ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00732680
Conditions: Empty Nose Syndrome Atrophic Rhinitis
Keywords: Empty nose syndrome Over resection of turbinate Atrophic rhinitis
Sponsor: Mayo Clinic
Start date: 2008-12-01; Completion date: 2009-11-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive action to airflow of the resected turbinates.

This study will research the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A (Botox).

Detailed description:
Background:

Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge, crusting, dryness, dysosmia, and pain.

Treatment modalities include adjunctive comfort measures (primarily irrigation), mechanical measures (Silicon cones, cotton wads) and surgical treatment (alloderm implants, plastipore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of botulinum toxin type A into the dilator nasalis muscle thus collapsing the internal nasal valve to provide added resistance to air flow.

Objective:

To evaluate effectiveness of botulinum toxin type A in improving overall quality of life in ENS patients.

Methods:

ENS patients in this study will receive botulinum toxin type A along with adjunctive treatment which will include several measures. First of all, patients will be given a nasal rinse bottle and will be instructed to irrigate their noses twice a day as follows:

* Irrigate the nose 250cc (about 125cc each side) to clear the mucus.
* Stop and gently clear the nose.
* Irrigate the nose 250cc (about 125cc each side) once again.
* Sit quietly for 10 minutes. No blowing.
* Do not blow the nose for 2 hours.

Patients will be asked to use sesame oil once a day to prevent drying of the nasal mucosa with further administration as needed. In addition they will advised to make certain lifestyle modifications that will include sleeping with a cool mist humidifier, drinking plenty of fluids and engaging in regular physical activity.

Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will measure changes in physical and mental health.

Arms: arm 1: Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
Interventions: intervention 1: Botulinum Toxin Type A
Intervention descriptions: intervention 1: 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.

Protocol documents:
Clinical trial NCT00732992
Conditions: Neoplasm, Malignant
Keywords: Solid tumor malignancy sunitinib pemetrexed phase 1 neoplasms
Sponsor: Pfizer
Start date: 2008-08-01; Completion date: 2009-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sunitinib, Pemetrexed intervention 2: Sunitinib, Pemetrexed
Intervention descriptions: intervention 1: Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity. intervention 2: Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00736957
Conditions: Chronic Pain
Keywords: Chronic Pain Acetaminophen Tramadol JNS013
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2008-05-01; Completion date: 2009-11-01
Enrollment: 219 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) with long term administration in participants with chronic pain.

Detailed description:
This is an open-label (both physician and participant know the name of the study drug), non-randomized, multicenter (when more than one hospital or medical school team work on a medical research study) and long-term efficacy and safety study of JNS013 (combination of tramadol hydrochloride (TRAM) with acetaminophen \[APAP\]) in participants with chronic pain (aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain). This study consists of 4 periods; screening period: 1 week, treatment period I: 4 weeks, treatment period II: 48 weeks and follow-up period: 1 week. During Treatment Period I, restrictions on concomitant treatments will be established and the participants will be treated with one or two tablets of JNS013, four times daily for four weeks. During Treatment Period II, the participants will be treated for 48 weeks using the same dosing method and dose level for JNS013 as was used during Treatment Period I, permitting modifications to the concomitant drugs/therapies as during normal medical care. Throughout both Treatment Period I and Treatment Period II, the decision will be made to permit the participants to select to use either one or two tablets of JNS013 per dose according to the extent of the participant's pain and tolerability. The total duration of treatment period will be of 52 weeks. Efficacy will be assessed using change from baseline in Visual Analogue Scale for pain (VAS24) score at the pre-defined time point until Week 52. Participants safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)
Intervention descriptions: intervention 1: Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.

Protocol documents:
Clinical trial NCT00741611
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: C. R. Bard
Start date: 2008-07-01; Completion date: 2009-11-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.

Detailed description:

Arms: arm 1: Ablation with HD Mesh Ablation System arm 2: Treatment with anti-arrhythmic drugs
Interventions: intervention 1: HD Mesh Ablation System intervention 2: Anti-arrhythmic drugs
Intervention descriptions: intervention 1: Ablation using the HD Mesh Ablation System intervention 2: 5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation

Protocol documents:
Clinical trial NCT00742859
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation Betrixaban Factor Xa inhibitor Warfarin
Sponsor: Portola Pharmaceuticals
Start date: 2008-10-01; Completion date: 2009-11-01
Enrollment: 508 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation over time.

Detailed description:
To assess the safety and tolerability of betrixaban at doses of 40 mg, 60 mg and 80 mg given orally once a day for at least 3 months compared to dose-adjusted warfarin in patients with non-valvular atrial fibrillation (AF).

This is a Phase 2, exploratory, randomized, parallel group, multicenter, active comparator, dose finding study of patients with documented non-valvular AF. Patients will be randomized (1:1:1:1) to 1 of 4 treatment groups (approximately 125 patients per group) using an interactive voice response system (IVRS). A dynamic randomization will be used to balance patients by country, concurrent aspirin use (yes or no) and antecedent warfarin (yes or no). The study will be open label for randomization to warfarin versus betrixaban, but the three daily doses of betrixaban, 40 mg, 60 mg or 80 mg, will be double-blind (identical capsules for all three dose levels). The warfarin-treated patients will be managed according to each center's usual clinical routine with INR monitoring and dose-adjustments in order to maintain a target INR of 2.0 to 3.0 at maximum intervals of four weeks. No loading doses or dose titrations will be used for betrixaban. The betrixaban dose should be ingested in the evening (e.g. at bedtime), preferably at least 2 hours after the evening meal. Note: acenocumerol may be substituted for warfarin as indicated by local practice.

Arms: arm 1: Betrixaban, 40 mg, orally, once daily for at least 3 months. arm 2: Betrixaban, 60 mg, orally, once daily for at least 3 months arm 3: Betrixaban, 80 mg, orally, once daily for at least 3 months arm 4: Warfarin will be prescribed by investigators according to the standard of care.
Interventions: intervention 1: betrixaban intervention 2: Warfarin
Intervention descriptions: intervention 1: orally, once daily for at least 3 months intervention 2: Warfarin will be prescribed by the investigator according to the standard of care.

Protocol documents:
Clinical trial NCT00749463
Conditions: Tobacco Dependence
Keywords: nicotine dependence, smoking cessation, NRT
Sponsor: McNeil AB
Start date: 2009-02-01; Completion date: 2009-11-01
Enrollment: 300 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit

Detailed description:
Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral supports.

Arms: arm 1: Nicotine Gum 2 mg for subjects smoking less than 20 cigarettes per day; 2 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks arm 2: Nicotine Gum 4 mg for subjects smoking 20 or more cigarettes per day; 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks arm 3: Nicotine Patch; Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.
Interventions: intervention 1: Nicotine Gum intervention 2: Nicotine Patch
Intervention descriptions: intervention 1: 2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks intervention 2: Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.

Protocol documents:
Clinical trial NCT00753896
Conditions: Type 2 Diabetes
Keywords: Amylin Lilly exenatide once weekly thiazolidinedione metformin
Sponsor: AstraZeneca
Start date: 2008-10-01; Completion date: 2009-11-01
Enrollment: 134 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine the safety of exenatide once weekly (2.0 mg) in approximately 134 patients receiving treatment with thiazolidinedione alone or thiazolidinedione in combination with metformin. Patients are expected to be treated with exenatide once weekly for at least 52 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: exenatide
Intervention descriptions: intervention 1: subcutaneous injection, 2.0mcg, once weekly

Protocol documents:
Clinical trial NCT00770861
Conditions: Hypertension
Keywords: nebivolol Bystolic ™ Hypertension Hispanic Hypertension in Hispanic patients
Sponsor: Forest Laboratories
Start date: 2008-09-01; Completion date: 2009-11-01
Enrollment: 277 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension

Detailed description:

Arms: arm 1: Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration arm 2: Matching placebo tablets, oral administration
Interventions: intervention 1: Nebivolol intervention 2: Placebo
Intervention descriptions: intervention 1: Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration intervention 2: Matching placebo tablets, oral administration

Protocol documents:
Clinical trial NCT00792636
Conditions: Migraine Disorders
Keywords: sumatriptan and naproxen sodium migraine with or without aura naproxen sodium sumatriptan blood pressure migraine headaches
Sponsor: GlaxoSmithKline
Start date: 2008-11-01; Completion date: 2009-11-01
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only naproxen sodium when these drugs are taken to treat migraine headaches that occur during a 6-month period.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: sumatriptan and naproxen sodium combination tablet intervention 2: sumatriptan tablet intervention 3: naproxen sodium tablet
Intervention descriptions: intervention 1: sumatriptan 85mg and naproxen sodium 500mg intervention 2: sumatriptan 85mg intervention 3: Naproxen sodium 500mg

Protocol documents:
Clinical trial NCT00805545
Conditions: Infection
Sponsor: University of Florida
Start date: 2008-11-01; Completion date: 2009-11-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current standard of care to prevent post partum infectious morbidities is to administer antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is to administer the antibiotic immediately after the umbilical cord is clamped. This study will compare the incidence of post partum infectious morbidities when the extended spectrum prophylaxis given before the incision time vs. the time of cord clamp.

Detailed description:
Some studies suggest that administering the antibiotics prior to skin incision decrease the incidence of post partum infectious morbidities without increasing the risks to the baby from the exposure to the antibiotics. Our investigation will validate these findings in a larger series of patients. We will be conducting a prospective controlled randomized trial that will compare both methods of antibiotic prophylaxis. All patients undergoing cesarean delivery will be eligible except for the patients with the diagnosis of chorioamnionitis. One group will receive Cefazolin 1gm intravenous + Azithromycin 500mg intravenous 30-60 minutes prior to incision. The second group will receive the same antibiotics immediately after cord clamp. The primary outcomes will be endometritis, wound infection, neonatal sepsis evaluations, proven cases of neonatal infection. Secondary outcomes will be patients that required post procedure antibiotics, the duration of treatment for mother and neonate and the pattern of antibiotic resistance in microorganisms isolated and characteristics of the neonatal bowel flora.

Arms: arm 1: Group of patients that will receive antibiotics 30-60 minutes prior to incision arm 2: Group of patients that will receive antibiotics immediately after clamping the umbilical cord
Interventions: intervention 1: Antibiotic intervention 2: Antibiotic
Intervention descriptions: intervention 1: Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously intervention 2: Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously

Protocol documents:
Clinical trial NCT00806221
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis Prevention Skin Barrier
Sponsor: Oregon Health and Science University
Start date: 2006-11-01; Completion date: 2009-11-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.

Detailed description:
All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.

Arms: arm 1: Skin barrier protection from birth
Interventions: intervention 1: emollient (Cetaphil cream)
Intervention descriptions: intervention 1: Cetaphil cream applied daily from birth

Protocol documents:
Clinical trial NCT00806624
Conditions: Atrial Fibrillation Stroke
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2007-10-01; Completion date: 2009-11-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).

Detailed description:

Arms: arm 1: DU-176b tablets: high-dose arm 2: Warfarin tablets arm 3: DU-176b tablets: low-dose
Interventions: intervention 1: DU-176b tablets intervention 2: DU-176b tablets intervention 3: Warfarin tablets
Intervention descriptions: intervention 1: DU-176b tablets taken once daily for up to 3 months intervention 2: DU-176b tablets taken once daily for up to 3 months intervention 3: Warfarin tablets taken once daily for up to 3 months

Protocol documents:
Clinical trial NCT00812331
Conditions: Hepatitis C
Keywords: Hepatitis C TMC435
Sponsor: Tibotec Pharmaceuticals, Ireland
Start date: 2009-03-01; Completion date: 2009-11-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.

Detailed description:
This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435. Approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group). The study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication). Safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.

Arms: arm 1: Participants with chronic genotype 2 hepatitis C virus (HCV) infection arm 2: Participants with chronic genotype 3 HCV infection arm 3: Participants with chronic genotype 4 HCV infection arm 4: Participants with chronic genotype 5 HCV infection arm 5: Participants with chronic genotype 6 HCV infection
Interventions: intervention 1: TMC435
Intervention descriptions: intervention 1: From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.

Protocol documents: