ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00423176
Conditions: Sinusitis
Sponsor: Organon and Co
Start date: 2006-12-01; Completion date: 2008-06-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography \[CT\] imaging of the sinuses).

Detailed description:

Arms: arm 1: Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID. arm 2: Matching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID
Interventions: intervention 1: MFNS and antibiotic intervention 2: Matching Placebo nasal spray plus antibiotic
Intervention descriptions: intervention 1: MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days intervention 2: Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days

Protocol documents:
Clinical trial NCT00440505
Conditions: Pelvic Pain
Keywords: chronic pain pelvic pain nicotine patch
Sponsor: Columbia University
Start date: 2004-02-01; Completion date: 2008-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.

Detailed description:
Potential subjects are female non-smokers presenting to their physicians for treatment of chronic pelvic pain. When consented, the subjects fill out a questionnaire on demographic information and pain experience. The trial is conducted at home over three days. Each subject uses three different levels of nicotine (0mg, 5mg, and 10mg) administered in a random order; the study is double-blinded and patients act as their own controls. Subjects apply the placebo or nicotine patches in the morning and remove them in the evening when they fill out a pain diary for the day. During the study, patients will continue their typical course of pain medication and report pain medication use in the pain diary.

Arms: arm 1: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. arm 2: Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. arm 3: Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
Interventions: intervention 1: Placebo intervention 2: Nicotine (5 mg) intervention 3: Nicotine (10 mg)
Intervention descriptions: intervention 1: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. intervention 2: Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. intervention 3: Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

Protocol documents:
Clinical trial NCT00441584
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-07-01; Completion date: 2008-06-01
Enrollment: 117 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve sustained virological response (SVR) when treated with PegIntron plus Rebetol.

Detailed description:

Arms: arm 1: PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
Interventions: intervention 1: PegIntron (peginterferon alfa-2b) intervention 2: Rebetol (ribavirin)
Intervention descriptions: intervention 1: Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 2: 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks

Protocol documents:
Clinical trial NCT00443261
Conditions: Squamous Cell Carcinoma
Keywords: Head and Neck Cancer
Sponsor: University of Kansas Medical Center
Start date: 2007-02-01; Completion date: 2008-06-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN).

Detailed description:
Open-label, non-randomized and dose escalation study in which groups of 3-6 patients with squamous cell carcinoma of the head and neck will receive sequentially increased dosages of azacitidine SC injection in combination with a fixed dose of cisplatin IV injection until dose-limiting toxicity is demonstrated in 2 of the 6 patients.

Arms: arm 1: Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Patients will receive Azacitidine and cisplatin.
Interventions: intervention 1: Azacitidine intervention 2: Cisplatin
Intervention descriptions: intervention 1: SC azacitidine intervention 2: cisplatin 75 mg/m\^2 day 8 every 28 days

Protocol documents:
Clinical trial NCT00443456
Conditions: Hypertension
Sponsor: Pfizer
Start date: 2007-05-01; Completion date: 2008-06-01
Enrollment: 134 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

Detailed description:
NCT00415623 (protocol A0531085)

Arms: arm 1: None
Interventions: intervention 1: Amlodipine
Intervention descriptions: intervention 1: Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

Protocol documents:
Clinical trial NCT00443820
Conditions: Onychomycosis
Keywords: Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2008-06-01
Enrollment: 526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

Detailed description:

Arms: arm 1: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks arm 2: Vehicle (placebo) for 48 weeks arm 3: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks arm 4: Vehicle (placebo) for 24 weeks
Interventions: intervention 1: terbinafine intervention 2: Placebo intervention 3: terbinafine intervention 4: Placebo
Intervention descriptions: intervention 1: Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks intervention 2: Vehicle (placebo) once daily for 48 weeks intervention 3: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks intervention 4: Vehicle (placebo) once daily for 24 weeks

Protocol documents:
Clinical trial NCT00443898
Conditions: Onychomycosis
Keywords: Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2008-06-01
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

Detailed description:

Arms: arm 1: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks arm 2: vehicle (placebo) applied once daily for 48 weeks arm 3: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks arm 4: vehicle (placebo) applied once daily for 24 weeks
Interventions: intervention 1: terbinafine intervention 2: Placebo intervention 3: terbinafine intervention 4: Placebo
Intervention descriptions: intervention 1: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks intervention 2: vehicle (placebo) applied once daily for 48 weeks intervention 3: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks intervention 4: vehicle (placebo) applied once daily for 24 weeks

Protocol documents:
Clinical trial NCT00445315
Conditions: Hepatitis C
Sponsor: Pfizer
Start date: 2007-01-01; Completion date: 2008-06-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: PF-00868554 intervention 2: PF-00868554 intervention 3: PF-00868554 intervention 4: PF-00868554 intervention 5: Placebo
Intervention descriptions: intervention 1: 300 mg BID intervention 2: 450 mg BID intervention 3: 100 mg BID intervention 4: 300 mg TID intervention 5: Placebo

Protocol documents:
Clinical trial NCT00457015
Conditions: Hereditary Angioedema (HAE)
Sponsor: Shire
Start date: 2007-04-01; Completion date: 2008-06-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.

Detailed description:
This is a randomized placebo-controlled trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. This study is conducted under Special Protocol Assessment with the FDA and is designed to provide pivotal efficacy data on ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Arms: arm 1: DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections. arm 2: Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
Interventions: intervention 1: ecallantide intervention 2: Phosphate Buffer Saline (PBS), pH 7.0
Intervention descriptions: intervention 1: dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections. intervention 2: given as three 1mL subcutaneous injections.

Protocol documents:
Clinical trial NCT00461123
Conditions: Prostatic Hypertrophy, Benign
Sponsor: Bayer
Start date: 2007-03-01; Completion date: 2008-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of the laser application and consequently shortening of the required duration of laser application.

Detailed description:

Arms: arm 1: One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. arm 2: One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
Interventions: intervention 1: Vardenafil (Levitra, BAY38-9456) intervention 2: Placebo
Intervention descriptions: intervention 1: One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. intervention 2: One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.

Protocol documents:
Clinical trial NCT00465569
Conditions: Milk Hypersensitivity
Keywords: Food Allergy Oral Immunotherapy Immunoglobulin E
Sponsor: Johns Hopkins University
Start date: 2006-08-01; Completion date: 2008-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.

Detailed description:
This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Bloodwork, skin prick tests (SPTs), pulmonary function tests (PFTs), and oral secretion samples will be done initially and at periodic intervals.

Arms: arm 1: Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians arm 2: None
Interventions: intervention 1: cow's milk powder intervention 2: Placebo
Intervention descriptions: intervention 1: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks intervention 2: None

Protocol documents:
Clinical trial NCT00468559
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: pediatrics neonates
Sponsor: AstraZeneca
Start date: 2007-04-01; Completion date: 2008-06-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.

Detailed description:

Arms: arm 1: This is an open label, run-in phase. All patients received Esomeprazole. arm 2: This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. arm 3: This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.
Interventions: intervention 1: Open Label Run In Esomeprazole intervention 2: Double Blind Esomeprazole intervention 3: Double Blind Placebo
Intervention descriptions: intervention 1: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) intervention 2: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) intervention 3: Double Blind Placebo

Protocol documents:
Clinical trial NCT00475319
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Syndromes OPC-12759
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2007-05-01; Completion date: 2008-06-01
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients

Detailed description:

Arms: arm 1: 0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. arm 2: 1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. arm 3: 2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
Interventions: intervention 1: placebo intervention 2: 1% OPC-12759 ophthalmic suspension intervention 3: 2% OPC-12759 ophthalmic suspension
Intervention descriptions: intervention 1: comparison of different dosages of drug intervention 2: comparison of different dosages of drug intervention 3: comparison of different dosages of drug

Protocol documents:
Clinical trial NCT00475904
Conditions: Post Herpetic Neuralgia PHN Neuropathy Nerve Pain
Keywords: Post Herpetic Neuralgia PHN Neuropathy Nerve Pain Topical
Sponsor: EpiCept Corporation
Start date: 2007-07-01; Completion date: 2008-06-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)

Detailed description:
This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. Qualifying patients will be randomized on a 2:2:1 basis to NP-1, oral gabapentin, or placebo. The treatment period will be 4-Weeks.

Arms: arm 1: Np-1 cream and placebo gabapentin arm 2: gabapentin caps and placebo cream arm 3: placebo cream and capsules
Interventions: intervention 1: EpiCept-NP-1 Cream intervention 2: Gabapentin Capsules intervention 3: placebo
Intervention descriptions: intervention 1: ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks intervention 2: 1800mg/day capsules for 4 weeks intervention 3: placebo cream and caps

Protocol documents:
Clinical trial NCT00477152
Conditions: Dehydration
Keywords: dehydration fluid therapy pediatrics emergency medicine hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis subcutaneous hydration subcutaneous rehydration hyaluronan rHuPH20
Sponsor: Baxter Healthcare Corporation
Start date: 2007-08-01; Completion date: 2008-06-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

Detailed description:
Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC infusion over the first hour, and additional SC rehydration could be continued as clinically indicated. The preferred anatomic site for the SC infusion was the anterior thigh, unless there was an overriding preference for an alternate site.

The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum of 72 hours. The investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other assessments of effectiveness and safety were made directly during the rehydration period and ED stay, and by telephone on Days 3 and 7 after discharge from the ED.

Arms: arm 1: Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Interventions: intervention 1: hyaluronidase (human recombinant)/rehydration fluid
Intervention descriptions: intervention 1: Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.

Protocol documents:
Clinical trial NCT00491894
Conditions: Cerebral Palsy Neurological Conditions Mental Retardation Sialorrhea
Keywords: Mental Retardation Neurological Impairment Cerebral Palsy Drooling Neurological Conditions
Sponsor: Shionogi
Start date: 2007-03-01; Completion date: 2008-06-01
Enrollment: 137 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum benefit from the study drug (greatest improvement in drooling) while experiencing minimum side effects. All patients will receive close attention by study staff throughout the study.

Detailed description:

Arms: arm 1: Arm receiving study drug
Interventions: intervention 1: Oral Glycopyrrolate Liquid
Intervention descriptions: intervention 1: Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver

Protocol documents: