ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01632995
Conditions: HIV Infections
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2012-10-01; Completion date: 2015-02-01
Enrollment: 557 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD) clinics and a community health center in the United States.

Detailed description:
A previous study (iPrEx) showed that daily PrEP with FTC/TDF provided with a comprehensive package of prevention services is effective in preventing HIV infection among men who have sex with men (MSM). The PrEP administered in that study was given in the context of a research setting/controlled trial, but it is important to evaluate the acceptability, sustainability, and safety of PrEP in a "real world" setting. This study will evaluate PrEP administered to HIV-uninfected MSM and transgender females at two STD clinics and one community health center in the United States.

Each participant will receive PrEP for up to 1 year and will have up to 8 study visits. PrEP will consist of one fixed-dose FTC/TDF combination tablet orally each day. All participants will have study visits at screening, enrollment, and 4 weeks after enrollment; participants will continue to have visits at Weeks 12, 24, 36, 48, and 52 if they do not seroconvert. Participants who seroconvert will discontinue PrEP and will have a post-drug discontinuation visit 4 weeks after discontinuing PrEP. At most visits, participants will undergo blood, urine, and hair sample collection; give a medical history; undergo a physical exam; receive risk-reduction counseling and condoms; undergo testing for HIV and other STDs; receive study drugs; and undergo a pill count and adherence assessment (follow-up visits only). For participants who stop taking the study drug but remain in the study, urine, blood, and hair samples will not be collected at 12-week follow-up visits if all stop procedures have been completed and if there are no lab abnormalities that require additional follow-up. Participants will also answer questionnaires at screening, 12-week visits, and at study exit.

Arms: arm 1: All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
Interventions: intervention 1: FTC 200 mg/TDF 300 mg fixed-dose combination tablet
Intervention descriptions: intervention 1: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.

Protocol documents:
Clinical trial NCT01700335
Conditions: Myelodysplastic Syndrome
Sponsor: SymBio Pharmaceuticals
Start date: 2012-06-01; Completion date: 2015-02-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate tolerability when SyB L-1101 is administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be investigated.

Detailed description:

Arms: arm 1: In Cohort 1, SyB L-1101 1200 mg/day group, Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.

In Cohort 2, SyB L-1101 1800 mg/day group, Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.

For both Cohorts, the treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles.
Interventions: intervention 1: SyB L-1101
Intervention descriptions: intervention 1: SyB L-1101（rigosertib sodium） will be administered to two cohorts at either 1200 mg/day or 1800 mg/day.

The dose will be administered intravenously for 72 continuous hours (3 days), followed by 11-day observation period. The treatment period of 14 days (3 days of administration + 11 days of observation) constitutes 1 cycle.

The study will involve treatment through the second cycle, but treatment can be continued for 3 or more cycles if conditions for continued administration are satisfied.

Protocol documents:
Clinical trial NCT00453102
Conditions: Marginal Zone Lymphoma
Keywords: Marginal Zone Lymphoma Non-gastric extranodal Marginal Zone Lymphoma Splenic Marginal Zone Lymphoma Nodal Marginal Zone Lymphoma Gastric Marginal Zone Lymphoma MZL Non-gastric extranodal MZL Splenic MZL Nodal MZL Gastric MZL
Sponsor: University of Miami
Start date: 2006-02-01; Completion date: 2015-02-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).

Detailed description:
This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.

Arms: arm 1: Ibritumomab Tiuxetan (Zevalin) + Rituximab
Interventions: intervention 1: Rituximab intervention 2: Ibritumomab Tiuxetan
Intervention descriptions: intervention 1: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ intervention 2: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:

0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³

Protocol documents:
Clinical trial NCT00491491
Conditions: Non-Hodgkin's Lymphoma
Keywords: non-Hodgkin's lymphoma autologous stem cell transplantation radioimmunotherapy zevalin
Sponsor: Sheba Medical Center
Start date: 2007-06-01; Completion date: 2015-02-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.

Detailed description:

Arms: arm 1: ibritumomab tiuxetan (zevalin) BEAM arm 2: standard BEAM chemotherapy
Interventions: intervention 1: ibritumomab tiuxetan intervention 2: BEAM chemotherapy and autologous stem-cell transplantation
Intervention descriptions: intervention 1: 0.4 mCi/kg intervention 2: None

Protocol documents:
Clinical trial NCT00605566
Conditions: Neuroendocrine Tumors
Keywords: Neuroendocrine sorafenib cyclophosphamide pharmacodynamic
Sponsor: University Health Network, Toronto
Start date: 2008-01-01; Completion date: 2015-02-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II clinical trial to assess the efficacy of the combination of metronomic cyclophosphamide and tailored sorafenib dosing in advanced, progressive NET. NET are highly vascular tumors, and high VEGF expression has been correlated with worse clinical and pathological characteristics as well as poor prognosis. A novel antiangiogenic approach relies on targeting not only the endothelial cells but also rendering them more sensitive to VEGFR blockade by achieving pericyte detachment. In this study, the dose of sorafenib will be titrated up to a maximum of 800mg BID based on patients' toxicity and on a novel pharmacodynamic assay that measures inhibition of molecular target(PDGFR) in patients' peripheral blood mononuclear cells. Dual VEGFR targeting is achieved by administering sorafenib plus metronomic low dose cyclophosphamide.

Detailed description:

Arms: arm 1: Patients will receive sorafenib and cyclophosphamide.
Interventions: intervention 1: Sorafenib intervention 2: Cyclophosphamide
Intervention descriptions: intervention 1: During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of \> 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After "run-in" period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally. intervention 2: During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of \> 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After "run-in" period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally.

Protocol documents:
Clinical trial NCT00737438
Conditions: Esophageal Cancer Gastric Cancer
Keywords: BEVACIZUMAB (AVASTIN) CAPECITABINE (ORAL) CISPLATIN EPIRUBICIN IRINOTECAN (CPT-11) CAMPTOSAR TAXOTERE (DOCETAXEL) ESOPHAGUS STOMACH 08-081
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-08-01; Completion date: 2015-02-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to find out how effective a new treatment strategy is on your cancer. In this strategy, the response your tumor has to the first cycle of therapy will help select the next treatments. We also will find out the effects, both good and/or bad, a drug called bevacizumab has on you and your tumor when given with chemotherapy.

Detailed description:

Arms: arm 1: Initial chemo for ALL pts (ECX + BEV): Epirubicin 50 mg/m2 d1 every 21 days Cisplatin 60 mg/m2 d1 every 21 days, Capecitabine 625 mg/m2 po bid days 2-21 (held for 48 hours prior to FDG-PET/CT in week 3) Bev 15 mg/kg d1 every 21 days (cycle 1 \& cycle 2 only) Salvage chemotherapy for metabolic non-responders (DI + BEV): Docetaxel 30 mg/m2 d1, d8 every 21 days, CPT-11 50 mg/m2 d1, d8 every 21 days, Bev 15 mg/kg d1, cycle 2 only 2 cycles are planned prior to resection.

Pts who aren't Cisplatin candidates (i.e. Creatinine clearance 40-60/cc, older age, marginal PS,etc.) may get oxaliplatin instead of cisplatin after discus with the PI. Oxaliplatin will be admin at 130 mg/m2 on day 1 every 21 days. Pts who aren't able to get Capecitabine (i.e. insurance restriction, unable to swallow, etc.) may get infusional fluorouracil instead of capecitabine after discus with the PI. Fluorouracil will be admin at 200 mg/m2/d x 21 days (held for 48 hours prior to FDGPET/ CT scan in week 3 of cycle 1).
Interventions: intervention 1: epirubicin, cisplatin, capecitabine, bevacizumab, docetaxel and irinotecan
Intervention descriptions: intervention 1: Patients with FDG avid locally advanced but resectable gastric or GEJ adenocarcinoma will receive preoperative therapy with epirubicin, cisplatin, capecitabine (ECX), and bevacizumab. Each cycle of therapy is 21 days. Near the completion of cycle 1 of therapy (eg during week 3, target days 18-21), patients will undergo a second FDG-PET/CT scan. Note, patients will hold capecitabine for 48 hours prior to the FDG-PET/CT scan.

Patients with a good metabolic response (eg. \> 35% reduction in FDG uptake at the primary tumor on the week 3 PET scan as compared with baseline FDG uptake) will continue ECX for 2 additional cycles (cycle 2 and 3).

Cycle 2 will be administered with bevacizumab and cycle 3 will be administered without bevacizumab. Patients will then proceed to surgery approximately 4-6 weeks following the completion of cycle 3. There is a 10-12 week time interval (eg. 70-84 days) between the last bevacizumab treatment and surgery.

Protocol documents:
Clinical trial NCT00737568
Conditions: Hepatitis B
Keywords: Tenofovir DF Emtricitabine Chronic hepatitis B Combination therapy
Sponsor: Gilead Sciences
Start date: 2008-09-01; Completion date: 2015-02-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy. Durable suppression of viral replication is achieved in the treatment of chronic viral diseases by preventing of the emergence of drug-resistant mutations. The clinical guidelines for the management of lamivudine resistant patients are variable. Some recommend switching to another agent without cross-resistance, while others recommend adding on another agent without cross-resistance. Limited clinical data exists to demonstrate whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for lamivudine resistant patients or if it should be used as part of a combination therapy regimen.

This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or without the rtL180M mutation) over a 240-week period. Participants in this study must be receiving lamivudine treatment at the time of enrollment.

Detailed description:

Arms: arm 1: TDF plus placebo to match FTC/TDF arm 2: FTC/TDF plus placebo to match TDF
Interventions: intervention 1: TDF intervention 2: FTC/TDF intervention 3: TDF Placebo intervention 4: FTC/TDF Placebo
Intervention descriptions: intervention 1: Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet administered orally once daily intervention 2: Emtricitabine (FTC)/TDF 200/300 mg fixed-dose combination tablet administered orally once daily intervention 3: TDF placebo tablet administered orally once daily intervention 4: FTC/TDF placebo tablet administered orally once daily

Protocol documents:
Clinical trial NCT00862719
Conditions: Leukemia, Myeloid, Acute Acute Lymphoblastic Leukemia Myelodysplasia Leukemia, Myelogenous, Chronic Lymphoma, Non-Hodgkin
Sponsor: Indiana University School of Medicine
Start date: 2009-03-01; Completion date: 2015-02-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this trial is to study whether the drug sitagliptin can be given safely to patients undergoing umbilical cord blood transplantation to speed up engraftment (recovery of blood counts after transplant).

Detailed description:
Umbilical cord blood (UCB) is increasingly used as a source of stem cells for patients with blood cancers who need an allogeneic stem cell transplant (a transplant with stem cells from another person) but who have no suitably matched donors. The advantages of UCB are that (1) it is associated with less risk of transmitting an infection from a donor, (2) it can be more safely given even if not completely matched compared to bone marrow or blood stem cells, and (3) it is much more quickly available than unrelated donor bone marrow or blood stem cells. While more commonly used for transplantation in children, UCB is increasingly being used in adults. However, because they are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults, and engraftment can be delayed. This study is investigating whether the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation, overcoming the limitation of small stem cell doses associated with umbilical cord blood.

Sitagliptin is a drug given in tablet form that has been recently approved by the Food and Drug Administration (FDA) for the treatment of certain patients with diabetes mellitus (a disease that results in high blood sugar). Sitagliptin has been given to both normal healthy volunteers and diabetic patients and has been found to be safe and well-tolerated. The drug improves control of blood sugar in diabetics by inhibiting an enzyme called "CD26/DPP-IV." Recent studies at Indiana University (and other centers) have shown that this same enzyme plays an important role in the way transplanted stem cells find their way to the bone marrow and engraft. Transplant studies in mice have found that inhibiting CD26/DPP-IV significantly increases the engraftment of stem cells. Based on these studies, it is believed that drugs that inhibit CD26/DPP-IV, such as sitagliptin, may also increase engraftment in patients who receive clinical stem cell transplants.

Arms: arm 1: 600 mg sitagliptin once per day orally starting on Day -1 for a total of 4 doses arm 2: 600 mg sitagliptin twice per day orally starting on Day -1 for a total of 8 doses arm 3: 600 mg sitagliptin three times per day orally starting on Day -1 for a total of 12 doses
Interventions: intervention 1: Sitagliptin
Intervention descriptions: intervention 1: 600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms.

Protocol documents:
Clinical trial NCT00900627
Conditions: Neoplasms Breast Neoplasms Breast Cancer
Keywords: Cancer Tumour Breast cancer Metastatic Secondary
Sponsor: AstraZeneca
Start date: 2009-06-01; Completion date: 2015-02-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.

Detailed description:

Arms: arm 1: AZD8931 plus Paclitaxel arm 2: Placebo plus Paclitaxel
Interventions: intervention 1: AZD8931 intervention 2: Paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: Tablet Oral bid intervention 2: IV once weekly for 3 weeks followed by a week off (repeated cycles) intervention 3: Oral bid (twice daily)

Protocol documents:
Clinical trial NCT01001910
Conditions: Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma
Sponsor: Albert Einstein College of Medicine
Start date: 2008-07-01; Completion date: 2015-02-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well pemetrexed disodium and carboplatin work in treating patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response rate of combination pemetrexed (pemetrexed disodium) (Alimta) and carboplatin (Paraplatin) in recurrent ovarian, primary peritoneal, and fallopian tube carcinoma.

SECONDARY OBJECTIVES:

I. To evaluate the progression free interval, overall survival, and adverse effects among patients receiving this drug combination.

OUTLINE:

Patients receive pemetrexed disodium intravenously (IV) over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive pemetrexed disodium IV over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Carboplatin intervention 2: Laboratory Biomarker Analysis intervention 3: Pemetrexed Disodium
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Given IV

Protocol documents:
Clinical trial NCT01137396
Conditions: Cocaine Dependence
Sponsor: Yale University
Start date: 2010-04-01; Completion date: 2015-02-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The medication modafinil has been shown to reduce cocaine use in some cocaine users. The investigators have shown that modafinil taken in the morning improves sleep in chronic cocaine users. The investigators hypothesize that the beneficial effects of modafinil in reducing cocaine use may be related to specific effects modafinil has on sleep. This study will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Modafinil intervention 2: Cognitive Behavioral Therapy
Intervention descriptions: intervention 1: Modafinil 400mg PO QDaily following up-titration for \~8weeks intervention 2: Once weekly cognitive behavioral therapy for cocaine dependence

Protocol documents:
Clinical trial NCT01202110
Conditions: Traumatic Brain Injury
Sponsor: Cedars-Sinai Medical Center
Start date: 2010-06-01; Completion date: 2015-02-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine in patients with traumatic brain injury (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia (heart rate \< 60 beats per minute), hypotension (defined as systolic blood pressure \< 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to treatment that occur without propranolol.

Detailed description:

Arms: arm 1: Propranolol 1mg iv arm 2: Routine care
Interventions: intervention 1: Propranolol
Intervention descriptions: intervention 1: None

Protocol documents: