ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00988169
Conditions: Lung Cancer
Keywords: AT-101 erlotinib Unresectable Stage IIIB 09-026
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-09-01; Completion date: 2010-05-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Advanced stage lung cancer is generally treated with anti-cancer medication called chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers develop in people who never smoked or who only smoked for a short period of time. This type of lung cancer may respond to a medication called erlotinib (Tarceva). Erlotinib is an anticancer pill that is approved by the Food and Drug Administration (FDA) for use in patients with advanced lung cancer. Unfortunately, erlotinib does not work for all patients or only works for a period of time. The doctors are trying to find ways to improve the effect of erlotinib by combining it with another anti-cancer medication.

Ascenta Therapeutics, Inc. has developed a drug called AT-101 as a potential treatment for cancer. AT-101 is an investigational drug. That means that AT-101 is not approved by the United States Food and Drug Administration (FDA) for general use. The FDA does permit its use in studies like this one to determine whether it is safe and effective.

This is the first study to examine the effects of AT-101 and erlotinib. It is hoped that by combining AT-101 with erlotinib, AT-101 may help erlotinib work better to shrink lung cancer. Studies that have been performed in the laboratory suggest that AT-101 in combination with erlotinib may be more effective at shrinking tumors than erlotinib alone.

Detailed description:

Arms: arm 1: This will be an open-label, single institution, phase II trial. The study will assess the efficacy of the combination of the epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib, and the novel pan-Bcl-2 inhibitor, AT-101, in treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations A planned pause of 21 days will be performed after enrollment of the 10th and 20th patient to assess for excessive toxicity.
Interventions: intervention 1: oral erlotinib and pulsed doses of oral AT-101
Intervention descriptions: intervention 1: Patients will receive oral erlotinib 100 mg daily and pulsed doses of oral AT-101 given 40 mg twice daily on days 1-3 of a 21-day cycle. If the initial combination of erlotinib and AT-101 is tolerated, dose escalation of erlotinib to 150 mg daily will be allowed at the discretion of the treating investigator at the start of cycle 2. Patients will continue receiving treatment on study until they refuse further therapy, develop evidence of progressive disease, or develop unacceptable toxicity or a medical condition that would, in the judgment of the investigator,

Protocol documents:
Clinical trial NCT00990704
Conditions: Secondary Hyperparathyroidism Hemodialysis
Keywords: Secondary hyperparathyroidism Hemodialysis paricalcitol maxacalcitol
Sponsor: Abbott
Start date: 2009-10-01; Completion date: 2010-05-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.

Detailed description:

Arms: arm 1: 2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis arm 2: 5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis
Interventions: intervention 1: paricalcitol intervention 2: maxacalcitol
Intervention descriptions: intervention 1: Intravenous administration 3 times a week immediately before completion of dialysis intervention 2: Intravenous administration 3 times a week immediately before completion of dialysis

Protocol documents:
Clinical trial NCT00991809
Conditions: Hyperalgesia
Keywords: opioid induced hyperalgesia
Sponsor: Johns Hopkins University
Start date: 2009-02-01; Completion date: 2010-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to follow a person's response to experimental pain after multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can tolerate the pain more, less, or the same at the end of the study.

Detailed description:
This project investigates the phenomenon of opioid-induced hyperalgesia (OIH). Opioid analgesics, in addition to their therapeutic anti-nociceptive effects, under some conditions produce pro-nociceptive effects. This phenomenon of pain or pain sensitivity being increased by prior opioid administration is called opioid-induced hyperalgesia. It is thought to be relevant both to pain management complications and to complications of opioid dependence and its treatment. This study investigated the time-course of opioid-induced hyperalgesia development in healthy normal volunteers (N=12 completers), using a series of acute alfentanil administrations (15 mg/kg mg intramuscular (IM) per day) spaced at 3-4 day intervals, with testing for pain tolerance using the cold pressor test (CPT), and mechanical quantitative sensory testing (MQST) each administered repeatedly over time within each testing day. The goal was to determine the time course of OIH development following acute opioid administration, and to assess whether this changes over repeated acute opioid administrations.

Arms: arm 1: Subjects received a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals. arm 2: Subjects received a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.
Interventions: intervention 1: Alfentanil intervention 2: Diphenhydramine
Intervention descriptions: intervention 1: 15 mcg/kg IM intervention 2: 25 mg IM

Protocol documents:
Clinical trial NCT01001572
Conditions: Essential Hypertension
Keywords: Blood pressure hypertension Exforge valsartan/amlodipine
Sponsor: Novartis
Start date: 2009-09-01; Completion date: 2010-05-01
Enrollment: 932 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.

Detailed description:

Arms: arm 1: One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks arm 2: One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks arm 3: Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
Interventions: intervention 1: Valsartan/amlodipine 160/5 mg intervention 2: Valsartan 160 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily. intervention 2: Valsartan 160 mg capsule taken orally once daily. intervention 3: 1 capsule or tablet taken orally once daily

Protocol documents:
Clinical trial NCT01004770
Conditions: Healthy
Keywords: CECT - Contrast-enhanced computed tomography HCG - Human Chorionic Gonadotropin HU - Hounsfield Units Patient Safety Tolerance Pharmacokinetic
Sponsor: GE Healthcare
Start date: 2009-10-01; Completion date: 2010-05-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145 through the evaluation of serum and urine. It will evaluate the radiographic density in regions of interest (ROI) and the overall diagnostic quality following administration of GE-145.

Detailed description:

Arms: arm 1: None arm 2: An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.
Interventions: intervention 1: GE-145 (AN113111) Injection intervention 2: Visipaque (iodixanol) Injection
Intervention descriptions: intervention 1: 40 healthy volunteers (10 per treatment group) will receive AH113111 320 mg I/mL at 1 of 4 possible doses (300, 450, 600, or 900 mg I/kg) as a single intravenous (IV) administration. intervention 2: An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.

Protocol documents:
Clinical trial NCT01010503
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-06-01; Completion date: 2010-05-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: tocilizumab 8 mg/kg intravenous infusion once in 4 weeks

Protocol documents:
Clinical trial NCT01014585
Conditions: Fibromyalgia
Keywords: Milnacipran Pain Durability of Effect Loss of Therapeutic Response Fatigue Forest Research Institute Savella ®
Sponsor: Forest Laboratories
Start date: 2009-11-01; Completion date: 2010-05-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

Detailed description:

Arms: arm 1: Placebo tablets administered orally twice daily arm 2: Milnacipran tablets administered orally twice daily
Interventions: intervention 1: Placebo intervention 2: Milnacipran
Intervention descriptions: intervention 1: Placebo tablets administered orally twice daily intervention 2: Milnacipran tablets administered orally twice daily

Protocol documents:
Clinical trial NCT01014689
Conditions: Acne Vulgaris
Keywords: acne vulgaris
Sponsor: Galderma R&D
Start date: 2009-08-01; Completion date: 2010-05-01
Enrollment: 378 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Adapalene/ BPO gel with Lymecycline capsules intervention 2: Adapalene/ BPO vehicle gel with Lymecycline capsules
Intervention descriptions: intervention 1: Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning intervention 2: Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Protocol documents:
Clinical trial NCT01014871
Conditions: Wrinkles
Keywords: Forehead Wrinkles Toxin
Sponsor: Galderma R&D
Start date: 2009-07-01; Completion date: 2010-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles.

One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.

Detailed description:
There are two formulations of BoNT-A available: Botox®/Vistabel®, Allergan and Dysport®/Azzalure®, Ipsen - Galderma. These formulations behave distinctly in different ways electrophysiologically and clinically and results obtained with one formulation cannot be extrapolated to the other. There are only few clinical research directly comparing the two formulations in the treatment of forehead lines.

Arms: arm 1: None
Interventions: intervention 1: Botulinum Toxin Type A - Azzalure intervention 2: Botulinum Toxin Type A - Vistabel
Intervention descriptions: intervention 1: One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized. intervention 2: One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.

Protocol documents:
Clinical trial NCT01018134
Conditions: Psoriasis
Keywords: Psoriasis Topical corticosteroids Plaque psoriasis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2009-11-01; Completion date: 2010-05-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients with moderate to severe plaque psoriasis.

Detailed description:

Arms: arm 1: Desoximetasone topical spray 0.05% administered once daily to affected area arm 2: Desoximetasone topical spray 0.05% administered twice daily to affected area arm 3: Desoximetasone topical spray 0.25% administered once daily to affected area arm 4: Desoximetasone topical spray 0.25% administered twice daily to affected area arm 5: Vehicle administered to affected areas once daily arm 6: Vehicle administered to affected areas twice daily
Interventions: intervention 1: Desoximetasone 0.05% once daily intervention 2: Desoximetasone 0.05% twice daily intervention 3: Desoximetasone 0.25% once daily intervention 4: Desoximetasone 0.25% once daily intervention 5: Vehicle once daily intervention 6: Vehicle twice daily
Intervention descriptions: intervention 1: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days intervention 2: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days intervention 3: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days intervention 4: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days intervention 5: Vehicle topical spray administered to affected areas once daily for 28 days intervention 6: Vehicle topical spray administered to affected areas twice daily for 28 days

Protocol documents:
Clinical trial NCT01025843
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-12-01; Completion date: 2010-05-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hypothesis is that single oral doses of MK-5478 are sufficiently safe and well tolerated.

Detailed description:

Arms: arm 1: Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. arm 2: 1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods. arm 3: 1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. arm 4: 1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods. arm 5: Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods. arm 6: 2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. arm 7: 2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. arm 8: 2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods. arm 9: Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. arm 10: Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
Interventions: intervention 1: MK-5478 intervention 2: Comparator: Candesartan cilexetil intervention 3: Comparator: Pbo
Intervention descriptions: intervention 1: In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg. intervention 2: Single dose administration of candesartan, 32 mg oral tablet intervention 3: Placebo

Protocol documents:
Clinical trial NCT01028911
Conditions: Alzheimer's Disease
Keywords: Phase 1 Alzheimer's disease Safety Tolerability Pharmacokinetics
Sponsor: Pfizer
Start date: 2009-12-01; Completion date: 2010-05-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in subjects will mild to moderate Alzheimer's disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-03654746 intervention 2: Placebo
Intervention descriptions: intervention 1: PF-03654746 capsule of 0.25 mg, 0.5 mg, and 1.0 mg strength. Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and safety assessments done by the investigator. intervention 2: Matching placebo capsules to PF-03654746 with strengths of 0.25 mg, 0.5 mg, and 1.0 mg.

Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and safety assessments done by the investigator.

Protocol documents:
Clinical trial NCT01038609
Conditions: Pain
Keywords: Postoperative Pain
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2009-12-01; Completion date: 2010-05-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.

Detailed description:
The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 5 treatment arms. In order to maintain the single-blind nature of the study, all participants were dosed with study drug (active and/or placebo) every 6 hours.

Arms: arm 1: 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). arm 2: 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). arm 3: 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). arm 4: 1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). arm 5: 1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Interventions: intervention 1: Hydrocodone/Acetaminophen Extended Release intervention 2: Acetaminophen intervention 3: Morphine Extended Release intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: