ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00835198
Conditions: Acne Vulgaris
Sponsor: Allergan
Start date: 2008-12-01; Completion date: 2009-08-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris

Detailed description:

Arms: arm 1: Dapsone gel 5% and Tretinoin gel 0.025% arm 2: Tretinoin gel 0.025%
Interventions: intervention 1: Dapsone; Tretinoin intervention 2: Tretinoin
Intervention descriptions: intervention 1: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks intervention 2: Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks

Protocol documents:
Clinical trial NCT00843986
Conditions: Hyponatremia Acute Decompensated Heart Failure
Keywords: hyponatremia euvolemic hyponatremia hypervolemic hyponatremia acute decompensated heart failure conivaptan Vaprisol
Sponsor: Cumberland Pharmaceuticals
Start date: 2009-04-01; Completion date: 2009-08-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).

Detailed description:
Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate urine output.

Arms: arm 1: Matching loading dose and continuous intravenous infusion for 48 hours arm 2: 20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
Interventions: intervention 1: conivaptan intervention 2: placebo
Intervention descriptions: intervention 1: Premix bag intervention 2: Premix bag

Protocol documents:
Clinical trial NCT00846391
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-01; Completion date: 2009-08-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.

Detailed description:

Arms: arm 1: MK8245 arm 2: MK8245 arm 3: Placebo
Interventions: intervention 1: MK8245 5 mg (twice a day) b.i.d. intervention 2: MK8245 50 mg b.i.d. intervention 3: Placebo
Intervention descriptions: intervention 1: All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.

Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening. intervention 2: All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.

Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening. intervention 3: All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.

Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.

Protocol documents:
Clinical trial NCT00852761
Conditions: Plaque-Type Psoriasis
Keywords: Psoriasis
Sponsor: Stiefel, a GSK Company
Start date: 2009-03-01; Completion date: 2009-08-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.

Detailed description:
This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.

Arms: arm 1: Olux-E (clobetasol propionate 0.05%) foam arm 2: Clobex (clobetasol propionate 0.05%) lotion.
Interventions: intervention 1: Olux-E Foam intervention 2: Clobex lotion
Intervention descriptions: intervention 1: Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15. intervention 2: Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15

Protocol documents:
Clinical trial NCT00853242
Conditions: Kidney Failure, Chronic
Keywords: Chronic Kidney Disease Phosphate Binder Phosphate Hyperphosphatemia
Sponsor: Genzyme, a Sanofi Company
Start date: 2009-02-01; Completion date: 2009-08-01
Enrollment: 349 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.

Detailed description:

Arms: arm 1: Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks. arm 2: Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. arm 3: Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. arm 4: Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. arm 5: Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. arm 6: Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. arm 7: Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Interventions: intervention 1: Placebo intervention 2: Genz-644470 intervention 3: Sevelamer carbonate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00853567
Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Sponsor: Repros Therapeutics Inc.
Start date: 2009-02-01; Completion date: 2009-08-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Detailed description:
Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Arms: arm 1: 25 mg oral daily dose of Proellex arm 2: 50 mg oral daily dose of Proellex arm 3: Placebo treatment
Interventions: intervention 1: Proellex intervention 2: placebo
Intervention descriptions: intervention 1: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo intervention 2: Placebo

Protocol documents:
Clinical trial NCT00853957
Conditions: Hypertension
Keywords: Hypertension African Americans Aliskiren Amlodipine Systolic blood pressure Diastolic blood pressure Stage II Combination
Sponsor: Novartis
Start date: 2009-02-01; Completion date: 2009-08-01
Enrollment: 443 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.

Detailed description:

Arms: arm 1: Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg arm 2: Amlodipine 5mg titrated to 10 mg
Interventions: intervention 1: Aliskiren/Amlodipine intervention 2: Amlodipine
Intervention descriptions: intervention 1: Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg intervention 2: Amlodipine 5 mg titrated to 10mg

Protocol documents:
Clinical trial NCT00854061
Conditions: Cataract
Sponsor: Bausch & Lomb Incorporated
Start date: 2009-02-01; Completion date: 2009-08-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study of T-PRED(TM) Compared to Pred Forte(R)

Detailed description:
This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.

The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.

Arms: arm 1: Tobramycin prednisolone acetate combination arm 2: Prednisolone acetate
Interventions: intervention 1: T-Pred intervention 2: Pred Forte
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution

Protocol documents:
Clinical trial NCT00856908
Conditions: Type II Diabetes
Keywords: Type II Diabetes
Sponsor: AstraZeneca
Start date: 2009-02-01; Completion date: 2009-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin

Detailed description:

Arms: arm 1: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days arm 2: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
Interventions: intervention 1: AZD1656 intervention 2: Placebo
Intervention descriptions: intervention 1: Tolerable dose given twice daily intervention 2: Tolerable dose given twice daily

Protocol documents:
Clinical trial NCT00857454
Conditions: Hypogonadism
Sponsor: Eli Lilly and Company
Start date: 2008-10-01; Completion date: 2009-08-01
Enrollment: 71 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08 (NCT00702650) trial.

Detailed description:

Arms: arm 1: In this open-label extension of the MTE08 trial, participants received Testosterone Metered Dose (MD)-Lotion for 60 days (dosing from Day 121 of the MTE08 trial to Day 180 of the MTE09 trial). Participants in MTE08 initially received 3.0 milliliters (mL) (60 micrograms \[mg\]) of 2% Testosterone MD-Lotion, and may have had their dose of testosterone adjusted upwards or downwards.

Doses could be titrated to one of the following:

1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied daily by 2 doses to the axilla (1.5 mL to one axilla).

3.0 mL (60 mg)of 2% Testosterone MD-Lotion applied daily by 2 doses to the axilla (1.5 mL to each axilla).

4.5 mL (90 mg)of 2% Testosterone MD-Lotion applied daily by 3 doses to the axilla (2 x 1.5 mL to one axilla and 2 x 1.5 mL to the other axilla).

6.0 (120 mg)of 2% Testosterone MD-Lotion applied daily by 4 doses to the axilla (2 x 1.5 mL to each axilla).
Interventions: intervention 1: Testosterone MD-Lotion
Intervention descriptions: intervention 1: 30 mg to 120 mg administered topically once daily for 60 days

Protocol documents:
Clinical trial NCT00857623
Conditions: Pain Diabetic Neuropathy
Keywords: Pain Diabetic Neuropathy PDN Analgesia Efficacy
Sponsor: AstraZeneca
Start date: 2009-02-01; Completion date: 2009-08-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD2066 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28. intervention 2: Capsule, once daily

Protocol documents:
Clinical trial NCT00859313
Conditions: Pain, Postoperative
Sponsor: Talphera, Inc
Start date: 2009-04-01; Completion date: 2009-08-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery.

Another goal of this study is to assess the safety and effectiveness of this non-invasive, sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient experiences following knee replacement surgery.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sufentanil NanoTab PCA System/15 mcg
Intervention descriptions: intervention 1: 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

Protocol documents:
Clinical trial NCT00860795
Conditions: Upper Respiratory Tract Infections
Keywords: Echinacea prevention immune modulation
Sponsor: University of Washington
Start date: 2009-03-01; Completion date: 2009-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving the Echinacea will have evidence of immune stimulation and those receiving placebo will not.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Echinacea purpurea intervention 2: placebo
Intervention descriptions: intervention 1: Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days intervention 2: placebo 25 ml daily in 2 divided doses for 10 days

Protocol documents:
Clinical trial NCT00861601
Conditions: Liver Diseases
Sponsor: GlaxoSmithKline
Start date: 2009-01-01; Completion date: 2009-08-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open label, multi-centre, dose ranging study to assess efficacy, safety and pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease.

Detailed description:

Arms: arm 1: eltrombopag 12.5 mg/day arm 2: eltrombopag 25 mg/day arm 3: eltrombopag 37.5 mg/day
Interventions: intervention 1: eltrombopag 12.5 milligrams (mg) tablet intervention 2: eltrombopag 25 mg tablet
Intervention descriptions: intervention 1: eltrombopag 12.5 mg tablet once a day intervention 2: eltrombopag 25 mg tablet once a day

Protocol documents:
Clinical trial NCT00862849
Conditions: Diabetes Mellitus
Keywords: rHuPH20 Recombinant Human Hyaluronidase Insulin Lispro Regular Human Insulin
Sponsor: Halozyme Therapeutics
Start date: 2009-03-01; Completion date: 2009-08-01
Enrollment: 22 participants; Allocation: ; Intervention model: CROSSOVER

Brief summary:
Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with both insulin lispro and regular human insulin in order to determine if it improves the absorption of these insulins to more closely mimic the body's natural increase in insulin in response to a meal.

Detailed description:
The purpose of this study is to compare the pharmacokinetics (absorption, distribution, breakdown and elimination) of regular human insulin + recombinant human hyaluronidase (rHuPH20) versus insulin lispro alone, and to compare the pharmacokinetics of insulin lispro + rHuPH20 versus insulin lispro alone. The effects of regular human insulin + rHuPH20, insulin lispro + rHuPH20, and insulin lispro alone on the body will be evaluated by blood glucose measurements and by calculating the rate at which a glucose solution is infused to maintain blood glucose within a certain range. The safety and tolerability of insulin lispro with and without rHuPH20 and regular human insulin with rHuPH20 will be studied. The study drugs will be administered by subcutaneous (under the skin) injection.

Arms: arm 1: All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C).

Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)

Intervention B: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20

Intervention C: a single, SC injection of 0.15 U/kg insulin lispro alone

There was a washout period of 3 to 14 days between interventions.

The treatment sequence (ABC, ACB, BAC, BCA, CAB, or CBA) was repeated once so that each participant received up to 6 injections.
Interventions: intervention 1: Insulin Lispro intervention 2: Regular Human Insulin intervention 3: rHuPH20
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00863551
Conditions: Elderly Pharmacokinetics Overactive Bladder
Sponsor: Allergan
Start date: 2009-04-01; Completion date: 2009-08-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.

Detailed description:

Arms: arm 1: Trospium Chloride Extended Release, 60 mg
Interventions: intervention 1: Trospium Chloride
Intervention descriptions: intervention 1: Extended release, 60 mg, oral daily

Protocol documents:
Clinical trial NCT00867490
Conditions: Hypertension
Keywords: Hypertension aliskiren cardiovascular diseases
Sponsor: Novartis
Start date: 2009-03-01; Completion date: 2009-08-01
Enrollment: 186 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.

Detailed description:
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg

Arms: arm 1: None
Interventions: intervention 1: Candesartan+HCTZ - Phase 1 intervention 2: Aliskiren+HCTZ - Phase 2 intervention 3: Aliskiren+HCTZ+amlodipine - Phase 3
Intervention descriptions: intervention 1: 4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am. intervention 2: Patients with uncontrolled mean sitting diastolic blood pressure (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am. intervention 3: The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg in a single tablet plus an amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.

Protocol documents:
Clinical trial NCT00881608
Conditions: Amenorrhea
Keywords: Menstruation
Sponsor: Repros Therapeutics Inc.
Start date: 2009-02-01; Completion date: 2009-08-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.

Detailed description:
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally

Arms: arm 1: Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. arm 2: First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18. arm 3: Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18. arm 4: Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18. arm 5: Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
Interventions: intervention 1: Placebo intervention 2: Proellex
Intervention descriptions: intervention 1: Placebo, 1 capsule daily for five days intervention 2: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days

Protocol documents: