ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01268943
Conditions: Rectal Neoplasms
Keywords: rectal neoplasms aged radiotherapy drug therapy dose-escalation capecitabine
Sponsor: Chinese Academy of Medical Sciences
Start date: 2010-11-01; Completion date: 2014-01-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to seek the proper dose of capecitabine in post-operative concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical surgery, and evaluate the toleration of this modality in such patients.

Detailed description:
For those "younger" locally advanced (stage II/III) rectal cancer patients (usually means patients less than 70), it is suggested that after radical surgery, patients should receive concurrent chemo-radiation. Capecitabine is a widely used chemotherapy medicine under such condition. Based on experience, the investigators think this modality can also be tolerated by patients over 70, and will increase local control rate as which has been proved in younger ones. As the first step to test this hypothesis, we designed this phase I study to seek the proper dose of capecitabine, a widely used oral chemotherapy medicine, in postoperative concurrent chemo-radiation for stage II/III rectal cancer patients over 70, and to evaluate the safety of this modality in this group of patients.

Arms: arm 1: capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients. arm 2: capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients. arm 3: capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients. arm 4: capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Interventions: intervention 1: Capecitabine intervention 2: Capecitabine intervention 3: Capecitabine intervention 4: Capecitabine
Intervention descriptions: intervention 1: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation. intervention 2: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation. intervention 3: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation. intervention 4: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.

Protocol documents:
Clinical trial NCT01272141
Conditions: Breast Neoplasms Breast Cancer Cancer of the Breast
Keywords: Metastatic breast cancer Triple negative breast cancer Estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2)-negative breast cancer
Sponsor: Emory University
Start date: 2010-12-01; Completion date: 2014-01-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The patient is being asked to join this clinical research study to find out if lapatinib, an agent that targets a protein, called epidermal growth factor receptor (EGFR) on the surface of cancer cells in combination with everolimus, an agent that targets a protein in the cancer cell, called mammalian target of rapamycin (mTOR) is effective in metastatic triple negative breast cancers that are no longer controlled by standard chemotherapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lapatinib and Everolimus
Intervention descriptions: intervention 1: Lapatinib: 1250 mg by mouth daily

Everolimus: 5mg by mouth daily

Protocol documents:
Clinical trial NCT01274637
Conditions: Venous Thromboembolism Postpartum
Keywords: postpartum low molecular weight heparin venous thromboembolism prophylaxis Dalteparin Sodium
Sponsor: Ottawa Hospital Research Institute
Start date: 2011-03-01; Completion date: 2014-01-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if it is feasible to conduct a multi-center randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH), is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.

Detailed description:
The PROPSER pilot is a randomized, open-label pilot study comparing prophylactic low molecular weight heparin (LMWH) to saline placebo. The PROSPER pilot study will assess the feasibility of conducting a full trial as measured by the number of subjects recruited per center per month. In addition, clinical data will be collected to determine an estimate of the primary outcome event rate (symptomatic VTE or asymptomatic proximal deep vein thrombosis (DVT) and major bleeding event rate for the full trial in LMWH and control groups. If our pilot results indicate that no substantial changes are needed to the study design, we will include the pilot data in the primary and secondary outcome analyses for the full trial (i.e. a "Vanguard trial" or internal pilot trial).

Eligible consenting women at risk of postpartum thrombosis will be randomized within 36 hours after delivery of the placenta and will be equally allocated to 2 trial arms, either the treatment group: prophylactic-dose LMWH, subcutaneously once daily for 10 days (+/-3 days), or the control group.

At 10 days (+/- 3 days), all women will have a study visit to assess for study outcomes, including bilateral leg ultrasound screening for VTE and a D-dimer test. A final telephone follow-up will occur at 90 days for outcome assessment of subsequent VTE, bleeding or other adverse events.

Arms: arm 1: Prophylactic-dose (5000 IU/0.2ml)low molecular weight heparin (LMWH), administered subcutaneously once daily in pre-filled glass syringes for 10 days (+/- 3 days) for a total of 10 (+/-3) study drug injections. arm 2: No treatment control group.
Interventions: intervention 1: Dalteparin Sodium
Intervention descriptions: intervention 1: 5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.

Protocol documents:
Clinical trial NCT01310855
Conditions: Glioblastoma
Keywords: adult giant cell glioblastoma adult glioblastoma adult gliosarcoma recurrent adult brain tumor
Sponsor: University College, London
Start date: 2011-05-01; Completion date: 2014-01-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cediranib maleate given together with gefitinib is more effective than cediranib maleate given alone in treating patients with recurrent or progressive glioblastoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib maleate together with gefitinib and to see how well it works compared with giving cediranib maleate together with a placebo in treating patients with recurrent or progressive glioblastoma.

Detailed description:
OBJECTIVES:

* To compare progression-free survival, overall survival, radiological response, and safety and tolerability of cediranib maleate in combination with gefitinib versus cediranib maleate in combination with a placebo in patients with recurrent or progressive glioblastoma following standard front-line treatment.

OUTLINE: This is a multicenter study.

Patients receive cediranib maleate and gefitinib or cediranib maleate and a placebo once daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected from some patients for genetic profiling and biomarker analysis.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Arms: arm 1: Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit. arm 2: Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.
Interventions: intervention 1: cediranib maleate intervention 2: gefitinib intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01313117
Conditions: Peripheral Neuropathy
Keywords: chemotherapy peripheral neuropathy paclitaxel breast cancer
Sponsor: Northwestern University
Start date: 2012-02-01; Completion date: 2014-01-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done because peripheral neuropathy, a condition that interrupts sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel. The purpose of this study is to assess the safety and tolerability of ALA and to find the best dose of ALA in patients that receive chemotherapy.

Detailed description:

Arms: arm 1: Oral administration three times daily (morning, mid-day, night)
Interventions: intervention 1: Alpha lipoic acid
Intervention descriptions: intervention 1: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.

Protocol documents:
Clinical trial NCT01326546
Conditions: Chronic Hepatitis B
Keywords: Therapeutic HBV Vaccine Chronic Hepatitis B HBeAg positive HBV-specific Cytotoxic T Lymphocyte
Sponsor: Chongqing Jiachen Biotechnology Ltd.
Start date: 2010-06-01; Completion date: 2014-01-01
Enrollment: 378 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (mimogen-based)) Joint entecavir treatment in chronic hepatitis B patients.

Detailed description:
Eligible subjects are enrolled and assigned into 2 groups randomly with a 1:1 ratio：

1. Therapeutic HBV vaccine Joint Entecavir group：Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day ；
2. Empty liposome Joint Entecavir group：Inject empty liposome at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day.

The study cycle consists of screening and enrollment period (week -4～0), treatment and follow-up period (week 0-96).

Arms: arm 1: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day. arm 2: Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
Interventions: intervention 1: Therapeutic HBV vaccine intervention 2: entecavir intervention 3: placebo
Intervention descriptions: intervention 1: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48. intervention 2: 0.5mg,per day,oral intake. intervention 3: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.

Protocol documents:
Clinical trial NCT01345630
Conditions: HIV-1
Keywords: Double-blind comparative trial maraviroc versus emtricitabine/tenofovir both with darunavir/ritonavir antiretroviral-naive Ccr5 tropic Hiv 1 patients.
Sponsor: ViiV Healthcare
Start date: 2011-09-01; Completion date: 2014-01-01
Enrollment: 813 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

Detailed description:
The study was terminated on October 8, 2013 following a preliminary review of the Week 48 primary efficacy data by the study's external independent Data Monitoring Committee (DMC). The DMC assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures. The DMC recommended and the Sponsor concurred that the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to the comparator arm (Emtricitabine/Tenofovir).

Arms: arm 1: Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. arm 2: Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
Interventions: intervention 1: Maraviroc intervention 2: Emtricitabine/tenofovir intervention 3: darunavir/ritonavir 800/100 mg intervention 4: placebo for emtricitabine/tenofovir intervention 5: placebo for maraviroc
Intervention descriptions: intervention 1: Maraviroc tablet 150 mg once daily for 96 weeks. intervention 2: Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks. intervention 3: darunavir/ritonavir 800/100 mg intervention 4: placebo for emtricitabine/tenofovir intervention 5: placebo for maraviroc

Protocol documents:
Clinical trial NCT01357239
Conditions: Fragile X Syndrome
Keywords: Fragile X Syndrome Martin-Bell Syndrome Genetic Diseases X-Linked Escalante's syndrome
Sponsor: Novartis Pharmaceuticals
Start date: 2011-05-01; Completion date: 2014-01-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: AFQ056 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01370499
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2011-08-01; Completion date: 2014-01-01
Enrollment: 288 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily in the adjunctive treatment with an Selective Serotonin Reuptake Inhibitors (SSRI) for up to approximately 1 year in participants with Major Depressive Disorder (MDD) who were partial responders to their SSRI treatment.

Detailed description:

Arms: arm 1: LY2216684: 12 milligrams (mg) or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).

During the open-label phase, all participants started at the 12 mg dose and could have the dose increased to 18 mg after the first week of treatment. During the first 12 weeks, participants were allowed (at scheduled or unscheduled visits) to decrease their dose to 12 mg based on response. After a decrease in dose to 12 mg, participants could have had an increase back up to 18 mg at any scheduled visit based on response and tolerability. After 12 weeks of treatment, participants maintained a stable dose.

Open-label treatment was followed by a 1-week abrupt discontinuation phase. Participants who either completed study visits through Week 52 or discontinued early from the study for any reason returned 1 week later for follow-up visit. Participants did not receive LY2216684 but continued their SSRI treatment at a stable dose.
Interventions: intervention 1: LY2216684 intervention 2: SSRI
Intervention descriptions: intervention 1: None intervention 2: Participants were to enter the study taking their current stable SSRI treatment dose and maintain the same dose throughout the study.

Protocol documents:
Clinical trial NCT01372384
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2012-01-01; Completion date: 2014-01-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 150 mg orally daily

Protocol documents:
Clinical trial NCT01374217
Conditions: Multiple Myeloma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2012-04-01; Completion date: 2014-01-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.

Detailed description:
This is an early phase study to evaluate the safety and efficacy of the combination of tadalafil with lenalidomide and dexamethasone (Rd) or BiRd. 19 patients on Rd or BiRd will be treated with tadalafil for a minimum of 6 months. The investigational drug will be discontinued if there is evidence of disease progression as defined by the International Uniform Response criteria \[1\]. For responding patients (patients who have a CR, VGPR, PR or SD), the therapy will be continued until progression or intolerable adverse effects. Blood and bone marrow will be collected for various studies as detailed in section 14.10. Clinical response will be monitored every month during the study.

Arms: arm 1: Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd)
Interventions: intervention 1: Tadalafil intervention 2: Lenalidomide intervention 3: Dexamethasone intervention 4: Clarithromycin
Intervention descriptions: intervention 1: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days intervention 2: Lenalidomide will be administered as it was prior to study entry. intervention 3: Dexamethasone will be administered as it was prior to study entry. intervention 4: Clarithromycin will be administered as it was prior to study entry.

Protocol documents:
Clinical trial NCT01388946
Conditions: Pain, Postoperative Chronic Postoperative Pain
Keywords: acute postoperative pain late pain chronic pain wound irrigation with local anesthetic
Sponsor: University of Athens
Start date: 2010-05-01; Completion date: 2014-01-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the analgesic consumption during the first 24 hours.

Detailed description:
Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter was inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions were administered by means of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring was applied. Anesthesia was induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration (MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed with sugammadex 2 mg/kg., the patient was extubated and transferred to the Post-anesthesia Care Unit (PACU).

Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and the total amount of carbon dioxide insufflated are recorded every 5 minutes.

Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale (VAS) score is above 40 mm.In the ward Lonarid tablets are given instead.

VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours after surgery.

The catheter is removed 24 hours after surgery. One and three months after surgery patients are interviewed by phone for the presence of pain due to surgery.

Arms: arm 1: Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours arm 2: Continuous infusion of normal saline 2 ml/h for 24 hours
Interventions: intervention 1: Ropivacaine 0.75 intervention 2: Normal saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01389856
Conditions: Persistent Pulmonary Hypertension of the Newborn
Keywords: Persistent pulmonary hypertension, newborn PPHN
Sponsor: Actelion
Start date: 2011-12-01; Completion date: 2014-01-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.

Detailed description:

Arms: arm 1: Bosentan arm 2: Matching placebo
Interventions: intervention 1: Bosentan intervention 2: Matching placebo
Intervention descriptions: intervention 1: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube. intervention 2: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube.

Protocol documents:
Clinical trial NCT01390181
Conditions: Bicuspid Aortic Valve Thoracic Aortic Aneurysm
Sponsor: University of Michigan
Start date: 2011-09-01; Completion date: 2014-01-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The specific aims of this study are to:

* Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements \>40mm.
* Assess the effect on MMP levels during treatment with losartan, an angiotensin II receptor blocking agent.
* In the setting of losartan therapy for one year, evaluate the response of MMP levels in these patients, and clinical outcomes including effects on aortic growth rate

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cozaar
Intervention descriptions: intervention 1: Angiotensin II Receptor Blocker

Protocol documents: