ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01948141
Conditions: Recurrent Non-small Cell Lung Cancer Squamous Cell Lung Cancer Stage III Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2014-01-30; Completion date: 2016-08-16
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well nintedanib works in treating patients with advanced non-small cell lung cancer who have failed up to two previous chemotherapy regimens. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the 6-month progression-free survival (PFS) rate of fibroblast growth factor receptor 1 (FGFR1) amplified squamous cell lung cancer patients treated with BIBF 1120 (nintedanib).

SECONDARY OBJECTIVES:

I. Compare the 6-month PFS rate for the entire FGFR1 amplified group versus the FGFR1 non-amplified patients.

II. Compare the 6-month PFS rate for each FGFR1 amplified group (low, intermediate, and high) versus historical controls and FGFR1 non-amplified patients.

III. To assess the following endpoints overall and by FGFR1 group: PFS, overall survival (OS), confirmed tumor response rate, and adverse events.

TERTIARY OBJECTIVES:

I. The relation of FGFR1 gene copy number with PFS, OS, confirmed response rate, and adverse events.

II. The relationship fibroblast growth factor receptor (FGFR) polymorphisms with toxicity and efficacy.

OUTLINE:

Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 8 weeks.

Arms: arm 1: Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: nintedanib
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT02321800
Conditions: Urinary Tract Infections
Keywords: S-649266 complicated urinary tract infection cefiderocol acute uncomplicated pyelonephritis Gram-negative pathogens imipenem/cilastatin
Sponsor: Shionogi
Start date: 2015-02-05; Completion date: 2016-08-16
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the efficacy and safety of intravenous cefiderocol (S-649266) in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens.

Detailed description:

Arms: arm 1: Participants received 2 g cefiderocol by intravenous injection once every 8 hours for 7 to 14 days. arm 2: Participants received 1 g each of imipenem/cilastatin by intravenous injection once every 8 hours for 7 to 14 days.
Interventions: intervention 1: Cefiderocol intervention 2: Imipenem/cilastatin
Intervention descriptions: intervention 1: 2000 mg intravenously every 8 hours for 7 to 14 days; dose adjustments for participants with reduced renal function (estimated CrCl ≤ 70 mL/minute) and/or body weight (\< 70 kg) included every 6-hour dosing intervals and/or reduced doses. intervention 2: 1000 mg of each intravenously every 8 hours for 7 to 14 days; dose adjustments for participants with reduced renal function (estimated CrCl ≤ 70 mL/minute) and/or body weight (\< 70 kg) included every 6-hour dosing intervals and/or reduced doses.

Protocol documents:
Clinical trial NCT02547623
Conditions: Cataract
Sponsor: ICON Bioscience Inc
Start date: 2015-11-06; Completion date: 2016-08-16
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.

Detailed description:
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks

Arms: arm 1: dexamethasone depot 517 mcg arm 2: prednisolone drops 1%
Interventions: intervention 1: Dexamethasone intervention 2: Prednisolone
Intervention descriptions: intervention 1: depot intracameral intervention 2: Prednisolone eye drops 1%

Protocol documents:
Clinical trial NCT01979614
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
Sponsor: Novartis Pharmaceuticals
Start date: 2014-02-03; Completion date: 2016-08-17
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a mechanistic study in patients with coronary artery disease on the effects of Serelaxin on micro- and macrovascular function.

Detailed description:
double blind, randomized, parallel group, placebo controlled study

Arms: arm 1: Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours arm 2: Placebo was administered by intravenous infusion for 48 hours
Interventions: intervention 1: Serelaxin intervention 2: Placebo
Intervention descriptions: intervention 1: Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution intervention 2: 5% v/v glucose solution

Protocol documents:
Clinical trial NCT01866293
Conditions: Relapsed or Refractory Multiple Myeloma
Keywords: Cabozantinib (XL184) 12-240
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2013-05-28; Completion date: 2016-08-18
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an open label phase I/II trial to investigate the safety and efficacy of Cabozantinib for patients with relapsed or refractory myeloma.

Detailed description:

Arms: arm 1: Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.
Interventions: intervention 1: Cabozantinib (XL184)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01938573
Conditions: Recurrent Bladder Carcinoma Stage II Bladder Cancer Stage III Bladder Cancer Stage IV Bladder Cancer
Sponsor: University of Washington
Start date: 2013-10-01; Completion date: 2016-08-18
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies the side effects and best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and to see how well they work in treating patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sirolimus together with cisplatin and gemcitabine hydrochloride may be an effective treatment for bladder cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To define the maximum-tolerated dose (MTD) of sirolimus (rapamycin) combined with gemcitabine hydrochloride and cisplatin (GC). (Phase I)

II. To determine the pathologic complete response rate at cystectomy in patients with localized, muscle invasive carcinoma of the bladder (clinical tumor \[T\]2-4, node \[N\]0 or N1). (Phase II)

SECONDARY OBJECTIVES:

I. To assess the response rate to rapamycin combined with GC. (Phase I)

II. To assess effect of rapamycin with GC on deoxyribonucleic acid (DNA) damage surrogates in cancer associated stroma compared to untreated and GC treated stroma. (Phase I)

III. To assess effect of rapamycin with GC on DNA damage surrogates in cancer associated stroma compared to untreated and GC treated stroma. (Phase II)

IV. To assess toxicity of the MTD dose of rapamycin with GC. (Phase II)

OUTLINE: This is a phase I, dose de-escalation study of sirolimus followed by a phase II study.

Patients receive sirolimus orally (PO) two hours before or after grapefruit juice on day -2, cisplatin intravenously (IV) on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo cystectomy as clinically appropriate after 1-4 courses of treatment.

After completion of study treatment, patients are followed up for 28 days.

Arms: arm 1: Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)
Interventions: intervention 1: Cisplatin intervention 2: Gemcitabine Hydrochloride intervention 3: Sirolimus intervention 4: Cystectomy
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given PO intervention 4: Undergo cystectomy when appropriate

Protocol documents:
Clinical trial NCT02267083
Conditions: Soft Tissue Sarcoma
Keywords: soft tissue sarcoma
Sponsor: Gem Pharmaceuticals
Start date: 2015-01-07; Completion date: 2016-08-18
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and efficacy of GPX-150 administered intravenously every 3 weeks in the treatment of patients with soft tissue sarcoma.

Detailed description:
This is an open-label, single arm study of GPX-150 in patients with soft tissue sarcoma. Approximately 22 patients will be treated in this study. The population for this study is adult patients with histologically proven advanced and/or metastatic malignant soft tissue sarcoma of intermediate or high histologic grade.

All patients who meet all entry criteria will receive GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity or subject withdrawal.

Prior to initiation of treatment, subjects will undergo screening and baseline evaluations. During all study visits, subjects will be evaluated for safety. The dose of GPX-150 may be reduced when subjects meet specified dose reduction safety criteria. Subjects will be evaluated regularly for safety and tolerability. Tumor measurements will be calculated at baseline (within 28 days prior to treatment initiation), then at regular intervals while receiving treatment for up to 1 year. After discontinuing the treatment phase of the study, safety assessments and tumor measurements will be performed 3 weeks after the last dose of study drug.

Arms: arm 1: GPX-150 for Injection, 265 mg/m2, every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity, or subject withdrawal.
Interventions: intervention 1: GPX-150 for Injection
Intervention descriptions: intervention 1: GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study.

Protocol documents:
Clinical trial NCT02291861
Conditions: Tardive Dyskinesia
Keywords: Dyskinesias Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms
Sponsor: Auspex Pharmaceuticals, Inc.
Start date: 2014-10-31; Completion date: 2016-08-19
Enrollment: 298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Detailed description:

Arms: arm 1: Placebo tablets taken twice daily for 12 weeks. arm 2: SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks. arm 3: SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks. arm 4: SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
Interventions: intervention 1: SD-809 intervention 2: Placebo
Intervention descriptions: intervention 1: SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food. intervention 2: Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.

Protocol documents:
Clinical trial NCT02451007
Conditions: Solid Tumors
Sponsor: PharmaMar
Start date: 2015-08-12; Completion date: 2016-08-19
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in patients with selected solid tumors.

Detailed description:

Arms: arm 1: lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
Interventions: intervention 1: lurbinectedin (PM01183)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02254304
Conditions: Relapsing Multiple Sclerosis Clinically Isolated Syndrome
Keywords: Relapsing multiple sclerosis Clinically isolated syndrome RMS CIS RebiSmart™ Rebif® Interferon beta-1a
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2014-12-31; Completion date: 2016-08-20
Enrollment: 106 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rebif
Intervention descriptions: intervention 1: Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.

Protocol documents:
Clinical trial NCT02643862
Conditions: Food Allergy
Sponsor: Stanford University
Start date: 2015-03-18; Completion date: 2016-08-20
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot randomized, double-blind, placebo controlled study which will be conducted at a single center. All participants will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in IND 14831). In a 3:1 ratio, 36\* participants will receive Xolair for 16 weeks while 12\* will receive corresponding placebo instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair. These 12 controls are not part of the randomization. The total number of participants randomized to the two arms is 48\*.

Detailed description:
We will enroll multi food allergic participants (4-55 years of age) with proven "multi food allergies". We anticipate enrolling 60 participants with allergies to, at least two foods. Participants must have food specific IgE\>4kU/L for each allergen or a skin test reactivity to each food allergen ≥ 6 mm wheal diameter. We have chosen criteria associated with a very low likelihood of natural loss of food allergy for the duration of this protocol. These values of specific IgE and SPT were chosen based on the opinions of 4 experts. Participants also must have a total IgE \<1500kU/L, a clinical reaction during a double blind placebo controlled food challenge (DBPCFC) with food proteins/powders to establish sensitivity to given food proteins/powders (milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, walnut, hazelnut) and no clinical reaction during placebo (oat) as per CMC section of IND.

Participants will undergo a rush desensitization day at week 8 to a maximum dose of 1,250 mg total protein. Participants will be ingesting either 2 to 5 food allergens, depending on their allergy screening. They will consume home doses for two weeks based on the these results and document reactions. Upon returning to the CFRU (Clinical Food Research Unit) two weeks later, a dose escalation will be attempted. This cycle will continue until the participant reaches a maximum dose of 2,000 mg protein daily of each food allergen (two to five food allergens to be ingested by the participant). No more than 5 allergens will be given.

Arms: arm 1: Pts will be randomized to receive xolair at a 3 active:1 placebo ratio arm 2: This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair
Interventions: intervention 1: Xolair intervention 2: Placebo
Intervention descriptions: intervention 1: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria intervention 2: Placebo

Protocol documents:
Clinical trial NCT00614822
Conditions: Non Small Cell Lung Cancer
Sponsor: Christiana Care Health Services
Start date: 2007-11-01; Completion date: 2016-08-22
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look for an improvement in progression free survival with the combination of bevacizumab, carboplatin and pemetrexed in patients with newly diagnosed advanced/metastatic non small cell lung cancer. Overall survival and safety will also be assessed.

Detailed description:
Carboplatin: AUC 5 IV over 30-60 minutes on day 1 Pemetrexed: 500mg/M2 IV over 10 minutes on day 1 Bevacizumab: 15mg/kg IV over 90 minutes on day 1 (if rate is tolerated the 2nd dose may be decreased to 60 minutes and subsequent doses to 30 minutes This regimen will be administered every 6 weeks for up to a maximum of 6 cycles if the patient tolerates the treatment and has stable disease. Bevacizumab will be continues if tolerated for up to 1 year at every 3 week intervals.

Folic acid 1mg by mouth daily, Vitamin B12 1000 ug IM every 9 weeks and Dexamethasone 4mg by mouth twice a day and and antiemetic may be prescribed by the physician investigator to help reduce side effects associated with the Pemetrexed. The Folic acid and Vitamin B12 will continue until 3 weeks after the end of treatment.

Physical exams, vital signs and blood work will be done prior to each chemotherapy cycle. A urine dipstick to check for protein in the urine will be done prior to the first treatment and before cycles 3 and 5. A CAT scan of the chest will be done pretreatment, prior to cycles 3 and 5 and at the end of treatment.

Arms: arm 1: Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease.
Interventions: intervention 1: Carboplatin, Pemetrexed and Bevacizumab
Intervention descriptions: intervention 1: Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles

Protocol documents:
Clinical trial NCT01497899
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment-Naive
Sponsor: Gilead Sciences
Start date: 2011-12-28; Completion date: 2016-08-22
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Detailed description:

Arms: arm 1: E/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks arm 2: E/C/F/TDF plus E/C/F/TAF placebo for at least 48 weeks arm 3: Following study unblinding, participants from the E/C/F/TAF and E/C/F/TDF arms may have the option to receive E/C/F/TAF during an open-label extension phase.

Also, participants who are actively participating in a Gilead-sponsored study of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate and receive E/C/F/TAF in this open-label extension phase.
Interventions: intervention 1: E/C/F/TDF intervention 2: E/C/F/TAF Placebo intervention 3: E/C/F/TAF intervention 4: E/C/F/TDF Placebo
Intervention descriptions: intervention 1: 150/150/200/300 mg FDC tablet administered orally once daily intervention 2: Tablet administered orally once daily intervention 3: 150/150/200/10 mg FDC tablet administered orally once daily intervention 4: Tablet administered orally once daily

Protocol documents:
Clinical trial NCT02131155
Conditions: Head and Neck Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2014-07-17; Completion date: 2016-08-22
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

Detailed description:

Arms: arm 1: Once daily arm 2: Once daily
Interventions: intervention 1: Placebo intervention 2: Afatinib
Intervention descriptions: intervention 1: Once daily intervention 2: Once daily

Protocol documents: