ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00681538
Conditions: Spasticity Multiple Sclerosis
Keywords: Spasticity Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Start date: 2008-01-01; Completion date: 2009-01-01
Enrollment: 572 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Sativex® versus Placebo is effective in the relief of symptoms of spasticity in subjects with multiple sclerosis, who have been identified as having a capacity to respond to Sativex.

Detailed description:
This 19 week, multicentre study was conducted in two phases. Phase A was a preliminary, single-blind four week treatment period to identify subjects with a capacity to respond to Sativex; eligible, consenting subjects entered a seven day screening period prior to returning to the study centre to begin a four week single-blind course of Sativex treatment. At the end of this phase, subjects' response to Sativex was assessed; those with the capacity to respond (i.e. at least a 20% reduction in mean 0-10 point numerical rating scale (NRS) spasticity score between screening and the end of the four week Phase A treatment) were eligible for entry into Phase B while those who did not respond took no further part in the study other than a follow up visit 14 days later.

Phase B was a 12 week double-blind, randomised, placebo controlled, parallel group study with visits at 28 day intervals and a final follow up visit 14 days after completion or withdrawal.

The level of spasticity, spasm frequency and sleep disruption were collected each day during the entire study via an interactive voice response system (IVRS). In addition, study medication dosing data were recorded via IVRS throughout Phases A and B. Assessments of other secondary and functional measures of spasticity, safety and tolerability, QOL (quality of life) and mood were also gathered throughout the study.

Arms: arm 1: Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.

Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours arm 2: Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
Interventions: intervention 1: Sativex® intervention 2: Placebo
Intervention descriptions: intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum dose within any 24-hour interval is 12 sprays (THC 32.4 mg: CBD 30 mg) intervention 2: containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colouring FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).

Protocol documents:
Clinical trial NCT00682461
Conditions: Healthy Volunteer Smokers
Keywords: Nicotine Tolerability NRT
Sponsor: GlaxoSmithKline
Start date: 2007-09-01; Completion date: 2009-01-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the oral tolerability of a nicotine prototype

Detailed description:

Arms: arm 1: Marketed nicotine replacement therapy product arm 2: Nicotine prototype
Interventions: intervention 1: Nicotine intervention 2: Nicotine
Intervention descriptions: intervention 1: Marketed nicotine replacement therapy formulation intervention 2: Nicotine prototype

Protocol documents:
Clinical trial NCT00685945
Conditions: Obesity
Keywords: Bradykinin Obesity Nitric Oxide Donor tissue type plasminogen activator isosorbide dinitrate phosphodiesterase inhibitor Renin-Angiotensin Aldosterone System Fibrinolysis Angiotensin converting enzyme
Sponsor: Vanderbilt University
Start date: 2007-12-01; Completion date: 2009-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to determine if giving isosorbide,a drug that is used to treat chest pain, affects blood vessel release of an anti-clotting factor.

Detailed description:
To test the hypothesis that the administration of the NO donor isosorbide dinitrate,but not the phosphodiesterase inhibitor sildenafil, will attenuate stimulated vascular t-PA release whereas both agents will improve glucose uptake.

Arms: arm 1: Bradykinin (Clinalfa AG, Läufelfingen, Switzerland) arm 2: N-monomethyl-L-arginine (L-NMMA, NO synthase inhibitor; Bachem, Torrance, CA) arm 3: Isosorbide (NO donor) arm 4: Sildenafil (phosphodiesterase type 5 (PDE5) inhibitor
Interventions: intervention 1: Control (bradykinin) intervention 2: L-NMMA + bradykinin intervention 3: Isosorbide + L-NMMA + bradykinin intervention 4: Sildenafil + L-NMMA + bradykinin
Intervention descriptions: intervention 1: Graded doses of bradykinin (Clinalfa AG, Läufelfingen, Switzerland) will be infused at 50, 100, and 200ng/min. Each dose will be infused for 5 minutes and FBF will measured during the last 2 minutes of infusion. Arterial and venous blood samples will be obtained for measurement of net t-PA release after each dose. intervention 2: Thirty minutes after administration of bradykinin a continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be started started. While continuing the infusion of L-NMMA, baseline measurements and infusion of bradykinin will be repeated. intervention 3: Following the second bradykinin infusion, 12 subjects will receive 5mg isosorbide dinitrate (an exogenous NO donor; Major Pharmaceuticals Inc, Livonia MI). Sixty minutes after the administration of isosorbide the continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be restarted and baseline measurements and bradykinin infusion will be repeated. intervention 4: Following the second bradykinin infusion, 12 subjects will receive 50mg sildenafil (phosphodiesterase type 5 (PDE5) inhibitor to increase cGMP without increasing NO; Pfizer, NY). Sixty minutes after the administration of sildenafil the continuous intra-arterial infusion of L-NMMA at 12 micromol/min will be restarted and baseline measurements and bradykinin infusion will be repeated.

Protocol documents:
Clinical trial NCT00687973
Conditions: Hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2008-01-01; Completion date: 2009-01-01
Enrollment: 393 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.

Detailed description:

Arms: arm 1: Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. arm 2: Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Interventions: intervention 1: Valsartan/amlodipine 80/5 mg tablets intervention 2: Amlodipine 5 mg capsules intervention 3: Amlodipine 10 mg capsules intervention 4: Atenolol 50 mg tablets intervention 5: Atenolol 100 mg tablets
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00688636
Conditions: Crohn's Disease
Sponsor: University of Pittsburgh
Start date: 2005-01-01; Completion date: 2009-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: infliximab intervention 2: placebo
Intervention descriptions: intervention 1: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6 intervention 2: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

Protocol documents:
Clinical trial NCT00689884
Conditions: Hematologic Malignancies
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2007-01-01; Completion date: 2009-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells (PBSCs), defined as cell yield ≥ 3 x 10e6 CD34+/kg and to assess the costs related to Pegfilgrastim use in the mobilization of autologous PBSCs. Also to determine the side effects of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells.

Detailed description:

Arms: arm 1: All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
Interventions: intervention 1: Pegfilgrastim
Intervention descriptions: intervention 1: Pegfilgrastim: Sub Cutaneous, 6 mg on Day 3 of chemotherapy regimen or as otherwise indicated by chemotherapy regimen (ie., 24 hours after completion of chemotherapy).

Protocol documents:
Clinical trial NCT00691665
Conditions: Seasonal Allergic Rhinitis
Keywords: Rhinitis Seasonal Allergic Rhinitis allergies
Sponsor: Alcon Research
Start date: 2008-05-01; Completion date: 2009-01-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

Detailed description:

Arms: arm 1: Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily arm 2: Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Interventions: intervention 1: Olopatadine HCL Nasal Spray, 0.6% intervention 2: Fluticasone Propionate Nasal Spray, 50 mcg
Intervention descriptions: intervention 1: Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily intervention 2: Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Protocol documents:
Clinical trial NCT00696787
Conditions: Fibromyalgia
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2008-06-01; Completion date: 2009-01-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.

Detailed description:

Arms: arm 1: In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. arm 2: In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. arm 3: In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Interventions: intervention 1: Desvenlafaxine Sustained Release (DVS SR) intervention 2: Lyrica® (Pregabalin) intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00702468
Conditions: Spasticity Multiple Sclerosis
Keywords: Spasticity Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Start date: 2007-11-01; Completion date: 2009-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have been receiving long-term benefit from treatment with Sativex®.

Detailed description:
This five week (one week baseline and four weeks randomised treatment period), multi-centre, placebo controlled, parallel group, randomized withdrawal study will evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term benefit from treatment with Sativex®. Subjects will be selected from the Supply of Unlicensed Sativex® (SUS) or named patient supply programmes and must have been receiving Sativex® for at least 12 weeks prior to study entry. Following informed consent and screening, eligible subjects will enter the study (Visit 1, Day 1) and commence a seven day open label baseline period, before returning for a randomisation visit (Visit 2, Day 7), at which point they are randomised to receive either Sativex® or placebo (randomised withdrawal period). Subjects will return to the centre for an end of study visit at week five (Visit 3, Day 35) or earlier if they withdraw from treatment. Spasticity and sleep disruption review and dosing diaries will be completed each day from the start of the baseline period until completion or withdrawal.

Arms: arm 1: Sativex arm 2: Placebo
Interventions: intervention 1: Sativex intervention 2: Placebo
Intervention descriptions: intervention 1: containing delta-9-tetrahydrocannabinol (THC)(27 mg/ml):cannabidiol (CBD)(25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Dose: 100 µl oromucosal spray, as required for symptom relief intervention 2: Contains no active drug and is delivered in 100 microlitre actuations by a pump action oromucosal spray

Protocol documents:
Clinical trial NCT00715676
Conditions: Osteoporosis
Keywords: Osteoporosis 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3 Vitamin D Bone Density Conservation Agents Bone Regeneration
Sponsor: Deltanoid Pharmaceuticals
Start date: 2007-03-01; Completion date: 2009-01-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of a 1-year administration of the vitamin D analog 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density (BMD), safety, and tolerability.

Detailed description:
DP001 is a vitamin D analog that has been shown to stimulate bone formation in pre-clinical studies. In a Phase 1B study of postmenopausal women, an increase in the bone formation marker, osteocalcin, was evident without an increase in serum calcium. The aim of this study is to determine if 1-year administration of DP001 to postmenopausal women with osteopenia results in a significant increase in BMD at doses that are safe and well tolerated.

Arms: arm 1: None arm 2: 220 ng arm 3: 440 ng
Interventions: intervention 1: Placebo intervention 2: DP001
Intervention descriptions: intervention 1: oral, once daily intervention 2: oral, once daily

Protocol documents:
Clinical trial NCT00717522
Conditions: Soft Tissue Sarcoma
Keywords: Soft Tissue Sarcoma CC-4047 Pomalidomide
Sponsor: Celgene
Start date: 2008-08-01; Completion date: 2009-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.

Detailed description:

Arms: arm 1: 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
Interventions: intervention 1: Pomalidomide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00719914
Conditions: ST-Elevation Myocardial Infarction
Keywords: eptifibatide Integrilin ST-Elevation Myocardial Infarction Acute Myocardial Infarction
Sponsor: Brigham and Women's Hospital
Start date: 2007-11-01; Completion date: 2009-01-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.

Detailed description:
The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the improvement in percent diameter stenosis of the culprit artery following the IC bolus administration of eptifibatide vs. IC placebo (saline) as assessed with quantitative coronary angiography (QCA).

Arms: arm 1: Intracoronary injection of eptifibatide arm 2: Intra-coronary injection of normal saline.
Interventions: intervention 1: eptifibatide intervention 2: eptifibatide intervention 3: normal saline
Intervention descriptions: intervention 1: Intra-coronary injection, weight based, of eptifibatide. intervention 2: Intra-coronary injection, based on weight, of eptifibatide intervention 3: Intra-coronary injection, weight based, of normal saline.

Protocol documents:
Clinical trial NCT00731653
Conditions: Major Depressive Disorder
Keywords: depression combination
Sponsor: Massachusetts General Hospital
Start date: 2008-07-01; Completion date: 2009-01-01
Enrollment: 81 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049.

The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.

Detailed description:
Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Arms: arm 1: BCI-024 and BCI-049
Interventions: intervention 1: Combination Product: BCI-024 + BCI-049
Intervention descriptions: intervention 1: BCI-024 and BCI-049 once a day at bedtime for 6 weeks

Protocol documents:
Clinical trial NCT00736853
Conditions: Pain
Keywords: Chronic pain Acetoaminophen Tramadol Osteoarthritis of the knee Low back pain
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2008-06-01; Completion date: 2009-01-01
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).

Detailed description:
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tramadol Hydrochloride Plus Acetaminophen (Open-Label) intervention 2: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) intervention 3: Placebo (Double-Blind)
Intervention descriptions: intervention 1: Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets). intervention 2: Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose \[number of tablets\] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks. intervention 3: Matching placebo will be given up to 4 weeks.

Protocol documents:
Clinical trial NCT00764751
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2008-09-01; Completion date: 2009-01-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All subjects will apply LEO 19123 cream to psoriasis lesions on the left or right side of the body and either Dovonex® cream or cream vehicle to lesions on the other side.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: LEO 19123 Cream (calcipotriol plus LEO 80122) intervention 2: Dovonex® cream intervention 3: Cream vehicle
Intervention descriptions: intervention 1: Once daily application intervention 2: Twice daily application intervention 3: Twice daily application

Protocol documents: