ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01512979
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2012-01-01; Completion date: 2013-04-01
Enrollment: 316 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.

Detailed description:

Arms: arm 1: patients receive linagliptin tablet once daily arm 2: patients receive linagliptin tablet once daily and metformin tablets twice daily
Interventions: intervention 1: metformin intervention 2: linagliptin intervention 3: metformin placebo intervention 4: metformin placebo
Intervention descriptions: intervention 1: 1000 mg to 2000 mg per day intervention 2: 5 mg daily intervention 3: 0 to 2 tablets daily intervention 4: 4 tablets daily

Protocol documents:
Clinical trial NCT01529203
Conditions: Aging
Sponsor: Galderma R&D
Start date: 2012-02-01; Completion date: 2013-04-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.

This will be an open, multi-centre study.

Detailed description:

Arms: arm 1: All subjects will be injected with Azzalure and Restylane
Interventions: intervention 1: Botulinum Toxin Type A (Azzalure) intervention 2: Restylane ranges
Intervention descriptions: intervention 1: Powder for solution for injection intervention 2: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)

Protocol documents:
Clinical trial NCT01542684
Conditions: Leukemia
Keywords: Leukemia Myelodysplastic Syndrome MDS Azacytidine 5-Azacytidine 5-AZA Vidaza 5-AZC Aza-CR Ladakamycin NSC-102816 GM-CSF Sargramostim Leukine
Sponsor: M.D. Anderson Cancer Center
Start date: 2012-03-01; Completion date: 2013-04-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if the combination of azacitidine and GM-CSF can help to control MDS. The safety of these drugs will also be studied.

Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white blood cells. This may help to fight infections.

Detailed description:
Study Drug Administration:

If you are found to be eligible to take part in this study, on Days 1-4 of every cycle, you will receive azacitidine by vein over 15-30 minutes.

You may receive drugs to help prevent nausea and vomiting before you receive your dose of azacitidine.

On Days 5-7 of every cycle, you will receive GM-CSF by vein over about 15 minutes or by injection.

Each study cycle will be about 4-6 weeks, depending on the study doctor's decision.

Study Visits:

One (1) time each week during every cycle, blood (about 2-3 teaspoons) will be drawn for routine tests.

At any time, if your doctor thinks it is needed, you will have a bone marrow aspirate to check the status of the disease.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your follow-up visits will be per standard of care for the disease.

This is an investigational study. Both azacitidine and GM-CSF are FDA approved and commercially available for the treatment of MDS. The study drug combination to treat MDS is considered investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m\^2, daily for 4 days.

GM-CSF administered IV or subcutaneously at 250 mcg/m\^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.

Each treatment cycle will last at least 4 weeks
Interventions: intervention 1: Azacytidine intervention 2: GM-CSF
Intervention descriptions: intervention 1: Starting dose: 40 mg/m\^2 intravenously (IV) or subcutaneously (SQ) daily for 4 days. intervention 2: 250 mcg/m\^2 IV or SQ one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.

Protocol documents:
Clinical trial NCT01569464
Conditions: Restless Legs Syndrome
Keywords: Rotigotine Restless Legs Syndrome Neupro®
Sponsor: UCB Pharma
Start date: 2012-03-01; Completion date: 2013-04-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to show that Rotigotine improves Restless Legs Syndrome (RLS) symptoms in subjects with moderate to severe RLS during both day and evening.

Detailed description:

Arms: arm 1: Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg /24 hr or until effective or maximum dose is reached. arm 2: Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks
Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg /24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance) intervention 2: Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours.

7 weeks (titration plus maintenance)

Protocol documents:
Clinical trial NCT01574651
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149 Health related quality of life Formoterol Tiotropium COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-01; Completion date: 2013-04-01
Enrollment: 934 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use. arm 2: Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
Interventions: intervention 1: QVA149 intervention 2: Placebo to tiotropium intervention 3: Placebo to formoterol intervention 4: Tiotropium intervention 5: Formoterol intervention 6: Placebo to QVA149
Intervention descriptions: intervention 1: QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler intervention 2: Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules intervention 3: Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules. intervention 4: Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device. intervention 5: Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device. intervention 6: Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules

Protocol documents:
Clinical trial NCT01599104
Conditions: Essential Hypertension
Keywords: Essential hypertension LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2012-06-01; Completion date: 2013-04-01
Enrollment: 1161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension

Detailed description:

Arms: arm 1: LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks arm 2: LCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks arm 3: Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks
Interventions: intervention 1: LCZ696 intervention 2: Olmesartan intervention 3: Placebo
Intervention descriptions: intervention 1: 200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily intervention 2: Olmesartan 20 mg capsule one daily intervention 3: Placebo to LCZ696 or Olmesartan

Protocol documents:
Clinical trial NCT01615822
Conditions: Malaria
Keywords: Malaria PK OZ439 Mefloquine Healthy Volunteers
Sponsor: Medicines for Malaria Venture
Start date: 2012-08-01; Completion date: 2013-04-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. The study findings will be used to inform the dose and design of future studies. The aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy volunteers.

Detailed description:

Arms: arm 1: OZ439 100mg single dose oral suspension arm 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet arm 3: OZ439 400mg single dose oral suspension arm 4: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets arm 5: Placebo
Interventions: intervention 1: OZ439 100mg intervention 2: OZ439 400mg intervention 3: MQ 250 mg, single dose intervention 4: MQ 750mg, single dose intervention 5: Placebo
Intervention descriptions: intervention 1: OZ439 100mg oral suspension, single dose intervention 2: OZ439 400mg oral suspension, single dose intervention 3: Mefloquine 250 mg tablet, single dose intervention 4: Mefloquine 750mg oral tablet, single dose intervention 5: None

Protocol documents:
Clinical trial NCT01631227
Conditions: Essential Hypertension
Sponsor: Abbott
Start date: 2012-06-01; Completion date: 2013-04-01
Enrollment: 665 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

Detailed description:

Arms: arm 1: Eprosartan + Placebo Eprosartan Mesylate arm 2: Eprosartan Mesylate + Placebo Eprosartan
Interventions: intervention 1: Eprosartan intervention 2: Eprosartan Mesylate intervention 3: Placebo Eprosartan mesylate intervention 4: Placebo Eprosartan
Intervention descriptions: intervention 1: Eprosartan 450 mg intervention 2: Eprosartan mesylate 600 mg intervention 3: Placebo Eprosartan mesylate intervention 4: Placebo Eprosartan

Protocol documents:
Clinical trial NCT01632566
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-06-01; Completion date: 2013-04-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to healthy Japanese and non-Japanese participants as multiple doses. In addition, effects of 28-day oral dosing of LY3031207 on the amount of a cholesterol-lowering drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of it will be determined. The effects of LY3031207 after single and 28-day dosing on blood pressure will also be studied. Information about any side effects that may occur will be collected.

Detailed description:

Arms: arm 1: Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage. arm 2: Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days. arm 3: Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207. arm 4: Daily oral administration of 75 mg LY3031207 or 225 mg LY3031207 for 28 days. Single, oral 10 mg simvastatin open-label dose administered before and after 28-day dosing of LY3031207.
Interventions: intervention 1: Placebo intervention 2: LY3031207 intervention 3: Celecoxib intervention 4: Simvastatin
Intervention descriptions: intervention 1: Capsules administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally

Protocol documents:
Clinical trial NCT01641640
Conditions: Chronic Hepatitis C
Keywords: HCV genotype 1 (GT-1) HCV genotype 4 (GT-4) HCV genotype 5 (GT-5) HCV genotype 6 (GT-6) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy Treatment-Naïve GS-7977 Ribavirin RBV Peginterferon Alfa 2a PEG
Sponsor: Gilead Sciences
Start date: 2012-06-01; Completion date: 2013-04-01
Enrollment: 328 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sofosbuvir intervention 2: RBV intervention 3: PEG
Intervention descriptions: intervention 1: Sofosbuvir 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Protocol documents:
Clinical trial NCT01646827
Conditions: Schizophrenia
Keywords: Schizophrenia, extended release antipsychotic
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-05-01; Completion date: 2013-04-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body

Detailed description:
Extended-release gluteal intramuscular (IM) injection of aripiprazole has been tested in subjects with schizophrenia for safety and tolerability. This study will compare the gluteal IM aripiprazole injection with deltoid IM aripiprazole injection for safety and tolerability.

Arms: arm 1: Deltoid injection site arm 2: Gluteal injection site
Interventions: intervention 1: Aripiprazole IM Depot
Intervention descriptions: intervention 1: One injection of 400 mg aripiprazole IM depot

Protocol documents:
Clinical trial NCT01671319
Conditions: Female Breast Cancer
Keywords: breast cancer female women adjuvant
Sponsor: University of Wisconsin, Madison
Start date: 2011-06-01; Completion date: 2013-04-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the feasibility of giving standard TC chemotherapy on a dose dense schedule (ddTC) as well as evaluating the nature and frequency of ddTC side effects.

Detailed description:
A standard chemotherapy treatment option for breast cancer after surgery (adjuvant therapy) is docetaxel + cyclophosphamide (TC). This study looks at a different schedule for giving the same adjuvant chemotherapy so that treatment can be completed faster (in 8 weeks rather than 12 weeks). This study uses a growth factor drug, pegfilgrastim, to help build blood cells that are lowered because of chemotherapy, making it possible to receive TC treatment every 2 weeks (referred to as "dose dense TC" or "ddTC") instead of the standard 3 week schedule. The main study procedures are blood draws, chemotherapy treatment, physical exams, and pegfilgrastim injections.

Arms: arm 1: Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle
Interventions: intervention 1: docetaxel + cyclophosphamide + pegfilgrastim
Intervention descriptions: intervention 1: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle

Protocol documents:
Clinical trial NCT01677377
Conditions: Schizophrenia
Keywords: Schizophrenia Schizophrenic Schizophrenias
Sponsor: Indivior Inc.
Start date: 2012-08-01; Completion date: 2013-04-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages of risperidone with clinically stable schizophrenia

Detailed description:
This will be an open-label, Phase 2A, multiple ascending dose study in 1 to 3 sites, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple subcutaneous injections of 60mg, 90mg, and 120mg doses of risperidone in the RBP-7000 formulation, in subjects with clinically-stable schizophrenia who are on a once daily stable dose of 2mg, 3mg, or 4mg of oral risperidone.

Arms: arm 1: Participants who were stable on 2 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 60 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 2 mg oral daily risperidone on days 85-87. arm 2: Participants who were stable on 3 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 90 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 3 mg oral daily risperidone on days 85-87. arm 3: Participants who were stable on 4 mg oral daily risperidone during the run-in period received 3 single,unblinded, subcutaneous (SC) injection doses of 120 mg risperidone in RBP-7000 on study days 1, 29 and 57. Participants returned to 4 mg oral daily risperidone on days 85-87.
Interventions: intervention 1: Risperidone intervention 2: RBP-7000
Intervention descriptions: intervention 1: Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87. intervention 2: RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57.

Protocol documents:
Clinical trial NCT01682460
Conditions: Glaucoma Dry Eyes
Sponsor: University of Waterloo
Start date: 2012-08-01; Completion date: 2013-04-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Research indicates that many people who are being treated for glaucoma have dry eyes. The purpose of this study is to test the use of artificial tears to alleviate dryness signs and symptoms in people who are using medication to treat glaucoma. The study hypothesis is that the use of artificial tears will result in an improvement in clinical signs and symptoms associated with dry eyes.

Detailed description:

Arms: arm 1: Artificial tears eye drops QID for 1 month
Interventions: intervention 1: Refresh Tears Lubricant Eye Drops (Allergan)
Intervention descriptions: intervention 1: Eye drops QID for 1 month

Protocol documents:
Clinical trial NCT01698684
Conditions: Erectile Dysfunction
Keywords: ED
Sponsor: VIVUS LLC
Start date: 2012-09-01; Completion date: 2013-04-01
Enrollment: 440 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Avanafil 100 mg intervention 3: Avanafil 200 mg
Intervention descriptions: intervention 1: One dose 15 minutes before attempting intercourse intervention 2: One dose 15 minutes before attempting intercourse intervention 3: One dose 15 minutes before attempting intercourse

Protocol documents:
Clinical trial NCT01701375
Conditions: Relapsed Acute Leukemia Refractory Acute Leukemia High-Risk Myelodysplasia
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2012-09-01; Completion date: 2013-04-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
1.1 Primary Objectives

* To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease
* To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts
* To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone
* To determine if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS

1.2 Secondary Objectives:

* To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo
* To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest malignant cells in the G 1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity

Detailed description:

Arms: arm 1: * PD 0332991 will be given orally days 1,2,3
* Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
* Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose
Interventions: intervention 1: PD 0332991
Intervention descriptions: intervention 1: • PD 0332991 will be given orally days 1,2,3

Protocol documents: