ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01246973
Conditions: Radiation-induced Dermatitis
Keywords: Oral Curcumin Radiation Dermatitis Breast Cancer Patients
Sponsor: University of Rochester
Start date: 2011-02-01; Completion date: 2015-01-01
Enrollment: 686 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether curcumin, an ingredient of some foods, can prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues..

Detailed description:
Radiation is a toxic agent and a widely accepted form of treatment for various types of cancer. Approximately half of all women with breast cancer receive radiation therapy. Despite advances in medical technology, radiation therapy still causes severe skin effects. Radiation dermatitis occurs in approximately 90% of patients and ranges in severity from mild redness to more severe skin changes. Dermatitis is a common side effect of radiation treatment, but few effective treatments have been developed for it; currently, there is no standard treatment for the prevention of radiation-induced dermatitis. Curcumin is a natural compound found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance the functions of normal tissues.

Arms: arm 1: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week arm 2: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Interventions: intervention 1: Curcumin intervention 2: Placebo
Intervention descriptions: intervention 1: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week intervention 2: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week

Protocol documents:
Clinical trial NCT01260194
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-06-01; Completion date: 2015-01-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: Loading dose of 8 mg/kg on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression in combination with standard chemotherapy

Protocol documents:
Clinical trial NCT01272635
Conditions: Asthma Wheezing
Keywords: Asthma Wheezing Respiratory Tract Illness Azythromycin Prednisolone Preschool-age
Sponsor: Milton S. Hershey Medical Center
Start date: 2011-03-01; Completion date: 2015-01-01
Enrollment: 607 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms using oral corticosteroids.

Detailed description:
Preschool aged children often have severe bouts of coughing and/or wheezing that lead to visits to the doctor's office, urgent care, emergency room and often hospitalization. APRIL-OCELOT is a randomized, double-blind, placebo controlled study in 600 preschool children with a history of significant wheezing episodes in the year prior to enrollment. All children enter the APRIL portion of the study, which will compare azithromycin to placebo, given for 5 days during the early signs of an upper respiratory tract illness, for preventing the development of lower respiratory tract symptoms. APRIL is a 78 week study, but participation will end earlier if the child requires a fourth course of APRIL treatment or develops significant lower respiratory tract symptoms. Only those children who develop significant lower respiratory tract symptoms during APRIL will enter the OCELOT portion of the study, which will compare oral corticosteroid to placebo for treating lower respiratory tract symptoms as measured by the Pediatric Respiratory Assessment Measure (PRAM). OCELOT participation will be complete after 14 days. Children may not reenter APRIL after completing OCELOT.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Azithromycin intervention 2: Prednisolone intervention 3: Placebo Azithromycin intervention 4: Placebo Prednisolone
Intervention descriptions: intervention 1: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day intervention 2: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day intervention 3: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day intervention 4: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Protocol documents:
Clinical trial NCT01288807
Conditions: Fibromyalgia
Keywords: Fibromyalgia pain
Sponsor: University of California, San Diego
Start date: 2011-02-01; Completion date: 2015-01-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators want to study the effects of milnacipran treatment on neurotransmitter release in fibromyalgia.

Detailed description:
Fibromyalgia (FM) is a chronic pain condition with significant morbidity. Current research suggests a primarily central mediation of the widespread pain including central sensitization at the spinal level and abnormal pain processing at the cerebral level. Findings in FM patients include abnormal neurotransmitter levels in cerebrospinal fluid (CSF), abnormal activation of cerebral pain processing areas and abnormal peripheral pain and sensory thresholds. Continuous low level spinal cord activation by primary nociceptive afferents (C and A delta fibers) is believed to significantly drive the central sensitization. One major spinal neurotransmitter released by these pain fibers is substance P (SP). Several studies have shown that FM patients have up to three times higher baseline SP levels in the CSF compared to controls. Since spinal neurotransmitter release and therefore nociceptive afferent activity is also regulated via a descending inhibitory pathway releasing norepinephrine (NE) and serotonin (5HT), decreased activity of this pain modulating system could also be involved in abnormal pain processing in FM. Indeed, there is support in the literature for decreased CSF levels of both NE and 5HT or their metabolites. Milnacipran, a NE and 5HT reuptake inhibitor, has been shown to potentially effectively reduce FM pain and symptoms of FM by affecting the above pathologies.

The investigators propose an open label clinical trial with milnacipran 200 mg over 12-weeks in order to investigate the pain pathway in FM patients at peripheral and spinal levels before and after treatment. In addition, the investigators will assess pain intensity and symptoms of FM before, during and after treatment. To determine if there are peripheral effects, the investigators will characterize the systemic neurotransmitter release and their metabolites in plasma. The investigators will also measure the heart rate variability using an electrocardiogram to look for effects on the sympathetic nervous system.

Arms: arm 1: Titrated Milnacipram doses
Interventions: intervention 1: Milnacipram
Intervention descriptions: intervention 1: Titration to 200mg PO daily

Protocol documents:
Clinical trial NCT01290887
Conditions: Eosinophilic Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2011-06-01; Completion date: 2015-01-01
Enrollment: 1052 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

Detailed description:
Study patients deemed eligible based on activities from the preceding Teva sponsored double blind study of reslizumab in eosinophilic asthma. Specifically, as per inclusion criterion c, patients must have either completed treatment in a previous Teva-sponsored study or have received at least 2 doses of study drug treatment in a pulmonary function study.

Eligible patients could enroll in this study only after completion of the end of treatment visit in a Teva sponsored, randomized, placebo controlled, double blind study of reslizumab in eosinophilic asthma, which served as the screening/baseline visit for participation in this open label extension study. The use of systemic corticosteroids for asthma in any of the previous Teva sponsored double blind studies of reslizumab did not exclude patients from this study. The previous Teva studies were C38072/3081 (NCT01270464), C38072/3082 (NCT01287039), and C38072/3083 (NCT01285323).

Arms: arm 1: Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Interventions: intervention 1: Reslizumab
Intervention descriptions: intervention 1: Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months

Protocol documents:
Clinical trial NCT01292304
Conditions: Ascites Cirrhosis
Keywords: Cirrhotic Tolvaptan v2 receptor antagonist
Sponsor: University of Florida
Start date: 2012-03-01; Completion date: 2015-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

Detailed description:
This is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment) of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. Subjects are monitored for changes in frequency of paracentesis, quantity of ascites removed, and body weight. Additionally, subjects laboratory values were checked frequently during the first days of dosing to ensure tolerability and slow correction/increase in serum sodium.

Arms: arm 1: Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Interventions: intervention 1: Tolvaptan
Intervention descriptions: intervention 1: Oral administration once daily Dosage will range from 15 mg to 30 mg

Protocol documents:
Clinical trial NCT01364259
Conditions: Trigeminal Neuralgia
Keywords: tic douloureux
Sponsor: Stanford University
Start date: 2008-09-01; Completion date: 2015-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while minimizing side effects. To this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.

Detailed description:
Patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. Pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed. Patients will be treated in a single session with 75 Gy maximal dose covering a 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. Treatment will be delivered using the CyberKnife Robotic Radiosurgery System with the patient in the supine position. An aquaplast head mask will be used to ensure adequate immobilization during therapy. The target volume shall be the 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. Patients will receive subcutaneous injection of amifostine (500 mg) or placebo 30 minutes +/- 30 minutes prior to SRS. Facial pain will be assessed using the Visual Analog Scale and Short-form McGill Pain Questionnaire. Following SRS, patients will be followed at 1, 3, 6, and 9 months ±7 days. Facial numbness will be assessed using the Barrow Neurologic Institute (BNI) Facial Numbness Score. Patient reported BNI facial numbness scoring and complete cranial nerve exam by a physician will be performed pre-treatment and at follow-up visits.

Arms: arm 1: Placebo and SRS arm 2: Amifostine and CyberKnife stereotactic radiosurgery
Interventions: intervention 1: Amifostine intervention 2: CyberKnife stereotactic radiosurgery
Intervention descriptions: intervention 1: Amifostine and CyberKnife stereotactic radiosurgery intervention 2: CyberKnife stereotactic radiosurgery

Protocol documents:
Clinical trial NCT01402908
Conditions: Cancer Liver Cancer Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma PI-88 Phase III Adjuvant Therapy Hepatoma Liver Cancer
Sponsor: Cellxpert Biotechnology Corp.
Start date: 2011-08-01; Completion date: 2015-01-01
Enrollment: 520 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Detailed description:
Primary liver cancer (hepatocellular carcinoma or HCC) is the fifth most common cancer worldwide. Surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. At the moment there is no recommended standard treatment for HCC immediately after the tumour has been removed surgically. PI-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. Previous experience with PI-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Arms: arm 1: Arm 1 arm 2: Arm 2
Interventions: intervention 1: PI-88 intervention 2: Placebo
Intervention descriptions: intervention 1: Lyophilized powder reconstituted to provide 160 mg of PI-88 intervention 2: Lactose lyophilized powder

Protocol documents:
Clinical trial NCT01403246
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL Lenalidomide Chlorambucil No previous treatment
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Start date: 2011-11-01; Completion date: 2015-01-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I multicenter, open label study in previously untreated and elderly patients (\> 60 years) with CLL: a non-comparative phase aimed at defining the MTD of lenalidomide given in combination with chlorambucil and the efficacy and safety of the lenalidomide and chlorambucil combination.

Detailed description:
All patients will receive six monthly courses of the chlorambucil (C) and lenalidomide (L) schedule consisting of 8 days of C (d1-d8) combined with L given daily until response assessment which will take place 12 weeks from the start (d+1) of course VI, while patients continue their treatment with lenalidomide daily.

In the first phase of the induction phase of the study the dose of L given with C will be gradually escalated to reach the MTD.

Patients who will achieve a response after 6 courses of CL induction phase -PR, CRi, CR

The study was first designed to be a phase I-II trial, yet the second phase of the study was not conducted due to different reasons, among which: poor accrual and lack of interest.

Arms: arm 1: None
Interventions: intervention 1: Lenalidomide; Chlorambucil
Intervention descriptions: intervention 1: MTD of lenalidomide given in combination with chlorambucil

Protocol documents:
Clinical trial NCT01488409
Conditions: Abdominal Obesity Insulin Resistance Hypertriglyceridemia
Sponsor: Massachusetts General Hospital
Start date: 2012-05-01; Completion date: 2015-01-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to examine whether a medication called acipimox can improve your body's mitochondria. Mitochondria are the "power house" of the cell and make energy for your body.

Obesity is associated with increased risk for developing diabetes. However, the investigators do not know how obesity leads to diabetes. Previous studies have shown levels of fat in the blood (free fatty acids or FFA) are higher in obesity, and elevated FFA can affect how our body uses glucose and responds to insulin. Recent studies have shown that changes in mitochondria may be involved in the development of diabetes and may be affected by FFA. The investigators propose to improve the function of mitochondria in obese people with pre-diabetes by treating with acipimox, a medication which decreases FFA. The investigators will use state of the art techniques to evaluate the mitochondria, including a new magnetic resonance imaging (MRI) technique to measure function of mitochondria in muscle.

Detailed description:

Arms: arm 1: Treatment with the study drug Acipimox arm 2: Treatment with Placebo control.
Interventions: intervention 1: Acipimox intervention 2: Placebo
Intervention descriptions: intervention 1: 250 mg by mouth (PO) three times daily intervention 2: 0 mg by mouth (PO) three times daily

Protocol documents:
Clinical trial NCT01489254
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, glatiramer acetate, MRI, lesions, MS relapse rate, Copaxone
Sponsor: Synthon BV
Start date: 2011-10-01; Completion date: 2015-01-01
Enrollment: 794 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis

Detailed description:
GTR is being developed by Synthon as a similar version of Copaxone®. GTR has a similar quantitative and qualitative composition as Copaxone®, with regard to active substance and excipients and is presented in the same dosage form (pre-filled syringe containing a solution for injection). Introduction of GTR is anticipated to have a price lowering effect and will give doctors and patients more choice in the pharmaceutical armamentarium for MS.

This trial consists of two parts:

Part 1 is a multi-country, multi-centre, randomized, double-blind, active and placebo-controlled, equivalence trial comparing the efficacy and safety and tolerability of GTR versus Copaxone® in subjects with RRMS. Eligible subjects will be randomly assigned to receive daily 20 mg GTR (Synthon BV), 20 mg Copaxone® (TEVA) or placebo for a period of 9 months.

In Part 2, the trial continues as an open-label uncontrolled trial to evaluate efficacy and safety of long-term treatment with GTR. Subjects completing the 9-month double-blind period will be treated with open-label 20 mg daily GTR for another 15 months.

Arms: arm 1: Drug arm 2: Drug arm 3: Drug
Interventions: intervention 1: Glatiramer Acetate (GTR) intervention 2: Glatiramer Acetate (Copaxone®) intervention 3: Placebo
Intervention descriptions: intervention 1: Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2) intervention 2: Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2) intervention 3: Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

Protocol documents:
Clinical trial NCT01526148
Conditions: Bipolar Disorder
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2012-01-01; Completion date: 2015-01-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lithium intervention 2: Quetiapine
Intervention descriptions: intervention 1: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels \> 0.6mEq/L. intervention 2: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.

Protocol documents:
Clinical trial NCT01549951
Conditions: Prostate Cancer
Keywords: Metastatic castrate resistant prostate cancer, mCRPC, orteronel, TAK-700, Phase 2, QT, QTc
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2012-05-01; Completion date: 2015-01-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with Metastatic Castration-Resistant Prostrate Cancer

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Orteronel+Prednisone
Intervention descriptions: intervention 1: Orteronel 400-mg plus prednisone 5-mg will be administered BID orally continuously throughout the treatment cycle of the study.

Protocol documents: