ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01465022
Conditions: Breast Feeding Contraception
Keywords: Breastfeeding rates Contraceptive continuation Birth control pills Lactation
Sponsor: University of New Mexico
Start date: 2005-01-01; Completion date: 2008-06-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objectives

To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:

1. To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills.
3. To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.

Hypothesis

Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.

Detailed description:

Arms: arm 1: Study Arm A is one of two interventions (Combined estrogen-progestin pill) arm 2: Study Arm B is one of two interventions (Progestin-only pill)
Interventions: intervention 1: Combined estrogen-progestin pill intervention 2: Progestin-only pill
Intervention descriptions: intervention 1: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo intervention 2: .35 mg norethindrone once a day orally

Protocol documents:
Clinical trial NCT01519921
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2005-10-01; Completion date: 2008-06-01
Enrollment: 150 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

Detailed description:

Arms: arm 1: Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up. arm 2: Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
Interventions: intervention 1: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

Protocol documents:
Clinical trial NCT01536145
Conditions: Multiple Myeloma
Keywords: IGF-1R inhibitor CP-751871 multiple myeloma
Sponsor: Pfizer
Start date: 2003-12-01; Completion date: 2008-06-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design.

Detailed description:

Arms: arm 1: dose escalation design
Interventions: intervention 1: CP-751,871
Intervention descriptions: intervention 1: CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability

Protocol documents:
Clinical trial NCT01634360
Conditions: Parkinson's Disease
Sponsor: Eisai Inc.
Start date: 2004-11-01; Completion date: 2008-06-01
Enrollment: 185 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A 48-month open label multi-centered extension study to evaluate the long-term safety, tolerability and efficacy of E2007 in patients with Parkinson's Disease with "wearing off" motor fluctuations and "on" period Dyskinesias.

Detailed description:

Arms: arm 1: Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204), and dosed placebo or perampanel. Subjects started this open-label extension study on perampanel 1 mg once daily for two weeks, followed by 2 mg once daily for two weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
Interventions: intervention 1: Perampanel
Intervention descriptions: intervention 1: 1mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.

Protocol documents:
Clinical trial NCT02071823
Conditions: Parkinson
Keywords: Opicapone, Parkinson, Bial, BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2008-05-01; Completion date: 2008-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.

Detailed description:
Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study.

Arms: arm 1: A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fed Washout Period (7days) Period 2: Fasted arm 2: A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:

Period 1: Fasted Washout Period (7days) Period 2: Fed
Interventions: intervention 1: BIA 9-1067
Intervention descriptions: intervention 1: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.

Protocol documents:
Clinical trial NCT02156271
Conditions: Insomnia
Keywords: Insomnia
Sponsor: Duke University
Start date: 2007-07-01; Completion date: 2008-06-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.

Detailed description:

Arms: arm 1: Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon. arm 2: 15 subjects will be randomized to receive the placebo
Interventions: intervention 1: ramelteon intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01368562
Conditions: Opioid-induced Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2003-01-24; Completion date: 2008-06-02
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.

Detailed description:

Arms: arm 1: Participants will receive single dose of MNTX 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC). Subsequent dosing could be adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability.
Interventions: intervention 1: Methylnaltrexone
Intervention descriptions: intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the arm.

Protocol documents:
Clinical trial NCT00495469
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus HbA1c
Sponsor: GlaxoSmithKline
Start date: 2007-08-17; Completion date: 2008-06-05
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus

Detailed description:

Arms: arm 1: Participants will receive GSK189075 for 12 weeks arm 2: Participants will receive GSK189075 matching Placebo for 12 weeks
Interventions: intervention 1: GSK189075 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet intervention 2: Available as Placebo matching tablet to GSK189075

Protocol documents:
Clinical trial NCT00479882
Conditions: Primary Hypercholesterolemia Mixed Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-15; Completion date: 2008-06-16
Enrollment: 2414 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values.

Detailed description:

Arms: arm 1: After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks. arm 2: After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks. arm 3: After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks. arm 4: After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
Interventions: intervention 1: Comparator: simvastatin intervention 2: MK-0524A intervention 3: Placebo intervention 4: MK-0524B
Intervention descriptions: intervention 1: None intervention 2: Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00089791
Conditions: Osteoporosis
Keywords: Postmenopausal Osteoporosis
Sponsor: Amgen
Start date: 2004-08-01; Completion date: 2008-06-17
Enrollment: 7808 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.

Detailed description:

Arms: arm 1: Placebo administered subcutaneously once every 6 months for 3 years. arm 2: Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
Interventions: intervention 1: placebo intervention 2: Denosumab
Intervention descriptions: intervention 1: Placebo administered by subcutaneous injection intervention 2: Denosumab 60 mg administered by subcutaneous injection

Protocol documents:
Clinical trial NCT00326625
Conditions: Amyotrophic Lateral Sclerosis
Sponsor: Teva Pharmaceutical Industries, Ltd.
Start date: 2006-07-27; Completion date: 2008-06-17
Enrollment: 366 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).

Detailed description:

Arms: arm 1: Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day. arm 2: Pre-filled syringe of matching placebo, administered subcutaneously once a day.
Interventions: intervention 1: 40 mg glatiramer acetate intervention 2: Placebo
Intervention descriptions: intervention 1: parenteral drug intervention 2: None

Protocol documents:
Clinical trial NCT00799812
Conditions: Topical Antisepsis
Keywords: antimicrobial antisepsis
Sponsor: CareFusion
Start date: 2007-11-13; Completion date: 2008-06-19
Enrollment: 335 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.

Detailed description:
Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick.

Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.

Arms: arm 1: Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time arm 2: Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially arm 3: Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base arm 4: Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time. arm 5: Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.
Interventions: intervention 1: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). intervention 2: CHG 2% w/v & IPA 70% v/v swab applied sequentially intervention 3: Aqueous CHG 4% w/v applied according to mfr's directions intervention 4: Sterile swabstick with sterile water (3 @ once) intervention 5: Sterile swabstick with sterile water (one-at-a-time)
Intervention descriptions: intervention 1: 3 swabsticks topically applied at the same time to intact skin intervention 2: Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin. intervention 3: Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated. intervention 4: 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time. intervention 5: Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00239720
Conditions: Arthritis, Psoriatic
Keywords: Psoriatic Arthritis Arthritis Psoriasis Psoriatic PsA
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2006-03-16; Completion date: 2008-06-25
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.

Detailed description:
Psoriatic arthritis is a form of inflammatory arthritis that affects approximately 7% of people who have psoriasis. Treatment typically include drugs such as methotrexate, azathioprine, and etanercept, which suppress the immune system in a nonspecific fashion in an attempt to control the immune responses causing the disease. In some severe cases of psoriatic arthritis, these drugs cannot adequately control the disease, often requiring patients to undergo continuous treatment to prevent or combat disease activity. hOKT3gamma1 (Ala-Ala) is a genetically engineered monoclonal antibody directed against the CD3 antigen on T cells. hOKT3gamma1 (Ala-Ala) specifically targets immune cells that are actively involved in destructive immune responses, such as those that cause psoriatic arthritis. In a small pilot study of eight people with psoriatic arthritis who received a 2-week course of hOKT3gamma1 (Ala-Ala), the drug appeared safe and caused no serious side effects. This study will test the safety and efficacy of hOKT3gamma1 (Ala-Ala) in alleviating symptoms in psoriatic arthritis patients.

This study will last 2 years. Individuals with psoriatic arthritis who are receiving methotrexate or azathioprine therapy and have active disease are eligible to participate. Participants will be randomly assigned to receive hOKT3gamma1 (Ala-Ala) or placebo. Participants will receive a 5-day treatment with the drug or placebo every month for the first 4 months of the study. There will be 5 study visits over 2 years to assess the safety and effectiveness of hOKT3gamma1 (Ala-Ala) and to evaluate laboratory measures related to the underlying immune problems that cause psoriatic arthritis.

Arms: arm 1: Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle arm 2: Intravenous dose of placebo given over 5 days of each 28 day cycle
Interventions: intervention 1: hOKT3gamma1(Ala-Ala) intervention 2: Placebo
Intervention descriptions: intervention 1: Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle intervention 2: Intravenous dose of placebo given over 5 days of each 28 day cycle

Protocol documents:
Clinical trial NCT00421707
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Irritable Bowel Syndrome safety
Sponsor: GlaxoSmithKline
Start date: 2006-10-14; Completion date: 2008-06-25
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008

Detailed description:

Arms: arm 1: GW876008 arm 2: Placebo
Interventions: intervention 1: GW876008 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00099021
Conditions: Head and Neck Cancer Oral Leukoplakia
Sponsor: National Cancer Institute (NCI)
Start date: 2003-06-01; Completion date: 2008-06-27
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well pioglitazone hydrochloride works in preventing head and neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of pioglitazone hydrochloride may be effective in preventing head and neck cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine whether pioglitazone (pioglitazone hydrochloride) reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia.

SECONDARY OBJECTIVES:

I. Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 12 weeks in the absence of disease progression, unacceptable toxicity, or the development of carcinoma.

Patients are followed up at 4, 8, 12, and 16 weeks.

Arms: arm 1: Patients receive pioglitazone hydrochloride PO QD for 12 weeks in the absence of disease progression, unacceptable toxicity, or the development of carcinoma.
Interventions: intervention 1: pioglitazone hydrochloride
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00875394
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-02-01; Completion date: 2008-06-27
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Detailed description:

Arms: arm 1: sitagliptin + metformin arm 2: metformin + any other oral antidiabetic drug arm 3: metformin
Interventions: intervention 1: sitagliptin phosphate intervention 2: Comparator: metformin intervention 3: Comparator: metformin intervention 4: Comparator: Antidiabetic Standard of Care
Intervention descriptions: intervention 1: sitagliptin 100 mg Once a day (QD) for 24 weeks intervention 2: metformin 850 mg Twice a day (BID) for 24 weeks intervention 3: metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks intervention 4: Patient can take any oral antidiabetic drug (other than metformin)

Protocol documents:
Clinical trial NCT00412880
Conditions: Carcinoma, Small Cell
Sponsor: Boehringer Ingelheim
Start date: 2007-02-14; Completion date: 2008-06-30
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.

Detailed description:

Arms: arm 1: Total Patients
Interventions: intervention 1: BI 2536
Intervention descriptions: intervention 1: Intravenous Infusion

Protocol documents: