ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00555477
Conditions: Breast Cancer
Keywords: premenopausal breast cancer with chemotherapy-induced ovarian failure
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2007-08-01; Completion date: 2013-09-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Women with hormone-receptor positive breast cancer are typically treated with hormone therapy as part of their treatment after surgery. In the past few years it has been found that treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women. Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are not effective in women who have functioning ovaries. Some women are premenopausal at the time they are diagnosed with breast cancer, but then stop having menstrual periods when they are treated with chemotherapy. It is unclear if these women can also be treated safely with aromatase inhibitors.

In this clinical trial the researchers will try to answer this question. Women with hormone receptor positive breast cancer who become postmenopausal with chemotherapy will be invited to participate in this study. Each woman will be treated with one of the aromatase inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries do not start making estrogen. If her estrogen level remains low, then she will continued to be followed for 18 months. If the level increases to the level typically seen in premenopausal women, however, then she will stop taking part in this study.

The study will also evaluate multiple factors that may help doctors predict who will tolerate the therapy without having their ovaries start making estrogen again. Some of the factors to be evaluated include other hormone levels (blood tests) as well as family history of early menopause (mother, sisters). In addition, changes in certain genes that affect how patients' bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients recover ovarian function. Overall, the purpose of the study is to determine which patients who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor treatment safely, and how often the patients' ovarian function needs to be tested during treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: anastrozole
Intervention descriptions: intervention 1: 1 mg tablet by mouth once a day

Protocol documents:
Clinical trial NCT00582114
Conditions: Hemodialysis Hypertension Left Ventricular Hypertrophy
Keywords: Hemodialysis Hypertension Left ventricular hypertrophy
Sponsor: Indiana University
Start date: 2005-08-01; Completion date: 2013-09-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We will directly test the hypothesis that an initial strategy of lisinopril-based therapy will be more effective than atenolol-based therapy in causing regression of left ventricular hypertrophy (LVH) over one year in patients with hemodialysis hypertension despite similar degree of BP reduction.

Detailed description:
This is a parallel group, active control, single-center, open-label, randomized controlled trial comparing the safety and efficacy of initial therapy with an angiotensin converting enzyme (ACE) inhibitor (lisinopril) vs. beta-blocker therapy (atenolol) each administered three times weekly after dialysis.

Arms: arm 1: Atenolol arm 2: Lisinopril
Interventions: intervention 1: Lisinopril intervention 2: Atenolol
Intervention descriptions: intervention 1: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg. intervention 2: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to \<140/90 mm Hg.

Protocol documents:
Clinical trial NCT00672594
Conditions: Prostate Cancer Prostatectomy
Sponsor: Duke University
Start date: 2006-07-01; Completion date: 2013-09-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.

Detailed description:
Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may undergo an additional study of IFP monitoring before treatment and during week 4 of study treatment. Safety and tolerability of Sunitinib malate therapy at this dose and schedule in this patient population will be assessed. Extensive correlative science evaluations, including assessment of physiologic, cellular, molecular and genetic changes during treatment with Sunitinib malate, will be performed

Arms: arm 1: Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
Interventions: intervention 1: Sunitinib Malate
Intervention descriptions: intervention 1: Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks

Protocol documents:
Clinical trial NCT00685399
Conditions: Non-infectious Uveitis
Keywords: Uveitis eye IL-17 IL-17A IL17 AIN457 Vogt-Koyanagi-Harada Behcet's Behcet Sympathetic ophthalmia Multifocal choroiditis Birdshot HLA-B27 Birdshot retinochoroiditis Retinal vasculitis Sarcoidosis Intermediate uveitis Panuveitis Posterior uveitis
Sponsor: Novartis Pharmaceuticals
Start date: 2008-06-01; Completion date: 2013-09-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was performed to evaluate the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.

Detailed description:

Arms: arm 1: Participants were administered with AIN457 (Sp2/0derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22. arm 2: Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort. arm 3: Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22. arm 4: Extension period: Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator. arm 5: Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all. arm 6: Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43). arm 7: Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43). arm 8: Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
Interventions: intervention 1: AIN457 intervention 2: AIN 457 intervention 3: AIN457
Intervention descriptions: intervention 1: AIN457 subcutaneous dose intervention 2: AIN457 low dose (i.v) intervention 3: AIN457 high dose (i.v)

Protocol documents:
Clinical trial NCT00727532
Conditions: Hereditary Clear Cell Renal Cell Carcinoma Kidney Cancer
Keywords: clear cell renal cell carcinoma hereditary clear cell renal cell carcinoma recurrent renal cell cancer stage I renal cell cancer stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer
Sponsor: Northwestern University
Start date: 2008-07-01; Completion date: 2013-09-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sorafenib 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 sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying how well sorafenib works in treating patients with locally advanced or metastatic kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* To demonstrate the feasibility and safety of sorafenib tosylate when given prior to nephrectomy or metastasectomy.
* To evaluate the ability of diffusion-weighted magnetic resonance imaging (DW-MRI) to detect early and ongoing microstructural changes in primary and metastatic renal cell carcinoma lesions during neoadjuvant therapy with sorafenib tosylate.
* To correlate early and ongoing microstructural changes in primary and metastatic renal cell carcinoma lesions with pathologic and clinical findings at the time of nephrectomy or metastasectomy.
* To evaluate the ability of changes in DW-MRI to predict subsequent favorable response to treatment (complete or partial response or stable disease) after 4 weeks of therapy.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Patients then undergo a nephrectomy or metastasectomy in week 5. Patients with residual metastatic disease may continue sorafenib tosylate twice daily and undergo a diffusion-weighted MRI (DW-MRI) every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo a DW-MRI of the abdomen and pelvis at baseline and prior to week 5 to evaluate microstructure tumor changes and to allow for prediction of sorafenib tosylate benefit. DW-MRI results are correlated with surgical and pathologic findings obtained at week 5.

Resected tumor tissue are analyzed for vascular density and to distinguish apoptotic cell death from necrotic cell death via immunohistochemistry and to measure apoptotic cell death via TUNEL assay.

After completion of study treatment, patients are followed every 3 months for 2 years.

Arms: arm 1: Eligible patients undergo pre-treatment DW-MRI of the abdomen and pelvis. Patient then receive Sorafenib 400mg orally twice daily on days 1-28. Following completion of 28 days of sorafenib, patients obtain a second DW-MRI.
Interventions: intervention 1: Sorafenib
Intervention descriptions: intervention 1: 400mg by mouth twice daily for 28 consecutive days

Protocol documents:
Clinical trial NCT00734305
Conditions: Advanced Solid Tumors
Keywords: cancer, solid tumors, oncology, Phase I, ErbB3, HER3 (erbB-3, HER-3)
Sponsor: Merrimack Pharmaceuticals
Start date: 2008-07-01; Completion date: 2013-09-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design to determine maximum tolerated dose/recommended Phase 2 dose.

Detailed description:
Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 2 dose was identified. The study initially explored a dosing schedule every 7-days, which may have been modified to longer intervals under certain circumstances but did not expand to more than weekly. When the maximum tolerated dose/recommended Phase 2 dose was identified, an Expansion Cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints. There were 3 sites that participated.

Arms: arm 1: Cohorts of escalating doses of MM-121 administered IV QW to determine MTD or RP2D + expansion cohort at MTD/RP2D
Interventions: intervention 1: MM-121
Intervention descriptions: intervention 1: Dose escalation Frequency - once weekly

Protocol documents:
Clinical trial NCT00744328
Conditions: Postpartum Depression
Keywords: Postpartum depression estradiol Postpartum major depressive disorder
Sponsor: Northwestern University
Start date: 2008-08-01; Completion date: 2013-09-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether estrogen patches are effective for the treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.

Detailed description:
This study aims to advance our therapeutic armamentarium by evaluating the efficacy of estradiol (E2) therapy for Postpartum Major Depression (PPMD), which has received minimal research attention in America. The design of the proposed study is an 8 week randomized double-blind clinical trial of SERT vs. E2 vs. Placebo. Responders enter a continuation phase with the blind intact through 6.5 months postpartum. The primary aims of this investigation are to: 1) Test the efficacy of E2 compared to placebo for the treatment of PPMD. Sertraline will be included as an active comparator. We have powered the study to test for differences among the three groups and also test for differences between the E2 and placebo group. We will test the hypothesis that E2 will be significantly more effective than placebo and that SERT will be significantly more effective than placebo. 2) Evaluate developmental outcomes in infants exposed to the disorder, PPMD, and the medications (SERT, exogenous E2 or Placebo) which may be transmitted to the infants through breastfeeding. All infants in this study will have exposure to mothers with depression. We will assess maternal depression, mother-infant serum SERT and E2 levels and relate them to mother-infant interactional quality and infant developmental outcomes on the Bayley Scales of Infant Development. These data will enhance the sophistication of risk-benefit analyses for pharmacotherapy during lactation.

Arms: arm 1: Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The capsules for women in this arm do not contain any active ingredients. The skin patch contains transdermal estradiol ranging in dose from 50 to 200 mcg/day arm 2: Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The skin patch contains no active ingredients, though packaging is designed to match active patches. The capsules contain sertraline ranging in dose from 25 to 200mg/day arm 3: Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The capsules for women in this arm do not contain any active ingredients. The skin patch contains no active ingredients, though packaging is designed to match active patches.
Interventions: intervention 1: Transdermal Estradiol intervention 2: Sertraline intervention 3: Placebo
Intervention descriptions: intervention 1: Estradiol patch ranging in dose from 50 to 200 mcg/day intervention 2: Sertraline dose will range from 50 - 200 mg/day intervention 3: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

Protocol documents:
Clinical trial NCT00748969
Conditions: Mucopolysaccharidosis I Mucopolysaccharidosis II Mucopolysaccharidosis VI
Keywords: MPS I MPS II MPS VI growth hormone short stature
Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Start date: 2008-11-01; Completion date: 2013-09-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether growth hormone is a safe and effective treatment for short stature in children with Mucopolysaccharidosis type I, II, and VI.

Detailed description:
Although children with MPS I, II, and VI who are treated with Hematopoietic Cell Transplantation (HCT) and/or enzyme replacement therapy (ERT) are living into adulthood with good cognitive development, their quality of life is significantly impacted by their skeletal abnormalities (i.e., kyphosis, scoliosis, and genu valgum), contractures, and severe short stature. Here at the University of Minnesota we have seen some promising clinical outcomes in children with MPS IH whom we have treated with human growth hormone (hGH). There are currently no reports in the literature of the impact of treating children with MPS and short stature, with hGH on their growth velocity or characteristic skeletal abnormalities. This study will advance the care of these children by providing data in this yet unexplored area of pediatric medicine with the goal of improving the quality of life for these children by improving height, mobility, and neuropsychological functioning.

This is a Phase II/III randomized, single-center, 12 month clinical trial of growth hormone in male and female participants with MPS I, II, or VI, followed by 12 months open label. Participants with height ≤ -2 SDS for age and gender will be randomized for the first 12 months 1:1 to treatment or no treatment. At the conclusion of the 12 months, all subjects will be offered an additional 12 months of treatment.

Arms: arm 1: Growth hormone treatment arm. Somatropin (DNA origin) arm 2: No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
Interventions: intervention 1: Somatropin (DNA origin)
Intervention descriptions: intervention 1: The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month.

Protocol documents:
Clinical trial NCT00749203
Conditions: Stress Disorders, Post-Traumatic PTSD Depression Anxiety Disorder
Keywords: Stress Disorders, Post-Traumatic PTSD anxiety disorder ketamine depression depressed mood
Sponsor: Dennis Charney
Start date: 2009-01-01; Completion date: 2013-09-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the proposed study is to test if a single IV dose of ketamine (0.5 mg/kg) decreases symptoms of PTSD.

Detailed description:
PTSD is a debilitating anxiety disorder characterized by intrusive re-experiences of the traumatic events, avoidance of situations and stimuli that could serve as reminders of these events, and feeling jumpy or easily startled. Patients with PTSD are often also depressed, and many have significant memory impairments. Existing drug treatments are unsuccessful in a majority of patients, especially in those with combat-related PTSD.

Our aim is to test the effectiveness of a potential new drug for PTSD, ketamine. For many years, intravenous ketamine has been extensively used for anesthesia. More recently, using doses lower than those used in anesthesia, a single ketamine infusion was shown to rapidly reduce depressed mood as well as anxiety in patients with severe depression. Some clinical evidence of potential efficacy in depressed patients with co-morbid PTSD also exists.

Adverse effects in these studies have been limited to feeling intoxicated and having increased blood pressure during the infusion.

In the present study, we expect a single ketamine infusion to reduce core PTSD symptoms. In addition, in those patients with PTSD who are depressed, we expect ketamine to reduce depressed mood.

Finally, ketamine is known to impair memory function temporarily. We will also test if the extent of ketamine-induced memory impairment during the infusion can predict how well people do after the infusion. Forty patients with PTSD (with and without combat-related trauma histories) will be tested, using a design that will compare the effectiveness of intravenous ketamine to that of midazolam, another anesthetic drug without any known long-term effects on anxiety, depressed mood, and memory function. If ketamine is found to have the expected effects, future studies may explore additional benefits of repeated infusions and / or alternatives to intravenous drug administration. Our study may contribute to improved function of patients with PTSD by providing a new means to rapidly treat their debilitating symptoms.

Arms: arm 1: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes arm 2: single dose 0.045 mg/kg IV infused over 40 minutes
Interventions: intervention 1: Midazolam intervention 2: Ketamine
Intervention descriptions: intervention 1: single dose 0.045 mg/kg IV infused over 40 minutes intervention 2: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes

Protocol documents: