ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01749956
Conditions: Rectal Cancer
Keywords: Rectal Cancer Chemoradiation Aflibercept Surgery
Sponsor: SCRI Development Innovations, LLC
Start date: 2013-01-01; Completion date: 2015-09-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase II study will be to investigate the antiangiogenic agent, aflibercept, in combination with chemoradiation as preoperative treatment for patients with stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.

Detailed description:

Arms: arm 1: Preoperative Chemoradiation: (6 weeks)

* 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42;
* Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6;
* Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.

Surgery at least 6 weeks after last day of aflibercept: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.

Postoperative Chemotherapy and Aflibercept Treatments (four 28-day cycles):

* Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle.
* Modified FOLFOX6:

  * Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.
  * Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.
  * 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.
Interventions: intervention 1: Radiation intervention 2: Aflibercept intervention 3: Surgery intervention 4: FOLFOX6
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines intervention 4: None

Protocol documents:
Clinical trial NCT01752933
Conditions: Hepatocellular Carcinoma
Sponsor: Astex Pharmaceuticals, Inc.
Start date: 2012-12-01; Completion date: 2015-09-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at 16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC after failure of prior sorafenib.

Detailed description:

Arms: arm 1: SGI-110 administered subcutaneously (SC) daily on Days 1 - 5 every 28 days
Interventions: intervention 1: SGI-110
Intervention descriptions: intervention 1: SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT01758432
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Sponsor: Portola Pharmaceuticals
Start date: 2012-12-01; Completion date: 2015-09-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

Detailed description:
A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect fXa inhibitors in healthy volunteers

Arms: arm 1: 90 mg PRT064445 given as a single IV arm 2: 210 mg PRT064445 given as a single IV bolus arm 3: 420 mg PRT064445 given as a single IV bolus arm 4: 600 mg PRT064445 given as follows: 420 mg IV over \~14 minutes (\~30 mg/min), followed by a continuous infusion of 180 mg (4 mg/min over 45 minutes) arm 5: 600 mg PRT064445 given as follows: up to 420 mg IV over \~14 minutes (\~30 mg/min), followed by a second bolus of 180 mg IV over \~6 minutes (\~30 mg/min), 45 minutes after completion of the bolus arm 6: 900 mg PRT064445 given as follows: 420 mg IV, followed by a continuous infusion of 480 mg (4 mg/min over 120 minutes arm 7: Placebo administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
Interventions: intervention 1: PRT064445/Apixaban intervention 2: Placebo/Apixaban intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01798316
Conditions: Postoperative Pain Postoperative Nausea Postoperative Vomiting
Keywords: IV Acetaminophen Laparoscopic cholecystectomy Postoperative nausea Postoperative vomiting
Sponsor: Northwell Health
Start date: 2013-03-01; Completion date: 2015-09-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.

Detailed description:
The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.

Arms: arm 1: IV Acetaminophen administered on admission to post-anesthesia care unit arm 2: Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit
Interventions: intervention 1: IV Acetaminophen intervention 2: Standard of Care
Intervention descriptions: intervention 1: Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen intervention 2: Standard of care pain management regimen, no IV Acetaminophen,

Protocol documents:
Clinical trial NCT01846299
Conditions: Macular Edema (ME)
Keywords: Vision Impairment
Sponsor: Novartis Pharmaceuticals
Start date: 2013-10-01; Completion date: 2015-09-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Detailed description:

Arms: arm 1: A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. arm 2: Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
Interventions: intervention 1: Sham control intervention 2: Ranibizumab
Intervention descriptions: intervention 1: The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye. intervention 2: Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.

Protocol documents:
Clinical trial NCT01848210
Conditions: Chronic Venous Insufficiency
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-05-01; Completion date: 2015-09-01
Enrollment: 829 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of the fixed-dose combination of coumarin and troxerutin versus placebo in the symptomatic treatment of chronic venous insufficiency.

Detailed description:
The drug being tested in this study is the fixed-dose combination of coumarin and troxerutin called Venalot®. Venalot is being tested to treat the symptoms of chronic venous insufficiency. This study will look at symptom relief in people who take Venalot®.

The study will enroll approximately 808 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Combination coumarin + troxerutin extended release tablets
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take two tablets three times a day throughout the study.

This multi-centre trial will be conducted in Brazil. The overall time to participate in this study is up to 18 weeks. Participants will make 6 visits to the clinic.

Arms: arm 1: Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks. arm 2: Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
Interventions: intervention 1: Coumarin/troxerutin intervention 2: Placebo
Intervention descriptions: intervention 1: Coumarin + troxerutin fixed-dose combination tablets intervention 2: Coumarin + troxerutin placebo-matching tablets

Protocol documents:
Clinical trial NCT01858389
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer T790M mutation. dacomitinib
Sponsor: Pfizer
Start date: 2013-07-01; Completion date: 2015-09-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.

Detailed description:

Arms: arm 1: Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor. arm 2: Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations.
Interventions: intervention 1: Dacomitinib intervention 2: Dacomitinib
Intervention descriptions: intervention 1: Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg. intervention 2: Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.

Protocol documents:
Clinical trial NCT01864538
Conditions: Metastatic Melanoma
Keywords: TH-302 Advanced Melanoma Metastatic Biomarker Mucosal Melanoma Evofosfamide
Sponsor: ImmunoGenesis
Start date: 2013-05-01; Completion date: 2015-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the response rate, duration of response,progression-free survival and overall survival of subjects with advanced melanoma treated with TH-302.

Detailed description:
Hypoxia is an independent marker of a poor prognosis for subjects with metastatic melanoma (Simonetti 2012, Lartigau 1997). Hypoxic melanoma cells are more likely to exhibit a stem-cell like phenotype with an associated increased propensity for invasion, angiogenesis, and metastasis formation compared to normoxic cells. Moreover, this phenotype is also associated with treatment resistance. TH-302, a hypoxia activated prodrug (HAP), was designed to target the hypoxic nature of tumours while having a minimal effect on normoxic tissue. TH-302 belongs to a class of alkylating agents that have significant experimental and clinical activity (Brock 1989). Preclinical data support the hypothesis that TH-302 targets hypoxic regions of tumours and is also able to kill tumour cells in normoxic regions as a result of cytotoxin diffusion, leading to significant effects on tumour growth (Meng 2011). TH-302 has been investigated in over 700 subjects with solid tumours or hematologic malignancies, including subjects with metastatic melanoma. In this subset a disease control rate of 63% (3 subjects with partial responses and 9 subjects with stable disease out of a total of 19) was observed in an early phase clinical trial of TH-302 (Weber 2010). Predictive biomarkers for response and toxicity have yet to be identified for subjects with advanced melanoma treated with TH-302. Optimal patient selection may be critical to maximize the clinical benefit. A predictive biomarker approach will be investigated to try to identify subjects most likely to benefit from TH-302. Given the hypoxia-targeting mechanism of TH- 302, it is believed that hypoxia biomarkers will be the most informative for identifying subjects likely to benefit from TH- 302; however, additional biomarkers including DNA repair biomarkers will also be investigated. In addition, this approach will also have potential to synergise with future immunotherapeutic approaches as suppressive T regulatory cells are thought to reside within hypoxic niches within the tumour microenvironment that would be amenable to targeting by TH-302.

Arms: arm 1: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
Interventions: intervention 1: TH-302
Intervention descriptions: intervention 1: 480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.

Protocol documents:
Clinical trial NCT01869478
Conditions: Stroke Ischemic Stroke
Sponsor: Mayo Clinic
Start date: 2013-01-01; Completion date: 2015-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A randomized trial is justified for the following reasons: 1) The high rate of death and disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates critical analysis of alternate therapies with therapeutic potential, 2) endovascular treatment for acute ischemic stroke is expanding in North America without compelling evidence of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from controlled studies.

Detailed description:

Arms: arm 1: 0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes. arm 2: Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
Interventions: intervention 1: Intravenous Thrombolysis intervention 2: Endovascular Arterial Reperfusion
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01931150
Conditions: Cetuximab-induced Papulopustular (Acneiform) Rash Who Have Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma
Keywords: Topical Dapsone 5% Gel Moisturizer rash 13-012
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2013-08-01; Completion date: 2015-09-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.

Detailed description:

Arms: arm 1: Dapsone 5% gel to LEFT side of face and chest BID (morning and evening) Moisturizer to RIGHT side of face and chest BID (morning and evening) AND oral antibiotics (doxycycline 100 mg bid OR minocycline 100 mg once daily or other antibiotic daily) arm 2: Moisturizer to LEFT side of face and chest BID (morning and evening) Dapsone 5% gel to RIGHT side of face and chest BID (morning and evening) AND oral antibiotics (doxycycline 100 mg bid OR minocycline 100 mg once daily or other antibiotic daily)
Interventions: intervention 1: Topical Dapsone 5% Gel intervention 2: Moisturizer intervention 3: oral antibiotics
Intervention descriptions: intervention 1: None intervention 2: The moisturizer for the study will be Vanicream™ Lite Lotion. intervention 3: None

Protocol documents:
Clinical trial NCT01932060
Conditions: Postpartum Hemorrhage
Keywords: Oxytocin blood loss Cesarean delivery
Sponsor: Stanford University
Start date: 2013-08-01; Completion date: 2015-09-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.

Detailed description:
Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.

Arms: arm 1: Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit. arm 2: Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Interventions: intervention 1: Oxytocin Infusion
Intervention descriptions: intervention 1: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.

Protocol documents:
Clinical trial NCT01936181
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Infliximab Biosimilar
Sponsor: Samsung Bioepis Co., Ltd.
Start date: 2013-08-01; Completion date: 2015-09-01
Enrollment: 584 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.

Detailed description:

Arms: arm 1: SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70 arm 2: Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46 arm 3: SB2 3mg/kg at week 54, 62, 70 arm 4: Remicade 3mg/kg at week 54, 62, 70
Interventions: intervention 1: Remicade (infliximab) intervention 2: SB2 (proposed biosimilar to infliximab)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01947907
Conditions: Growth Hormone Deficiency (GHD)
Keywords: Human Growth Hormone rhGH hGH GHD
Sponsor: Ascendis Pharma A/S
Start date: 2013-07-01; Completion date: 2015-09-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.

Detailed description:

Arms: arm 1: Once weekly subcutaneous injection of ACP-001 arm 2: Once weekly subcutaneous injection of ACP-001 arm 3: Once weekly subcutaneous injection of ACP-001 arm 4: Once daily subcutaneous injection of human Growth Hormone (rhGH)
Interventions: intervention 1: ACP-001 intervention 2: Human Growth Hormone
Intervention descriptions: intervention 1: Once weekly subcutaneous injection intervention 2: Once daily subcutaneous injection of human Growth Hormone

Protocol documents:
Clinical trial NCT01948791
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease ENA713 Chinese patients INSTINCT
Sponsor: Novartis Pharmaceuticals
Start date: 2014-08-01; Completion date: 2015-09-01
Enrollment: 222 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration

Detailed description:

Arms: arm 1: Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
Interventions: intervention 1: ENA713
Intervention descriptions: intervention 1: The following strengths of Rivastigmine capsules were provided: Rivastigmine capsule strengths: 1.5mg, 3mg, 4.5mg. The 6mg dose was administered as one 1.5mg capsule and one 4.5mg capsule, and when necessary, the 3mg dose could also be administered as two 1.5mg capsules. Rivastigmine was administered from 3mg/d at baseline. Then dose escalation was made in 3mg/d increments, at a minimun of 4 weeks between dose increases to a maximum dose of 12mg/d or the individual's best tolerated dose.

Protocol documents: