ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01395914
Conditions: Cachexia Non-Small Cell Lung Cancer
Sponsor: Helsinn Therapeutics (U.S.), Inc
Start date: 2011-07-01; Completion date: 2015-02-01
Enrollment: 513 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Detailed description:
This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.

Arms: arm 1: 100 mg yellow coated, oval tablet; oral administration once daily arm 2: Placebo tablets identical in appearance to active tablets; oral administration once daily
Interventions: intervention 1: Anamorelin HCl intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01404650
Conditions: Gastrointestinal Stromal Tumor
Keywords: GIST Refractory Gastrointestinal Stromal Tumor
Sponsor: SCRI Development Innovations, LLC
Start date: 2011-12-01; Completion date: 2015-02-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, non-randomized, single agent, Phase II study of AUY922 in patients with refractory Gastrointestinal Stromal Tumor (GIST). The primary endpoint of this study is to determine progression-free survival (PFS) for patients with GIST receiving AUY922 intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle with restaging at 6 and 12 weeks and then every 9 weeks thereafter. Patients may continue treatment until evidence of disease progression.

Detailed description:
Gastrointestinal stromal tumors (GIST) are common sarcomas that arise in the gastrointestinal tract. Sunitinib (Pfizer) and imatinib (Novartis) are FDA-approved for treatment of patients with GIST. However, patients with advanced or refractory GIST who are resistant to these agents eventually experience disease progression or death. Heat shock protein-90 (Hsp90) is a substance found in various malignancies that encourages tumor cells to grow and survive. As an inhibitor of Hsp90, AUY922 may decrease growth of tumor cells that were resistant to prior therapies. This study investigates AUY922 monotherapy as treatment for patients who either progressed on, or were resistant to, imatinib and sunitinib.

Arms: arm 1: None
Interventions: intervention 1: AUY922
Intervention descriptions: intervention 1: AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles will be repeated every 21 days. Patients will be evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter. Patients may continue treatment until evidence of disease progression.

Protocol documents:
Clinical trial NCT01409811
Conditions: Estrogen Receptor-positive Breast Cancer Invasive Ductal Breast Carcinoma Progesterone Receptor-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer
Sponsor: City of Hope Medical Center
Start date: 2012-09-14; Completion date: 2015-02-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies biomarkers in tissue samples from patients with newly diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue in the laboratory from patients receiving ZA may help doctors learn more about the effects of ZA on cells. It may also help doctors understand how well patients respond to treatment.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate 14 tumor biomarkers of growth and metastasis (10 by microarray and 4 by RT-PCR) for change in response to ZA.

SECONDARY OBJECTIVES:

I. To evaluate 30 measures of immunologic function (by Luminex panel) for change in response to ZA a) after 48-72 hours and b) after 10-23 days.

II. To explore additional tumors biomarkers (approximately 20 by immunohistochemistry) for change in response to ZA.

OUTLINE: Patients receive zoledronic acid intravenously (IV) over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis.

After completion of study treatment, patients are followed up at 40-44 days.

Arms: arm 1: Patients receive a single dose of zoledronic acid 4 mg IV over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis.

zoledronic acid: Given IV

laboratory biomarker analysis: Correlative studies

therapeutic conventional surgery: Undergo definitive lumpectomy or mastectomy
Interventions: intervention 1: zoledronic acid intervention 2: laboratory biomarker analysis intervention 3: therapeutic conventional surgery
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Undergo definitive lumpectomy or mastectomy

Protocol documents:
Clinical trial NCT01444417
Conditions: Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura Immune Thrombocytopenia
Keywords: Immune (Idiopathic) Thrombocytopenic Purpura Pediatric Immune (Idiopathic) Thrombocytopenic Purpura Immune Thrombocytopenia
Sponsor: Amgen
Start date: 2012-01-01; Completion date: 2015-02-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured by durable platelet response.

Detailed description:

Arms: arm 1: Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L. arm 2: Participants received weekly subcutaneous placebo for 24 weeks.
Interventions: intervention 1: Romiplostim intervention 2: Placebo
Intervention descriptions: intervention 1: The starting dose of romiplostim is 1 µg/kg administered weekly by subcutaneous injection. Participants will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg/kg up to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10\^9/L and ≤ 200 x 10\^9/L. intervention 2: Matching placebo administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01457846
Conditions: Gastro-oesophageal Junction Cancer Gastric Cancer
Keywords: gastro-oesophageal junction cancer gastric cancer lower third oesophageal cancer polysomy amplification FGFR
Sponsor: AstraZeneca
Start date: 2011-11-01; Completion date: 2015-02-01
Enrollment: 960 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

Detailed description:
A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.

Arms: arm 1: AZD4547 taken orally in tablet formation, 80mg b.d., in a 2 week on, 1 week off schedule arm 2: Paclitaxel - 80mg/m² as a 1 hour infusion given weekly on days 1, 8 and 15 of a 28 day cycle (up to the maximum number of cycles per local practice)
Interventions: intervention 1: AZD4547 intervention 2: paclitaxel
Intervention descriptions: intervention 1: Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule. intervention 2: Infusion administered once a week, 3 weeks on and 1 week off

Protocol documents:
Clinical trial NCT01469819
Conditions: Chronic Idiopathic Constipation
Keywords: chronic constipation constipation idiopathic constipation SmartPill Wireless Motility Capsule lubiprostone (Amitiza) small intestinal bacterial overgrowth
Sponsor: Texas Tech University Health Sciences Center, El Paso
Start date: 2012-06-01; Completion date: 2015-02-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if lubiprostone may change the rate of movement of food and activities in the stomach and intestines in subjects whose gastrointestinal (GI) tract is slower due to constipation.

To be able to measure the time difference in the duration of transit of the FDA approved SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to lubiprostone.

The investigators anticipate to capture the possibility to reduce/eliminate the small intestinal bacterial overgrowth in chronically constipated patients after administration of study drug- lubiprostone.

Detailed description:
Lubiprostone is an effective treatment for chronic constipation. The mechanism of action of lubiprostone is through increasing fluid and mucus secretion and improving lubrication of the intestinal lumen. The effects of lubiprostone on gastrointestinal (GI) transit and small bacterial overgrowth (SIBO) have not been sufficiently explored.

The current study was designed to investigate whether: (a) lubiprostone alters GI transit and (b) affects SIBO in constipated patients.

Twenty nine female patients (mean age of 39 year: range 19-64) with chronic constipation received 2 weeks of lubiprostone (24 mcg b.i.d., P.O.). Stool consistency based on Bristol stool scale and the frequency of bowel movements were recorded. Gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT), combined small \& large bowel transit time (SLBTT) and whole gut transit time (WGT) were measured using wireless motility capsule. Small bacterial overgrowth (SIBO) status was assessed by the lactulose breath test.

Arms: arm 1: Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks.
Interventions: intervention 1: Lubiprostone
Intervention descriptions: intervention 1: 24 mcg twice a day (BID) for 2 weeks.

Protocol documents:
Clinical trial NCT01479465
Conditions: Colorectal Cancer
Keywords: GSI Gilead Gilead Sciences GS-6624 Colorectal Cancer KRAS Oncology monoclonal antibody
Sponsor: Gilead Sciences
Start date: 2011-12-01; Completion date: 2015-02-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

Detailed description:

Arms: arm 1: Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. arm 2: Participants will receive SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. arm 3: Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity. arm 4: Participants will receive placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Interventions: intervention 1: Simtuzumab intervention 2: Placebo to match SIM intervention 3: Leucovorin intervention 4: Irinotecan intervention 5: Fluorouracil
Intervention descriptions: intervention 1: SIM administered via intravenous infusion over 30 minutes intervention 2: Placebo to match SIM administered via intravenous infusion over 30 minutes intervention 3: l-Leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours intervention 4: Irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes intervention 5: Fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours

Protocol documents:
Clinical trial NCT01479595
Conditions: Asthma
Keywords: Asthma Interleukin QBX258 QAX576 VAK694
Sponsor: Novartis Pharmaceuticals
Start date: 2012-02-01; Completion date: 2015-02-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.

Detailed description:

Arms: arm 1: Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. arm 2: Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
Interventions: intervention 1: QBX258 intervention 2: Placebo
Intervention descriptions: intervention 1: QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg. intervention 2: The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.

Protocol documents:
Clinical trial NCT01482091
Conditions: Anemia, Sickle Cell Pain
Keywords: fentanyl intranasal sickle cell vasoocclusive crisis pain crisis pediatrics
Sponsor: Montefiore Medical Center
Start date: 2011-12-01; Completion date: 2015-02-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.

Detailed description:
Principles of therapy for treatment of vaso-occlusive crises include early aggressive analgesic therapy with opiates and non-steroidal anti-inflammatory agents as well as fluid administration. It is known that there is a significant delay in time to administration of analgesics in children with VOC in the ED. The most easily modifiable factor that contributes to delayed opiate administration is route of administration.

Intranasal medication administration is an easy, rapid way to administer opiates with minimal discomfort as well as bypassing first past metabolism and the blood brain barrier. Intranasal fentanyl has been shown to be a safe and effective analgesic for treatment of acute pain in children, reaching therapeutic effect in 2-10 minutes after administration.

The investigators believe that intranasal fentanyl therapy will be able to provide expedited and effective pain therapy to patients with sickle cell disease presenting to the pediatric emergency department with a vaso-occlusive crisis

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fentanyl Citrate intervention 2: Normal Saline
Intervention descriptions: intervention 1: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device intervention 2: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.

Protocol documents:
Clinical trial NCT01544114
Conditions: Juvenile Idiopathic Arthritis (JIA)
Sponsor: Amgen
Start date: 2012-04-01; Completion date: 2015-02-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.

Detailed description:
Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Three VIMOVO strengths will be used in this study: 250 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 250/20), 375 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 375/20), and 500 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 500/20). The VIMOVO strength allocated to each participant will be determined by the participant's weight at baseline and based on investigator's discretion.

The target dose of the naproxen component will be within the range of 10-20 mg/kg/day divided twice daily (BID) with a maximum daily dose of 1000 mg.
Interventions: intervention 1: VIMOVO 250/20 intervention 2: VIMOVO 375/20 intervention 3: VIMOVO 500/20
Intervention descriptions: intervention 1: 250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months intervention 2: 375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months intervention 3: 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Protocol documents:
Clinical trial NCT01550510
Conditions: Stage IV Colorectal Cancer
Keywords: Stage IV Colorectal cancer Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Ascorbic Acid Vitamins Irinotecan Integrative Medicine Complementary Medicine Alternative Medicine Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors
Sponsor: Thomas Jefferson University
Start date: 2011-12-01; Completion date: 2015-02-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.

Detailed description:
Phase I: To assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated. This aim will be assessed by enrolling a minimum of 6 subjects meeting inclusion criteria, using a modified 3+3 design. Safety will be assessed with the following: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, basic metabolic panel, and CBC. From our experience and in the experience of our study collaborators, we hypothesize that the combination of IV AA with irinotecan will not be associated with adverse events.

Phase II: To utilize CT or PET/CT (when available) scans to evaluate disease progression to assess overall tumor response rate (complete and partial response) in subjects with advanced or recurrent colorectal cancer treated with the combination of ascorbic acid and irinotecan versus irinotecan alone.

Arms: arm 1: Ascorbic Acid (50-100g, 3x weekly) with 350mg/m2 irinotecan once a week every 3 weeks arm 2: 350mg/m2 irinotecan once a week every 3 weeks
Interventions: intervention 1: Ascorbic Acid intervention 2: Irinotecan
Intervention descriptions: intervention 1: 3x a week for 9 weeks intervention 2: 350mg/m2 once a week every 3 weeks

Protocol documents:
Clinical trial NCT01572909
Conditions: Reperfusion Injury STEMI
Keywords: Myocardial Reperfusion Primary PCI Stenting for ST-segment Elevation Myocardial Infarction
Sponsor: Stealth BioTherapeutics Inc.
Start date: 2012-04-01; Completion date: 2015-02-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of IV administered elamipretide (also known as MTP-131, or Bendavia) on a background of standard-of-care therapy for reduction of reperfusion injury in patients with first time acute, anterior wall ST-segment elevation myocardial infarction (STEMI).

Detailed description:
The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of IV administered elamipretide on a background of standard-of-care therapy for reduction of reperfusion injury in patients with first time acute, anterior wall STEMI.

Patients were randomized to receive either an infusion of elamipretide at 0.05 mg/kg/hr or an identically appearing placebo administered as an IV infusion at 60 mL/hr. The infusion began at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel.

The reduction of reperfusion injury, or infarct size, was estimated using the area under the curve (AUC) of the serum creatine kinase (CK) isoenzyme, as well as using magnetic resonance imaging (MRI) performed on the Day 4±1 and on Day 30±7 (both MRI assessments measured infarct size and the ratio of infarct size to myocardial mass). The analyses of cardiac MRI data were performed for both the primary endpoint population and also in all patients who had adequate Day 4/Day 30 cardiac MRI studies.

After completion of the percutaneous coronary intervention (PCI) and stenting, patients received standard medical treatment.

Arms: arm 1: Bendavia™ administered intravenously at 0.05 mg/kg/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel. arm 2: Placebo administered intravenously at 60 mL/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel.
Interventions: intervention 1: Bendavia (MTP-131) intervention 2: Placebo
Intervention descriptions: intervention 1: 0.05 mg/kg/hr intervention 2: Identically appearing placebo

Protocol documents: