ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00956930
Conditions: Liver Cancer
Keywords: advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma
Sponsor: Northwestern University
Start date: 2009-08-01; Completion date: 2016-07-15
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet known which treatment regimen is more effective in treating patients with liver cancer.

PURPOSE: This randomized phase II trial is studying radioembolization to see how well it works compared with chemoembolization in treating patients with liver cancer that cannot be treated with Radiofrequency Ablation or removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression.

Secondary

* Characterize the safety and toxicity profile of these regimens.
* Determine the need for subsequent treatment in these patients.
* Determine tumor response in these patients
* Characterize change in quality of life and functional status in these patients.
* Determine time to progression in these patients.

OUTLINE: Patients are randomized to receive either TACE or Y90

* Arm I (radioembolization): Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
* Arm II (transarterial chemoembolization \[TACE\]): Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.
* In both arms, treatment modifications may apply according to response.

After completion of study treatment, patients are followed every 3 months.

Arms: arm 1: Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. arm 2: Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.
Interventions: intervention 1: yttrium Y 90 glass microspheres intervention 2: Doxorubicin
Intervention descriptions: intervention 1: Patients undergo radioembolization. intervention 2: 75mg fixed dose

Protocol documents:
Clinical trial NCT02034006
Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia
Keywords: pathological myopia choroidal neovascularization ranibizumab mono-bilateral poor visual acuity retinal disease eye disease Angiogenesis Inhibitors Angiogenesis Modulating Agents
Sponsor: Novartis Pharmaceuticals
Start date: 2014-06-10; Completion date: 2016-07-15
Enrollment: 200 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to investigate current criteria driving re-treatment in patients affected by Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM) and experiencing a relapse of the disease after the first administration of ranibizumab.

Detailed description:

Arms: arm 1: Patients treated with a single ranibizumab 0.5 mg/0.05ml intravitreal injection
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: All patients received a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per Committee for Human Medicinal Products (CHMP)approval. Further injections might have been required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, was evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment was allowed provided at least 14 days of intercurrence.

Protocol documents:
Clinical trial NCT02546544
Conditions: Relapsed Ewing Sarcoma Refractory Ewing Sarcoma
Keywords: Linsitinib anti-IGF-1R/IR Ewing Sarcoma dual IGF-1R/IR inhibition Relapsed Ewing Sarcoma Refractory Ewing Sarcoma Metastatic Ewing Sarcoma
Sponsor: University of Oxford
Start date: 2014-03-01; Completion date: 2016-07-15
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an international, multi-centre, single arm Bayesian designed phase 2 study to identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7 European centres. Each patient will be treated with single agent linsitinib, 600 mg orally once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue toxicity.

Detailed description:
An important development in ES has been the identification of IGF-1R pathway dependency. The reasons for the remarkable single agent efficacy observed in a small subset of patients remains unknown, as is the relative lack of efficacy in the majority of patients. There may be heterogeneity in response due to partial signal pathway inhibition at the tumour level, inherent resistance in ES cells or the presence of alternative pathway activation through IR-A receptor signalling.

Here we aim to establish pharmacodynamic responses in ES tumours using functional imaging 18FDG-PET-CT and repeat post treatment biopsy for biomarker responses, toxicity and clinical outcome to the dual anti-IGF-1R/IR kinase blocking single agent linsitinib.

This is a single arm phase 2 study utilising adaptive Bayesian analysis. Approximately 40 patients will be recruited the national bone sarcoma centre in 5 EU countries over 18 months.

Eligible patients will take 4x 150 mg tablets once a day, days 1-3 of the week followed by 4 days off - repeated for 3 weeks = one treatment cycle. Patients can remain on treatment for as long as they gain clinical benefit.

The primary objectives are to determine the effect of linsitinib on the patient's tumours in terms of changes in biomarker and PET scans and to establish the safety of the trial drug (linsitinib) in Ewing sarcoma at the dose and treatment schedule being used in the trial.

Arms: arm 1: Linsitinib is to be taken orally once a day on days 1-3, 8-10 and 15-17 on a 21 day cycle. The starting dose is 600 mg
Interventions: intervention 1: Linsitinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02656485
Conditions: Acne Vulgaris
Sponsor: AOBiome LLC
Start date: 2015-08-05; Completion date: 2016-07-15
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single center, randomized, double-blind, placebo-controlled study in subjects with acne vulgaris.

Detailed description:
After a screening visit and a one-week washout (if applicable), three sequential ascending doses of the study drug will be applied twice-daily (BID) for 14 days in three groups of subjects. Each group of subjects will be randomized to receive the planned doses of B244 or placebo BID

Arms: arm 1: B244 Dose 1 (dose level \[cells/mL\] 20,000,000,000) arm 2: B244 Dose 2 (dose level \[cells/mL\] 40,000,000,000) arm 3: B244 Dose 3 (dose level \[cells/mL\] 80,000,000,000) arm 4: Placebo to Match B244
Interventions: intervention 1: B244 intervention 2: Placebo
Intervention descriptions: intervention 1: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days intervention 2: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days

Protocol documents:
Clinical trial NCT00006227
Conditions: Adult Type Ovarian Granulosa Cell Tumor Ovarian Gynandroblastoma Ovarian Sertoli-Leydig Cell Tumor Ovarian Sex Cord Tumor With Annular Tubules Ovarian Steroid Cell Tumor
Sponsor: Gynecologic Oncology Group
Start date: 2000-11-20; Completion date: 2016-07-16
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.

II. To evaluate the value of inhibin for predicting response.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.

Arms: arm 1: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Paclitaxel
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT02191137
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Hypertension,Riociguat,Living with Pulmonary Hypertension Questionnaire
Sponsor: Bayer
Start date: 2014-09-23; Completion date: 2016-07-16
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and living in the United States. In addition, the study explored the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients with PAH.

Detailed description:

Arms: arm 1: Single arm, open label
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521)
Intervention descriptions: intervention 1: Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.

Protocol documents:
Clinical trial NCT01393964
Conditions: Multiple Myeloma
Sponsor: Bristol-Myers Squibb
Start date: 2012-01-06; Completion date: 2016-07-18
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.

Detailed description:

Arms: arm 1: Severe Renal Impairment arm 2: End-stage renal disease arm 3: Normal renal function
Interventions: intervention 1: Lenalidomide intervention 2: Dexamethasone intervention 3: Dexamethasone intervention 4: Dexamethasone intervention 5: Elotuzumab (BMS-901608; HuLuc63)
Intervention descriptions: intervention 1: Capsules, Oral, 15 mg, One capsule every 48 hours through Days 1-21 (Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 2: Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 3: Tablets, Oral, 40 mg, weekly, on days 8, 15 \& 22 (cycle 1); days 8 \&22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 4: Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 5: Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Protocol documents:
Clinical trial NCT01716039
Conditions: Ulcerative Colitis
Keywords: Moderately to severely active Ulcerative Colitis
Sponsor: Alimentiv Inc.
Start date: 2013-06-01; Completion date: 2016-07-18
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active ulcerative colitis.

Detailed description:
Assess the Pharmacokinetic dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active UC.

Arms: arm 1: Receive once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab 18 weekly doses of MTX and/or placebo in addition to doses of adalimumab arm 2: Once weekly oral dosing with MTX 25 mg (n=40) two weeks prior to the initiation of adalimumab 18 weekly doses of MTX in addition to doses of adalimumab arm 3: Once weekly oral dosing with placebo (n=20) two weeks prior to the initiation of adalimumab. Subjects will receive 18 weekly doses of placebo in addition to doses of adalimumab
Interventions: intervention 1: MTX 12.5 intervention 2: MTX 25 intervention 3: Adalimumab
Intervention descriptions: intervention 1: once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or \>9).

Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab intervention 2: once weekly oral dosing with MTX 25 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or \>9).

Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab intervention 3: Subjects will receive 18 weekly doses of adalimumab

Protocol documents:
Clinical trial NCT01834651
Conditions: Prostate Cancer
Keywords: liver metastasis lung metastasis metastatic castrate-resistant prostate cancer
Sponsor: Edwin Posadas, MD
Start date: 2013-04-30; Completion date: 2016-07-18
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.

Detailed description:
Cabozantinib (XL184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a powerful clinical phenotype in men with metastatic castrate resistant prostate cancer (mCRPC) both before and after chemotherapy. This phenotype consists of rapid reduction in pain (when present) and improvement in bone scans that may or may not be accompanied by decrease in serum prostate specific antigen (PSA) concentrations. In previous studies of cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded. Hence, this protocol creates a unique opportunity to define the activity of this disease in the population of men with visceral disease - a marker for poorer prognosis in mCRPC.

Primary Objectives:

\- To assess the clinical benefit (complete response + partial response + stable disease) of cabozantinib in patients with mCRPC with visceral metastases.

Secondary Objectives:

* To assess the impact of cabozantinib on numbers live circulating tumor cells (CTCs) using NanoVelcro Chips
* To test the feasibility of measuring variation in gene expression in circulating tumor cells (CTCs) in response to therapy.
* To determine if there is an impact of cabozantinib on live circulating tumor cell (CTC) number and patterns of gene expression.
* To measure the impact of cabozantinib on serum HGF (hepatocyte growth factor) and VEGF (vascular endothelial growth factor) levels in men with metastatic, castration-resistant prostate cancer (mCRPC).
* To assess the safety and tolerability of lower doses (i.e. doses below 100 mg daily) of cabozantinib in mCRPC with visceral involvement.
* To collect blood, urine, tissue, and plasma which may be used determine if there are germline genetic variations that correlate with toxicity.
* To pilot correlations between molecular content between circulating tumor cells (CTCs), large oncosomes, and tumor tissue.

Arms: arm 1: Cabozantinib 60mg orally daily until disease progression
Interventions: intervention 1: Cabozantinib
Intervention descriptions: intervention 1: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.

Protocol documents:
Clinical trial NCT02455167
Conditions: Hepatitis C
Keywords: HCV Hepatitis C
Sponsor: University of Colorado, Denver
Start date: 2015-05-01; Completion date: 2016-07-18
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV).
2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.

Detailed description:
The proposed study will quantify hepatic improvement and antiviral efficacy of the open-label interferon-free combination of 12 weeks of simeprevir (SMV, Simeprevir), sofosbuvir (SOF, Sofosbuvir), and ribavirin (RBV) in patients with HCV genotype 1 infection and early decompensation of cirrhosis. Early decompensation is defined by clinical complications or laboratory deterioration but with a model for end-stage liver disease (MELD) score of 10 or less.

The primary objective of this trial is determination of hepatic functional improvement as measured by the HepQuant (HQ) test during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV). Standard laboratory tests, clinical models (MELD, CTP), liver biopsy, hepatic venous pressure gradient (HVPG), and other imaging tests are insensitive, invasive, or nonspecific.

They may not adequately assess the liver's improvement after viral eradication. In contrast, HepQuant (HQ) tests (Systemic Hepatic Filtration Rate (HFR), Portal HFR, SHUNT,single point cholate concentration (STAT), and DSI) are noninvasive, sensitive, specific, and target an endogenous function, the hepatic uptake of cholate. HQ tests uses serum sampling over a time period of up to 90 minutes to quantify the systemic circulation, portal circulation, and portal-systemic shunt and to derive a disease severity index (DSI) in intact human subjects. The primary endpoint in this treatment trial will be improvement in hepatic function measured by HepQuant (HQ) tests that occurs during and after successful Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV).

Arms: arm 1: A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.
Interventions: intervention 1: Simeprivir (SMV) intervention 2: Sofosbuvir (SOF) intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: Experimental Single arm study. All participants will get the same treatment. intervention 2: Experimental Single arm study. All participants will get the same treatment. intervention 3: Experimental Single arm study. All participants will get the same treatment.

Protocol documents:
Clinical trial NCT01074047
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia Cytarabine Vidaza azacitidine Intensive Chemotherapy Low Dose Cytarabine Celgene
Sponsor: Celgene
Start date: 2010-06-01; Completion date: 2016-07-25
Enrollment: 488 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

Detailed description:

Arms: arm 1: Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity arm 2: Conventional Care Regimen
Interventions: intervention 1: Azacitidine intervention 2: Conventional Care Regimen
Intervention descriptions: intervention 1: 75 mg/m\^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity intervention 2: Physician pre-selects prior to randomization from one of the following:

* Intensive chemotherapy (cytarabine 100-200 mg/m\^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
* Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
* Best Supportive Care only; until study end

Protocol documents:
Clinical trial NCT02047110
Conditions: Ankylosing Spondylitis (AS)
Sponsor: AbbVie
Start date: 2014-01-28; Completion date: 2016-07-25
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.

Detailed description:

Arms: arm 1: Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period. arm 2: Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks arm 3: Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period arm 4: Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Interventions: intervention 1: placebo for risankizumab intervention 2: risankizumab
Intervention descriptions: intervention 1: Placebo for risankizumab administered by subcutaneous (SC) injection intervention 2: Risankizumab administered by subcutaneous (SC) injection

Protocol documents:
Clinical trial NCT02424344
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2015-04-27; Completion date: 2016-07-25
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.

Detailed description:

Arms: arm 1: 8 weeks, double blind treatment period arm 2: 8 weeks, double blind treatment period
Interventions: intervention 1: Aclidinium/Formoterol intervention 2: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler intervention 2: Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler

Protocol documents: