ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01216735
Conditions: Tobacco Abuse Smoke
Keywords: smokers inhaled corticosteroids brachial flow airway blood flow albuterol spirometry endothelial dysfunction
Sponsor: University of Miami
Start date: 2008-09-01; Completion date: 2010-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The hypothesis underlying the proposed study is that the blunted endothelium-dependent vasodilation seen in the airway of current smokers is also present in the brachial artery, and that the same inhaled corticosteroid (ICS) treatment regime that reversed endothelial function in the airway of current smokers will also restore endothelium-dependent relaxation in the brachial artery. Non-smokers will be used as controls and will not receive any intervention or treatment.

Detailed description:
Cigarette smoking can lead to systemic endothelial dysfunction. Since the airway circulation is exposed to a high concentration of cigarette smoke constituents, we reasoned that airway vascular endothelial dysfunction could be present in healthy smokers without systemic endothelial dysfunction.

The purpose of this study was to compare airway and systemic endothelial function and measure markers of systemic inflammation in lung-healthy current smokers. Since endothelial dysfunction in smokers has been related to systemic inflammation, we also investigated its response to an inhaled glucocorticosteroid (ICS).

Vascular endothelial function was assessed in the airway by the airway blood-flow (Qaw) response to inhaled albuterol (ΔQaw) and in the extrapulmonary circulation by brachial arterial flow-mediated vasodilation (FMD). Venous blood was collected for C-reactive protein and IL-6.

Qaw was measured with a noninvasive inhaled soluble gas uptake technique. The uptake of the gas from the anatomical deadspace reflecting airways perfused by the airway circulation was quantitated.

Qaw was express as μL/min normalized for anatomical deadspace: μL/min/mL.

Arms: arm 1: The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) . The subjects and the investigators will be blinded to the random choice of inhaler. arm 2: The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler. arm 3: The healthy non-smokers will have only visit 1 and no intervention.
Interventions: intervention 1: Fluticasone intervention 2: Placebo
Intervention descriptions: intervention 1: 220 ug twice a day for 3 weeks intervention 2: Placebo for 3 weeks

Protocol documents:
Clinical trial NCT01387542
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Extended Release (ER) INVEGA
Sponsor: Janssen-Cilag Ltd.,Thailand
Start date: 2009-08-01; Completion date: 2010-09-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

Detailed description:
This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance) study to evaluate the efficacy and safety of paliperidone ER in adult Thai schizophrenia participants. The study consists of a screening phase and an open-label treatment phase. Study duration will be 10 weeks and participants can either be inpatient or outpatient. The recommended paliperidone ER starting and maintenance dose will be 6 milligram (mg) per day for most participants. Throughout the study, flexible dosing ranging from 3 to 12 mg per day may be used at the discretion of the investigator. Throughout the study, participants will be evaluated for efficacy using clinician rating (Clinical and Global Impressions-Severity \[CGI-S\] scale, and Personal and Social Performance Scale \[PSP\]) scales. Safety of the participants will be monitored.

Arms: arm 1: Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
Interventions: intervention 1: Paliperidone extended release (ER)
Intervention descriptions: intervention 1: Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks

Protocol documents:
Clinical trial NCT01515891
Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-05-01; Completion date: 2010-09-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the absorption, metabolism and excretion of BIA 9-1067.

Detailed description:
Monocentre, open, non-placebo-controlled, single-group, single-dose study

Arms: arm 1: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
Interventions: intervention 1: BIA 9-1067
Intervention descriptions: intervention 1: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).

Protocol documents:
Clinical trial NCT01573052
Conditions: Alcohol Withdrawal
Sponsor: VA Salt Lake City Health Care System
Start date: 2004-03-01; Completion date: 2010-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, double-blind controlled trial comparing treatment outcomes between chlordiazepoxide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent veteran subjects. The objective of this trial is to compare the safety and effectiveness of these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence, withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and alcohol craving.

Detailed description:
Chlordiazepoxide 25 mg and matching placebo capsules or gabapentin 300 mg and matching placebo capsules were were used. The chlordiazepoxide/placebo and gabapentin/placebo capsules were not identical in appearance. Study medications were packaged into a 7-day medication organizer. The dosing for each subject was either gabapentin 1200mg or chlordiazepoxide 100 mg orally days 1-3, gabapentin 900 mg or chlordiazepoxide 75 mg day 4, gabapentin 600 mg or chlordiazepoxide 50 mg day 5, and gabapentin 300 mg or chlordiazepoxide 25 mg day 6.

Adherence was assessed by pill counts and serum samples were obtained for study drug analysis. Serum samples were batched and sent to a contract laboratory so that study clinicians were blinded to the results until after the trial was completed. Presence of the assigned study medication in the blood served as a surrogate adherence marker.

Subjects also received prescriptions for daily oral therapeutic multiple vitamin tablets, folic acid 1 mg, and thiamine 100 mg.

A psychiatric history and physical examination, breath alcohol concentration, vital signs, CIWA-Ar (alcohol withdrawal scale), and blood chemistry including transaminases and complete blood cell count were obtained for baseline for all participants. Subjects were seen on weekdays for clinic follow-up appointments. Assessments performed at each study visit included CIWA-Ar, ESS (Epworth Sleepiness Scale), PACS (Penn Alcohol Craving Scale), and a brief examination to document mental status and assess coordination, which included assessment of stance, tandem gait, Romberg test, pronator drift, toe and heel walk, rapid-alternating-movements, and point-to-point movements. Breath alcohol concentration (BAC) was also measured (AlcoSensor, Intoximeters, Inc.) at each visit.

Arms: arm 1: Chlordiazepoxide 25mg capsule or matching placebo capsule arm 2: Gabapentin 300mg capsule or matching placebo capsule
Interventions: intervention 1: Chlordiazepoxide intervention 2: Gabapentin
Intervention descriptions: intervention 1: 25mg four times daily x 3 days then tapered over 3 days intervention 2: 300mg four times daily x 3 days then tapered over 3 days

Protocol documents:
Clinical trial NCT01648699
Conditions: Pain
Keywords: Pain Cancer Osmotic Release Oral System OROS Hydromorphone Jurnista
Sponsor: Janssen Pharmaceutica
Start date: 2010-04-01; Completion date: 2010-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.

Detailed description:
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.

Arms: arm 1: OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.
Interventions: intervention 1: Osmotic Release Oral System (OROS) hydromorphone
Intervention descriptions: intervention 1: OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.

Protocol documents:
Clinical trial NCT01959464
Conditions: Infertility Pregnancy
Keywords: Assisted reproductive technology Infertility Progesterone Vaginal gel Luteal-phase support
Sponsor: Wake Forest University Health Sciences
Start date: 2008-11-01; Completion date: 2010-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if sexual intercourse lowers serum progesterone in women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their male sexual partners. We hypothesize, based on previous estrogen studies done by our group, that intercourse will interfere with absorption of vaginal progesterone.

Detailed description:
The effects of intercourse on the absorption of vaginal progesterone for the female user and her sexual partner have not been studied. However, a previous study performed by our group found that intercourse lowered the absorption of vaginal estrogen cream in women, and men absorbed a small but statistically significant amount of estradiol during intercourse. Vaginal progesterone gel may be used by women for several clinical indications, and if intercourse alters the absorption and distribution of vaginal progesterone, clinical outcomes may be compromised. If intercourse lowers absorption, the efficacy of the treatment could be reduced. If intercourse enhances absorption, side effects may be increased. Also, if the male sexual partner absorbs vaginal progesterone, undesirable side effects may occur.

Arms: arm 1: Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.

On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream. arm 2: The couple will be given a prefilled applicator containing either Crinone gel (progesterone) or placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.
Interventions: intervention 1: Crinone vaginal progesterone gel intervention 2: Placebo vaginal gel
Intervention descriptions: intervention 1: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator. intervention 2: Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.

Protocol documents:
Clinical trial NCT02153788
Conditions: Insomnia
Keywords: Insomnia HIV
Sponsor: Duke University
Start date: 2009-09-01; Completion date: 2010-09-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and one of which is a placebo (an inactive substance that looks just like the temazepam), to see if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are given in research studies to try and make sure that subjects are responding to the effects of the study drug and not to other factors, like the attention they are receiving. If you decide to take part in this study, you will take 1 capsule of study drug every night approximately 30 minutes before bedtime for approximately 12 weeks.

This study is to test the study drug called temazepam for the treatment of insomnia (trouble sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the treatment of insomnia. However, because this study requires treatment for 12 weeks instead of the 7 to 10 days approved by the FDA, the use of temazepam is considered to be investigational in this study.

Detailed description:

Arms: arm 1: After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. arm 2: After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.
Interventions: intervention 1: Temazepam intervention 2: Placebo
Intervention descriptions: intervention 1: Temazepam 15 mg orally at bedtime intervention 2: None

Protocol documents:
Clinical trial NCT00928486
Conditions: Multiple Myeloma
Sponsor: Celgene
Start date: 2009-04-28; Completion date: 2010-09-10
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients with previously treated multiple myeloma.

Detailed description:

Arms: arm 1: Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Interventions: intervention 1: Lenalidomide intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Lenalidomide 25mg PO for (days 1 - 21) of a 28-day cycle intervention 2: Dexamethasone 40 mg by mouth (PO) daily (QD) on days 1-4, 9-12 and 17-20 of each 28 day cycle

Protocol documents:
Clinical trial NCT00604812
Conditions: Migraine Disorders
Sponsor: Organon and Co
Start date: 2007-12-17; Completion date: 2010-09-17
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.

After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.

Detailed description:

Arms: arm 1: Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.

Subjects weighing 20-39 kg were allocated to Panel A. arm 2: Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.

Subjects weighing 20-39 kg were allocated to Panel A. arm 3: Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.

Subjects weighing 40 kg and above were allocated to Panel B. arm 4: Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.

Subjects weighing 40 kg and above were allocated to Panel B. arm 5: Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.

Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. arm 6: Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.

Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
Interventions: intervention 1: rizatriptan benzoate (5 mg) intervention 2: rizatriptan benzoate (10 mg) intervention 3: Rizatriptan 5 mg Placebo intervention 4: Rizatriptan 10 mg Placebo
Intervention descriptions: intervention 1: A single dose of rizatriptan 5 mg administered on Day 1. intervention 2: A single dose of rizatriptan 10 mg administered on Day 1. intervention 3: A single dose of rizatriptan 5 mg placebo administered on Day 1. intervention 4: A single dose of rizatriptan 10 mg placebo administered on Day 1.

Protocol documents:
Clinical trial NCT01026831
Conditions: Open-angle Glaucoma Ocular Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-01-06; Completion date: 2010-09-17
Enrollment: 643 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was to compare the safety and efficacy of the preservative-free formulation of 0.0015% MK2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with open-angle glaucoma and ocular hypertension. This study was to demonstrate that the preservative-free formulation of 0.0015% tafluprost is non-inferior to preservative-free 0.5% timolol maleate.

Detailed description:

Arms: arm 1: Preservative-free tafluprost arm 2: Preservative-free timolol maleate
Interventions: intervention 1: Preservative-Free Tafluprost intervention 2: Comparator: timolol
Intervention descriptions: intervention 1: One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks intervention 2: One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00930059
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease PF-04447943 efficacy safety plasma concentrations
Sponsor: Pfizer
Start date: 2009-09-10; Completion date: 2010-09-22
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-04447943 intervention 2: Placebo
Intervention descriptions: intervention 1: tablets, 25 mg every 12 hours for 12 wks intervention 2: matching placebo tablets, every 12 hours for 12 wks

Protocol documents:
Clinical trial NCT00973973
Conditions: Endometriosis, Pain
Keywords: Pelvic Pain,NBI-56418,Endometriosis
Sponsor: AbbVie
Start date: 2009-10-12; Completion date: 2010-09-22
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.

Detailed description:
Participants were randomized (1:1) to 150 mg elagolix once daily or placebo once daily for the first 8 weeks of the study. Following 8 weeks of dosing, participants continued in the study for an additional 16 weeks in an open-label phase where all participants still enrolled in the study received 150 mg elagolix once daily.

There was no pre-specified primary efficacy end point for this study as there is no single key efficacy outcome measure in this exploratory Phase 2 study. However, the efficacy measures of primary interest included the daily assessment of dysmenorrhea, non-menstrual pelvic pain and dyspareunia on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

Arms: arm 1: Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period. arm 2: Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.
Interventions: intervention 1: Placebo intervention 2: Elagolix
Intervention descriptions: intervention 1: Matching placebo tablets taken orally once a day intervention 2: Immediate release (IR) tablets taken orally once a day

Protocol documents: