ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00967616
Conditions: Colorectal Cancer Neoplasms, Colorectal
Keywords: metastatic colon rectum combination chemotherapy
Sponsor: Daiichi Sankyo
Start date: 2009-09-01; Completion date: 2013-04-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy will participate in the study, which will be conducted on an outpatient basis. It is anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.

Detailed description:

Arms: arm 1: Participants who received irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). FOLFIRI was administered by intravenous (IV) injection once every 2 weeks. The FOLFIRI regimen consisted of:

* Irinotecan, 180 mg/m\^2 IV infusion over 30 to 120 minutes
* Leucovorin, 400 mg/m\^2 IV infusion to match the duration of the irinotecan infusion
* 5-FU, 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46 to 48 hours continuous infusion) arm 2: Participants who received CS7017 plus irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). Two CS-7017 tablets were administered by mouth (PO) twice a day (BID) every 12 hours. FOLFIRI was administered IV once every 2 weeks. The FOLFIRI regimen consisted of:

* Irinotecan, 180 mg/m\^2 IV infusion over 30 to 120 minutes
* Leucovorin, 400 mg/m\^2 IV infusion to match the duration of the irinotecan infusion
* 5-FU, 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46 to 48 hours continuous infusion)
Interventions: intervention 1: CS7017 intervention 2: irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)
Intervention descriptions: intervention 1: CS-7017 (0.25mg tablet) Two CS-7017 tablets will be administered by mouth (PO) BID every 12 hours. FOLFIRI will be administered IV once every 2 weeks. intervention 2: FOLFIRI will be administered IV once every 2 weeks.

The FOLFIRI regimen consists of:

* Irinotecan, 180 mg/m\^2 IV infusion over 30 to 120 minutes
* Leucovorin, 400 mg/m\^2 IV infusion to match the duration of the irinotecan infusion
* 5-FU, 1200 mg/m\^2/day x 2 days (total 2400 mg/m\^2 over 46 to 48 hours continuous infusion)

Protocol documents:
Clinical trial NCT00992394
Conditions: Psoriasis
Keywords: Plaque psoriasis - etanercept - response maintenance
Sponsor: Pfizer
Start date: 2010-01-01; Completion date: 2013-04-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.

The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.

Detailed description:

Arms: arm 1: Subjects randomized to arm 1 stop their etanercept treatment on entry into the study and may be retreated by etanercept 50 mg once weekly after medical review and agreement between the subject and the investigator arm 2: Subjects randomized to arm 2 in which subjects continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the subject and the investigator
Interventions: intervention 1: etanercept intervention 2: etanercept
Intervention descriptions: intervention 1: etanercept 50 mg once weekly as requested. intervention 2: etanercept 25 mg or 50 mg as requested.

Protocol documents:
Clinical trial NCT00993148
Conditions: HIV-1 Infection HIV Infections
Keywords: Treatment naive
Sponsor: Northwestern University
Start date: 2010-05-01; Completion date: 2013-04-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.

Detailed description:

Arms: arm 1: Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
Interventions: intervention 1: maraviroc intervention 2: darunavir intervention 3: ritonavir
Intervention descriptions: intervention 1: 150 mg tab by mouth once daily for 96 weeks intervention 2: 800 mg tab by mouth once daily for 96 weeks intervention 3: 100 mg capsule by mouth once daily for 96 weeks

Protocol documents:
Clinical trial NCT01044303
Conditions: Transplant; Failure, Kidney
Keywords: Kidney Transplantation Mycophenolic Acid Donor-Specific Antibodies Kidney Rejection
Sponsor: East Carolina University
Start date: 2010-01-01; Completion date: 2013-04-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.

Detailed description:
The development of DSA post-transplant has been associated with chronic rejection and graft failure. EC-MPS is thought to be the key drug preventing both cellular and antibody mediated rejections. Several studies have shown that recipients receiving an optimal dose of EC-MPS have fewer antibody mediated rejections and may require a lower dose of calcineurin inhibitors and/or corticosteroids thus reducing side effects and extending graft survival.

Arms: arm 1: Participants EC-MPS dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.
Interventions: intervention 1: Myfortic Escalation
Intervention descriptions: intervention 1: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of EC-MPS is achieved. Maximum dose will not exceed 2160 mg daily.

Protocol documents:
Clinical trial NCT01054768
Conditions: Anemia, Sickle Cell
Keywords: Antioxidant Inflammation Sickle Cell Disease Oxidative Stress Cytokines anti-inflammatory Acetylcarnitine
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2009-08-01; Completion date: 2013-04-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether alpha-lipoic acid and acetyl-L-carnitine will lower systemic inflammation in patients with Sickle Cell Disease by reducing oxidative stress, which will result in a decrease in the frequency of vaso-occlusive pain episodes and improve their quality of life.

Detailed description:
People with sickle cell disease have more inflammation (a response of body tissues to injury or irritation) than people without sickle cell disease. This inflammation can be measured in the blood by checking the level of a protein called C reactive protein as well as other changes we see in blood due to inflammation (such as changes in platelets and other cells). There is even more inflammation during sickle-related complications (like pain or acute chest syndrome). We want to test if inflammation in people with sickle cell disease can be reduced by the use of antioxidant compounds.

Antioxidants are nutrients (certain vitamins, minerals and enzymes) that can counteract the effects of oxidative stress arising from free radicals in our cells. The formation of free radicals is a normal cell process, but uncontrolled oxidative stress can cause problems for us. One such harmful problem is inflammation.

We know from other research studies that antioxidants help with some conditions related to inflammation. In this study the antioxidant being tested is a combination of alpha-lipoic acid and acetyl-L-carnitine, both of which are natural parts of many of the foods we eat and are needed by our cells to make energy from food.

Arms: arm 1: alpha-lipoic acid and acetyl-L-carnitine1400 mg tablet twice a day for 6 months. arm 2: 1400 mg placebo tablet twice a day for 6 months.
Interventions: intervention 1: alpha-lipoic acid and acetyl-L-carnitine intervention 2: Control
Intervention descriptions: intervention 1: none to report intervention 2: none to report

Protocol documents:
Clinical trial NCT01056822
Conditions: Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
Sponsor: Novartis Pharmaceuticals
Start date: 2010-05-01; Completion date: 2013-04-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.

Detailed description:

Arms: arm 1: Mycophenolate mofetil arm 2: Miycophenolate sodium
Interventions: intervention 1: 1 intervention 2: 2
Intervention descriptions: intervention 1: Continue with same dose of MMF as patient was taking before randomisation intervention 2: Increase MPS by 180mg every 12h based on investigator's judgement up to a maximum of 720 mg of MPS every 12 hours

Protocol documents:
Clinical trial NCT01072643
Conditions: Pulmonary Hypertension
Keywords: Sedation Pulmonary Hypertension Pediatric Cardiac Catheterization Pulmonary Vascular Resistance
Sponsor: Aruna Nathan
Start date: 2010-03-01; Completion date: 2013-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Clinical dose escalation drug trial to evaluate the effect of 3 different doses of dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary vascular resistance (PVR). The study will be conducted in 2 parts, with part 1 incorporating stopping rules to optimize safety of the drug in this population. The second part of this study will evaluate if the lowest safest dose, as determined in part 1, is adequate to provide effective sedation during a cardiac catheterization procedure.

Detailed description:
Clinical dose escalation drug trial to evaluate the effect of 3 different doses of dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary vascular resistance. The study will be conducted in 2 parts, with a pilot phase incorporating stopping rules to optimize safety of the drug in this population. Study subjects will include pediatric subjects with Pulmonary Hypertension (PHTN).

Part 1: This will be the dose escalation phase of the study. Twenty four evaluable subjects will be enrolled. Subjects will include pediatric subjects with pulmonary hypertension (PVR\>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine (DEX). The dose will be escalated to the next dose of DEX once all subjects have been enrolled in the preceding DEX dose cohort, and safety has been established at that level. Inadequate sedation despite the highest dose of DEX at each level will be considered a treatment failure on an intention to treat basis. Part 2: This part of the study will be conducted after the pilot phase is safely completed, and the full complement of subjects will be recruited.

Arms: arm 1: To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr
Interventions: intervention 1: Dexmedetomidine
Intervention descriptions: intervention 1: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR\>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine.

Protocol documents:
Clinical trial NCT01091974
Conditions: Insomnia Fatigue Breast Cancer
Keywords: Insomnia Fatigue QOL CBT Breast cancer Survivors Chemotherapy
Sponsor: University of Rochester
Start date: 2008-02-01; Completion date: 2013-04-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.

Detailed description:
Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized, controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least one month post treatment. The seven-week intervention is designed to determine the efficacy and acceptability of these treatment strategies in reducing insomnia in cancer survivors. Assessments will be made by questionnaires before, during, and two weeks following the study intervention. All ancillary treatments, as appropriate for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated.

Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data collection phase of the study, must have withdrawn from all sleep medications, including: prescription, over-the-counter, CAM and herbal remedies for at least one week prior to beginning the study.

CBT-I (Arms 3 \& 4): CBT-I will be provided on an individual basis to all patients in study Arms 3 \& 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in these two study arms will receive 7 weeks of CBT-I, using a structured research grade protocol developed at the UR-SNRL. This manualized intervention, which exists as a published text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy, Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy.

Data Collection: Patients will complete the Insomnia Severity (ISI) at the time of consent and every Friday during weeks 3-11 of the study. A follow-up call by study personnel will be made to each participant not currently receiving CBT-I on each of these Fridays to promote compliance, prompt completion, assess potential side effects of study medication, and answer patient questions.

Arms: arm 1: CBT-I and placebo arm 2: CBT-I + Armodafinil arm 3: Placebo only arm 4: Armodafinil only
Interventions: intervention 1: armodafinil intervention 2: Placebo Comparator intervention 3: CBT-I
Intervention descriptions: intervention 1: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg) intervention 2: Placebo for 47 days intervention 3: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Protocol documents:
Clinical trial NCT01101334
Conditions: Advanced Non-small Cell Lung Cancer (NSCLC)
Keywords: NSCLC
Sponsor: Daiichi Sankyo
Start date: 2010-03-01; Completion date: 2013-04-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2 and open-label (subject will know the treatment he or she is receiving) study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.

The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CS-7017 intervention 2: erlotinib
Intervention descriptions: intervention 1: CS-7017, Two 0.25mg Tablets administered twice daily intervention 2: Erlotinib; One 150mg tablet administered once daily

Protocol documents:
Clinical trial NCT01104376
Conditions: Efavirenz, Metabolism and Pharmacokinetics Changes
Keywords: Cytochrome P450 CYP2B6 Voriconazole Efavirenz Pharmacokinetics Drug-Interactions Pharmacogenetics Healthy volunteers
Sponsor: Indiana University
Start date: 2010-03-01; Completion date: 2013-04-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if administration of medicines and genetic differences affects the activity of a liver enzyme called CYP2B6 in healthy volunteers.

Detailed description:
The investigators will test the hypothesis that CYP2B6 genetic variants that show effects in vitro also influence the in vivo activity of CYP2B6 and its responsiveness to metabolic inhibition, using the metabolism of efavirenz (100 mg dose) as a marker of activity. The metabolism and pharmacokinetics of efavirenz will be determined in a total of 60 healthy volunteers with CYP2B6\*1/\*1, CYP2B6\*1\*6 and CYP2B6\*6\*6 at baseline (control) and after pretreatment with voriconazole.

Arms: arm 1: Healthy volunteers will receive Efavirenz and Vericonazole as follow:

In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.
Interventions: intervention 1: Efavirenz intervention 2: voriconazole
Intervention descriptions: intervention 1: In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.

In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily. intervention 2: In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.

In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.

Protocol documents:
Clinical trial NCT01112514
Conditions: High Risk Polyposis Syndrome Distal Colonic Lesions Colorectal Polyps
Keywords: ICG indocyanine green
Sponsor: Massachusetts General Hospital
Start date: 2010-02-01; Completion date: 2013-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Standard white light endoscopy involves the passage of a thin, flexible camera into the colon from the anus. Although standard white light endoscopy can detect most polyps and precancerous areas in the gastrointestinal tract and colon, many studies have shown that even the most experienced doctors, under optimal conditions, can miss up to 15-25% of precancerous areas. Thus, there remains a clear need to develop new methods of improving standard white light endoscopy. We are investigating whether indocyanine green (ICG) can serve to highlight areas which are precancerous when the colon is visualized with a special cameral which shines fluorescent light. Information from other studies suggests that this ICG agent may help to visualize blood vessels flowing to precancerous areas in the colon. We are looking at the ability of ICG, in combination with an endoscope which shines fluorescent light, to visualize precancerous areas in the colon.

Detailed description:
* Participants will be scheduled for their regular lower endoscopy. On the day of the procedure, participants will come to the endoscopy unit at Massachusetts General Hospital. After arriving, participants will receive an intravenous line and meet with the research doctor to go over the procedure. The participant will then be transferred to the endoscopy procedure room and be administered sedatives until they are comfortable to proceed with the procedure.
* The research doctor will pass the flexible study sigmoidoscope into the lower part of the rectum. At this time, a dose of the ICG contrast agent will be administered through the intravenous line. Any areas that are suspicious will be photographed using the camera in the scope. We will also biopsy/remove any suspicious areas and send it to the pathologist as we normally do during endoscopy.
* Over the course of the study procedure, small doses of ICG will be administered to help find any precancerous areas. Altogether, the study exam should not take more than 10 to 15 minutes.

Arms: arm 1: These participants underwent a colonoscopy after having an ICG injection.
Interventions: intervention 1: indocyanine green
Intervention descriptions: intervention 1: Administered intravenously during endoscopic near-infrared (NIR) imaging

Protocol documents: