ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00857532
Conditions: Parkinson's Disease
Keywords: amyloid burden Parkinson's disease florbetapir PET amyloid PET imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2009-01-01; Completion date: 2011-11-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.

Detailed description:

Arms: arm 1: Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores of ≥9, indicating normal cognitive performance. arm 2: Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores between 6 and 8, inclusive, indicating mild cognitive deficits. arm 3: Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores below 5, indicating moderate to severe cognitive impairment.
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: 10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection

Protocol documents:
Clinical trial NCT00869999
Conditions: Diffuse Large B-cell Lymphoma
Keywords: rituximab everolimus DLBCL mTOR
Sponsor: Massachusetts General Hospital
Start date: 2009-05-01; Completion date: 2011-11-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or refractory DLBCL. Everolimus is an investigational drug that works by blocking a special protein that helps cancer cells grow. The safety and effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and is still investigational. The other drug in this study, rituximab, is approved by the US Food and Drug Administration (FDA) for use in patients who have diffuse large B-cell lymphoma and certain other types of non-Hodgkin lymphoma. Rituximab is a drug that destroys both normal and cancerous B-cells.

Detailed description:
Participants will receive oral Everolimus and intravenous rituximab for DLBCL that has relapsed or been refractory to prior therapy.

* Each treatment cycle lasts 28 days (4 weeks). Everolimus will be taken orally, once daily in the morning.
* Rituximab will be administered by an intravenous (IV) infusion on Days 1, 8, 15 and 22 of Cycle 1. In Cycles 2-6, rituximab will be administered only on Day 1 of each cycle.
* Participants will come into the clinic weekly during the first cycle, then on Day 1 of all cycles thereafter. The following tests and procedures will be performed:
* Weekly During Cycle 1: blood tests
* Day 1 of all Subsequent Cycles: brief physical examination; review of current medications, treatments, symptoms and side effects; vital signs; performance status evaluation; blood tests.
* A full body CT and PET scan to assess the participants tumor will be done within 7 days of completing cycles 2, 4, 6, 9 and 12.

Responding subjects may receive up to 6 cycles of Everolimus plus rituximab, and an additional 6 months of oral Everolimus for participants continuing to respond.

Interventions: intervention 1: Everolimus intervention 2: rituximab
Intervention descriptions: intervention 1: Taken orally once daily in the morning intervention 2: Given intravenously on Days 1, 8, 15, and 22 of Cycle 1 then on Day 1 of cycles 2-6

Protocol documents:
Clinical trial NCT00879619
Conditions: Prostate Cancer Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer
Sponsor: John P. Fruehauf
Start date: 2009-07-01; Completion date: 2011-11-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and prednisone together with sunitinib malate may kill more tumor cells.

PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel and prednisone together with sunitinib malate and to see how well it works in treating patients with prostate cancer that progressed after hormone therapy.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response by prostate specific antigen (PSA) of docetaxel/prednisone plus sunitinib (sunitinib malate) in chemotherapy-naive, hormone refractory prostate cancer subjects with biochemical relapse.

SECONDARY OBJECTIVES:

I. To determine the objective response rate (ORR) and duration of response (DR) in subjects with measurable disease.

II. To determine overall survival (OS) and time to progression (TTP). III. To evaluate the safety and tolerability of sunitinib in combination with docetaxel and prednisone.

OUTLINE:

Patients receive docetaxel intravenously (IV) over 60 minutes on day 1, prednisone orally (PO) twice daily (BID) on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for 3 years.

Arms: arm 1: Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate intervention 2: docetaxel intervention 3: prednisone
Intervention descriptions: intervention 1: Given PO intervention 2: Given IV intervention 3: Given PO

Protocol documents:
Clinical trial NCT00908349
Conditions: Partial Epilepsy
Sponsor: Supernus Pharmaceuticals, Inc.
Start date: 2009-06-01; Completion date: 2011-11-01
Enrollment: 214 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

Detailed description:
NAP

Arms: arm 1: Open Label Study
Interventions: intervention 1: Oxcarbazepine XR
Intervention descriptions: intervention 1: Open Label Study

Protocol documents:
Clinical trial NCT00929669
Conditions: Gonadotroph Adenomas
Keywords: pituitary tumor endocrine
Sponsor: University of Pennsylvania
Start date: 2009-06-01; Completion date: 2011-11-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.

Detailed description:
Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors. For this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be treated with a long-acting form of pasireotide once a month for one year. The effect of pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be judged by the serum concentration.

Arms: arm 1: 80 mg IM once monthly
Interventions: intervention 1: pasireotide LAR
Intervention descriptions: intervention 1: pasireotide LAR 80 mg IM once a month

Protocol documents:
Clinical trial NCT00931996
Conditions: Schizophrenia
Keywords: schizophrenia antipsychotic risperidone
Sponsor: University of Illinois at Chicago
Start date: 2009-06-01; Completion date: 2011-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia. However, the regional disturbances in brain function causing these deficits are not yet known. This application proposes a series of integrated behavioral studies designed to identify causes of deficits in schizophrenia.

Detailed description:
We will be assessing clinical symptoms and cognition before and after treatment.

Arms: arm 1: Antipsychotic
Interventions: intervention 1: Antipsychotic
Intervention descriptions: intervention 1: Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks.

Protocol documents:
Clinical trial NCT00947297
Conditions: Urea Cycle Disorders
Keywords: Urea Cycle Disorder UCD hyperammonemia Buphenyl Sodium Phenylbutyrate
Sponsor: Amgen
Start date: 2009-11-01; Completion date: 2011-11-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events were characterized with respect to contributing factors, such as intercurrent illness, diet, and noncompliance with medication.

Detailed description:
This was a one year long-term safety study of HPN-100 in UCD subjects. Subjects were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events were characterized with respect to contributing factors, such as intercurrent illness, diet, and noncompliance with medication.

Forty subjects with a diagnosis of UCD who completed Study HPN-100-006 were enrolled.

Twenty additional UCD subjects ≥ 6 years of age were enrolled. These subjects included those who did not qualify for HPN-100-006 \[e.g., subjects between the ages of 6-17; subjects with other UCD subtypes or adult subjects who have not taken sodium phenylbutyrate (NaPBA) in the past 6 months, etc.\]. For adult subjects not receiving NaPBA in the past 6 months, subjects must, in the judgment of the investigator, be anticipated to benefit from the addition of a nitrogen-scavenging agent to their current treatment. See the inclusion criteria for examples of clinical evidence of potential benefit.

Monthly assessments included safety laboratory tests, amino acid panel, vital signs, electrocardiogram (ECG) monitoring, venous ammonia, and blood and urine metabolites. Adverse events (AEs) and concomitant medications were recorded on an ongoing basis.

Study acquired from Horizon in 2024.

Arms: arm 1: Patients who were treated with HPN-100
Interventions: intervention 1: HPN-100
Intervention descriptions: intervention 1: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (\~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do.

Protocol documents:
Clinical trial NCT00956709
Conditions: Nerve Block
Sponsor: Nantes University Hospital
Start date: 2008-12-01; Completion date: 2011-11-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve \[4\]. Our hypothesis is that this lack of difference is due to the use of a neurostimulator for locating the injection site (indiscriminate nature of the anatomical approach to the sciatic nerve). Indeed, the sensitivity of neurostimulation is low compared with ultrasound \[58\] and ultrasound, for accurate visualization of the deposit of the local anesthetic around the nerve to improve the quality of the block and reduce the onset of action of local anesthetic \[46, 47\].

The investigators propose to make a comparative trial between levobupivacaïne 0.5% ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block. The use of ultrasound will reduce the variability of results because the changes would be linked exclusively to the local anesthetic. The investigators test the hypothesis that levobupivacaïne gives better results in terms of onset of action than ropivacaine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: levobupivacaïne 0,5 % intervention 2: ropivacaïne 0,5 %
Intervention descriptions: intervention 1: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 % intervention 2: 20mL de ropivacaïne 0,5 %

Protocol documents:
Clinical trial NCT00961233
Conditions: Eosinophilic Esophagitis
Keywords: eosinophilic esophagitis
Sponsor: University of North Carolina, Chapel Hill
Start date: 2009-10-01; Completion date: 2011-11-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: inhaled/swallowed budesonide intervention 2: viscous/swallowed budesonide
Intervention descriptions: intervention 1: medication will be nebulized and then swallowed intervention 2: viscous suspension of budesonide will be swallowed

Protocol documents:
Clinical trial NCT00962585
Conditions: Menopause
Sponsor: Ausio Pharmaceuticals, LLC
Start date: 2010-06-01; Completion date: 2011-11-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats.

Detailed description:
The study is a randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of 3 doses of S-equol to placebo in menopausal patients with vasomotor symptoms. The study objective is an evaluation of the dose response of 3 dose levels of AUS-131 (S-equol) and placebo with respect to reducing the mean number of moderate to severe vasomotor symptoms after 4 weeks of treatment. The safety of S-equol will be evaluated during the study.

Arms: arm 1: Placebo arm 2: S-equol 20 mg total daily dose arm 3: S-equol 100 mg total daily dose arm 4: S-equol 300 mg total daily dose
Interventions: intervention 1: Placebo intervention 2: S-equol
Intervention descriptions: intervention 1: None intervention 2: Eligible patients meeting all study entry criteria were randomly assigned to receive one of the following active treatments for 4 weeks:

* S-equol 10 mg BID (20 mg total daily dose)
* S-equol 50 mg BID (100 mg total daily dose)
* S-equol 150 mg BID (300 mg total daily dose)

Protocol documents:
Clinical trial NCT00993798
Conditions: Postoperative Pain
Keywords: Post operative pain Local anaesthesia Postoperative pain after arthroscopic shoulder surgery
Sponsor: Durect
Start date: 2009-04-01; Completion date: 2011-11-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.

Detailed description:

Arms: arm 1: double-blind arm 2: double-blind arm 3: double-blind arm 4: double-blind arm 5: double-blind arm 6: double-blind
Interventions: intervention 1: SABER-Bupivacaine Treatment 1a intervention 2: Placebo SABER-Bupivacaine Treatment 1b intervention 3: Bupivacaine HCl Treatment 1c intervention 4: SABER-Bupivacaine Treatment 2a intervention 5: Placebo SABER-Bupivacaine Treatment 2b intervention 6: Bupivacaine HCl Treatment 2c
Intervention descriptions: intervention 1: 5.0 ml intervention 2: 5.0 ml intervention 3: 20.0 ml intervention 4: 7.5 ml intervention 5: 7.5 ml intervention 6: 20.0 ml

Protocol documents:
Clinical trial NCT01003275
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease Vitamin D Paricalcitol Placebo Kidney Renal Oxidative Stress Immune cell function Glucose Glucose tolerance
Sponsor: University of Washington
Start date: 2009-10-01; Completion date: 2011-11-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).

Detailed description:
Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD.

This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.

Arms: arm 1: Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. arm 2: Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
Interventions: intervention 1: Paricalcitol intervention 2: Placebo
Intervention descriptions: intervention 1: Two 1 mcg soft gels by mouth daily for 8 weeks intervention 2: Two soft gels by mouth daily for 8 weeks

Protocol documents:
Clinical trial NCT01003899
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2009-10-01; Completion date: 2011-11-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours\[RECIST\] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.

Detailed description:

Arms: arm 1: patient to receive afatinib(BIBW 2992) po QD in an open-label manner
Interventions: intervention 1: afatinib (BIBW 2992)
Intervention descriptions: intervention 1: afatinib (BIBW 2992) po QD

Protocol documents:
Clinical trial NCT01029925
Conditions: Metastatic Breast Cancer Lung Cancer
Keywords: metastatic breast cancer lung cancer Previously treated metastatic breast cancer stage IIIb lung cancer stage IV lung cancer
Sponsor: Jonsson Comprehensive Cancer Center
Start date: 2009-12-01; Completion date: 2011-11-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the response rate by RECIST criteria of oral dichloroacetate in patients with recurrent and/or metastatic and pretreated breast and non-small cell lung cancer.

Detailed description:
In the United States, approximately 180,000 new cases of breast cancer occur annually, and there are more than 40,000 deaths. More than 150,000 cases develop each year in Canada and the European community together, resulting in over 60,000 deaths from breast cancer. The vast majority of patients who die from breast cancer succumb to metastatic disease. Endocrine therapy and chemotherapy (using either sequential single agents or combination regimens) remain the principal treatments for women with metastatic breast cancer. A wide variety of classes of chemotherapeutic agents have activity as single agents. Median survival remains approximately two years for women with metastatic breast cancer, and less than 3% of patients will experience long-term survival after treatment. The development of new treatment strategies is therefore essential to improve outcome for patients with metastatic breast cancer. The population selected for this study will have previously received, where appropriate, those drugs with clearly defined survival advantages (anthracyclines, taxanes, trastuzumab, and hormonal therapy).

Patients with metastatic non-small cell lung cancer are considered incurable. Palliative chemotherapies, such as platinum-based doublet, Taxotere or Pemetrexed or Erlotinib (an epidermal growth factor tyrosine kinase) have been proven to improve symptoms, and survival in patients with good performance status. Despite these treatments, the median survival of metastatic non-small cell lung cancer is about one year. Therefore, there is an urgent need to develop novel therapy in these patients.

Arms: arm 1: Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
Interventions: intervention 1: Dichloroacetate (DCA)
Intervention descriptions: intervention 1: Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart

Protocol documents:
Clinical trial NCT01052077
Conditions: Major Depressive Disorder
Keywords: OPC-34712 Major Depressive Disorder Adjunctive Treatment
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-03-01; Completion date: 2011-11-01
Enrollment: 773 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.

Detailed description:

Arms: arm 1: OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT arm 2: Placebo + ADT
Interventions: intervention 1: OPC-34712 intervention 2: Placebo intervention 3: ADT
Intervention descriptions: intervention 1: Tablets, Oral, 1 - 3 mg OPC-34712 intervention 2: Placebo intervention 3: None

Protocol documents: