ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00505778
Conditions: Ulcerative Colitis
Sponsor: Warner Chilcott
Start date: 2007-07-01; Completion date: 2009-07-01
Enrollment: 1027 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.

Detailed description:
Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? This study will confirm whether there are benefits to once daily dosing beyond increased convenience. In order to understand how the QD regimen compares to BID in a "real life" practice setting, the patient will remain on the total daily dose of Asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a QD or BID regimen. This is an investigator-blinded study.

Arms: arm 1: an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day) arm 2: an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Interventions: intervention 1: Mesalamine Once-Daily intervention 2: Mesalamine Twice-Daily
Intervention descriptions: intervention 1: Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks intervention 2: Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks

Protocol documents:
Clinical trial NCT00521989
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis Knee CRx-102 prednisolone dipyridamole CombinatoRx WOMAC
Sponsor: Zalicus
Start date: 2007-08-01; Completion date: 2009-07-01
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects.

CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA. It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication.

Detailed description:

Arms: arm 1: 2.7 mg prednisolone plus 90 mg dipyridamole

Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 2: 2.7 mg prednisolone plus 180 mg dipyridamole

Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 3: 2.7 mg prednisolone plus 360 mg dipyridamole

Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 4: 2.7 mg prednisolone

Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. arm 5: Placebo

Subjects were dose twice daily through day 98.
Interventions: intervention 1: CRx-102 (2.7/90) intervention 2: Prednisolone intervention 3: Placebo intervention 4: CRx-102 (2.7/180) intervention 5: CRx-102 (2.7/360)
Intervention descriptions: intervention 1: CRx-102 dose 1 intervention 2: Prednisolone intervention 3: Placebo intervention 4: CRx-102 dose 2 intervention 5: CRx-102 dose 3

Protocol documents:
Clinical trial NCT00527826
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Severe and very severe COPD (GOLD stage III / IV) exacerbations health care utilisation Chronic Obstructive Pulmonary Disease (COPD) quality of life compliance salmeterol/fluticasone combination
Sponsor: GlaxoSmithKline
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12 month randomized, open-label, parallel-group study to obtain data on the frequency and variability of exacerbations in severe and very severe Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200 subjects will be enrolled in approximately 30 study centres in Germany. Data on health care utilisation will be collected to compare direct costs associated with COPD in these two groups.

Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50 µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects will return for study visits every two to three months until week 52. Additional telephone calls will be made between scheduled visits every 4 weeks. Assessments will include monitoring of frequency of exacerbations, health care utilisation (including emergency visits and hospitalizations) and rescue medication, lung function, drug compliance, health-related quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.

Detailed description:
A 12 month open-label randomized parallel group study to investigate the influence of salmeterol xinafoate/fluticasone propionate either in fixed combination (SFC50/500 µg bid) or separately (SAL 50 µg and FP 500 µg bid) via Diskus inhalers on the course of the disease and frequency of exacerbations in subjects with severe and very severe COPD ( GOLD stage III+IV)

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Salmeterol / Fluticasone (50/500 µg) BID fixed combination intervention 2: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers
Intervention descriptions: intervention 1: comparator intervention 2: comparator

Protocol documents:
Clinical trial NCT00544544
Conditions: Bipolar Depression
Keywords: Bipolar depression
Sponsor: Mclean Hospital
Start date: 2007-06-01; Completion date: 2009-07-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is associated with elevated brain glutamate activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate activity, will lead to clinical improvement in patients with bipolar depression.

Detailed description:
We hypothesize that riluzole will lead to significant reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in depressive symptoms will be associated with reduced glutamate levels in the anterior cingulate cortex, but not parieto-occipital cortex, both at day two and day 42.

Arms: arm 1: Riluzole 50 mg twice daily for 2 weeks, increased to riluzole 50 mg in the morning and 100 mg in the evening for 1 week if tolerated, with a further increase to riluzole 100 mg twice daily if tolerated for 3 weeks.
Interventions: intervention 1: Riluzole
Intervention descriptions: intervention 1: 50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks

Protocol documents:
Clinical trial NCT00545181
Conditions: Bacterial Vaginosis
Keywords: bacterial vaginosis vaginal acidifying gel recurrence
Sponsor: Indiana University School of Medicine
Start date: 2007-09-01; Completion date: 2009-07-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.

Detailed description:
Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.

Arms: arm 1: Receive metronidazole plus vaginal gel arm 2: Oral Metronidazole antibiotic therapy alone
Interventions: intervention 1: Vaginal acidifying gel (RepHresh) intervention 2: Metronidazole control
Intervention descriptions: intervention 1: placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH. intervention 2: oral metronidazole therapy alone

Protocol documents:
Clinical trial NCT00548691
Conditions: Anemia
Sponsor: American Regent, Inc.
Start date: 2007-10-01; Completion date: 2009-07-01
Enrollment: 513 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure

Detailed description:

Arms: arm 1: Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer. arm 2: SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
Interventions: intervention 1: Ferric Carboxymaltose intervention 2: Standard Medical Care (SMC)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00548860
Conditions: Anemia
Sponsor: American Regent, Inc.
Start date: 2007-10-01; Completion date: 2009-07-01
Enrollment: 2018 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Detailed description:

Arms: arm 1: Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) arm 2: Varied as determined by the Investigator
Interventions: intervention 1: Ferric Carboxymaltose intervention 2: Standard Medical Care (SMC)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00556075
Conditions: Endometriosis
Keywords: Endometriosis Pelvic pain Oral progesterone blocker
Sponsor: Repros Therapeutics Inc.
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.

Detailed description:

Arms: arm 1: Placebo once daily arm 2: Proellex 25 mg once daily arm 3: Proellex 50 mg once daily
Interventions: intervention 1: Proellex 25 mg intervention 2: Placebo intervention 3: Proellex 50 mg
Intervention descriptions: intervention 1: 1 capsule daily for 4 months intervention 2: 1 capsule daily for 4 months intervention 3: 2 capsules daily for 4 months

Protocol documents:
Clinical trial NCT00559364
Conditions: Exocrine Pancreatic Insufficiency Chronic Pancreatitis Pancreatectomy
Sponsor: Forest Laboratories
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is sponsored by Aptalis Pharma (formerly Axcan).

Detailed description:
This study is a Phase III, multicenter, randomized, double-blind, parallel, placebo-controlled study, to assess the efficacy and safety of Viokase® 16 for the correction of steatorrhea in patients with EPI due to CP or pancreatectomy. The study will include the following phases: screening phase (up to 10 days), wash-out phase (6 to 7 days), randomization phase (up to 10 days), and treatment phase (6 to 7 days).

In screening phase, patients will undergo screening procedures prior to entry into the study.

In wash-out phase, stool collection will be performed to allow determination of the baseline CFA.

In randomization phase, patients who qualify for the Treatment Phase (that is, patients who have a CFA% below 80%) will be randomized in the study.

In the treatment phase, patients will be randomized in a 2:1 ratio (Viokase® 16 or Placebo). In treatment phase, stool collection period will be performed to allow determination of the CFA% that will serve to assess the efficacy of Viokase® 16 for the correction of steatorrhea. Follow-up procedures will be scheduled 7 to 10 days after discharge. Patients who do not show abnormal findings, adverse events or concomitant medications during the treatment phase will be assessed via follow-up telephone call. Patients who show abnormal findings (physical examination, vital signs, clinical laboratory tests, adverse events, concomitant medications) during the treatment phase will complete a follow-up visit.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Viokase® 16 intervention 2: Placebo intervention 3: Proton pump inhibitor (PPI) intervention 4: Omeprazole
Intervention descriptions: intervention 1: Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. intervention 2: Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. intervention 3: Patients on PPI during Screening will continue their usual PPI therapy throughout the study. intervention 4: Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.

Protocol documents:
Clinical trial NCT00560703
Conditions: Blepharitis Meibomianitis Dry Eye
Sponsor: Galderma R&D
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea

Detailed description:

Arms: arm 1: COL-101 arm 2: Sugar capsule
Interventions: intervention 1: COL-101 (doxycycline, USP) capsules intervention 2: placebo
Intervention descriptions: intervention 1: 40mg, once per day for 84 days intervention 2: sugar capsule

Protocol documents:
Clinical trial NCT00562627
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee arthroplasty local infiltration analgesia TKA epidural analgesia operation surgery
Sponsor: Asker & Baerum Hospital
Start date: 2007-11-01; Completion date: 2009-07-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

The aim of this study is to:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Detailed description:
Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Arms: arm 1: Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine arm 2: Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine arm 3: standard continuous epidural analgesia
Interventions: intervention 1: ropivacaine intervention 2: adrenaline intervention 3: ketorolac intervention 4: morphine intervention 5: fentanyl intervention 6: bupivacaine
Intervention descriptions: intervention 1: intraoperative and 1. postoperative day intervention 2: intraoperative LIA (IV and IA) and continuous EDA intervention 3: intraoperative and 1. postoperative day intervention 4: intraoperative intervention 5: continuous postoperatively intervention 6: continuous postoperatively

Protocol documents:
Clinical trial NCT00566982
Conditions: Atrophy Vaginal Diseases
Keywords: Urogenital atrophy Menopausal symptoms Vulvar and vaginal atrophy in postmenopausal women Vaginal atrophy
Sponsor: Shionogi
Start date: 2007-10-01; Completion date: 2009-07-01
Enrollment: 426 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.

Detailed description:

Arms: arm 1: Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks. arm 2: Placebo will be taken once daily, in the morning, with food for 52 weeks.
Interventions: intervention 1: Ospemifene 60 mg intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food. intervention 2: Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)

Protocol documents:
Clinical trial NCT00571103
Conditions: Pathological Gambling
Keywords: acamprosate, impulse-control disorders
Sponsor: University of Iowa
Start date: 2007-10-01; Completion date: 2009-07-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.

Detailed description:
Because the opiate antagonists appear to be effective in the treatment of pathological gambling (PG), it is reasonable to ask whether acamprosate (calcium acetylhomotaurine; Campral), also FDA approved for the treatment of alcoholism, can be used effectively to treat PG. Acamprosate is not an opioid antagonist; rather, it is assumed that its therapeutic effects are due to actions on GABA receptors. Acamprosate is structurally related to 1-glutamic, which is an excitatory neurotransmitter. It has been proposed that acamprosate decreases the effects of the naturally-occuring excitatory neurotransmitter glutamate in the body. Because chronic alcohol consumption disrupts this system, and the changes last many months after alcohol ingestion is stopped, it is possible that acamprosate restores the glutamate system towards normal. Regardless, acamprosate decreases the pleasant "high" associated with alcohol consumption, and thus decreases the frequency of relapse during abstinence. We hypothesize that acamprosate will have similar actions in persons with PG.

Arms: arm 1: Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses.
Interventions: intervention 1: acamprosate
Intervention descriptions: intervention 1: Two 333mg tablets taken three times daily.

Protocol documents:
Clinical trial NCT00585221
Conditions: Gastrointestinal Stromal Tumors Cancer Brain Solid Tumors
Keywords: Gastrointestinal stromal tumors Imatinib Peginterferon α-2b Immunotherapy Targeted therapy
Sponsor: University of Utah
Start date: 2007-07-01; Completion date: 2009-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST). However, most patients become resistant to IM in less than two years. This clinical trial combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis: Apoptosis/necrosis of imatinib-sensitive GIST releases GIST-specific antigens in vivo while Peginterferon α-2b fulfills the role of cytokine signal (danger signal), this combination can induce effective innate and adaptive anti-GIST immunity, which can eradicate imatinib-resistant clones and GIST stem cells via recognition of common antigens shared with imatinib-sensitive GIST, leading to improved response rate and remission duration.

Detailed description:

Arms: arm 1: All participants enrolled in the study.
Interventions: intervention 1: Peginterferon-alpha 2b (PegIFNa2b); intervention 2: Imatinib
Intervention descriptions: intervention 1: Treatment include PegIFNa2b high dose (3 mcg/kg/wk) X 4 doses and low dose (1.5 mcg/kg/wk) X 18 doses, followed by surgical evaluation to render pt disease free if possible. intervention 2: Continue imatinib until progression.

Protocol documents: