ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01206140
Conditions: Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2015-04-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well giving selumetinib together with or without temsirolimus works in treating patients with metastatic, recurrent, or locally advanced soft tissue sarcoma that cannot be removed by surgery. Selumetinib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving selumetinib together with temsirolimus is more effective than giving selumetinib alone.

Detailed description:
PRIMARY OBJECTIVES:

I. Compare the progression-free survival of the MEK inhibitor, AZD6244 (selumetinib) alone, and the combination of AZD6244 and a mammalian target of rapamycin inhibitor (mTORi), temsirolimus (CCI-779) in patients with recurrent metastatic or recurrent locally unresectable soft-tissue sarcomas.

SECONDARY OBJECTIVES:

I. Determine the rates of apoptosis, autophagy, and proliferation with AZD6244 alone, and in combination with temsirolimus by immunohistochemistry in tumor and surrogate skin tissue biopsies. (exploratory) II. Assess the activation status of protein kinase B (Akt), 5E-BP1, eukaryotic translation initiation factor 4 gamma, 1 (eIF-4G), and ribosomal protein S6 kinase (S6K) in tumor biopsy samples and surrogate skin tissue biopsy samples.(exploratory) III. Assess inhibition of activated mitogen-activated protein kinase 1/2 (ERK1/2) in stimulated peripheral blood mononuclear cells. (exploratory) IV. Assess response by Choi criteria. V. Compare the response rate and 4-month progression-free survival (PFS) rate in patients treated with these regimens.

VI. Compare the response rate, 4-month PFS rate and toxicity of AZD6244 alone and in combination with temsirolimus.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive selumetinib orally (PO) twice daily on days 1-28 and temsirolimus intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22.

ARM II: Patients receive selumetinib as in arm I. Patients who experience disease progression may cross over to arm I.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up for 30 days.

Arms: arm 1: Patients receive selumetinib PO twice daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. arm 2: Patients receive selumetinib as in arm I. Patients who experience disease progression may cross over to arm I.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Selumetinib intervention 3: Temsirolimus
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Given IV

Protocol documents:
Clinical trial NCT01212744
Conditions: Phenylketonuria
Keywords: PEG PAL; PKU; injection;
Sponsor: BioMarin Pharmaceutical
Start date: 2011-03-01; Completion date: 2015-04-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of daily administration of rAvPAL-PEG on the reduction of blood Phe concentrations in subjects with PKU.

Detailed description:
This 16-week multi-center, open-label, Phase 2 study is designed to evaluate the safety, tolerability,and efficacy of daily SC injections of rAvPAL-PEG in subjects with PKU. Subjects who are naïve to prior treatment with rAvPAL-PEG and who have met the other study eligibility criteria will be enrolled at approximately 8 sites in the US and Canada. Up to 6 daily dose levels of rAvPAL-PEG are planned and may be assessed during this study (0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day;0.4 mg/kg/day, 0.6 mg/kg/day, or 0.8 mg/kg/day). Enrollment will begin with the 0.4 mg/kg/day dose level and additional higher or lower doses may be added. The additional dose levels chosen for assessment will be based on the safety (systemic reaction or clinically significant abnormal laboratory test results assessed as related to study drug) and efficacy (blood Phe reduction to less than or equal to 60 μmol/L) information of at least 3 subjects with at least 2 weeks of daily dosing with rAvPAL-PEG. Initiation of dosing at higher or lower dose levels will be per the determination of the Sponsor's Medical Officer in consultation with the Investigator.

Arms: arm 1: rAvPAL-PEG in varying doses
Interventions: intervention 1: rAvPAL-PEG
Intervention descriptions: intervention 1: 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day

Protocol documents:
Clinical trial NCT01214187
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: idiopathic pulmonary fibrosis IPF pulmonary fibrosis carbon monoxide
Sponsor: Brigham and Women's Hospital
Start date: 2011-07-01; Completion date: 2015-04-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.

Detailed description:
Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by destruction of normal epithelial structure, proliferation of fibroblasts, and deposition of connective-tissue matrix proteins. There are currently no effective therapies for IPF. Over the past two decades, preclinical studies of inhaled low dose carbon monoxide (CO) have shown that this biologically active diatomic gas possesses properties that would make it a viable novel therapy for IPF. CO therapy has been well tolerated in Phase I and Phase II human trials to date. This phase II study is designed to investigate whether IPF patients show evidence of decreased peripheral blood levels of matrix metalloproteinase-7 (MMP7) and stability of secondary indicators of disease progression after 3 months of inhaled therapy.

Arms: arm 1: The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment. arm 2: None
Interventions: intervention 1: inhaled carbon monoxide intervention 2: Oxygen
Intervention descriptions: intervention 1: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment. intervention 2: Room air oxygen concentrations will be administered as placebo

Protocol documents:
Clinical trial NCT01285050
Conditions: HIV Infection Hepatitis C
Keywords: HIV Human immunodeficiency virus Acquired Immune Deficiency Syndrome Virus AIDS Virus Immunodeficiency Virus, Human Virus, Human Immunodeficiency Hepatitis C Hepatitis C, chronic Hepatitis C virus Hepatitis C antibodies Hepatitis C antigens
Sponsor: Johns Hopkins University
Start date: 2011-01-01; Completion date: 2015-04-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).

Detailed description:
We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.

Arms: arm 1: HCV and HIV viral load pre and post antiretroviral therapy (ART). ART is the intervention and the comparison is the HIV and HCV viral load reductions as determined by RT-PCR after administration of interferon alfa in each instance (before and after ART)
Interventions: intervention 1: Antiretroviral therapy (ART) intervention 2: raltegravir intervention 3: Emtricitabine and tenofovir disoproxil fumarate
Intervention descriptions: intervention 1: Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate. intervention 2: raltegravir is an HIV medication given 400 mg twice daily by mouth intervention 3: Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth

Protocol documents:
Clinical trial NCT01330134
Conditions: Pain
Keywords: procedural
Sponsor: University of Chicago
Start date: 2011-02-01; Completion date: 2015-04-01
Enrollment: 481 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of our study is to determine if technique of lidocaine administration can decrease pain perception.

Hypothesis: There will be a significant difference in pain perception between patients who are given lidocaine on the skin surface prior to subcutaneous injection and patients who are given only subcutaneous injection by standard approach.

Detailed description:
This is a single center prospective, randomized, blinded study assessing pain perception following 2 different lidocaine administration techniques in subjects who have planned medical procedures requiring local injection of lidocaine. Subjects will be approached and consented to participate in the study. They will be interviewed after the scheduled medical procedure to assess their pain using validated pain scores. An investigator who is not present for the procedure and blinded to the randomization will gather data regarding perceptions of pain from the entire procedure.

Arms: arm 1: 1-2ml of 1% lidocaine dripped onto the surface of the skin immediately prior to subcutaneous injection of 1% lidocaine. arm 2: 1% lidocaine subcutaneous injection alone by standard approach
Interventions: intervention 1: lidocaine intervention 2: lidocaine
Intervention descriptions: intervention 1: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection intervention 2: 1% lidocaine subcutaneous injection alone

Protocol documents:
Clinical trial NCT01343368
Conditions: Multiple Myeloma Non-Hodgkin Lymphoma Hodgkin Disease Acute Myeloid Leukemia Myeloproliferative Disorders
Keywords: Post-menarchal
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2011-07-01; Completion date: 2015-04-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.

Detailed description:
This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women.

The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure.

The secondary objectives are

* to determine how effective GnRH agonists are at suppressing menses during
* to determine the incidence and timing of resumption of menstrual cycles after HCT
* to determine the incidence and timing of resumption of normal FSH and LH levels after HCT
* to determine the incidence of normal AMH levels after HCT
* to determine the effect of GnRH agonists on immune reconstitution after HCT
* to assess the safety and tolerability of GnRH agonists in the context of HCT

A total of 47 patients will be accrued in this study.

Arms: arm 1: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. arm 2: Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
Interventions: intervention 1: Leuprolide intervention 2: hematopoietic cell transplant intervention 3: reduced intensity allogeneic HCT
Intervention descriptions: intervention 1: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days intervention 2: Conventional bone marrow transplant regimen. intervention 3: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Protocol documents:
Clinical trial NCT01358357
Conditions: Bipolar I Disorder
Keywords: Lurasidone Latuda Bipolar I
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-06-01; Completion date: 2015-04-01
Enrollment: 965 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

Detailed description:
This study is to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lurasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter intervention 2: 20-80 mg flexible dose

Protocol documents:
Clinical trial NCT01365468
Conditions: Plexiform Neurofibroma Associated With Neurofibromatosis Type 1
Keywords: RAD001, Everolimus, Plexiform Neurofibroma, Neurofibromatosis Type 1
Sponsor: Novartis Pharmaceuticals
Start date: 2012-04-01; Completion date: 2015-04-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was to evaluate the antitumor activity and safety of RAD001 in patients with Plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).

The aim of the study was to :

1. determine whether RAD001, administrated orally daily on a continuous dosing schedule might:

   1. Increases time to disease progression (TTP) based on volumetric MRI measurements in children and adults with NF1 in inoperable documented progressive PN (stratum 1).
   2. Results in objective radiographic responses based on volumetric MRI measurements in children and adults with NF1 and inoperable PN in the absence of documented radiographic progression at the trail entry (stratum
2. To evaluate the tolerability and toxicity of chronic RAD001 administration in this patient population as assessed by the NCI Common Toxicity Criteria, version 4.0.

Detailed description:
Approximately 20 patients were to be enrolled to receive everolimus in an open label manner. A total of 9 patients were enrolled to either Stratum 1 or Stratum 2.

The study was open for enrollment up to 2 years. Because the target enrollment was not achieved in this period, study was terminated with less patient than planned.

Arms: arm 1: enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
Interventions: intervention 1: Everolimus (RAD001)
Intervention descriptions: intervention 1: oral daily dosing of tablet starting with 2.5 mg

Protocol documents:
Clinical trial NCT01382212
Conditions: End-Stage Renal Disease Secondary Hyperparathyroidism
Keywords: Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-10-01; Completion date: 2015-04-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.

Detailed description:

Arms: arm 1: Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Interventions: intervention 1: paricalcitol
Intervention descriptions: intervention 1: Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.

Protocol documents:
Clinical trial NCT01417026
Conditions: Autism Spectrum Disorders
Keywords: Autism Spectrum Disorders Oxytocin Clinical Trial Computer-based Intervention Social Perception Social Motivation Social Cognition
Sponsor: Robert Schultz
Start date: 2011-09-01; Completion date: 2015-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills.

Detailed description:
Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.

Arms: arm 1: * Intranasal oxytocin (Trade name: Syntocinon)
* Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.
* Route of administration: Intranasal
* Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.
* One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).
* Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland. arm 2: * Intranasal placebo
* The placebo is identical to the oxytocin formulation with the exception of the active compound.
* Route of administration: Intranasal
* Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
* One dose equals 6 spray puffs (3 puffs in each nostril).
* Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
Interventions: intervention 1: Intranasal Oxytocin (Trade name: Syntocinon)
Intervention descriptions: intervention 1: This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period.

Protocol documents:
Clinical trial NCT01443078
Conditions: Lung Cancer
Keywords: Carboplatin Cisplatin Pemetrexed (Altima) Taxotere (Docetaxel) Vinorelbine Tartrate (Navelbine) Stage IB-III non squamous non-small cell lung cancer 11-106
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2011-10-01; Completion date: 2015-04-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer.

It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery.

In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.

Detailed description:

Arms: arm 1: This is a phase 2 clinical trial for patients with clinical Stage IB-III resectable and operable non-small cell lung cancer, evaluating whether the switch to an alternative, non-platinum neoadjuvant chemotherapy is safe and effective in patients who do not respond to neoadjuvant platinum-based chemotherapy. Those who fail to respond to platinum-based chemotherapy will be switched to the alternative neoadjuvant chemotherapy vinorelbine 45 mg/m2 and docetaxel 45 mg/m2 on day 1 followed by pegylated filgrastim on day 2, repeated every 2 weeks for 4 doses, followed by repeat FDG PET and CT scan.
Interventions: intervention 1: pemetrexed intervention 2: cisplatin intervention 3: Carboplatin intervention 4: Gemcitabine Hydrochloride intervention 5: Vinorelbine Tartrate intervention 6: Docetaxel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents: