ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01118351
Conditions: Recurrent Bladder Cancer Transitional Cell Carcinoma of the Bladder
Sponsor: Case Comprehensive Cancer Center
Start date: 2008-10-01; Completion date: 2015-09-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with recurrent transitional cell bladder cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the clinical efficacy of oral sunitinib (Sutent) given continuously for a maximum of 12 weeks, with respect to complete response rates at 12 months after completion of treatment in patients with high-risk superficial bladder cancer who have failed previous intravesical BCG.

SECONDARY OBJECTIVES:

I. To assess the impact of sunitinib treatment in recurrence-free survival, progression-free survival, and overall survival in patients with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.

II. To evaluate the safety and tolerability of sunitinib (Sutent) administered in patients with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.

TERTIARY OBJECTIVES:

I. To assess pre-treatment tissue baseline angiogenic markers and to evaluate the magnitude of the difference among these variables with post-treatment tumor tissue after treatment with sunitinib (Sutent).

II. To evaluate the effects of Sunitinib (Sutent) on immunosuppressive regulatory T cells (Tregs).

III. To determine the presence of circulating tumor cells in superficial BCG-refractory TCC patients.

OUTLINE:

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate intervention 2: immunohistochemistry staining method intervention 3: TdT-mediated dUTP nick end labeling assay intervention 4: light microscopy intervention 5: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT01145183
Conditions: Cocaine Dependence
Keywords: Cocaine Dependence Substance Related Disorders genotype
Sponsor: Baylor College of Medicine
Start date: 2010-03-01; Completion date: 2015-09-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Doxazosin, an alpha 1-adrenergic receptor antagonist, may play an important role in cocaine addiction in humans. This study will evaluate to what extent the prospective screening for catecholamine related polymorphisms for alpha 1 NE receptor/transporter, COMT and DBH as main targets predict the treatment efficacy of doxazosin for cocaine-using behavior.

Detailed description:
The NE system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. The results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for cocaine addiction.

This 16-week double-blind, placebo controlled clinical trial will provide treatment for 100 cocaine-dependent patients and includes a 13 week medication trial (weeks 1-13) and up to 2 week washout period(weeks 14-15). Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation.

Subjects will be receiving 1 mg study medication/placebo capsules at week 1, with 4mg/week induction rate for weeks, according to their randomized assignments, and are maintained on these agents through week 13. At the end of the study (weeks 14-15), participants will undergo discontinuation from active/placebo medication over a 2-week period. Subjects who wish to be transferred to an appropriate treatment program or treatment-research program will be helped with referral during the 2 week period (weeks 14-15).

Arms: arm 1: Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system. arm 2: Matched placebo daily dosing.
Interventions: intervention 1: Doxazosin intervention 2: Placebo
Intervention descriptions: intervention 1: Doxazosin is initiated at 4 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 2 weeks. Participants will be maintained on 6mg-8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15. intervention 2: Matched placebo daily dosing

Protocol documents:
Clinical trial NCT01149369
Conditions: Gastroparesis
Keywords: gastroparesis nausea vomiting
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2013-04-01; Completion date: 2015-09-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.

Detailed description:
APRON is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related disorders. Screening for eligibility and collection of baseline data will span up to 4 weeks after obtaining informed consent and registration. Eligible patients will consist of patients with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg per day) or placebo for 4 weeks.

The symptoms will be measured with the Gastroparesis Cardinal Symptom Index Daily Diary (GCSIDD) for one week at baseline and for four weeks after randomization. In addition, the nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (VAS) for one week at baseline and daily for four weeks after randomization. There will be a 2 week washout period at the end of the treatment to ensure patient safety following the end of treatment.

Arms: arm 1: Aprepitant 125 mg per day arm 2: Placebo aprepitant 125mg per day
Interventions: intervention 1: Aprepitant intervention 2: Placebo
Intervention descriptions: intervention 1: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks intervention 2: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks

Protocol documents:
Clinical trial NCT01181674
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Insulin Glargine Metformin Acarbose Diet Exercise Lifestyle
Sponsor: Population Health Research Institute
Start date: 2011-01-01; Completion date: 2015-09-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.

Detailed description:
This is a pilot trial of 125 patients allocated to either usual care (1/3), 2 months or 4 months of intensive lifestyle and pharmacotherapy followed by cessation of all drug therapy.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: insulin glargine intervention 2: metformin intervention 3: acarbose intervention 4: lifestyle therapy intervention 5: insulin glargine intervention 6: metformin intervention 7: acarbose intervention 8: lifestyle therapy intervention 9: Standard glycemic care
Intervention descriptions: intervention 1: sc injection intervention 2: oral administration intervention 3: oral administration intervention 4: diet and exercise intervention 5: sc injection intervention 6: oral administration intervention 7: oral administration intervention 8: diet and exercise intervention 9: as informed by the current clinical practice guidelines

Protocol documents:
Clinical trial NCT01285635
Conditions: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2010-06-01; Completion date: 2015-09-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effects of an investigational drug called AT-101 in combination with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will help the researchers learn what effects, if any, the combination of AT-101 and Docetaxel has on your cancer. For instance, will the combination cause your tumor(s) to shrink or stop growing? The researchers will also learn about the safety of the combination of AT-101 and Docetaxel. For instance, are there any side effects? If so, what kind of side effects does the combination cause? How severe are the side effects, and how often do they occur?

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AT-101 intervention 2: Docetaxel
Intervention descriptions: intervention 1: Pulse Dose: AT-101 dose of 40 mg b.i.d. on days 1-3 Metronomic Dose: AT-101, 20 mg daily, days 1-14 intervention 2: Docetaxel 75 mg/m2 on Cycle Day 1

Protocol documents:
Clinical trial NCT01302392
Conditions: Multiple Myeloma
Sponsor: Amgen
Start date: 2010-09-01; Completion date: 2015-09-01
Enrollment: 315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for subjects with multiple myeloma who have received all available approved treatment options and may therefore be considered candidates for palliative care.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Carfilzomib intervention 2: Best Supportive Care
Intervention descriptions: intervention 1: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects). intervention 2: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).

Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).

Protocol documents:
Clinical trial NCT01315873
Conditions: Multiple Myeloma
Keywords: myeloma multiple myeloma relapsed myeloma refractory myeloma
Sponsor: NYU Langone Health
Start date: 2011-09-01; Completion date: 2015-09-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with myeloma that has either not responded to previous treatment or has returned after previous treatment will be given a combination of the drugs bendamustine and bortezomib.

The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4 of each cycle, with bortezomib being given first, before each dose of bendamustine. Each cycle will be 28 days long, so patients will be treated the first week of each cycle and then have 3 weeks 'off' (without any treatment). Disease assessments will be performed on day 22 of each cycle. Patients will receive the study drugs until their disease progresses or they are withdrawn from the study.

In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes to show that the combination of bortezomib and bendamustine will have activity in relapsed/refractory myeloma.

Detailed description:
Patients with relapsed and refractory myeloma who have a measurable paraprotein in the serum or urine or measurable protein by Freelite or measurable disease by plasmacytoma will be given a combination of bendamustine and bortezomib each cycle. Response rate (PR or better after 2 cycles) and duration of response will be assessed. Therapy will be continued until disease progression. The bendamustine would be used in a day 1, day 4 dosing schedule after each dose of bortezomib to take advantage of the chemosensitizing properties of bortezomib. This minimizes the days of treatment to just the first week and allows rebound of blood counts. This will be a phase II trial with dose reduction as necessary.

Bendamustine is a drug which appears to be non-cross-resistant with other alkylating agents in vitro and in vivo. Thus, we hypothesize that the combination of bortezomib and bendamustine will have activity in relapsed/refractory myeloma.

Arms: arm 1: None
Interventions: intervention 1: Bendamustine intervention 2: Bortezomib
Intervention descriptions: intervention 1: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m\^2 after bortezomib . Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment. intervention 2: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m\^2 followed by bendamustine given at 90 mg/m\^2. Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Protocol documents:
Clinical trial NCT01318356
Conditions: Q Fever Fatigue Syndrome, Chronic Coxiella Infection
Keywords: Q fever Cognitive behavioral therapy Doxycycline Fatigue Coxiella
Sponsor: Radboud University Medical Center
Start date: 2011-04-01; Completion date: 2015-09-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy of two treatment strategies for fatigue and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy (CBT).

Detailed description:
Q fever fatigue syndrome (QFS) is one of the most frequent sequelae of Q fever, and constitutes a significant problem in the current outbreak of Q fever. QFS leads to substantial morbidity and has a high socio-economic burden, related to increased use of healthcare facilities and absence from work. It is envisaged that over 750 patients will become chronically fatigued due to Q fever in The Netherlands (20% of 4000 patients from 2007 until now). Although the outbreak appears to diminish, it is expected that Q fever will remain an endemic disease, and therefore this number will continue to grow. A vast medical consumption can be anticipated, stressing the need for an accessible and effective intervention and clear treatment guidelines.

The study will contribute to a better understanding of effective treatment of QFS, providing evidence-based guidelines for general practitioners and medical specialists.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cognitive behavioral therapy intervention 2: Doxycycline intervention 3: Placebo
Intervention descriptions: intervention 1: CBT will consist of a protocolized intervention of 12 sessions during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions). intervention 2: Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy. intervention 3: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)

Protocol documents:
Clinical trial NCT01333501
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis cognitive symptoms relapsing-remitting multiple sclerosis (RRMS) fingolimod Magnetic resonance imaging (MRI)
Sponsor: Novartis Pharmaceuticals
Start date: 2011-05-01; Completion date: 2015-09-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate which test of the battery is the most sensitive in detecting differences between treatment groups.

Detailed description:

Arms: arm 1: 0.5 mg in capsules for oral administration once daily arm 2: 250 μg injected s.c. every other day
Interventions: intervention 1: Fingolimod intervention 2: Interferon beta 1b
Intervention descriptions: intervention 1: 0.5 mg in capsules for oral administration once daily intervention 2: 250 μg injected s.c. every other day

Protocol documents:
Clinical trial NCT01365481
Conditions: Hypertension Chronic Kidney Disease
Keywords: Hypertension, pediatric Hypertension with or without chronic kidney disease
Sponsor: Novartis Pharmaceuticals
Start date: 2011-08-01; Completion date: 2015-09-01
Enrollment: 150 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.

Detailed description:

Arms: arm 1: Valsartan starting dose: ≥18 kg to \<35 kg is 40 mg, ≥35 kg to \<80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to \<35 kg is 80 mg, ≥35 kg to \<80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
Interventions: intervention 1: Valsartan intervention 2: amlodipine intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily intervention 2: added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose intervention 3: added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose

Protocol documents:
Clinical trial NCT01371734
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD Depression
Sponsor: Pfizer
Start date: 2011-08-01; Completion date: 2015-09-01
Enrollment: 363 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Desvenlafaxine Succinate Sustained-Release intervention 2: Desvenlafaxine Succinate Sustained-Release intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit. intervention 2: Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit. intervention 3: Subjects randomized to the Placebo treatment arm will receive placebo tablets

Protocol documents:
Clinical trial NCT01384539
Conditions: Arterial Dysfunction Chronic Kidney Disease
Keywords: chronic kidney disease vitamin D deficiency
Sponsor: University of Colorado, Denver
Start date: 2011-07-01; Completion date: 2015-09-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin D (calcitriol) supplementation improves vascular endothelial function in patients with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.

Detailed description:

Arms: arm 1: Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months arm 2: Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Interventions: intervention 1: Cholecalciferol intervention 2: Calcitriol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01420146
Conditions: Breast Neoplasms Secondary HER2 Positive Carcinoma of Breast
Sponsor: Jules Bordet Institute
Start date: 2011-08-01; Completion date: 2015-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.

Detailed description:
This is the first belgian feasibility study of HER2 imaging using a labelled monoclonal antibody, namely trastuzumab labelled with zirconium 89.

The aims of this study are:

I/ Evaluate the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab (based on the Groningen experience), through the analysis of the correlation between the FDG-PET/CT and the HER2 immunoPET.

II/ PET quantification of HER2 receptor by using the images and the blood pharmacokinetic of the tracer.

III/ In the subset of patients for whom biopsies of metastatic sites have not been carried out previously and are of an easy access, tissue will be acquired as part of the validation of the HER2 immunoPET and as an attempt to better understand the molecular heterogeneity of HER2 positive breast cancer at the time of relapse.

IV/Evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality

Arms: arm 1: Zr89-trastuzumab PET/CT single arm
Interventions: intervention 1: Zr89-trastuzumab
Intervention descriptions: intervention 1: trastuzumab labelled with zirconium 89 for PET/CT

Protocol documents: