ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01500278
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab Pegol Cimzia Adalimumab Humira Rheumatoid Arthritis
Sponsor: UCB Pharma SA
Start date: 2011-12-01; Completion date: 2016-01-01
Enrollment: 915 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Those subjects who received Certolizumab Pegol (400 mg at Weeks 0, 2, 4 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) at Baseline and are Non-Responders at Week 12, switch to Adalimumab (40 mg) + Methotrexate (ADA + MTX) after Week 12. arm 4: Those subjects who received Adalimumab (40 mg + Placebo at Weeks 0, 2, 4 followed by 40 mg ADA every two weeks) + Methotrexate (ADA+ MTX) at Baseline and are Non-Responders at Week 12, switch to Certolizumab Pegol (400 mg at Weeks 12, 14, 16 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) after Week 12.
Interventions: intervention 1: Certolizumab Pegol (CZP) intervention 2: Adalimumab (ADA) intervention 3: Methotrexate (MTX)
Intervention descriptions: intervention 1: * Active substance: an injectable volume of 1 ml solution for injection CZP
* Pharmaceutical form: prefilled syringes CZP
* Concentration: 200 mg/ml CZP
* Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal. intervention 2: * Active substance: an injectable volume of 0.8 ml solution for injection ADA
* Pharmaceutical form: prefilled syringes ADA
* Concentration: 40 mg/0.8 ml ADA
* Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal. intervention 3: * Active substance: Methotrexate
* Pharmaceutical form: oral tablet
* Concentration: 15-25 mg/week
* Route of Administration: MTX orally

Protocol documents:
Clinical trial NCT01508676
Conditions: Neuralgia Postherpetic Neuralgia Reflex Sympathetic Dystrophy Complex Regional Pain Syndrome (CRPS)
Keywords: neuropathic pain postherpetic neuralgia complex regional pain syndrome reflex sympathetic dystrophy
Sponsor: Massachusetts General Hospital
Start date: 2011-11-01; Completion date: 2016-01-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to see if the drug Pennsaid (Diclofenac) can help reduce pain felt by people with chronic nerve pain. The drug will be used 2-4 times each day for 2 weeks.

The U.S. Food and Drug Administration (FDA) has approved Pennsaid to treat osteoarthritis (bone pain), but the FDA has not approved Pennsaid to treat neuropathic (nerve) pain.

The research study will compare Pennsaid to placebo.

Detailed description:
The research study will compare Pennsaid to placebo. The placebo looks like Pennsaid, but it doesn't contain any Pennsaid. The investigators use placebos in research to see if the results are due to the study drug or to other reasons. At some time during the study the investigators will give the patient Pennsaid. At another time, the investigators will give the patient placebo. The investigators are using Quantitative Sensory Testing (QST), which is temperature testing before and after using the study drug to see if Pennsaid is helpful in reducing people's nerve pain.

In this test, a small metal plate, about the size of a matchbox, is put on the area where the patient has pain. The plate is connected to a computer that can warm or cool the plate. The patient will use a computer mouse button to tell us when the plate feels warm. The QST machine is approved by the Food and Drug Administration (FDA). It is often used by nerve doctors to see if a person has neuropathy (pain caused by damage to a nerve).

Arms: arm 1: Pennsaid (20-40 drops; 2-4 times daily) Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects. arm 2: Study subject will topically apply placebo lotion (20-40 drops) 2-4 times daily to the painful area for the next two weeks. The dose titration will be based on the size of painful area (approximately 10 drops for every 4 square inches). Subjects will be asked to fill in a daily pain diary and report any side effects to the research center. A phone number and a beeper number will be provided to subjects.
Interventions: intervention 1: Pennsaid intervention 2: Placebo (2.3% DMSO solution)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01524224
Conditions: Advanced Cancer
Keywords: Metastases Neoplasm Advanced Cancer Metastatic Cancer
Sponsor: Eli Lilly and Company
Start date: 2008-01-01; Completion date: 2016-01-01
Enrollment: 29 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
This study is a multicenter, open-label, dose-escalation phase 1 study of intravenous (IV) LY2495655 in participants with advanced cancer.

Detailed description:
This study will consist of the following parts:

1. Dose Escalation - Cohorts of at least 3 participants will be treated with increasing doses of LY2475655 until maximum tolerated dose (MTD) criteria are met in 1 of the 6 dose levels, or the 6th cohort is completed without meeting maximum tolerated dose criteria.
2. Dose Confirmation - Up to 10 more participants will be enrolled to the MTD dose level, or if it was not possible to define the MTD during dose escalation, all clinical and bioanalytical data will be reviewed to select the recommended Phase 2 dose and an up to 10 additional participants will be enrolled to this dose level.

Arms: arm 1: Administered intravenously (IV) every 2 weeks (14 days) for four (4) 14 day cycles. Participants receiving clinical benefit may continue to receive treatment until one or more of the discontinuation criteria are met.

Starting dose in Part 1 (dose escalation) will be 2 mg. The dose will be subsequently increased to 7 mg, 21 mg, 70 mg, 210 mg, and 700 mg. The dose administered in Part 2 (dose confirmation) will be determined from Part 1.
Interventions: intervention 1: LY2495655
Intervention descriptions: intervention 1: administered intravenously

Protocol documents:
Clinical trial NCT01555489
Conditions: Stage IV Pancreatic Cancer
Keywords: Pancreatic Neoplasms Pancreatic Cancer cells Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Ascorbic Acid Gemcitabine Vitamins Vitamin C Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Erlotinib Integrative Medicine Alternative Medicine Complementary Medicine
Sponsor: Thomas Jefferson University
Start date: 2011-10-01; Completion date: 2016-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data

Detailed description:
Intravenous high dose ascorbic acid is a widely used alternative cancer treatment. Patients will receive standard care gemcitabine/erlotinib for treatment of their metastatic pancreatic adenocarcinoma. They will be closely monitored for disease response/ progression. If vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient. This study requires several days of treatment per week and treatments are given in two different locations. The intravenous vitamin C treatments are given 3 times per week, these are given every week for an initial cycle of 15 weeks.

Arms: arm 1: Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer
Interventions: intervention 1: Ascorbic Acid
Intervention descriptions: intervention 1: 3x per week

Protocol documents:
Clinical trial NCT01581281
Conditions: Migraine Migraine Disorders Headache
Keywords: Pediatric Children Adolescent Headache Migraine
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2012-06-01; Completion date: 2016-01-01
Enrollment: 488 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.

Detailed description:
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents. The investigators want to see if amitriptyline and/or topiramate are better than placebo (sugar pill) in reducing headache frequency in children and adolescents ages 8 to 17 with migraines. At this time, there are no FDA approved medicines approved in the US for the prevention treatment of migraine headaches in children and adolescents.

Arms: arm 1: Drug to be administered twice daily. arm 2: Drug to be administered twice daily. arm 3: To be administered twice daily.
Interventions: intervention 1: Amitriptyline intervention 2: Topiramate intervention 3: Placebo
Intervention descriptions: intervention 1: Amitriptyline will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based. intervention 2: Topiramate will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. Dosing of topiramate will be weight-based. intervention 3: Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.

Protocol documents:
Clinical trial NCT01630200
Conditions: Chronic Obstructive Pulmonary Disease and Allied Conditions
Keywords: COPD comorbidity arterial stiffness roflumilast
Sponsor: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Start date: 2012-05-01; Completion date: 2016-01-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and mortality in COPD. Early changes of vascular integrity can be detected via markers of subclinical atherosclerosis.

Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data.

The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of systemic inflammation in the peripheral circulation of patients with stable chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Active arm including patients who receive the study drug (500µg Roflumilast once daily) arm 2: Control arm including patients who receive the placebo tablet (once daily)
Interventions: intervention 1: Roflumilast intervention 2: Placebo
Intervention descriptions: intervention 1: Roflumilast coated tablet, 500µg oral application, once daily in the morning intervention 2: Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning

Protocol documents:
Clinical trial NCT01669720
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Colorectal Cancer Resected or Ablated Metastatic Colorectal Cancer
Sponsor: Brown University
Start date: 2012-12-01; Completion date: 2016-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate if aflibercept can reduce the chance that metastatic (spread of) colorectal cancer can grow back after finishing standard treatment. The study will also look at the side effects of aflibercept and the effect on quality of life.

Detailed description:
There are over 1.2 million new cases of colorectal cancer and 600,000 deaths worldwide. The liver is the dominant site of metastases. Approximately 20-25% of patients with advanced colorectal cancer will be candidates for resection/ablation of all sites of metastatic disease.1 Unfortunately, despite resection/ablation of all metastatic sites only about 20% of these patients are ultimately cured.1 An effective adjuvant agent would prevent tumor recurrence.

Aflibercept and bevacizumab are effective when combined with FOLFIRI for metastatic colon cancer. Neither has been tested in a randomized study in the adjuvant setting for patients with resected metastatic disease. Since aflibercept more effectively inhibits all forms of VEGF including VEGF-A, VEGF-B and PIGF, in striking contrast to bevacizumab which inhibits only VEGF-A, aflibercept likely will be more effective than bevacizumab as a single agent in the adjuvant metastatic setting. Therefore, we propose a randomized study of adjuvant aflibercept for patients metastatic colorectal cancer who have received 10-12 cycles of perioperative FOLFOX and have had had a complete response to all sites of metastases after chemotherapy and local modalities such as surgical resection or ablation. SBRT may also be used to produce a complete response in a metastatic site not easily amenable to surgery or ablation. Only patients with very high risk of recurrence, defined as 3 or more metastatic sites, will be included in this study.

Arms: arm 1: Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years arm 2: Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
Interventions: intervention 1: Aflibercept
Intervention descriptions: intervention 1: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years

Protocol documents:
Clinical trial NCT01687244
Conditions: Superficial Bladder Cancer
Keywords: BCG Refractory or Relapsed Superficial Bladder Cancer rAd-IFN Syn3 Intravesical transitional cell carcinoma of the bladder superficial non-muscle invasive tumor Interferon alpha2b INSTILADRIN
Sponsor: FKD Therapies Oy
Start date: 2012-09-01; Completion date: 2016-01-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN with Syn3) when given intravesically to patients with high grade non-muscle invasive bladder cancer who are refractory to or have relapsed from BCG therapy. The pharmacodynamics of INSTILADRIN will also be studied by measuring the interferon (IFNα2b) levels excreted in the urine. rAd-IFN is a non-replicating recombinant adenovirus type 5 (Ad5)-vector encoding the interferon alpha-2b (IFNα2b) gene. Syn 3 is clinical surfactant excipient which enhances the ability of the adenoviral vector to transfect cells in the bladder wall.

Detailed description:
Criteria for Evaluation:

Efficacy: A Response is defined as no evidence of recurrence of a high grade tumor by cystoscopy, cytology or if clinically indicated, biopsy.

Safety: The safety and tolerability of INSTILADRIN will be evaluated based on adverse event reports, vital signs, ECGs, clinical laboratory values and results of physical examination.

Arms: arm 1: Subjects will be randomly assigned to one of two INSTILADRIN arms. arm 2: Subjects will be randomly assigned to one of two INSTILADRIN arms.
Interventions: intervention 1: INSTILADRIN
Intervention descriptions: intervention 1: The INSTILADRIN components will be mixed with a diluent. The total dose will be given as a single, one-hour intravesical administration which may, depending on clinical response, be repeated every 3 months up to a maximum of 4 instillations.

Protocol documents:
Clinical trial NCT01716754
Conditions: Asthma
Keywords: asthma asthma control allergy atopic IgE double-blind placebo omalizumab
Sponsor: Novartis Pharmaceuticals
Start date: 2012-12-01; Completion date: 2016-01-01
Enrollment: 471 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

Detailed description:

Arms: arm 1: Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks. arm 2: Participants received QGE031 240 mg s.c. q4w for 16 weeks. arm 3: Participants received QGE031 180 mg s.c. q2w for 16 weeks. arm 4: Participants received QGE031 120 mg s.c. q2w for 16 weeks. arm 5: Participants received QGE031 36 mg s.c. q2w for 16 weeks. arm 6: Participants received QGE031 12 mg s.c. q2w for 16 weeks. arm 7: Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks. arm 8: Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks. arm 9: Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks. arm 10: Participants received QGE031 180 mg s.c. q2w for 16 weeks. arm 11: Participants received QGE031 120 mg s.c. q2w for 16 weeks. arm 12: Participants received QGE031 36 mg s.c. q2w for 16 weeks. arm 13: Participants received QGE031 12 mg s.c. q2w for 16 weeks. arm 14: Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
Interventions: intervention 1: QGE031 intervention 2: Omalizumab intervention 3: Placebo
Intervention descriptions: intervention 1: QGE031 was supplied as 120 mg liquid in vial per 1 mL intervention 2: Omalizumab was supplied as 150 mg lyophilisate in vial intervention 3: Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL

Protocol documents:
Clinical trial NCT01719744
Conditions: Advanced Metastatic Soft Tissue Sarcoma
Keywords: ENMD-2076 advanced metastatic soft tissue sarcoma
Sponsor: University Health Network, Toronto
Start date: 2013-01-01; Completion date: 2016-01-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma. This study will help to understand how well ENMD-2076 works and how safe and tolerable the drug is in this patient population.

Detailed description:
ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.

Arms: arm 1: ENMD-2076 capsules, 275 mg once daily, by mouth.
Interventions: intervention 1: ENMD-2076
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01743521
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C Individualised therapy Response-guided therapy Telaprevir PEG-IFN Ribavirin Hepatitis
Sponsor: Kirby Institute
Start date: 2013-01-01; Completion date: 2016-01-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.

Detailed description:
DARE-C is a prospective open label multi-centre pilot study examining the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin and Telaprevir) for the treatment of early chronic HCV genotype 1 infection in individuals with and without HIV infection.

Arms: arm 1: 8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy arm 2: 12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy arm 3: 24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
Interventions: intervention 1: TPV/PEG-IFN/RBV
Intervention descriptions: intervention 1: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.

Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg).

Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly.

Protocol documents: