ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00833976
Conditions: High Triglycerides Hypercholesterolemia Schizophrenia Schizoaffective Disorder Bipolar Disorder
Sponsor: Massachusetts General Hospital
Start date: 2009-07-01; Completion date: 2013-03-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.

Detailed description:
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second generation) antipsychotic medication. Eligible subjects include men and women, ages 18-75, who have been taking an atypical antipsychotic for at least three months prior to enrollment. Atypical antipsychotics include: clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega), asenapine (Saphris), iloperidone (Fanapt), and lurasidone (Latuda). Eligible subjects must also have serum triglycerides \>200 mg/dl or high cholesterol \>250 mg/dl at baseline.

Arms: arm 1: 4g per day (4g once a day or 2g two times a day) for 16 weeks
Interventions: intervention 1: Lovaza
Intervention descriptions: intervention 1: 4 grams per day

Protocol documents:
Clinical trial NCT00845832
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-03-01; Completion date: 2013-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.

All patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: rituximab [MabThera/Rituxan] intervention 3: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: iv on days 1 and 15 (Parts 1 and 2) intervention 2: 0.5g iv on days 1 and 15 (Parts 1 and 2) intervention 3: 2mg/kg-8mg/kg iv in Part 1 and selected dose in Part 2, on weeks 4, 8 and 12---Arm 1\\n8mg/kg iv on weeks 4,8 and 12 (Parts 1 and 2)--- Arm 2

Protocol documents:
Clinical trial NCT00848497
Conditions: Hypogonadism Erectile Dysfunction
Keywords: hormone replacement therapy radical prostatectomy erectile dysfunctions scheduled for removal of prostate gland
Sponsor: Mohit Khera
Start date: 2007-11-01; Completion date: 2013-03-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.

Subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.

Detailed description:
There was only one patient who began treatment with the study drug. After blind was broken, it was noted that he received placebo Testim and Viagra.

Arms: arm 1: Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night arm 2: Placebo Testim® gel once daily + Viagra® 25 mg tablet every night
Interventions: intervention 1: Testim® intervention 2: Placebo Testim® intervention 3: Viagra®
Intervention descriptions: intervention 1: Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily. This was the dose given to the patient which he started. intervention 2: Placebo Testim® 5 g of gel (one tube) intervention 3: Viagra 25mg was the dose given to the patient which he started.

Protocol documents:
Clinical trial NCT00884390
Conditions: Hemophilia A
Keywords: Hemophilia A
Sponsor: Pfizer
Start date: 2009-05-01; Completion date: 2013-03-01
Enrollment: 208 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.

Detailed description:
The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in March 2013 was agreed with EMA prior to closure activity.

Arms: arm 1: None
Interventions: intervention 1: moroctocog alfa (AF-CC) (ReFacto AF) intervention 2: Laboratory tests
Intervention descriptions: intervention 1: Providing moroctocog alfa (AF-CC) as test article for use during this study. intervention 2: Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.

Protocol documents:
Clinical trial NCT00886795
Conditions: Urticaria
Keywords: hives rash pruritis
Sponsor: Johns Hopkins University
Start date: 2009-05-01; Completion date: 2013-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).

Detailed description:

Arms: arm 1: 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.
Interventions: intervention 1: abatacept (Orencia ®)
Intervention descriptions: intervention 1: 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.

Protocol documents:
Clinical trial NCT00908791
Conditions: Breast Cancer
Keywords: Conjugated Linoleic Acid Proof of Principle Lipogenic Pathway Clarinol
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2009-06-01; Completion date: 2013-03-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Conjugated Linoleic Acid (CLA) is obtained in the human diet by consumption of foods containing ruminant fat. Milk and dairy products have shown the highest amounts of CLA. Clarinol (CLA), is considered a natural supplement and is not regulated by the Food and Drug Administration (FDA). CLA is known to inhibit proliferation of human breast cancer cells and tumors in rodent breast cancer models and reduced Spot 14 (THRSP, S14) and Fatty Acid Synthase (FASN) gene expression in breast cancer cells and tht the two major CLA isomers used in nutritional supplements (C9, t11 and t10, c12) were equipotent in reducing breast cancer cell growth. This study looks at the hypothesis that S14 expression is decreased by CLA and will characterize the major pharmacodynamic (PD) effects of CLA in newly diagnosed Breast cancer patients on Tumor tissue lipogenic pathway. FASN, S14 and Lipoprotein Lipase (LPL), Ki67 and apoptotic index expression will be assessed by quantitative immunohistochemistry (IHC) in initial breast cancer biopsies and compared to that in resected breast tumor tissue after the study subject has been taking CLA for ten to twenty-eight days. Tissue from adjacent breast adipocytes will also be analyzed to determine whether adipose tissue effects can serve as a surrogate marker for those in tumor tissue. A sample of the original biopsy will be compared to the tumor resection sample to determine the levels of CLA in the breast cancer cells.

Detailed description:

Arms: arm 1: open-label, single-institution proof of principle study of oral CLA in patients with newly diagnosed adenocarcinoma of the breast.
Interventions: intervention 1: Conjugated Linoleic Acid (CLA)
Intervention descriptions: intervention 1: Conjugated linoleic acid (CLA, Clarinol™) oral soft gel capsules will be administered in an open-labeled, manner to all subjects enrolled in the study. Subjects will be treated with 7.5 grams of oral CLA daily, taken in divided dose, twice daily between 8 am and 12 noon and between 8 pm and 12 midnight. CLA will be taken for a minimum of ten days prior to surgical resection of their breast malignancy. In the event that the subject's surgical resection date is delayed, subjects may take CLA for up to 28 days. The last dose of CLA prior to the surgical resection will be taken at 12 midnight or as close as possible to that time and the patient will record the time of the last dosing.

Protocol documents:
Clinical trial NCT00914316
Conditions: Peripheral Arterial Disease
Keywords: Lower leg claudication Poor circulation of the leg muscles Cramping or discomfort in the lower legs Lower leg pain PAD (Peripheral arterial disease)
Sponsor: William Beaumont Hospitals
Start date: 2009-05-01; Completion date: 2013-03-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The goal of this study is to evaluate whether supervised treadmill exercise combined with ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance over supervised exercise alone in patients with stable claudication. Investigators also seek to determine if the administration of ranolazine provides a sustained benefit after the completion of a supervised exercise regimen. Lastly, investigators wish to determine whether both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in patients with stable claudication.

Detailed description:
The treatment groups are:

A. Group A will be randomized to a 12 week supervised exercise program and ranolazine, (Ranexa) 1000 mg orally, twice daily, by mouth.

B. Group B will be randomized to a 12 week supervised exercise program and placebo.

After the 12 week supervised exercise program, all participants will undergo a second randomization to ranolazine or placebo for an additional 12 weeks, during which independent walking will be encouraged.

Both groups will participate in a two week lead-in period after each randomization of the trial, allowing for the stabilization of their medications and dosing of ranolazine. Medications such as cilostazol, calcium channel blockers and nitrates will be discontinued during the lead-in period, unless their use is for management for high blood pressure. Anti-platelet (blood thinner) medications will be continued throughout the trial.

Arms: arm 1: This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth. arm 2: This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug. arm 3: This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth. arm 4: This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: Ranolazine, 1000 mg, capsule, twice daily, by mouth. intervention 2: twice daily

Protocol documents:
Clinical trial NCT00925899
Conditions: Cancer Fatigue
Keywords: Melatonin Palliative care Advanced cancer Symptoms Quality of life Randomized controlled trial
Sponsor: Bispebjerg Hospital
Start date: 2009-10-01; Completion date: 2013-03-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
BACKGROUND:

Patients with advanced cancer often suffer from fatigue and other symptoms and problems such as insomnia, appetite loss and pain. Problems that may have great consequences for their quality of life. Several studies suggest that a supplement of the hormone melatonin (MLT) may have a beneficial effect on these symptoms/problems. This needs further investigation.

AIM:

To investigate if a supplement of melatonin have an effect on a) fatigue (the primary outcome of the trial), b) the symptoms insomnia, appetite loss, depression and pain, and c) overall quality of life.

METHODS AND PATIENTS:

The trial takes place in the Department of Palliative Medicine, Bispebjerg Hospital, and 50 patients will participate. The participants have to be 18 years or above, have advanced cancer, and suffer from quite a bit or very much fatigue.

The study consists of two parts. In part I it is investigated if melatonin has a better effect than placebo on the outcomes mentioned above. This part is a consecutive, prospective, double blinded, randomized (MLT vs. placebo), cross-over study where the patients serve as their own control. In part II the effect of melatonin over time is investigated. Part II is a consecutive, prospective, open-label study.

The outcomes are assessed with weekly questionnaires (MFI-20 and EORTC QLQ-C15PAL) and a few daily diary questions.

Melatonin has been used in several studies, and the general conclusion is that it is a safe substance with few adverse drug reactions.

PERSPECTIVES:

If melatonin has the potential to alleviate fatigue and other symptoms in patients with advanced cancer and enhance the quality of life of these patients, this will be of benefit to many future patients. Trials such as this are important both nationally and internationally to develop an evidence-based palliative medicine.

Detailed description:

Arms: arm 1: 20 mg arm 2: None
Interventions: intervention 1: Melatonin intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg melatonin orally every evening about 1 hour before bedtime for one week. After having participated in the cross-over part of the trial (one week of melatonin followed by one week of placebo, or the other way around), the participant may receive melatonin for 6 weeks. intervention 2: Placebo tablet orally every evening about one hour before bedtime for one week. After having participated in the cross-over part of the trial (one week of placebo followed by one week of melatonin, or the other way around), the participant may receive melatonin for 6 weeks.

Protocol documents:
Clinical trial NCT00934661
Conditions: Hip Arthroplasty
Keywords: hip resurfacing hip arthroplasty
Sponsor: Wake Forest University
Start date: 2010-01-01; Completion date: 2013-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.

Hypothesis:

In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.

Detailed description:
Extended release epidural morphine (EREM, DepoDur®: Endo Pharmaceuticals, Chadds Ford PA) has been studied and increasingly utilized as a method to allow for the improved post-operative analgesia of epidural analgesia without infusions.

At Wake Forest University, the investigators have been using EREM, since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. The investigators initially decreased our dosages from those recommended (15 mg for lower extremity surgery and 10-15 mg for abdominal surgery), because side effects (nausea, vomiting and hypotension) were felt to be limiting to recovery. The investigators now use 4-7.5 mg in most patients, with 7.5 mg being the exception and have achieved better results. For hip arthroplasties, the investigators currently use 4-5 mg and have performed two retrospective chart reviews on this use; both suggesting that this approach is efficacious. However, these doses have not been studied in a prospective, randomized, double blind trial. The investigators would like to evaluate the efficacy of this dose of EREM used as part of a multimodal regimen. The investigators will compare EREM 4 mg with lumbar plexus block versus lumbar plexus block alone, (providing the rest of our multimodal approach for both patients).

Arms: arm 1: Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline arm 2: The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Interventions: intervention 1: Extended Release Epidural Morphine (EREM) intervention 2: Placebo
Intervention descriptions: intervention 1: A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline intervention 2: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush

Protocol documents:
Clinical trial NCT00947856
Conditions: Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin
Keywords: Antibodies, Monoclonal Antibody-Drug Conjugate Antigens, CD30 Drug Therapy Hematologic Diseases Immunotherapy Monomethylauristatin E
Sponsor: Seagen Inc.
Start date: 2009-07-01; Completion date: 2013-03-01
Enrollment: 110 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.

Detailed description:
This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:

* Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
* Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

Arms: arm 1: Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) arm 2: Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
Interventions: intervention 1: brentuximab vedotin
Intervention descriptions: intervention 1: Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure

Protocol documents:
Clinical trial NCT00956293
Conditions: Renal Transplantation
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2013-03-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standard treatment but optimizing immunosuppressive therapy with benefits in renal function, new-onset diabetes mellitus, cardiovascular risk, cancer and allograft nephropathy.

Detailed description:

Arms: arm 1: During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA. arm 2: During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
Interventions: intervention 1: Basiliximab intervention 2: Enteric Coated Mycophenolic Acid (MPA) intervention 3: RAD001 intervention 4: Cyclosporin A (CsA) intervention 5: Corticosteroids
Intervention descriptions: intervention 1: On day 0, 2 hours prior to transplant and day 4 post-transplant, 20 mg x2 were given to all participants. Post randomization, 20mg at weeks 7 and 12 were given to the Everolimus group. intervention 2: A loading dose regimen of 2880 mg/day during weeks 1 and 2 (pre-randomization) were given. During weeks 3 - 6 (pre-randomization), 2160 mg/day were given and during weeks 7 - 24, 1440 mg/day were given if tolerated. Dose reductions due to side effects were possible. intervention 3: Upon randomization, 3 mg (od) on Day 1, and 3 mg (1.5 mg every 12 hours) on Day 2 was given. Afterwards, the dosage was based on blood trough level (5 - 10 ng/mL). intervention 4: Dosage was based according to blood level intervention 5: Dosage was administered according to local standards and administration was optional as per clinical need and the Investigators' discretion. Steroid withdrawal occurred after week 2 (pre-randomization).

Protocol documents: