ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00274261
Conditions: Pregnancy
Keywords: contraception
Sponsor: Health Decisions
Start date: 2004-06-01; Completion date: 2008-09-01
Enrollment: 1565 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study treatment for up to twelve months (365 days) and twelve cycles of treatment upon completion of the first six months of treatment.

Detailed description:
Approximately 85% of American women (52 million) between the ages of 15 and 44 are sexually active . Approximately two-thirds or 38 million women use some form of birth control and/or STD prevention. With growing awareness of the risk of STDs, increasing numbers of women will require contraceptive methods that provide protection against STDs in addition to providing the basic contraceptive function. Currently there is no single, reasonably effective method to achieve both ends. Condoms, both male and female, present problems of acceptability for the partners of many at-risk women and, thus, cannot be considered an effective contraceptive and STD preventive for many people. A spermicide that also has the ability to prevent transmission of STDs would be a major advance, and of tremendous value to women worldwide.

C31G is an effective spermicide with in vitro activity equal to that of N-9 . C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. It is also active against enveloped viruses including HIV and HSV. Thus, the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol® Vaginal Gel. The secondary objectives are to determine the safety and acceptability of the compounds with use over a period of six months or twelve months. Additional evaluations include the incidence of urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol® Vaginal Gel.

Arms: arm 1: C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel arm 2: Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
Interventions: intervention 1: C31G intervention 2: nonoxynol-9 (N-9)
Intervention descriptions: intervention 1: The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study. intervention 2: The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.

Protocol documents:
Clinical trial NCT00287339
Conditions: Cough GERD
Keywords: Cough GERD
Sponsor: University of North Carolina, Chapel Hill
Start date: 2005-09-01; Completion date: 2008-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to investigate different doses of proton pump inhibitors in reducing cough symptoms felt to be associated with Gastroesophageal reflux disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by lowering the amount of acid in the stomach.

The proton pump inhibitor used in this study is called, Esomeprazole (brand name Nexium), and is already marketed for treating GERD. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation), belching and coughing. Even very small, unnoticeable amounts of rising stomach acid may cause patients to cough.

Because there may be a link between chronic cough and GERD, study doctors are interested in learning if giving high-dose Nexium (40 milligrams, twice daily) will help in treating chronic cough.

Detailed description:
This study will be a randomized, double-blind, placebo controlled, comparative parallel-group trial of subjects with chronic cough of unknown origin presenting to the Otolaryngology/ Head and Neck Surgery, Pulmonary Medicine, and Gastroenterology outpatient clinics at the University of North Carolina Hospital system.

Potential subjects with chronic cough of unknown origin will be identified through the above outpatient clinics. Those who meet the inclusion and exclusion criteria will be asked to join the study testing the efficacy of twice daily esomeprazole 40 mg taken for 3 months in the setting of chronic cough. Potential subjects will be consented for the study prior to leaving the enrolling clinic. A total of 40 subjects will be recruited into our study.

Arms: arm 1: 40mg Esomeprazole BID arm 2: placebo capsules
Interventions: intervention 1: Esomeprazole intervention 2: Placebo
Intervention descriptions: intervention 1: 40mg capsule BID for 12 weeks intervention 2: placebo capsule BID for 12 weeks

Protocol documents:
Clinical trial NCT00297102
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast COPD Chronic obstructive pulmonary disease
Sponsor: AstraZeneca
Start date: 2006-02-01; Completion date: 2008-09-01
Enrollment: 1523 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Detailed description:

Arms: arm 1: 500 mcg, once daily, oral administration in the morning arm 2: once daily
Interventions: intervention 1: Roflumilast intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mcg, once daily, oral administration in the morning intervention 2: once daily

Protocol documents:
Clinical trial NCT00306163
Conditions: Asthma
Keywords: Asthma AMP Ciclesonide Fluticasone propionate
Sponsor: AstraZeneca
Start date: 2006-05-01; Completion date: 2008-09-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Detailed description:

Arms: arm 1: Ciclesonide 160 µg arm 2: Fluticasone 100 µg
Interventions: intervention 1: Ciclesonide intervention 2: Fluticasone
Intervention descriptions: intervention 1: inhaled Ciclesonide 160 µg, once daily in the morning intervention 2: inhaled Fluticasone 100 µg, twice daily

Protocol documents:
Clinical trial NCT00306891
Conditions: Cancer
Keywords: Advanced solid tumours Advanced cancer tumor tumour RECENTIN
Sponsor: AstraZeneca
Start date: 2006-06-01; Completion date: 2008-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.

Detailed description:

Arms: arm 1: Part A: Cediranib 45 mg Fed State arm 2: Part A: Cediranib 45 mg Fasted State arm 3: Part B: Cediranib 45 mg Fixed Dose arm 4: Part B: Cediranib 30 - 90 mg Dose Escalation
Interventions: intervention 1: Cediranib intervention 2: Cediranib 30 - 90 mg
Intervention descriptions: intervention 1: 45 mg oral dose intervention 2: oral tablet dose escalation

Protocol documents:
Clinical trial NCT00309244
Conditions: Diabetes Type 2
Sponsor: Mannkind Corporation
Start date: 2006-02-01; Completion date: 2008-09-01
Enrollment: 677 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

Detailed description:

Arms: arm 1: Technosphere® Insulin Inhalation Powder + insulin glargine arm 2: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Interventions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Intervention descriptions: intervention 1: Inhalation, 15U/30U intervention 2: BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

Protocol documents:
Clinical trial NCT00313313
Conditions: Diabetes
Sponsor: AstraZeneca
Start date: 2006-04-01; Completion date: 2008-09-01
Enrollment: 768 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

Detailed description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Arms: arm 1: Metformin 500-2500 mg (as needed) arm 2: Metformin 500-2500 mg (as needed) arm 3: Metformin 500-2500 mg (as needed)
Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Glyburide intervention 4: Placebo intervention 5: Glyburide intervention 6: Metformin
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\]) intervention 2: Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT). intervention 3: Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) intervention 4: Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT) intervention 5: Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT) intervention 6: Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Protocol documents:
Clinical trial NCT00313820
Conditions: Central Neuropathic Pain
Keywords: Post-stroke pain, pregabalin
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-08-01; Completion date: 2008-09-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)

Detailed description:

Arms: arm 1: The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo. arm 2: The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13. intervention 2: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.

Protocol documents:
Clinical trial NCT00321893
Conditions: Lung Cancer
Keywords: Small cell lung cancer Non-small cell lung cancer Budesonide Entocort EC Pulmicort Respules Rhinocort aqua Aerosol budesonide treatment Smoking
Sponsor: National Cancer Institute (NCI)
Start date: 2006-01-01; Completion date: 2008-09-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.

PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo.

Secondary

* Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
* Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes.
* Determine treatment toxicity, side effects, and safety of inhaled budesonide.
* Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema.
* Determine the effect of inhaled budesonide on respiratory function before and after treatment.

OUTLINE: This is a randomized, double-blind, placebo controlled study.

Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid). Participants are randomized into 1 of 2 treatment arms.

* Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity.
* Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.

Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies.

After completion of study therapy, subjects are followed at 1 month and continue CT scan screening.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Arms: arm 1: Inhaled Budesonide 800 ug twice daily for 1 year arm 2: Inhaled placebo twice daily for 1 year
Interventions: intervention 1: Budesonide intervention 2: Placebo
Intervention descriptions: intervention 1: Inhaled Budesonide 800 micrograms (ug) twice daily for one year. intervention 2: Inhaled placebo twice daily for one year.

Protocol documents:
Clinical trial NCT00323310
Conditions: Central Nervous System Diseases
Keywords: disease of the central nervous system (brain or spine)
Sponsor: Bracco Diagnostics, Inc
Start date: 2006-04-01; Completion date: 2008-09-01
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: gadobenate dimeglumine
Intervention descriptions: intervention 1: A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.

Protocol documents:
Clinical trial NCT00329602
Conditions: Restless Legs Syndrome
Keywords: Moderate Restless Legs Syndrome Severe ropinirole
Sponsor: GlaxoSmithKline
Start date: 2006-03-01; Completion date: 2008-09-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.

Detailed description:
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.

Arms: arm 1: Double-blind (Ropinirole:Placebo) for 12 to 26 weeks arm 2: Open label ropinirole for 40 weeks
Interventions: intervention 1: Placebo intervention 2: Ropinirole
Intervention descriptions: intervention 1: Matching Placebo intervention 2: Ropinirole IR 0.25mg/day to 4mg/day for RLS

Protocol documents:
Clinical trial NCT00330681
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic lateral sclerosis free radical scavenger
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2006-05-01; Completion date: 2008-09-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.

Detailed description:

Arms: arm 1: MCI-186 arm 2: Placebo of MCI-186
Interventions: intervention 1: MCI-186 intervention 2: Placebo of MCI-186
Intervention descriptions: intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). intervention 2: Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Protocol documents:
Clinical trial NCT00332163
Conditions: Metastatic Colorectal Cancer Skin Rash Skin Toxicities Colon Cancer Colorectal Cancer
Keywords: STEPP STEP STEEP mCRC Skin Toxicities Skin Rash Metastatic Colorectal Cancer Anti-EGFr Skin Rash colon cancer colorectal cancer rectal cancer
Sponsor: Amgen
Start date: 2006-04-01; Completion date: 2008-09-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in patients with metastatic colorectal cancer (mCRC) who are receiving second-line irinotecan-based chemotherapy concomitantly with panitumumab.

Detailed description:

Arms: arm 1: Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy. arm 2: Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
Interventions: intervention 1: Panitumumab intervention 2: Irinotecan intervention 3: FOLFIRI intervention 4: Pre-emptive Skin Treatment intervention 5: Reactive Skin Treatment
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines. intervention 3: Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines. intervention 4: Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily). intervention 5: Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine)

Protocol documents:
Clinical trial NCT00332579
Conditions: Kleptomania
Keywords: Compulsive Shoplifting Kleptomania Compulsive Stealing
Sponsor: University of Minnesota
Start date: 2006-05-01; Completion date: 2008-09-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.

Detailed description:
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Arms: arm 1: Naltrexone arm 2: Placebo
Interventions: intervention 1: Naltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: daily intervention 2: daily

Protocol documents: