ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01396005
Conditions: Hepatitis C Virus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-09-01; Completion date: 2011-12-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will be given boceprevir. Blood samples will be taken at specified intervals to find out whether boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.

Detailed description:

Arms: arm 1: Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg \[4 x 200 mg capsules\], orally, every 8 hours) on Days 2 through 7) arm 2: Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg \[4 x 200 mg capsules\], orally, every 8 hours) on Days 2 through 7
Interventions: intervention 1: boceprevir intervention 2: methadone intervention 3: buprenorphine/naloxone
Intervention descriptions: intervention 1: boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7 intervention 2: methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8 intervention 3: buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8

Protocol documents:
Clinical trial NCT01404936
Conditions: Lymphoma
Keywords: Lymphoma Hodgkin's Disease Stage III and IV Adriamycin Doxorubicin Rubex Bleomycin Bleomycin Sulfate BLM Dacarbazine DTIC-DOME Interferon-2A Interferon-Alfa-2a Roferon-A Velban Vinblastine
Sponsor: M.D. Anderson Cancer Center
Start date: 1996-07-01; Completion date: 2011-12-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a clinical research study of interferon (IFN) plus chemotherapy with the standard combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD improves the immune response against Hodgkin's disease, and will determine whether the toxicity of ABVD is increased by adding IFN.

Detailed description:
Each treatment cycle will last 2 weeks. On days 1 - 4 of each cycle, patients will be given a shot of IFN under the skin. On day 4, patients will be given ABVD through a vein over one-hour.

The plan is for patients to receive 12 cycles of treatment. However, patients will leave the study if they have severe side effects or if the cancer grows or spreads. They will also leave if the cancer does not improve after 6 cycles. Patient who leave the study will be offered other treatments. A maximum of 35 patients will be treated with that dose.

Before the first treatment, patient will have a physical exam, blood tests, and a heart scan. Within 1 month of starting treatment, patients will have a chest X-ray, CT scans of the abdomen and pelvis, and a gallium scan.

During the study, patient will have blood tests every week and a physical exam every 2 weeks. The X-ray, CT scans, and gallium scan will be repeated after cycles 6 and 12.

All the drugs in this study are approved by the U.S. Food and Drug Administration and are available by prescription. ABVD is a standard treatment for Hodgkin's disease; IFN is an investigational treatment for Hodgkin's disease. About 35 patients will be enrolled in the study. All treatment will be given in the outpatient clinic at M.D. Anderson Cancer Center.

Arms: arm 1: Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
Interventions: intervention 1: Interferon-2A intervention 2: Adriamycin intervention 3: Bleomycin intervention 4: Velban intervention 5: Dacarbazine
Intervention descriptions: intervention 1: 4 (x106 IU/m\^2) subcutaneously on days 1-4. intervention 2: 25 mg/m\^2 by vein on day 4. intervention 3: 10 mg/m\^2 by vein on day 4. intervention 4: 6 mg/m\^2 by vein on day 4. intervention 5: 375 mg/m\^2 by vein on day 4.

Protocol documents:
Clinical trial NCT01411995
Conditions: Pain
Keywords: intrauterine device pain lidocaine gel
Sponsor: Washington University School of Medicine
Start date: 2011-08-01; Completion date: 2011-12-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.

Detailed description:
Double blind randomized controlled trial.

Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement

Arms: arm 1: Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal arm 2: Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal
Interventions: intervention 1: 2% lidocaine gel intervention 2: Water based lubricant
Intervention descriptions: intervention 1: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion intervention 2: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion

Protocol documents:
Clinical trial NCT01425632
Conditions: Perennial Allergic Rhinitis
Keywords: TAU-284 Bepotastine besilate Histamine H1 receptor antagonists
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2011-08-01; Completion date: 2011-12-01
Enrollment: 490 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of TAU-284.

Detailed description:
This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\])" as the primary endpoint; and to investigate the dose response, safety, and plasma concentrations of TAU-284.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: TAU-284 intervention 2: TAU-284 intervention 3: Placebo
Intervention descriptions: intervention 1: TAU-284 Low intervention 2: TAU-284 High intervention 3: Placebo

Protocol documents:
Clinical trial NCT01426958
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-08-01; Completion date: 2011-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration

Detailed description:

Arms: arm 1: 1 tablet afatinib single dose arm 2: 2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day arm 3: 2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
Interventions: intervention 1: afatinib intervention 2: ritonavir + afatinib intervention 3: ritonavir + afatinib
Intervention descriptions: intervention 1: standard therapeutic dose intervention 2: simultaneous intake of ritonavir and afatinib on second treatment day intervention 3: on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet

Protocol documents:
Clinical trial NCT01430104
Conditions: Osteoporosis
Sponsor: Eli Lilly and Company
Start date: 2011-08-01; Completion date: 2011-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients.

This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study. During the Treatment Period, daily administration of teriparatide will be added.

Detailed description:

Arms: arm 1: Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.
Interventions: intervention 1: Teriparatide intervention 2: Aspara-CA 600 mg intervention 3: Alfarol 1.0 µg
Intervention descriptions: intervention 1: Administered subcutaneously during the Treatment Period intervention 2: Administered orally throughout the study intervention 3: Administered orally throughout the study

Protocol documents:
Clinical trial NCT01432561
Conditions: Cystinosis Nephropathic Cystinosis
Keywords: Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors
Sponsor: University of California, San Diego
Start date: 2011-09-01; Completion date: 2011-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the rare disease cystinosis that became available in 1994, but there is inadequate knowledge of the food-effect on this drug's bioavailability. This study aims to investigate how food affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.

Detailed description:

Arms: arm 1: Cysteamine bitartrate, 500mg once a day, three days.
Interventions: intervention 1: Cysteamine bitartrate
Intervention descriptions: intervention 1: 500 mg total, single dose taken orally on visits 2, 3 \& 4 which must occur within a 14 day period.

Protocol documents:
Clinical trial NCT01432938
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-09-01; Completion date: 2011-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Warfarin is a commonly used drug to prevent the blood from clotting. The purpose of this study is to determine if dulaglutide (LY2189265) affects how warfarin works. The study involves two different treatments (Treatment 1: warfarin; Treatment 2: dulaglutide + warfarin) separated by a minimum washout period of 24 days. In Treatment 1, the participant will receive 10 milligrams (mg) of warfarin on Day 1. In Treatment 2, the participant will receive a 1.5-mg dose of dulaglutide (LY2189265) as an injection on Day 1 and then a 10 mg dose of warfarin on Day 3. Participants will be randomly assigned into different treatment sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2. Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.

Detailed description:

Arms: arm 1: A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 (Treatment 1). There was a washout period of at least 24 days between treatment periods. Then a single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2). arm 2: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg oral dose of warfarin on Day 3 (Treatment 2). There was a washout period of at least 24 days between treatment periods. Then a single, 10-mg oral dose of warfarin on Day 1 (Treatment 1).
Interventions: intervention 1: dulaglutide intervention 2: Warfarin
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01450098
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2011-10-01; Completion date: 2011-12-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects, and first-generation Japanese subjects after receiving a single oral dose of LY2484595 in a fasted state, after eating a low-fat meal, and after eating a high-fat meal.

Detailed description:

Arms: arm 1: LY2484595 (evacetrapib): 200 milligrams (mg) of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast. arm 2: LY2484595 (evacetrapib): 100 mg of LY2484595 administered orally as an RF tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast.
Interventions: intervention 1: LY2484595 Reference Formulation (RF) intervention 2: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01450306
Conditions: Specific Phobia
Sponsor: Hartford Hospital
Start date: 2010-07-01; Completion date: 2011-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the present study is to determine whether people receiving d-cycloserine and exposure therapy show different brain reactions to symptom provocation compared to people receiving placebo and exposure therapy.

Detailed description:
D-cycloserine (DCS) is a partial N-methyl-D-aspartate (NMDA) receptor agonist that may improve or accelerate extinction learning. We will randomly assign people with snake phobia to receive DCS or placebo, and then provide all participants with exposure therapy. We will examine whether people receiving DCS and vs. placebo show different brain reactions to symptom provocation before and after exposure therapy.

Arms: arm 1: Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session arm 2: Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Interventions: intervention 1: D-cycloserine intervention 2: Exposure therapy intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg d-cycloserine, oral, 1 dose intervention 2: Single session graded in vivo exposure therapy, 60-180 minutes intervention 3: Single capsule of oral placebo, administered once 1 hr prior to exposure therapy

Protocol documents:
Clinical trial NCT01456299
Conditions: Laryngismus
Keywords: laryngeal mask airway insertion sevoflurane remifentanil
Sponsor: Gachon University Gil Medical Center
Start date: 2011-04-01; Completion date: 2011-12-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

Detailed description:
For practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there have been no published reports addressing the use of remifentanil to facilitate LMA insertion during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

Arms: arm 1: The control group, which received an infusion of normal saline. arm 2: "Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml. arm 3: "Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml.
Interventions: intervention 1: Remifentanil 1 intervention 2: Control intervention 3: Remifentanil 2
Intervention descriptions: intervention 1: "Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml. intervention 2: The control group, which received an infusion of normal saline intervention 3: "Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.

Protocol documents:
Clinical trial NCT01470118
Conditions: Conjunctivitis, Allergic
Sponsor: Allergan
Start date: 2011-10-01; Completion date: 2011-12-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.

Detailed description:

Arms: arm 1: One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. arm 2: One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. arm 3: One drop of placebo instilled in each eye at Day 0 and Day 14.
Interventions: intervention 1: alcaftadine 0.25% ophthalmic solution intervention 2: olopatadine 0.2% ophthalmic solution intervention 3: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
Intervention descriptions: intervention 1: One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. intervention 2: One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. intervention 3: One drop of placebo instilled in each eye at Day 0 and Day 14.

Protocol documents:
Clinical trial NCT01500317
Conditions: Effects of 2 Mu-opiates on Gastrointestinal Transit
Keywords: tapentadol oxycodone mu-opiate stomach small intestine colon motility nausea constipation
Sponsor: Mayo Clinic
Start date: 2011-05-01; Completion date: 2011-12-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there is potential for off label use in chronic pain.

Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in pain relief. While its action reflects aspects of tramadol and morphine, its ability to control pain is more on the order of hydrocodone and oxycodone.

Its dual mode of action provides analgesia at similar levels of more potent narcotic analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect profile. Clinical studies showed that tapentadol effectively relieves moderate to severe pain in various pain care settings. In addition, it was reported to be associated with significantly fewer treatment discontinuations due to a significantly lower incidence of gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The combination of these reduced treatment discontinuation rates and tapentadol efficacy for the relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in pain therapy by increasing patient compliance with their treatment regimen.

Detailed description:
Single center, parallel group, randomized controlled trial of tapentadol, oxycodone and placebo effects on gastrointestinal and colonic transit in healthy human volunteers

Arms: arm 1: 75 mg tapentadol tid arm 2: 5 mg oxycodone tid arm 3: Placebo tid
Interventions: intervention 1: Tapentadol intervention 2: Oxycodone intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects received tapentadol immediate release formulation, 75 mg three times per day (tid) for 48 hours. intervention 2: Subjects received oxycodone immediate release formulation, 5 mg three times per day (tid) for 48 hours. intervention 3: Subjects received placebo three times per day (tid) for 48 hours.

Protocol documents:
Clinical trial NCT01506908
Conditions: Smoking Dependence Smoking
Keywords: craving
Sponsor: GlaxoSmithKline
Start date: 2011-09-01; Completion date: 2011-12-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers

Detailed description:

Arms: arm 1: None arm 2: mint mini lozenge with no active
Interventions: intervention 1: oral nicotine intervention 2: Placebo
Intervention descriptions: intervention 1: oral nicotine replacement product intervention 2: no active

Protocol documents:
Clinical trial NCT01514513
Conditions: Pediculosis Capitis
Sponsor: South Florida Family Health and Research Centers
Start date: 2011-08-01; Completion date: 2011-12-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.

Detailed description:
Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Licefreee Spray intervention 2: 1% permethrin creme rinse
Intervention descriptions: intervention 1: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present. intervention 2: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.

Protocol documents: