsor: SIGA Technologies
Start date: 2008-08-01; Completion date: 2008-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.

Detailed description:
This was a Phase I, double-blind, cross-over, single-dose study of the orally administered anti-orthopoxvirus compound, ST-246, to 12 healthy, fed volunteers between the ages of 18 and 50 years. Subjects were randomized such that 6 subjects received either ST-246 Form I (monohydrate) followed 10 days later after a wash-out period by Form V (hemihydrate), and 6 subjects received ST-246 Form V followed by Form I, as for the previous group.

Both forms of ST-246 were similar in the way they were manufactured. The only difference between Form I and Form V may be related to how it dissolves, and this may affect the way that it is absorbed in the human body. Information about any side-effects that may occur will also be collected in this study.

Arms: arm 1: Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemihydrate). Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat. arm 2: Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemihydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate). Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
Interventions: intervention 1: ST-246 Days 1 - 3 intervention 2: ST-246 Days 11 - 13
Intervention descriptions: intervention 1: First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2). intervention 2: Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 patients previously given ST-246 Form I (Arm 1) are now dosed once orally with ST-246 Form V, and the 6 patients previously given ST-246 Form V (Arm 2) are now dosed once orally with ST-246 Form I.

Protocol documents: