ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00671060
Conditions: Intrauterine Fetal Demise
Keywords: intrauterine fetal death misoprostol
Sponsor: Gynuity Health Projects
Start date: 2008-10-01; Completion date: 2011-12-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely evacuation is vital in order to avoid the possibility of, among other things, potentially life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these cases include dilatation and evacuation (D\&E) surgery (in less advanced pregnancies) and labor induction with a variety of products. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this indication in a number of small, non-FDA-approved trials which have been published in the peer-reviewed literature. In the absence of more formal study of this treatment, however, dosages are not standardized, pathways of administration vary, and other uncertainties linger. The purpose of the protocol proposed herein is to formally establish, via a randomized, double-blinded study, the safety and effectiveness of misoprostol for this indication, and to compare the value of two distinct doses, so that providers may henceforward proceed with greater authority and confidence.

Detailed description:

Arms: arm 1: Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose. arm 2: Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
Interventions: intervention 1: Misoprostol intervention 2: Misoprostol
Intervention descriptions: intervention 1: 200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered. intervention 2: 100 mcg buccal misoprostol administered every 6 hours for upto 48 hours

Protocol documents:
Clinical trial NCT00676650
Conditions: Prostatic Neoplasms
Keywords: Docetaxel-refractory mCRPC Second-line treatment with sunitinib and prednisone
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2011-12-01
Enrollment: 873 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Detailed description:

Arms: arm 1: Treatment Arm A - sunitinib + prednisone arm 2: Treatment Arm B - placebo + prednisone
Interventions: intervention 1: Prednisone intervention 2: sunitinib intervention 3: Placebo intervention 4: Prednisone
Intervention descriptions: intervention 1: 5 mg BID, oral intervention 2: 37.5 mg/day, oral, administered on a continuous daily dosing regimen intervention 3: 37.5 mg/day, oral, administered on a continuous daily dosing regimen intervention 4: 5 mg BID, oral

Protocol documents:
Clinical trial NCT00683644
Conditions: Tinnitus
Keywords: tinnitus, zinc
Sponsor: University of Iowa
Start date: 2008-01-01; Completion date: 2011-12-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group.

Detailed description:
There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group. 116 patients were tested. Tinnitus loudness and the Tinnitus Handicap Questionnaire are the outcome measures.

Arms: arm 1: Zinc sulfate (50 mg elemental zinc) taken once daily for 4 months. Washout 1 month. Placebo oral capsule taken once a day for 4 months. arm 2: Placebo oral capsule taken once a day for 4 months. Washout 1 month. Zinc sulfate (50 mg elemental zinc) taken once daily for 4 months.
Interventions: intervention 1: Zinc intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: Zinc taken once daily intervention 2: Placebo capsules taken once daily

Protocol documents:
Clinical trial NCT00699374
Conditions: Carcinoma, Hepatocellular
Keywords: sunitinib phase 3 randomized hepatocellular liver
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2011-12-01
Enrollment: 1075 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

Detailed description:
This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. Patients on sunitinib who are judged by the investigator as receiving clinical benefit may chose to remain on study and continue treatment with sunitinib until clinical benefit as per the investigator's judgment.

Arms: arm 1: sunitinib arm arm 2: sorafenib arm
Interventions: intervention 1: sunitinib malate intervention 2: sorafenib
Intervention descriptions: intervention 1: sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability. intervention 2: sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.

Protocol documents:
Clinical trial NCT00705523
Conditions: Alcoholism
Keywords: alcohol treatment nicotinic acetylcholine receptors pharmacotherapy outpatient
Sponsor: University of Pennsylvania
Start date: 2008-06-01; Completion date: 2011-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the treatment of alcohol dependence.

Detailed description:
By both providing a low level of reinforcement and down-grading any "high" associated with concurrent administration of the abused drug, combined agonist/antagonist therapies promote both initial and sustained abstinence. Based on varenicline's specific affinity for the nicotinic acetylcholine receptors that are implicated in alcohol reward circuitry, it appears to be a good candidate for treatment of alcohol dependence. Alcohol can exert its reinforcing and dopamine-enhancing effects through activation of nicotinic receptors. In addition to its partial agonist activity at heteromeric α4β2 nicotinic acetylcholine receptors, varenicline has also been shown to be a full agonist at homomeric α7 nicotinic acetylcholine receptors. That full agonism at α7 may be key in reducing alcohol withdrawal and craving during early alcohol abstinence, and thus reducing relapse, as α7 receptors are implicated in the neural reward circuitry activated by alcohol use.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: 1.0 mg BID for 12 weeks intervention 2: BID 12 weeks

Protocol documents:
Clinical trial NCT00720473
Conditions: Bipolar Depression
Keywords: Bipolar depression Elderly Lamotrigine Brain energy metabolism
Sponsor: Mclean Hospital
Start date: 2006-04-01; Completion date: 2011-12-01
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We propose to study the efficacy and tolerability of lamotrigine in the treatment of older adults with bipolar depression and to compare measures of brain energy metabolism between older subjects with bipolar depression and healthy age-matched controls in order to better understand treatment response in geriatric bipolar depression.

Detailed description:
We will use MRI techniques and neuropsychological testing to investigate potential markers of treatment response in elderly bipolar depressed patients receiving lamotrigine and age-matched, non-depressed controls.

We intend to test these hypotheses:

1. At least 50% of older subjects with bipolar depression will respond treatment with lamotrigine as evidenced by a 50% reduction on the Montgomery Asberg Rating Scale (MADRS). In addition, treatment with lamotrigine will be safe and well tolerated as evidenced by a drop-out rate of less than 10% due to adverse effects.
2. Compared with healthy age-matched, non-demented, non-depressed controls, subjects with geriatric bipolar depression will demonstrate abnormalities in cerebral energy metabolism as assessed by elevated levels of glutamate and lactate, and decreased levels of NAA, using 1H MRS at 4T.
3. Successful treatment with lamotrigine in geriatric bipolar depression will result in decreases in lactate and glutamate, and elevations in NAA.
4. Baseline measures of executive functioning and information processing speed (measured by performance on the Wisconsin Card Sorting Test (WCST), Trails A and B and Stroop tests) will be impaired in subjects with geriatric bipolar depression compared with healthy controls. These measures will improve with successful treatment with lamotrigine and correlate with improvements in markers of cerebral energy metabolism (lactate, glutamate, NAA).

Arms: arm 1: Open Label Study arm 2: None
Interventions: intervention 1: Lamotrigine
Intervention descriptions: intervention 1: Lamotrigine with dosage range from 25 mg to 200 mg per day.

Protocol documents:
Clinical trial NCT00738673
Conditions: Prostate Cancer
Keywords: Hormone refractory prostate cancer Agonist treatment failure
Sponsor: Ferring Pharmaceuticals
Start date: 2008-07-01; Completion date: 2011-12-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.

Detailed description:

Arms: arm 1: Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0.

Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Interventions: intervention 1: degarelix
Intervention descriptions: intervention 1: Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

Protocol documents:
Clinical trial NCT00747474
Conditions: Advanced Solid Tumors
Sponsor: Taiwan Liposome Company
Start date: 2008-09-01; Completion date: 2011-12-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find a safe and tolerable dose of Lipotecan® when administered to patients with advanced solid tumors.

Detailed description:
Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines in vitro and anti-tumor activities in several xenograft models with human tumor cell lines. Structurally, TLC388 HCl is related to other camptothecins, but it has been chemically modified to improve stability and potency, and to minimize toxicities.

Arms: arm 1: Intravenous Lipotecan (TLC388 HCl for Injection)
Interventions: intervention 1: Lipotecan
Intervention descriptions: intervention 1: Lipotecan IV day 1, 8, 15

Protocol documents:
Clinical trial NCT00753623
Conditions: Neuropathic Pain
Keywords: Pain Neuropathic pain Pain scores
Sponsor: Massachusetts General Hospital
Start date: 2008-09-01; Completion date: 2011-12-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This proposal is to conduct a double-blinded, randomized, placebo-controlled, crossover clinical study to examine the hypothesis that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.

Detailed description:
Neuropathic pain is a chronic pain condition resulting from injury to the peripheral and/or central nervous system. Despite extensive research over the last several decades, neuropathic pain remains poorly managed due to the lack of effective pharmacological tools. To date, little has been known regarding the effect of melatonin and its analogues on clinical neuropathic pain. We propose to conduct a randomized, placebo-controlled, double-blinded, and crossover clinical trial to examine the effect of ramelteon \[a melatonin (MT) 1/ MT2 receptor agonist\] on neuropathic pain. We hypothesize that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.

Arms: arm 1: In a crossover design, a subject will be first assigned to the ramelteon arm and then switched over to the placebo arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night.The ramelteon and placebo will be blinded by the central pharmacy.

The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long. arm 2: In a crossover design, a subject will be first assigned to the placebo arm and then switched over to the ramelteon arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night. The ramelteon and placebo will be blinded by the central pharmacy.

The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.
Interventions: intervention 1: Ramelteon intervention 2: Placebo
Intervention descriptions: intervention 1: ramelteon (8 mg) intervention 2: In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.

Protocol documents:
Clinical trial NCT00753714
Conditions: Non Small Cell Lung Cancer
Keywords: ZD6474 VANDETANIB ZACTIMA ADVANCED NSCLC LUNG CANCER ELDERLY PATIENTS GEMCITABINE PHASE II RANDOMIZED DOUBLE-BLIND histologically or cytologically-confirmed advanced (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) NSCLC
Sponsor: Genzyme, a Sanofi Company
Start date: 2008-10-01; Completion date: 2011-12-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate an improvement in Progression-Free Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC.

Detailed description:

Arms: arm 1: Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued. arm 2: Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
Interventions: intervention 1: ZD6474, Vandetanib intervention 2: Placebo to Match ZD6474, Vandetanib intervention 3: Gemcitabine
Intervention descriptions: intervention 1: 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first intervention 2: 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first intervention 3: administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle UP to 6 cycles or UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Protocol documents:
Clinical trial NCT00765765
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer male breast cancer
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2009-02-01; Completion date: 2011-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to the drug.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone given together with hydroxychloroquine and to see how well they work in treating patients with metastatic breast cancer.

Detailed description:
OBJECTIVES:

* The primary objective of this study is to assess the antitumor activity, measured by tumor response rate, in patients who receive this regimen as a third-line treatment. (Phase II)

Secondary

* To measure the duration of response for responding patients.
* To measure the time to progressive disease.
* To measure survival time.
* To characterize the quantitative and qualitative toxicities of this regimen in these patients.
* To develop pharmacodynamic markers for autophagy detection in patient specimens.
* To characterize the effects of hydroxychloroquine on autophagy in patients in vivo.
* To investigate whether the estrogen receptor, progesterone receptor, and/or HER2 status of breast tumors correlates with treatment response.

OUTLINE: This is a multicenter, phase I dose-escalation study of ixabepilone followed by a phase II study.

During the first course, patients receive ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 3-21. On all subsequent courses, patients receive ixabepilone IV over 3 hours on day 1 and oral hydroxychloroquine twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 6 months.

Arms: arm 1: None
Interventions: intervention 1: hydroxychloroquine intervention 2: ixabepilone
Intervention descriptions: intervention 1: Dose escalation from 200 mg po qd to 200 mg po bid. intervention 2: Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

Protocol documents:
Clinical trial NCT00768651
Conditions: Type 1 Diabetes
Sponsor: University of Alberta
Start date: 2008-10-01; Completion date: 2011-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We aim to study if the administration of medications to increase the secretion of hormones from the intestines can improve glycemic control, reduce insulin use and promote β-cell regeneration/expansion in subjects with type 1 diabetes following islet transplantation who are back using small doses of insulin because of early graft dysfunction. We believe that the results will enable us to understand whether these drugs could be useful in islet transplant recipients, particularly if glycemic control deteriorates.

Detailed description:
This is a single centre non-randomized pilot study. Subjects will be recruited from the current cohort of islet transplant recipients at the University of Alberta.

The primary objective of the study is to evaluate whether the combination of sitagliptin and pantoprazole can restore insulin independence in previously insulin independent islet transplant recipients experiencing early graft dysfunction. The study will also evaluate the safety of the combination drug therapy.

Arms: arm 1: Intervention Details:

Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.
Interventions: intervention 1: Pantoprazole intervention 2: Sitagliptin
Intervention descriptions: intervention 1: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months. intervention 2: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.

Protocol documents: