ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01301729
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2014-07-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Participants will receive Herceptin (loading dose of 4 mg/kg intravenously \[iv\], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
Interventions: intervention 1: Docetaxel intervention 2: Paclitaxel intervention 3: Trastuzumab
Intervention descriptions: intervention 1: 100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks) intervention 2: 90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks) intervention 3: 4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter

Protocol documents:
Clinical trial NCT01303380
Conditions: Mevalonate Kinase Deficiency
Keywords: Hyper IgD syndrome canakinumab HIDS mevalonate kinase deficiency MKD
Sponsor: Novartis Pharmaceuticals
Start date: 2011-03-01; Completion date: 2014-07-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Canakinumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01312038
Conditions: Otitis Media
Keywords: Eustachian tube otitis middle-ear pressure simethicone
Sponsor: University of Pittsburgh
Start date: 2011-03-01; Completion date: 2014-07-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to measure the effects of a chewable Simethicone tablet taken by mouth on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear pressure. In children and adults, middle-ear diseases such as otitis media (the buildup of fluid within the middle ear) and a form of temporary hearing loss occur if the Eustachian tube does not open, does not open often enough or is always open. Simethicone, available over-the-counter under several brand names including Gas-X, may help break up the bubbles that may block the opening of the Eustachian tube in the back of the nose during a cold, allowing air to pass between the nose and middle ear. This study requires a single visit to the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If eligible for the study, Eustachian tube function testing will be done; the Simethicone tablet or placebo (a tablet that looks and tastes like the Simethicone tablet but has no active ingredient) will be given and Eustachian tube function testing repeated.

Detailed description:
For the Eustachian tube function testing, the subject and a technician are seated comfortably within a pressure chamber, a room-like chamber in which the air pressure can be varied much like in an airplane or submarine. Middle ear pressure will be measured in each ear by tympanometry, a test done by inserting a small probe (an earplug attached to a rubber or plastic tube that measures ear pressure) half-way into the ear canal and changing the pressure in the probe. Then, microphones will be placed in the ear canals and a sound source placed into one nostril. The chamber pressure is then decreased and increased to various pressures and middle ear pressure is measured at these various pressures.

Arms: arm 1: 125 mg tablet arm 2: chewable calcium tablet
Interventions: intervention 1: Simethicone intervention 2: Placebo
Intervention descriptions: intervention 1: single 125 mg chewable tablet intervention 2: chewable calcium tablet

Protocol documents:
Clinical trial NCT01313884
Conditions: Bone Cancer Ewing's Sarcoma
Sponsor: Stanford University
Start date: 2011-05-01; Completion date: 2014-07-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.

Detailed description:

Arms: arm 1: Regimen A alternating with Regimen B every 21 days

Regimen A:

* Cytoxan 1200mg/m2
* Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2
* Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg
* Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle

Regimen B:

* Irinotecan 50 mg/m2/day x 5 days
* Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Interventions: intervention 1: Irinotecan intervention 2: Vincristine intervention 3: Temozolomide intervention 4: Doxorubicin intervention 5: Cytoxan intervention 6: Pegfilgrastim
Intervention descriptions: intervention 1: 50 mg/m2/day x 5 days intervention 2: 2 mg/m2 to a maximum of 2 mg intervention 3: 100 mg/m2/day x 5 days followed by 2 weeks treatment-free intervention 4: Starting dose 75 mg/m2 to a maximum of 450mg/m2 intervention 5: 1200 mg/m2 intervention 6: 6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Protocol documents:
Clinical trial NCT01325311
Conditions: Prostate Adenocarcinoma Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2011-12-01; Completion date: 2014-07-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine differences in prostate tissue steady state concentrations of calcitriol in participants treated with a single dose cholecalciferol (200,000 IU) and G-2535 (which provides 600 mg of genistein) and those receiving placebo.

SECONDARY OBJECTIVES:

I. To determine the effect of each intervention arm and resulting prostate tissue levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cholecalciferol orally (PO) on day 1 and genistein PO once daily (QD) on days 1-21 or 1-28. Patients then undergo prostatectomy.

ARM II: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.

Arms: arm 1: Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. arm 2: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Interventions: intervention 1: Cholecalciferol intervention 2: Genistein intervention 3: Laboratory Biomarker Analysis intervention 4: Pharmacological Study intervention 5: Placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Given PO

Protocol documents:
Clinical trial NCT01333865
Conditions: Autism Spectrum Disorders
Keywords: Memantine Namenda Autism Spectrum Disorders Pervasive Developmental Disorders Adults
Sponsor: Massachusetts General Hospital
Start date: 2010-01-01; Completion date: 2014-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of this study is to evaluate the safety and effectiveness of memantine (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.

During the 12 weeks of study duration, subjects will be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine will be administered in divided dose twice a day in the morning and evening. Titration of study medication will be guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects will be evaluated.

Protocol documents:
Clinical trial NCT01337700
Conditions: Autism Spectrum Disorder Asperger Syndrome Aspergers Syndrome
Keywords: ASD Autism Autism Spectrum Disorder Asperger Syndrome Asperger PDD PDD-NOS
Sponsor: Montefiore Medical Center
Start date: 2011-02-01; Completion date: 2014-07-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very substantial costs associated with caring for patients with ASD, and ASD has the highest Caregiver Burden Scores of any condition. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no Food and Drug administration (FDA) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have FDA approval for disruptive behaviors associated with autism.

This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile. intervention 2: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.

Protocol documents:
Clinical trial NCT01360840
Conditions: Prostate Cancer Metastatic
Keywords: Asymptomatic mildly symptomatic metastatic castrate-resistant prostate cancer mCRPC
Sponsor: EMD Serono
Start date: 2011-04-01; Completion date: 2014-07-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: EMD 525797 intervention 2: EMD 525797 intervention 3: Placebo intervention 4: Standard of Care (SoC)
Intervention descriptions: intervention 1: Subjects will be administered with EMD 525797 at a dose of 1500 milligram (mg) (diluted with 0.9 percent \[%\] sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. intervention 2: Subjects will be administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. intervention 3: Subjects will be administered with placebo (as 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. intervention 4: All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).

Protocol documents:
Clinical trial NCT01380782
Conditions: Glioblastoma Gliosarcoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma
Keywords: brain tumor recurrent disease
Sponsor: Patrick Y. Wen, MD
Start date: 2012-05-01; Completion date: 2014-07-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
BIBF 1120 is a newly discovered compound that may stop cancer cells from growing abnormally. This drug is currently being used in treatment for other cancers in research studies and information from those other research studies suggests that this agent, BIBF 1120, may help to stop recurrent malignant glioma cells from multiplying and it may also prevent the growth of new blood vessels at the site of the tumor. In this research study, the investigators are looking to see how well BIBF 1120 works in patients with recurrent malignant gliomas.

Detailed description:
This is a two arm, multicenter, open label phase II trial in adult patients with recurrent supratentorial high-grade glioma. One arm (the "bevacizumab naïve" arm) will enroll patients who have not received prior bevacizumab therapy, and the other arm (the "post-bevacizumab" arm) will enroll patients who have experienced progression on bevacizumab.

All subjects will receive BIBF 1120 at 200mg orally, twice daily in cycles of 28 days. Subjects will come to the clinic on Day 1 of each cycle (or within 2 days prior) for blood and urine tests and a physical and neurologic exam. Bloods will also be checked within 2 days before or after Day 15 of Cycles 1 and 2. An additional blood sample will be taken on Days 1 and 8 of Cycle 1, at the start of every even-numbered cycle, and at the end of active study treatment. Subjects will have gadolinium-enhanced brain MRI scans performed with tumor measurements at screening, at the start of even-numbered cycles, and at the end of active study treatment(unless already obtained within 4 weeks of completing study treatment). 40 study subjects will have diffusion- and perfusion-weighted MRI at baseline, after 1 week on therapy (± 2 days), within 2 days prior to the start of every even-numbered cycle, and at the end of treatment (unless already obtained within 4 weeks of completing study treatment).

Arms: arm 1: Bevacizumab naive subjects arm 2: Patients previously treated with bevacizumab
Interventions: intervention 1: BIBF 1120
Intervention descriptions: intervention 1: 200 mg BID oral for 28 day cycle

Protocol documents:
Clinical trial NCT01413542
Conditions: Hypertension Diabetes Type 2
Keywords: DPPIV inhibitors ACE inhibitors Bradykinin glucagon-like peptide (GLP-1) BNP diabetes hypertension
Sponsor: Vanderbilt University
Start date: 2011-11-01; Completion date: 2014-07-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4 inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people receiving enalapril (angiotensin converting enzyme or ACE inhibition), a blood pressure medicine. Understanding how these drugs interact in healthy people will help us learn their potential effects in people who have diabetes.

Detailed description:
To test the hypothesis that DPPIV inhibition with sitagliptin potentiates the vasodilator response to substance P in the presence of ACE inhibition with enalaprilat and to BNP and GLP-1 even in the presence of ACE inhibition. The aim promises to provide important new data regarding the mechanism of action of DPPIV inhibitors and interactive effects of these two drug classes used in a growing population of diabetic patients.

Arms: arm 1: The effect of vehicle and enalaprilat on the forearm blood flow and t-PA responses to bradykinin and substance P are studied after administration of placebo or sitagliptin (DPP4 inhibition). arm 2: The effect of vehicle and enalaprilat (ACE inhibition) on the forearm blood flow and t-PA responses to substance P and bradykinin are studied after administration of sitagliptin (DPP4 inhibition) or placebo arm 3: The effect of vehicle and enalaprilat (ACE inhibition) on the forearm blood flow and t-PA responses to glucagon-like peptide-1 and brain natriuretic pepdie are studied after administration of placebo or sitagliptin (DPP4 inhibition). arm 4: The effect of vehicle and enalaprilat on the forearm blood flow and t-PA responses to glucagon-like peptide and brain natriuretic peptide are studied after administration of placebo or sitagliptin (DPP4 inhibition).
Interventions: intervention 1: Sitagliptin (DPP4 inhibitor) intervention 2: Substance P, intervention 3: bradykinin intervention 4: enalaprilat (ACE inhibitor) intervention 5: Glucagon-like peptide 1 intervention 6: brain natriuretic peptide
Intervention descriptions: intervention 1: Sitagliptin 200 mg (DPP4 inhibitor) or matching placebo will be given one hour prior to intra-arterial infusions intervention 2: Substance P intra-brachial artery (2,4,8 pmol/min) intervention 3: bradykinin intra-brachial artery (23.6, 47.2, and 94.3 pmol/min) intervention 4: intra-brachial artery(0.33 µg/min per 100 mL forearm volume) intervention 5: intra-brachial artery (0.45-3.60 pmol/min) intervention 6: Intra-brachial artery (0.90, 1.80 and 3.6 pmol/min)

Protocol documents:
Clinical trial NCT01457573
Conditions: Lower Urinary Tract Symptoms
Sponsor: Timothy Boone, MD, PhD
Start date: 2011-10-01; Completion date: 2014-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A single center, pilot trial using tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline, 1, 2, and 3 months for urinary NGF, urine creatinine, NGF/CR ratio and patient reported outcomes through questionnaires.

Detailed description:
Single center, pilot trial, single arm study using once daily dosing of tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Assessments occur at Baseline, 1 Month, 2 Month and 3 Month to evaluate: urinary NGF (pg/mL), urine creatinine (mg/dL), NGF/Cr ratio and patient reported questionnaire outcomes (AUA Symptom Score/IPSS, Patient Perception of Bladder Condition, Patient Perception of Urge Intensity 'PPIUS', LUTS Urinary Symptoms and Quality of Life). Each participant is assessed from baseline to Month 3 measurements. Protection of human subjects will be provided through the Houston Methodist Research Institute Institutional Review Board (see appendix 2). All men will receive morning dosing with Tamsulosin 0.4 mg (1 tab) and Solifenacin 5 mg (1 tab) orally at the same time.

Arms: arm 1: All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg (1 tab) and Solifenacin (Vesicare) 5 mg (1 tab) orally at the same time.
Interventions: intervention 1: Tamsulosin intervention 2: Solifenacin
Intervention descriptions: intervention 1: Alpha blocker used to in the treatment of urinary difficulties related to enlarged prostate or symptomatic benign prostatic hypertrophy. All men will receive Tamsulosin (Flomax®) 0.4 mg, 1 tab, per morning with Solifenacin (Vesicare®). intervention 2: Antispasmodic/anticholinergic used to treat overactive bladder. All men will receive Solifenacin (Vesicare®) 5 mg, 1 tab, per morning with Tamsulosin.

Protocol documents:
Clinical trial NCT01467882
Conditions: Central Precocious Puberty
Sponsor: Debiopharm International SA
Start date: 2012-04-01; Completion date: 2014-07-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).

Detailed description:

Arms: arm 1: Triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
Interventions: intervention 1: Triptorelin
Intervention descriptions: intervention 1: Powder and solution for solution for injection

Protocol documents: