ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01204905
Conditions: HIV Infections
Keywords: HIV-1 CD4 Viral Load Human Immunodeficiency Virus (HIV)
Sponsor: University of Maryland, Baltimore
Start date: 2010-09-01; Completion date: 2014-05-16
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads \> 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.

This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.

Detailed description:
Seven antiretroviral naïve HIV infected participants will be treated with a combination of raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic suppression of (HIV-1 viral load \< 50 copies/ml).

Arms: arm 1: Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.
Interventions: intervention 1: Raltegravir and Maraviroc in combination
Intervention descriptions: intervention 1: Raltegravir 400 mg tablet twice a day, \~12 hours (10 to 14 hours) apart

Maraviroc 300 mg tablet twice a day, \~12 hours (10 to 14 hours) apart

Protocol documents:
Clinical trial NCT01441635
Conditions: Heavy Uterine Bleeding Uterine Fibroids
Keywords: Uterine Fibroids Heavy Uterine Bleeding Elagolix Menorrhagia ABT-620 Leiomyomata Elagolix sodium
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-09-08; Completion date: 2014-05-17
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.

Detailed description:

Arms: arm 1: Participants received elagolix 400 mg once a day (QD) for 3 months. arm 2: Participants received elagolix 100 mg twice a day (BID) for 3 months. arm 3: Participants received placebo to elagolix BID for 3 months. arm 4: Participants received elagolix 200 mg twice a day for 3 months. arm 5: Participants received placebo to elagolix twice a day for 3 months. arm 6: Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months. arm 7: Participants received elagolix 600 mg once a day for 3 months. arm 8: Participants received elagolix 300 mg twice a day for 3 months. arm 9: Participants received placebo to elagolix BID for 3 months. arm 10: Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Interventions: intervention 1: Elagolix intervention 2: Placebo intervention 3: Estradiol/Norethindrone acetate (E2/NETA) intervention 4: Estradiol intervention 5: Progesterone
Intervention descriptions: intervention 1: Elagolix tablets intervention 2: Matching placebo tablets intervention 3: A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg. intervention 4: 1.0 mg micronized estradiol tablets administered once a day intervention 5: Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle

Protocol documents:
Clinical trial NCT01358331
Conditions: Tumor, Solid
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-11-04; Completion date: 2014-05-20
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given as single agent oral therapy for participants with advanced solid tumors will be done into two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2 dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to see if MK-8353 is effective as single agent therapy.

Detailed description:

Arms: arm 1: 100 mg capsules administered orally twice daily for 28 days for each cycle arm 2: 200 mg capsules administered orally twice daily for 28 days for each cycle arm 3: 300 mg capsules administered orally twice daily for 28 days for each cycle arm 4: 350 mg capsules administered orally twice daily for 28 days for each cycle arm 5: 400 mg capsules administered orally twice daily for 28 days for each cycle arm 6: 800 mg capsules administered orally twice daily for 28 days for each cycle
Interventions: intervention 1: MK-8353
Intervention descriptions: intervention 1: Administered orally twice daily for 28 days for each cycle

Protocol documents:
Clinical trial NCT01660802
Conditions: Macular Edema
Sponsor: Allergan
Start date: 2012-09-04; Completion date: 2014-05-20
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.

Detailed description:

Arms: arm 1: 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. arm 2: Sham administered in the study eye on Day 1.
Interventions: intervention 1: 700 μg Dexamethasone intervention 2: Sham
Intervention descriptions: intervention 1: 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. intervention 2: Sham administered in the study eye on Day 1.

Protocol documents:
Clinical trial NCT01552902
Conditions: Attention-deficit/Hyperactivity Disorder
Keywords: ADHD
Sponsor: Shire
Start date: 2012-04-03; Completion date: 2014-05-22
Enrollment: 549 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lisdexamfetamine dimesylate intervention 2: Methylphenidate Hydrochloride intervention 3: Placebo
Intervention descriptions: intervention 1: Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance intervention 2: Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance intervention 3: Daily oral dosing in the AM for 6 weeks

Protocol documents:
Clinical trial NCT00764478
Conditions: Bipolar 1 Disorder
Sponsor: Organon and Co
Start date: 2012-04-06; Completion date: 2014-05-28
Enrollment: 367 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily \[BID\]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale \[YMRS\]) at Day 21 of the trial.

Detailed description:

Arms: arm 1: Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days arm 2: Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days arm 3: Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
Interventions: intervention 1: Asenapine intervention 2: Asenapine intervention 3: Placebo
Intervention descriptions: intervention 1: asenapine tablet, 5 mg sublingually BID for 21 days intervention 2: asenapine tablet, 10 mg sublingually BID for 21 days intervention 3: placebo sublingual tablet, administered BID for 21 days

Protocol documents:
Clinical trial NCT01254292
Conditions: Contraception
Sponsor: Bayer
Start date: 2011-01-06; Completion date: 2014-05-28
Enrollment: 567 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study.

Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index \[PI\]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.

Detailed description:

Arms: arm 1: Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months arm 2: Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Interventions: intervention 1: Levonorgestrel IUD (LCS, BAY86-5028) intervention 2: Yasmin (EE30/DRSP, BAY86-5131)
Intervention descriptions: intervention 1: LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only. intervention 2: Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.

Protocol documents:
Clinical trial NCT01344447
Conditions: Carotid Stenosis
Keywords: Supra-aortic vascular disease MRA CTA Males and females aged 18 years or older Stroke Transient Ischemic Attack (TIA)
Sponsor: Bayer
Start date: 2011-05-12; Completion date: 2014-05-28
Enrollment: 479 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Gadobutrol (Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: A single bolus injection of approx. 0.1mmol/kg

Protocol documents:
Clinical trial NCT01475513
Conditions: Insulin Sensitivity Cardiovascular Risk Perimenopausal Disorder
Keywords: oral contraceptive birth control pill women healthy volunteer insulin sensitivity insulin resistance cardiovascular risk factors endothelial function estrogen metabolism racial difference glucose intolerance
Sponsor: Virginia Commonwealth University
Start date: 2011-11-01; Completion date: 2014-05-28
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.

Detailed description:
The oral contraceptive pill is the most commonly used birth control method. It is debated whether the birth control pill affects how the body handles insulin and sugar, or whether the pill changes heart disease risk. The goal of this study is to evaluate whether certain factors, such as how the body processes hormones, and demographic factors (e.g. body weight and race), influence how the pill affects the handling of insulin and sugar, and heart health.

Arms: arm 1: African-American women arm 2: Caucasian women
Interventions: intervention 1: Ortho Cyclen®
Intervention descriptions: intervention 1: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.

Protocol documents:
Clinical trial NCT01992380
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2013-11-13; Completion date: 2014-05-30
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.

Detailed description:

Arms: arm 1: Healthy males or females 50 years or older with no evidence of cognitive impairment arm 2: Subjects 50 years or older with mild cognitive impairment (MCI) arm 3: Subjects 50 years or older with probable Alzheimer's Disease (AD)
Interventions: intervention 1: Flortaucipir F18 intervention 2: Brain PET scan
Intervention descriptions: intervention 1: IV injection, 370 MBq (10 mCi), two doses up to four weeks apart intervention 2: positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection

Protocol documents:
Clinical trial NCT00263328
Conditions: Kidney Transplantation
Keywords: immunosuppression JAK3 inhibitor kidney transplant tofacitinib Xeljanz CP-690 550 tacromilus mycophenolate mofetil
Sponsor: Pfizer
Start date: 2005-12-01; Completion date: 2014-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.

Detailed description:

Arms: arm 1: Standard of care arm 2: Treatment group 2 also receives mycophenolate mofetil arm 3: Treatment group 3 does not receive mycophenolate mofetil
Interventions: intervention 1: Tacrolimus intervention 2: CP-690,550 intervention 3: CP-690,550
Intervention descriptions: intervention 1: Standard of care intervention 2: CP-690,550 5 mg BID intervention 3: CP-690,550 10 mg BID

Protocol documents:
Clinical trial NCT01223027
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Dovitinib TKI Renal cell cancer RCC mRCC
Sponsor: Novartis Pharmaceuticals
Start date: 2011-03-01; Completion date: 2014-06-01
Enrollment: 564 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

Detailed description:

Arms: arm 1: Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule. arm 2: Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.
Interventions: intervention 1: Dovitinib intervention 2: Sorafenib
Intervention descriptions: intervention 1: Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language. intervention 2: Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.

Protocol documents:
Clinical trial NCT01399619
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2011-09-01; Completion date: 2014-06-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

Detailed description:

Arms: arm 1: patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks arm 2: patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks arm 3: patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
Interventions: intervention 1: PegIFN/RBV intervention 2: PegIFN/RBV intervention 3: BI201335 intervention 4: BI201335 24W intervention 5: PegIFN/RBV intervention 6: Bi 201335
Intervention descriptions: intervention 1: PegIFN/RBV for 24 or 48w intervention 2: PegIFN/RBV for 24 or 48w intervention 3: BI201335 for 12w intervention 4: BI201335 for 24w intervention 5: PegIFN/RBV for 24 or 48w intervention 6: BI 201335 for 24 w

Protocol documents:
Clinical trial NCT01481129
Conditions: Diffuse Large B Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2011-12-01; Completion date: 2014-06-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the antitumor activity of Akt inhibitor MK2206 (MK2206) in terms of objective response rate (ORR) at 4 months (complete response \[CR\], and partial response \[PR\]) as per the 2007 International Cheson response criteria.

SECONDARY OBJECTIVES:

I. To evaluate the antitumor activity of MK2206 in terms of ORR at 4 months (CR, unconfirmed complete response \[CRu\], and PR) as per the 1999 International Cheson response criteria.

II. To determine the duration of response, defined as the time from the date of the best response to the date of progression.

III. To determine the progression-free survival and overall survival of these patients.

IV. To determine the safety of MK2206. V. To identify predictive biomarkers for treatment outcome. (exploratory) VI. To conduct a pharmacodynamic study using FDG-PET scans. (exploratory)

OUTLINE: This a multicenter study.

Patients receive Akt inhibitor MK2206 orally (PO) once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Arms: arm 1: Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206 intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01507103
Conditions: Rectal Cancer
Keywords: Tecemotide (L-BLP25) Cyclophosphamide (CPA) Mode of action Neoplasms Neoplasms by Site Carcinomas Antineoplastic Agents Neoadjuvant Radiotherapy Pharmacologic Actions Immunosuppressive Agents Immunologic Function Therapeutic Uses Molecular Mechanisms of Pharmacological Action
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2012-02-01; Completion date: 2014-06-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy.

Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in all colorectal cancers and since the adaptive immune system plays a role in the prognosis of rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might boost the tumor-specific immune response and increase the number of tumor-infiltrating lymphocytes (TILs).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tecemotide (L-BLP25) intervention 2: cyclophosphamide (CPA) intervention 3: Chemoradiotherapy
Intervention descriptions: intervention 1: Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8, which will be administered concomitantly with the chemoradiotherapy, followed by a 9th subcutaneous injection 7 to 11 days prior to surgery. intervention 2: A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of CPA will be given 3 days before the first tecemotide (L-BLP25) administration. intervention 3: Radiotherapy of 45-52 grays (Gy) will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\^2, twice daily or equivalent dose of 5-fluorouracil (5-FU) will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.

Protocol documents: