ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00379834
Conditions: Glaucoma
Keywords: glaucoma diurnal intraocular pressure
Sponsor: West Virginia University
Start date: 2006-09-01; Completion date: 2008-04-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Detailed description:
Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.

Arms: arm 1: Cosopt twice daily in both eyes
Interventions: intervention 1: Cosopt
Intervention descriptions: intervention 1: Cosopt twice daily in both eyes

Protocol documents:
Clinical trial NCT00389064
Conditions: Anxiety Disorders
Keywords: Generalised Anxiety Disorder GAD
Sponsor: AstraZeneca
Start date: 2006-09-01; Completion date: 2008-04-01
Enrollment: 450 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder.

PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed description:

Arms: arm 1: Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily. arm 2: Matching placebo tablets orally administered once daily.
Interventions: intervention 1: Quetiapine XR intervention 2: Placebo
Intervention descriptions: intervention 1: Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period. intervention 2: Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.

Protocol documents:
Clinical trial NCT00402103
Conditions: Hypertension
Keywords: Hypertension, aliskiren, amlodipine, HCTZ, blood pressure
Sponsor: Novartis
Start date: 2006-11-01; Completion date: 2008-04-01
Enrollment: 556 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration intervention 2: All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration intervention 3: Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

Protocol documents:
Clinical trial NCT00403585
Conditions: Hepatitis B, Chronic Chronic Hepatitis B
Keywords: Adefovir Dipivoxil(Hepsera) Chronic Hepatitis B (CHB)
Sponsor: GlaxoSmithKline
Start date: 2006-07-01; Completion date: 2008-04-01
Enrollment: 80 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of long term (up to 3 years) adefovir dipivoxil 10mg therapy.

Detailed description:

Interventions: intervention 1: adefovir dipivoxil 10mg
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00405964
Conditions: Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2006-09-01; Completion date: 2008-04-01
Enrollment: 716 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 5-mg Desloratadine intervention 2: Placebo tablet
Intervention descriptions: intervention 1: 5-mg Desloratadine tablet, once daily for 12 weeks intervention 2: Placebo tablet, once daily for 12 weeks

Protocol documents:
Clinical trial NCT00412113
Conditions: Dyslipidemia Hypertension
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-01-01; Completion date: 2008-04-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

Detailed description:

Arms: arm 1: Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks. arm 2: Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo. arm 3: Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks. arm 4: Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .
Interventions: intervention 1: Amlodipine besylate intervention 2: Amlodipine besylate/atorvastatin calcium single pill combination intervention 3: Amlodipine besylate intervention 4: Amlodipine besylate/atorvastatin calcium single pill combination
Intervention descriptions: intervention 1: Amlodipine besylate 5 mg intervention 2: Amlodipine/atorvastatin single pill combination 10/20 mg intervention 3: Amlodipine besylate 10 mg intervention 4: Amlodipine/atorvastatin single pill combination 5/20 mg

Protocol documents:
Clinical trial NCT00417248
Conditions: Non-Small Cell Lung Cancer
Sponsor: Nasser Hanna, M.D.
Start date: 2007-06-01; Completion date: 2008-04-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.

Detailed description:
Outline: This is a multi-center study.

Chemotherapy/radiation therapy (2 cycles)

* Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle
* Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle
* Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with the following:

Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year.

Patients with progressive disease will discontinue treatment.

ECOG performance status 0 or 1

Hematopoietic:

* Absolute neutrophil count (ANC) ≥ 1500 mm3
* Platelet count ≥ 100,000 mm3
* Hemoglobin ≥ 9 g/dL
* PT or INR \< 1.5 x ULN unless on anti-coagulant therapy
* PTT \< 1.5 x ULN unless on anti-coagulant therapy

Hepatic:

* Bilirubin ≤ 1.5 x ULN
* ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
* AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)

Renal:

* Creatinine \< 1.5 X upper limit of normal (ULN)

Cardiovascular:

* No significant history of cardiac disease: Congestive heart failure \> class II NYHA.
* Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within 90 days prior to registration for initial therapy) or myocardial infarction within 6 months prior to registration for initial therapy.

Respiratory:

* FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.

Arms: arm 1: Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer
Interventions: intervention 1: Cisplatin intervention 2: Etoposide intervention 3: Radiotherapy intervention 4: Sorafenib
Intervention descriptions: intervention 1: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle intervention 2: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle intervention 3: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) intervention 4: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months

Protocol documents:
Clinical trial NCT00427011
Conditions: Parkinson's Disease
Sponsor: Eisai Inc.
Start date: 2007-02-01; Completion date: 2008-04-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will receive active study drug. The study will involve outpatient visits only. Patients who completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria will be enrolled and enter the 12-week Titration Phase (from "Dispense Study Drug" at Week 0 \[Visit 2\] through Week 12 \[Visit 7\]) followed by the Maintenance Phase (from Week 12 \[Visit 7\] to end of study).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E2007
Intervention descriptions: intervention 1: E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.

Protocol documents:
Clinical trial NCT00433199
Conditions: Hypogonadism
Keywords: Hypogonadism Testosterone Deficiency
Sponsor: Abbott
Start date: 2007-02-01; Completion date: 2008-04-01
Enrollment: 274 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Detailed description:

Arms: arm 1: Placebo arm 2: Testosterone (T) gel 1.62%
Interventions: intervention 1: Testosterone (T) Gel 1.62% intervention 2: Placebo
Intervention descriptions: intervention 1: Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient. intervention 2: Placebo Control

Protocol documents:
Clinical trial NCT00442598
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer CA-125 Third-line Glufosfamide
Sponsor: Eleison Pharmaceuticals LLC.
Start date: 2007-01-01; Completion date: 2008-04-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objectives:

* To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer
* To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing

Secondary objectives:

* To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival
* To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment

Exploratory objective:

* To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Detailed description:
Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen.

In the weekly dosing schedule, treatment with glufosfamide 2,500 mg/m2 will be initiated only after the 1,660 mg/m2 treatment cohort has been enrolled and there is evidence that the dose of 1,660 mg/m2 has been well tolerated (See below Section on Pharmacokinetic/Statistical Analyses).

Arms: arm 1: 1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle arm 2: 1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle arm 3: 1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle
Interventions: intervention 1: Glufosfamide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00458211
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Ziprasidone
Sponsor: Bronx Psychiatric Center
Start date: 2005-05-01; Completion date: 2008-04-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Because ziprasidone has not been extensively studied and is not widely accepted in the severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who need a change of medication because of ineffectiveness or side effects will be changed to ziprasidone and followed with detailed assessments for eight weeks.

The hypothesis is that they will improve and have fewer side effects.

Detailed description:
Ziprasidone has been found in studies and practice to be efficacious and tolerated well but has not been well studied or well accepted in the very severely ill in State Hospitals. This study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective disorder who require a change of medication because of poor response or unacceptable side effects.

After signing consent and having a baseline assessment they will, if necessary, be reduced to one antipsychotic then started on ziprasidone, increasing to 160mg the second day. The one antipsychotic they had been on will be reduced over a week and stopped. The ziprasidone can be increased to 240mg after three weeks if necessary.

The study will last eight weeks with efficacy assessed by Clinical Global Impressions (CGI), Positive and Negative Syndrome Scale (PANSS) every two weeks and Brief Assessment of Cognition, Calgary Depression Scale for Schizophrenia, Personal Evaluation of Transitions in Treatment and Medical Outcomes Study Cognitive Questions at the beginning and end. Side effects will be measured by movement disorder scales (Simpson-Angus scale for Parkinsonism (SANRS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Scale (BAS)), ECG and weight and blood metabolic measures.

The hypothesis is that ziprasidone will be generally effective and that side effects especially metabolic indices will be reduced.

Arms: arm 1: Open label change to ziprasidone
Interventions: intervention 1: ziprasidone
Intervention descriptions: intervention 1: Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks

Protocol documents:
Clinical trial NCT00458835
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
Sponsor: Covis Pharma S.à.r.l.
Start date: 2007-04-01; Completion date: 2008-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out period. The study will provide further data on the safety and tolerability of ciclesonide.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ciclesonide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00460811
Conditions: Irritable Bowel Syndrome With Constipation
Keywords: Irritable Bowel Syndrome with Constipation IBS Irritable Bowel Syndrome linaclotide acetate linaclotide MD-1100
Sponsor: Ironwood Pharmaceuticals, Inc.
Start date: 2007-04-01; Completion date: 2008-04-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Linaclotide Acetate intervention 2: Matching placebo
Intervention descriptions: intervention 1: Oral, once daily intervention 2: Oral, once daily

Protocol documents:
Clinical trial NCT00467649
Conditions: Type 2 Diabetes Mellitus
Keywords: Symlin Amylin insulin Humalog Novolog Apidra
Sponsor: AstraZeneca
Start date: 2007-05-01; Completion date: 2008-04-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pramlintide acetate (Symlin) intervention 2: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) intervention 3: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Intervention descriptions: intervention 1: subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals intervention 2: subcutaneous injection, dosing based on titration guidelines intervention 3: subcutaneous injection, dosing based on titration guidelines

Protocol documents:
Clinical trial NCT00469092
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2007-05-01; Completion date: 2008-04-01
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: biphasic insulin aspart intervention 2: insulin glargine intervention 3: metformin intervention 4: glimepiride
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. intervention 2: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. intervention 3: Tablets, 2550 mcg. Administered once daily. intervention 4: Tablets 2 mg. 4, 6 or 8 mg administered once daily.

Protocol documents:
Clinical trial NCT00476151
Conditions: Diabetic Peripheral Neuropathy Neuralgia
Keywords: DPN Diabetic Nerve Pain
Sponsor: EpiCept Corporation
Start date: 2007-07-01; Completion date: 2008-04-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.

Detailed description:
This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN).

Arms: arm 1: vehicle cream arm 2: active topical cream
Interventions: intervention 1: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream intervention 2: placebo cream
Intervention descriptions: intervention 1: topical cream applied daily for 4 weeks intervention 2: inactive placebo cream applied two times daily

Protocol documents:
Clinical trial NCT00477451
Conditions: Treatment of Induced Panic Attack
Keywords: Staccato™ Alprazolam, Panic Attack, Inhaled alprazolam
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2007-05-01; Completion date: 2008-04-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in patients with panic disorder.

Detailed description:
The study will be conducted at multiple centers. A total of 42 male and female panic disorder patients will be studied. The first 6 subjects will receive Staccato Alprazolam 1 mg open label to validate the dose selection. The remaining 36 subjects will be treated with either Staccato Alprazolam at the chosen dose; or with Staccato Placebo in a double blind, randomized order.

Arms: arm 1: Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial arm 2: Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial arm 3: Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation arm 4: Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment
Interventions: intervention 1: Inhaled placebo intervention 2: Inhaled alprazolam 1 mg intervention 3: Inhaled alprazolam 2 mg intervention 4: IV doxapram
Intervention descriptions: intervention 1: Inhaled Staccato Alprazolam Placebo intervention 2: Inhaled Staccato Alprazolam 1 mg intervention 3: Inhaled Staccato Alprazolam 2 mg intervention 4: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo

Protocol documents: