ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00893074
Conditions: Marijuana Abuse
Keywords: withdrawal acute effects cognitive performance Marijuana Use Marijuana Abstinence
Sponsor: Johns Hopkins University
Start date: 2009-04-01; Completion date: 2011-10-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.

Detailed description:

Arms: arm 1: 0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing
Interventions: intervention 1: Dronabinol 30mg/day intervention 2: Dronabinol 60mg/day intervention 3: Dronabinol 120mg/day intervention 4: Placebo
Intervention descriptions: intervention 1: 10mg dronabinol administered 3x/day for 5 days intervention 2: 20mg dronabinol administered 3x/day for 5 days intervention 3: 40mg dronabinol administered 3x/day for 5 days intervention 4: placebo dronabinol administered 3x/day for 5 days

Protocol documents:
Clinical trial NCT00910273
Conditions: Ankylosing Spondylitis
Keywords: IMT evaluation in AS patients treated with etanercept
Sponsor: Pfizer
Start date: 2009-07-01; Completion date: 2011-10-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients

Detailed description:

Arms: arm 1: etanercept 50 mg/week
Interventions: intervention 1: etanercept
Intervention descriptions: intervention 1: etanercept 50 mg/week

Protocol documents:
Clinical trial NCT00918281
Conditions: Solid Tumors High Grade Gliomas Lung Cancer Head and Neck Cancer Sarcoma Renal Cell Carcinoma Breast Cancer
Sponsor: GE Healthcare
Start date: 2009-06-01; Completion date: 2011-10-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.

Detailed description:

Arms: arm 1: Fluciclatide Injection
Interventions: intervention 1: Fluciclatide Injection
Intervention descriptions: intervention 1: Fluciclatide Injection (AH111585 (18F) Injection)

Protocol documents:
Clinical trial NCT00927394
Conditions: Hypertension
Keywords: Hypertension, Type II Diabetes, Aliskiren, Valsartan, Systolic blood pressure, Diastolic blood pressure, Stage II, Combination
Sponsor: Novartis
Start date: 2009-05-01; Completion date: 2011-10-01
Enrollment: 1143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.

Detailed description:
When protocol Amendment 2 was released, there were patients who had already been randomized into the study. These patients were included in the trial prior to making changes to the eligibility criteria. Thus, the study contains 2 distinct cohorts. Cohort 1 contains those patients who had already been randomized, and had been deemed eligible based on the original inclusion/exclusion criteria, prior to Amendment 2. No new patients were randomized to Cohort 1. Cohort 2 contains patients who were randomized, having been found eligible based on the revised inclusion/exclusion criteria, after Amendment 2. Differences in the inclusion and exclusion criteria are indicated below.

Arms: arm 1: To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks arm 2: To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Interventions: intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Placebo for Aliskiren intervention 4: Placebo for Valsartan
Intervention descriptions: intervention 1: Aliskiren 150 mg tablet intervention 2: Valsartan 160 mg capsules intervention 3: Placebo for Aliskiren 150 mg tablets intervention 4: Placebo for Valsartan 160 mg capsules

Protocol documents:
Clinical trial NCT00951483
Conditions: Depression Anxiety
Keywords: Cardiovascular Biomarkers Depression Quetiapine
Sponsor: Loyola University
Start date: 2009-07-01; Completion date: 2011-10-01
Enrollment: 91 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
No suitable treatment has been identified to reverse and ideally prevent, the cardiovascular disease risk associated with depression and anxiety. The purpose of this study is to determine if quetiapine treatment of depression can reverse the signs of arterial stiffening that often occurs in depression and anxiety, and which are believed to be risk factors for future heart disease.

Detailed description:
The evidence that depressive and anxiety disorders confer a high relative risk (RR) for cardiovascular disease (CVD) development is clear and compelling. A cadre of inflammation, platelet activation and other biomarkers of endothelial dysfunction strongly suggest multiple and possibly interrelated mechanisms underlying this co-morbidity. Early detection of the vulnerability to develop CVD has become an urgent health issue. However, detection alone of vulnerability without proper therapeutic intervention aimed at reversing it, is merely of scientific interest. The evidence to date that antidepressant drugs, while highly efficacious in restoring euthymia, may not normalize the biomarkers of CVD vulnerability. Hence, there is a need to identify other pharmacologic interventions for depression. Quetiapine, due to its unique molecular structure and unique pharmacological profile, belongs to none of the known classes of antidepressants. However, quetiapine clearly has antidepressant and anti-anxiety efficacies. Now, we propose to explore whether quetiapine can reverse those pathophysiological changes occurring in mixed depression/anxiety that have been linked causally to the development of CVD. Accordingly, the primary purpose of this study is to compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.

Arms: arm 1: Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks. arm 2: Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention.
Interventions: intervention 1: Quetiapine-XR
Intervention descriptions: intervention 1: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Protocol documents:
Clinical trial NCT00967694
Conditions: Glaucoma Sedation
Keywords: Glaucoma Nitrous oxide
Sponsor: Oregon Health and Science University
Start date: 2009-08-01; Completion date: 2011-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn if breathing nitrous oxide (also known as "laughing gas") changes the pressure in a person's eyes. Some patients who need regular eye exams to measure their eye pressure often need to be put to sleep with medicine in order to complete the eye exam. Some of these medicines are known to cause changes in a person's eye pressure. Because of this, such medicines are avoided if the eye doctor needs to measure the patient's eye pressure. One medicine that is frequently used to put patients to sleep is nitrous oxide. No one really knows what effect nitrous oxide might have on a persons' eye pressure. The investigators are interested to see if nitrous oxide causes an increase, decrease, or no change in eye pressure. The investigators also want to investigate if there is a difference in the effects of nitrous oxide on eye pressure between males and females. Understanding these effects of nitrous oxide is important because during such eye exams, the eye doctor uses the pressure measurements to make important decisions about treatment and surgery options for the patient.

The investigators hypothesize that the use of inhaled nitrous oxide (N2O) will result in a decrease in IOP in healthy volunteers.

The investigators aim to determine the magnitude and duration of change, if any, in IOP caused by inhalation of N2O, and to assess if the gender of the patient has a role in this effect.

Detailed description:
An initial pre-anesthetic evaluation and physical examination will be performed by an attending anesthesiologist, and an eye exam will be performed by an attending ophthalmologist to determine suitability for inclusion according to the above criteria. Ideally the eye exam will take place immediately prior to conduction of the study. However, logistical restraints may require that the eye exam take place at a separate time/date prior to conduction of the study. IOPs will be measured by the attending ophthalmologist (B.E.) who will be blinded to the actual readings of the Tonopen by means of a small screen, and a single trained observer (E.F.) will record observations from the Tonopen. The nitrous oxide sedation will be managed by the attending anesthesiologist (K.L.). All patients will be monitored throughout using standardized monitoring (continuous EKG, non-invasive BP, and continuous pulse oximetry).

Arms: arm 1: All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
Interventions: intervention 1: Nitrous oxide
Intervention descriptions: intervention 1: Nitrous oxide sedation by inhalation

Protocol documents:
Clinical trial NCT00975806
Conditions: Renal Cell Carcinoma
Sponsor: Celgene
Start date: 2009-09-01; Completion date: 2011-10-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.

Detailed description:

Arms: arm 1: Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle arm 2: Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 mg on days 1 to 14 or days 1 to 21 of each 21-day cycle
Interventions: intervention 1: Lenalidomide intervention 2: Sunitinib
Intervention descriptions: intervention 1: Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination intervention 2: Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G

Protocol documents:
Clinical trial NCT00977106
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-06-01; Completion date: 2011-10-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is \>100.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: placebo intervention 3: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: single iv infusion 8 mg/kg intervention 2: single iv infusion intervention 3: iv infusion 8mg/kg every 4 weeks for 11 months

Protocol documents:
Clinical trial NCT00977561
Conditions: Small Cell Lung Carcinoma
Keywords: Small Cell Lung Cancer Extensive stage disease SCLC IGF-1R inhibitor
Sponsor: Pfizer
Start date: 2010-04-01; Completion date: 2011-10-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.

Detailed description:
The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Arms: arm 1: Figitumumab (CP-751,871) Plus Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle arm 2: Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle
Interventions: intervention 1: figitumumab intervention 2: Cisplatin (Or Carboplatin) intervention 3: Etoposide intervention 4: Cisplatin (Or Carboplatin) intervention 5: Etoposide
Intervention descriptions: intervention 1: Figitumumab (20 mg/kg) intervention 2: Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5 intervention 3: Etoposide (100 mg/m2 IV on Days 1, 2 and 3) intervention 4: Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5 intervention 5: Etoposide (100 mg/m2 IV on Days 1, 2 and 3)

Protocol documents:
Clinical trial NCT00977665
Conditions: Multiple System Atrophy
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2009-12-01; Completion date: 2011-10-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.

Detailed description:

Arms: arm 1: rasagiline tablet, 1 mg/day for up to 48 weeks. arm 2: placebo tablet for up to 48 weeks.
Interventions: intervention 1: rasagiline mesylate intervention 2: placebo
Intervention descriptions: intervention 1: rasagiline 1 mg tablet/day for 48 weeks intervention 2: placebo tablet for 48 weeks

Protocol documents:
Clinical trial NCT00977769
Conditions: Effects of; Anesthesia, in Pregnancy
Keywords: cesarean delivery blood pressure cardiac output
Sponsor: Oslo University Hospital
Start date: 2009-11-01; Completion date: 2011-10-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.

Detailed description:
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.

Arms: arm 1: Carbetocin injection, 100µg, single injection arm 2: Oxytocin 5U, injection, single injection arm 3: Saline single injection
Interventions: intervention 1: carbetocin 100 µg intervention 2: oxytocin 5 u intervention 3: placebo (NaCl)
Intervention descriptions: intervention 1: Hemodynamic effect of intervention 2: Hemodynamic effect of intervention 3: Hemodynamic effect of

Protocol documents:
Clinical trial NCT01017575
Conditions: Hepatitis C Infection
Sponsor: Bristol-Myers Squibb
Start date: 2009-12-01; Completion date: 2011-10-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Detailed description:

Arms: arm 1: Treatment Naive arm 2: Treatment Naive arm 3: Treatment Naive arm 4: Non-Responder arm 5: Non-Responder
Interventions: intervention 1: Daclatasvir intervention 2: Daclatasvir intervention 3: Placebo intervention 4: Peginterferon alfa-2a intervention 5: Ribavirin
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, daily, 24-48 weeks intervention 2: Tablets, Oral, 60 mg, daily, 24-48 weeks intervention 3: Tablets, Oral, 0 mg, daily, 48 weeks intervention 4: Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks intervention 5: Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Protocol documents:
Clinical trial NCT01018979
Conditions: Multiple Myeloma Non-Hodgkin Lymphoma Hodgkin Disease
Sponsor: GPCR Therapeutics, Inc.
Start date: 2010-02-01; Completion date: 2011-10-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.

Detailed description:

Arms: arm 1: TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) arm 2: TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
Interventions: intervention 1: TG-0054 (2.24 mg/kg) intervention 2: TG-0054 (3.14 mg/kg)
Intervention descriptions: intervention 1: TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) intervention 2: TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

Protocol documents:
Clinical trial NCT01022190
Conditions: Ossification, Heterotopic
Keywords: Arthroplasty Hip Cemented Heterotopic ossification Selective Cyclooxygenase-2 Inhibitors Arthroplasty, Replacement Hip Prosthesis Cyclooxygenase Inhibitors
Sponsor: Radboud University Medical Center
Start date: 2009-12-01; Completion date: 2011-10-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine whether Arcoxia is effective in preventing heterotopic ossification after total hip arthroplasty.

Detailed description:
Rationale: Heterotopic ossification is a frequent complication after total hip replacement. Nonsteroidal anti-inflammatory drugs (NSAIDs) are known to effectively prevent heterotopic ossification, but gastrointestinal complaints are reported frequently. Selective cyclooxygenase-2 (COX-2) inhibiting NSAID produce less gastrointestinal side effects.

Objective: Preventing heterotopic ossification. Study design: A prospective two-stage study design for phase-2 clinical trials with 42 patients to determine if Arcoxia (a COX-2 inhibitor) 90-mg oral prevents heterotopic ossification. In the first stage, 19-patients are included. Another 23-patients are included when at least 90-percent of patients in first stage have Brooker classification 0, 1 or 2 at 6-months follow-up.

Study population: 42-patients with cemented total hip arthroplasty age 18 - 75 yr old.

Intervention: All subjects receive 90-mg Arcoxia oral for 7-days. Main study parameters/endpoints: The main study parameter is the degree of heterotopic ossification assessed on AP radiographs using the Brooker classification.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risks are associated with participating into the research. Besides the oral intake of Arcoxia, no extra burden is associated with participating in the study. The postoperative care does not change. Radiographic examinations will be routinely performed the day before surgery, immediately after operation, at 6-weeks and 6-months after surgery. The degree of heterotopic ossification will be determined by x-ray assessment.

Arms: arm 1: Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period.
Interventions: intervention 1: Etoricoxib (Arcoxia)
Intervention descriptions: intervention 1: Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days

Protocol documents:
Clinical trial NCT01048723
Conditions: Sarcoma
Keywords: Soft Tissue Retroperitoneal resectable
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2010-01-01; Completion date: 2011-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if the study drug RAD001 can stop or slow the growth of resectable soft tissue sarcoma. The patient's physical state, their symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if RAD001 is safe and effective in patients with this condition. The study drug, RAD001, is made by Novartis Pharmaceuticals Corporation.

Detailed description:
A single-arm, open label, proof of principle phase II study exploring the efficacy of RAD001 in resectable soft tissue sarcomas either in the extremities, trunk or retroperitoneum. Patients with resectable sarcomas as detailed below were to have a core biopsy for molecular markers prior to therapy with RAD001 10mg PO daily x 2 weeks. Within 7-14 days of the end of therapy with RAD001, the patients were to be brought to surgery for definitive resection or, should they be candidates for neoadjuvant radiation, would have 6 16 gauge core biopsies taken percutaneously or using image guidance. Pharmacodynamic markers as detailed in the objectives were to be assessed in the laboratory.

Patients were to be numbered sequentially from 1 to 40, or more if there were patients that dropped out due to drug toxicity, with the goal of achieving 40 patients in accrual for evaluation of the pre- and post-treatment tumor samples for Pharmacodynamic assays.

Arms: arm 1: RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
Interventions: intervention 1: RAD001
Intervention descriptions: intervention 1: Patients were instructed to take RAD001 in the morning, at the same time each day.

Protocol documents: