ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00275275
Conditions: Parkinson Disease
Keywords: PD Parkinson's
Sponsor: Rajesh Pahwa, MD
Start date: 2006-01-01; Completion date: 2008-05-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug.

Detailed description:
Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. Assessments of motor function before and after conversion will be done.

Arms: arm 1: Conversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex. arm 2: Conversion factor of Mirapex to Requip 24-Hour of 1:4 arm 3: Conversion factor of Mirapex to Requip 24-Hour of 1:5
Interventions: intervention 1: Requip PR intervention 2: Mirapex
Intervention descriptions: intervention 1: Requip 24-Hour once a day for one month intervention 2: All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.

Protocol documents:
Clinical trial NCT00276861
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer
Sponsor: University of Miami
Start date: 2005-09-01; Completion date: 2008-05-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.

Secondary

* Determine the overall and failure-free survival of patients treated with the chemotherapy regimen.
* Determine the duration of response (complete or partial) in patients treated with this regimen.
* Determine the percentage of patients who experience a 50% fall of serum carcinoembryonic antigen levels with a baseline elevation of \> 5 U/mL after receiving this regimen.
* Evaluate the toxicity associated with the administration of this regimen in these patients.

OUTLINE: This is a non-randomized study.

Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 1 year.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Interventions: intervention 1: gemcitabine hydrochloride intervention 2: oxaliplatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00290290
Conditions: Postoperative Wound Infection
Keywords: Prevention Antiseptic Preoperative Scrub Postoperative Wound Infection
Sponsor: Baylor College of Medicine
Start date: 2003-09-01; Completion date: 2008-05-01
Enrollment: 849 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.

Detailed description:
This is a prospective, randomized, multicenter clinical trial. All adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate.

Arms: arm 1: preoperative skin preparation with povidone-iodine arm 2: preoperative skin preparation with scrub and paint technique
Interventions: intervention 1: chlorhexidine-alcohol intervention 2: Povidone-Iodine
Intervention descriptions: intervention 1: Preoperative skin preparation with scrub and paint technique intervention 2: preoperative skin preparation with scrub and paint technique

Protocol documents:
Clinical trial NCT00293059
Conditions: Metrorrhagia
Keywords: Dysfunctional Uterine Bleeding
Sponsor: Bayer
Start date: 2005-12-01; Completion date: 2008-05-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Detailed description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Arms: arm 1: A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo arm 2: Matching placebo to be taken orally daily
Interventions: intervention 1: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Placebo
Intervention descriptions: intervention 1: 2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle) intervention 2: Matching placebo to be taken orally daily.

Protocol documents:
Clinical trial NCT00301080
Conditions: Neurotoxicity Pain Breast Cancer
Keywords: pain neurotoxicity breast cancer
Sponsor: Northwestern University
Start date: 2006-02-01; Completion date: 2008-05-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.

This randomized, double-blind, placebo-controlled clinical trial was designed to study D-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.

Detailed description:
This is a randomized, double-blind, placebo-controlled study. Initially, patients were randomized to 1 of 2 treatment arms (D-cycloserine 250 mg twice daily or placebo twice daily), and treated for up to 4 weeks in the absence of unacceptable toxicity.

Later, the design was changed to randomize patients to 1 of 3 arms as follows:

* D-cycloserine 50 mg twice daily for up to 12 weeks
* D-cycloserine 200 mg twice daily for up to 12 weeks
* Placebo twice daily for up to 12 weeks

Arms: arm 1: Placebo administered orally twice per day for 4 weeks. arm 2: D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks. arm 3: D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks. arm 4: This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks. arm 5: Placebo administered orally twice per day for 12 weeks.
Interventions: intervention 1: D-cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00303472
Conditions: Thrombocytopenia MDS Myelodysplastic Syndromes Refractory Cytopenias
Keywords: MDS Myelodysplastic Syndromes Refractory Cytopenias Thrombocytopenia
Sponsor: Amgen
Start date: 2006-02-01; Completion date: 2008-05-01
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.

Detailed description:

Arms: arm 1: Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 2: Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 3: Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 4: Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 5: Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who complete Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 6: Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who complete Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase. arm 7: Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who complete Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
Interventions: intervention 1: Romiplostim
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00303498
Conditions: Diastolic Heart Failure
Sponsor: Pfizer
Start date: 2006-03-27; Completion date: 2008-05-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study was to determine whether long-term (≥ 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sitexsentin sodium intervention 2: Placebo
Intervention descriptions: intervention 1: sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months intervention 2: placebo identical to the study drug in description, dose and duration

Protocol documents:
Clinical trial NCT00307801
Conditions: Metrorrhagia
Keywords: Dysfunctional uterine bleeding
Sponsor: Bayer
Start date: 2006-02-01; Completion date: 2008-05-01
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Detailed description:
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Arms: arm 1: A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo. arm 2: Matching placebo to be taken orally daily.
Interventions: intervention 1: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 pill per day taken orally over 7 cycles of 28 pills per cycle intervention 2: 1 pill per day taken orally over 7 cycles of 28 pills per cycle

Protocol documents:
Clinical trial NCT00313300
Conditions: Acute Coronary Syndrome (ACS)
Sponsor: Bristol-Myers Squibb
Start date: 2006-05-01; Completion date: 2008-05-01
Enrollment: 1741 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Apixaban intervention 2: Apixaban intervention 3: Placebo intervention 4: Apixaban
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, twice daily, 26 weeks intervention 2: Tablets, Oral, 10 mg, once daily, 26 weeks intervention 3: Tablets, Oral, 0, twice daily, 26 weeks intervention 4: Tablets, Oral 10 mg, twice daily, 26 weeks

Protocol documents:
Clinical trial NCT00327717
Conditions: Partial Seizures
Keywords: Epilepsy Partial seizures
Sponsor: Eisai Inc.
Start date: 2006-09-01; Completion date: 2008-05-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Zonisamide intervention 2: Placebo
Intervention descriptions: intervention 1: Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient. intervention 2: Patients in placebo group were titrated with placebo in the same way as in zonisamide group.

Protocol documents:
Clinical trial NCT00363896
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Lung function Exacerbations Quality of Life
Sponsor: AstraZeneca
Start date: 2006-07-01; Completion date: 2008-05-01
Enrollment: 843 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Detailed description:

Arms: arm 1: Aclidinium bromide 200 μg once-daily by inhalation arm 2: Placebo once-daily via inhalation
Interventions: intervention 1: Aclidinium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks intervention 2: Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Protocol documents:
Clinical trial NCT00364156
Conditions: TOBACCO USE CESSATION
Sponsor: University of Pennsylvania
Start date: 2004-06-01; Completion date: 2008-05-01
Enrollment: 568 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.

Detailed description:
Please see brief summary.

Arms: arm 1: Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions. arm 2: Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch.
Interventions: intervention 1: Standard Patch Treatment intervention 2: 24-weeks of nicotine patch
Intervention descriptions: intervention 1: 8-weeks of nicotine patch + 16-weeks of placebo intervention 2: 24-weeks of 21mg nicotine patch

Protocol documents:
Clinical trial NCT00368654
Conditions: Psoriasis
Sponsor: University of California, Davis
Start date: 2007-01-01; Completion date: 2008-05-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.

Detailed description:
The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.

The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly

Arms: arm 1: Monotherapy with Raptiva alone arm 2: Combination therapy with both Raptiva and Methotrexate arm 3: Continue Raptiva, discontinue methotrexate arm 4: Continue combination therapy with both Raptiva and Methotrexate
Interventions: intervention 1: Methotrexate intervention 2: Raptiva
Intervention descriptions: intervention 1: Initial dose 5 mg, then 15 mg per week intervention 2: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg

Protocol documents:
Clinical trial NCT00386308
Conditions: Menorrhagia Heavy Menstrual Bleeding
Keywords: Heavy Menstrual Bleeding Menorrhagia
Sponsor: Ferring Pharmaceuticals
Start date: 2006-10-01; Completion date: 2008-05-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tranexamic acid tablets intervention 2: Placebo tablets
Intervention descriptions: intervention 1: 3900 mg/Day intervention 2: None

Protocol documents:
Clinical trial NCT00393718
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2006-11-01; Completion date: 2008-05-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

Detailed description:

Arms: arm 1: Liraglutide 0.9 mg + glibenclamide placebo arm 2: Glibenclamide 1.25-2.5 mg + liraglutide placebo
Interventions: intervention 1: liraglutide intervention 2: glibenclamide intervention 3: placebo intervention 4: placebo
Intervention descriptions: intervention 1: 0.9 mg/day. Injected s.c. (under the skin) once daily. intervention 2: 1.25-2.5 mg tablet. Given orally once or twice daily. intervention 3: liraglutide placebo. Injected s.c. (under the skin) once daily. intervention 4: glibenclamide placebo. Given orally once or twice daily.

Protocol documents:
Clinical trial NCT00395746
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2006-10-01; Completion date: 2008-05-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

Detailed description:

Arms: arm 1: Liraglutide 0.6 mg + sulphonylurea arm 2: Liraglutide 0.9 mg + sulphonylurea arm 3: Liraglutide placebo 0.6 mg + sulphonylurea arm 4: Liraglutide placebo 0.9 mg + sulphonylurea
Interventions: intervention 1: sulfonylurea intervention 2: liraglutide intervention 3: liraglutide
Intervention descriptions: intervention 1: SU agent intervention 2: Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily. intervention 3: Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.

Protocol documents: