ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02204917
Conditions: Vesico-Ureteral Reflux
Keywords: Ultrasound Ultrasound Contrast Agents Optison contrast enhanced Voiding Urosonography (ceVUS) ceVUS Vesicoureteral Reflux Children Kidney Bladder Urethra Voiding Cystourethrography (VCUG) VCUG Safety Urinary tract
Sponsor: Kassa Darge
Start date: 2014-07-01; Completion date: 2017-03-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.

Detailed description:
Contrast enhanced Voiding Urosonography (ceVUS) is a radiation free, highly sensitive imaging modality for vesicoureteral reflux (VUR) and urethral imaging in children. It employs ultrasound technology in combination with ultrasound contrast agent, which is administered intravesically via a bladder catheter. Currently, second generation ultrasound contrast agents are commercially available, comprising of gas-filled microbubbles. CeVUS in children is being widely practiced, primarily in Europe, despite the fact that none of the commercially available ultrasound contrast agents are yet approved for clinical applications in pediatric population. In the United States, there is limited clinical experience with ceVUS in children. Among the currently commercially available ultrasound contrast agents, OPTISON has already been used in research and off-label in clinical settings involving adults and children. One in-vitro study has been conducted aiming to optimize the ultrasound technical parameters and the dose of OPTISON for intravesical administration in children. In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.

Arms: arm 1: Contrast enhanced Voiding Urosonography (ceVUS) will be performed with the intravesical administration of 0.1%-0.5% OPTISON / normal saline solution. The exact OPTISON dose (ml) that will be adjusted according to the age-related bladder filling capacity with a dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. Voiding Cystourethrography (VCUG) exam will be subsequently performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.
Interventions: intervention 1: OPTISON
Intervention descriptions: intervention 1: Contrast enhanced Voiding Urosonography (ceVUS) with intravesical administration of OPTISON for vesicoureteral reflux detection and urethral imaging in children. Voiding Cystourethrography (VCUG) examination will be subsequently performed as part of the standard care.

Protocol documents:
Clinical trial NCT02204982
Conditions: Follicular Lymphoma
Keywords: Phase 3, Follicular Lymphoma, FL, PI3K
Sponsor: SecuraBio
Start date: 2014-09-01; Completion date: 2017-03-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the safety and efficacy of duvelisib administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.

Detailed description:
Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of duvelisib in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.

Approximately 400 subjects will receive 25 mg of duvelisib or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.

Arms: arm 1: Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.

Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg. arm 2: Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.

Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Interventions: intervention 1: Duvelisib intervention 2: Placebo intervention 3: Rituximab
Intervention descriptions: intervention 1: PI3K Inhibitor intervention 2: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles. intervention 3: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

Protocol documents:
Clinical trial NCT02606500
Conditions: Obesity
Sponsor: University Medical Centre Ljubljana
Start date: 2016-03-01; Completion date: 2017-03-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the present study is to determine, whether clinical efficacy of 150 mcg of Corifollitropin alfa is the same in normal weighing and obese women. Furthermore, investigators want to determine whether oocytes retrieved from normal weighing and obese women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular level.

Detailed description:
The dosage of Corifollitropin alfa used for controlled ovarian hyperstimulation (COH) is adjusted according to the patient's body weight. Meaning, in women with a body weight ≤ 60 kg, a single dose of 100 mcg of Corifollitropin alfa is administered for COH and in women with a body weight \> 60 kg, a single dose of 150 micrograms of Corifollitropin alfa is administered for COH. These two protocols are comparable in safety and efficacy of follicular stimulation.

On the other hand, knowledge about the clinical efficacy of 150 mcg of Corifollitropin alfa in obese women (BMI\>30 kg/m2) is lacking.

Cumulus cells (CC) surround the oocyte and bi-directional communication between oocyte and CC is necessary for the development of mature and quality oocytes. It has been proposed, that analysis of genes, expressed in CC, can serve as an objective indicator of the oocyte's maturity and developmental potential. Expression of genes in CC as hyaluronan synthase 2 (HAS2), follicle-stimulating hormone receptor (FSHR), versican (VCAN), progesterone receptor (PR), vascular endothelial growth factor C (VEGFC), serine protease inhibitor E2 (SERPINE2), glutathione peroxidase (GPX3), pentraxin 3(PTX3) was reported to correlate with oocyte maturity and developmental potential.

The effect of Corifollitropin alfa on expression of these genes however, is unknown.

Arms: arm 1: Elonva 150 mcg intramuscular daily obese arm 2: Elonva 100 mcg intramuscular daily normal weight
Interventions: intervention 1: Elonva
Intervention descriptions: intervention 1: 20 obese women will be the study group and 20 normal weighing women will be the control group. Both groups will receive 150 mcg of Elonva for controlled ovarian hyperstimulation (COH). Gonadotropin-releasing hormone (GnRH) antagonist will be used to prevent premature luteinizing hormone (LH) surge. Additional daily doses of 200 IU of recombinant follicle stimulating hormone (rFSH) will be used if necessary. Human chorionic gonadotropin (hCG) will be used for oocyte maturation. 2 mature follicles will be aspirated separately in each patient. Cumulus cell (CC) samples will be collected and stored on -80 oC for subsequent analysis. Clinical and molecular parameters of IVF success will be assessed and compared between the groups.

The exclusion criteria will be: polycystic ovary syndrome, severely abnormal sperm parameters, and age \> 38 years.

Protocol documents:
Clinical trial NCT02607280
Conditions: Diabetic Peripheral Neuropathic Pain Post-herpetic Neuralgia
Keywords: Diabetic peripheral neuropathic pain post-herpetic neuralgia renal impairment
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2015-12-01; Completion date: 2017-03-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.

Detailed description:
The primary objective is the safety and tolerability of DS-5565 in Japanese subjects with moderate to severe renal impairment.

Arms: arm 1: DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Interventions: intervention 1: DS-5565
Intervention descriptions: intervention 1: DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02734810
Conditions: Exocrine Pancreatic Insufficiency Cystic Fibrosis
Keywords: Exocrine Pancreatic Insufficiency Cystic Fibrosis Liprotamase Pancreatic Enzyme Replacement Therapy (PERT)
Sponsor: Anthera Pharmaceuticals
Start date: 2016-06-01; Completion date: 2017-03-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Detailed description:

Arms: arm 1: Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age arm 2: Liprotamase Powder for Oral Solution in Subjects aged 28 days to \<7 years
Interventions: intervention 1: Liprotamase Powder for Oral Solution
Intervention descriptions: intervention 1: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy

Protocol documents:
Clinical trial NCT02739698
Conditions: Peritoneal Carcinomatosis
Keywords: ovarian cancer
Sponsor: Maimónides Biomedical Research Institute of Córdoba
Start date: 2012-07-01; Completion date: 2017-03-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues (R0) or macroscopic tumor residues \< 1cm (R1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel

Detailed description:

Arms: arm 1: Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in room temperature (36-37ºC). arm 2: Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in continuous hyperthermic perfusion (41-42ºC).
Interventions: intervention 1: Paclitaxel intervention 2: Radical surgery-peritonectomy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02940522
Conditions: Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women
Sponsor: AMAG Pharmaceuticals, Inc.
Start date: 2016-09-01; Completion date: 2017-03-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.

Detailed description:

Arms: arm 1: Subcutaneous (SQ) injection using an autoinjector arm 2: Intramuscular injection (IM) using syringe and needle
Interventions: intervention 1: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) intervention 2: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01846273
Conditions: Age-related Macular Degeneration Polypoidal Choroidal Vasculopathy
Keywords: Polypoidal choroidal vasculopathy Visual acuity Ranibizumab Verteporfin PDT
Sponsor: Novartis Pharmaceuticals
Start date: 2013-08-07; Completion date: 2017-03-02
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.

Detailed description:
Patients were randomized to the study in 2 treatment groups: ranibizumab + vPDT combination therapy, and ranibizumab monotherapy. Based on the results of the primary analysis at Month 12, patients still in the ranibizumab monotherapy group at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit. A total of 168 and 154 patients were included in the ranibizumab + vPDT combined therapy and ranibizumab monotherapy groups, respectively for the FAS (Month 12 analysis). However, the safety set included 172 and 149 patients, respectively. Four patients in the combination therapy group never took vPDT . Among them, 1 patient actually received verteporfin injection but no laser injection. Thus a total of 3 patients (4-1) in the combination therapy group did not take the actual full vPDT treatment. Additionally, 7 patients in the monotherapy group received vPDT and 1 patient from the monotherapy group did not receive ranibizumab treatment. Considering the above numbers, safety set included 172 patients (i.e., 168-3+7) in the ranibizumab + vPDT combination therapy group and 149 patients (i.e., 154-7+3-1) in the ranibizumab monotherapy group for Month 12 analysis. For the Month 24 safety analysis, the 14 patients in the ranibizumab monotherapy group who were switched to ranibizumab +vPDT combination therapy group were analyzed as a separate group, ie, ranibizumab 0.5 mg + vPDT (switched).

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Arms: arm 1: Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) determined at monthly visits based on defined retreatment criteria arm 2: Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) determined at monthly visits based on defined retreatment criteria
Interventions: intervention 1: Ranibizumab intervention 2: Verteporfin PDT intervention 3: Sham PDT
Intervention descriptions: intervention 1: Intravitreal injection of 0.5 mg ranibizumab intervention 2: Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm) intervention 3: Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)

Protocol documents:
Clinical trial NCT02219477
Conditions: Chronic Hepatitis C Decompensated Cirrhosis Hepatitis C Virus
Keywords: Cirrhosis Hepatitis C Child-Pugh B Hepatitis C Genotype 4 Interferon-Free Hepatitis C Genotype 1 Chronic Hepatitis C Decompensated Cirrhosis Hepatitis C Virus
Sponsor: AbbVie
Start date: 2014-11-24; Completion date: 2017-03-03
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.

Detailed description:

Arms: arm 1: ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants arm 2: ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants arm 3: ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir intervention 2: dasabuvir intervention 3: ribavirin
Intervention descriptions: intervention 1: tablet; paritaprevir co-formulated with ritonavir and ombitasvir intervention 2: tablet intervention 3: tablet

Protocol documents:
Clinical trial NCT01044433
Conditions: Head and Neck Cancer Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma Recurrent Metastatic Squamous Neck Cancer With Occult Primary Recurrent Salivary Gland Cancer Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Oropharynx Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Recurrent Verrucous Carcinoma of the Larynx Recurrent Verrucous Carcinoma of the Oral Cavity Salivary Gland Squamous Cell Carcinoma Stage IV Salivary Gland Cancer Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IV Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Stage IV Verrucous Carcinoma of the Larynx Stage IV Verrucous Carcinoma of the Oral Cavity
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2009-10-01; Completion date: 2017-03-03
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine together with lapatinib ditosylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine and lapatinib ditosylate together works in treating patients with squamous cell cancer of the head and neck.

Detailed description:
PRIMARY OBJECTIVE:

I. Overall survival (OS) will be the primary endpoint.

SECONDARY OBJECTIVES:

I. Progression free survival (PFS). II. Time to disease progression and sites of progression. III. Response rate. IV. Toxicity of the combination in this population. V. Quality of life.

OUTLINE:

Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 5 years.

Arms: arm 1: Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14.
Interventions: intervention 1: lapatinib ditosylate intervention 2: capecitabine
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT01001377
Conditions: Metastatic Colorectal Cancer
Keywords: Panitumumab Vectibix Colon Cancer Colorectal Cancer Rectal Cancer Cetuximab Erbitux Metastatic
Sponsor: Amgen
Start date: 2010-02-02; Completion date: 2017-03-07
Enrollment: 1010 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.

Detailed description:

Arms: arm 1: Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.

Participants were treated until disease progression, intolerability, withdrawal of consent, or death. arm 2: Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
Interventions: intervention 1: Cetuximab intervention 2: Panitumumab
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: Administered by intravenous infusion

Protocol documents:
Clinical trial NCT01520870
Conditions: Glioblastoma Brain Tumor, Recurrent
Keywords: Dacomitinib PF-299804 Glioblastoma, Recurrent EGFR
Sponsor: Grupo Español de Investigación en Neurooncología
Start date: 2012-02-01; Completion date: 2017-03-09
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, 2-stage, open-label, phase II trial aims to assess the efficacy and safety of dacomitinib in adult patients with recurrent Glioblastoma (GBM) with EGFR gene amplification and/or EGFRvIII mutation.

Detailed description:

Arms: arm 1: Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end. Patients at first recurrence will be enrolled onto 1 of 2 cohorts that will be recruited and analysed independently. Cohort A will include patients who have EGFRvIII mutations. Cohort B will include patients who have EGFR gene amplification but no EGFRvIII mutations.
Interventions: intervention 1: PF-299804 (Dacomitinib)
Intervention descriptions: intervention 1: Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end.

Protocol documents:
Clinical trial NCT01927120
Conditions: Graft-Versus-Host-Disease
Keywords: GVHD Allogeneic Hematopoietic Cell Transplant
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2014-03-25; Completion date: 2017-03-09
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
IL-2 add-back post allogeneic hematopoietic stem cell transplant (HSCT), combined with Sirolimus (SIR), Tacrolimus (TAC) will optimize Treg reconstitution and prevent graft versus host disease (GVHD).

Detailed description:
1\) Determine if a GVHD prophylaxis regimen of IL-2/SIR/TAC enhances in vivo Treg differentiation and growth; 2) Study the safety and effects of IL-2/SIR/TAC on the incidence of acute and chronic GVHD; 3) Evaluate the influence of dual IL-2 supplementation and mammalian target of rapamycin (mTOR) inhibition on T cell-specific signaling pathways and the polarization of emerging T helper cells.

Arms: arm 1: Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).
Interventions: intervention 1: IL-2 intervention 2: Tacrolimus intervention 3: Sirolimus
Intervention descriptions: intervention 1: A subcutaneous injection will be administered 3 times a week (separated by at least 1 day between injections), from day 0 to +90 (+/- 7 days). intervention 2: Will be administered at 0.01 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3 intervention 3: Orally on day -1. The dose for loading is 12 mg by mouth (PO)

Protocol documents: