ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02002832
Conditions: Schizophrenia
Keywords: schizophrenia Lurasidone LATUDA
Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Start date: 2013-12-01; Completion date: 2015-11-01
Enrollment: 388 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lurasidone tablets intervention 2: Risperidone tablets
Intervention descriptions: intervention 1: Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo) intervention 2: Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)

Protocol documents:
Clinical trial NCT02030405
Conditions: Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Recurrent Adult Acute Myeloid Leukemia
Sponsor: Steven E. Coutre
Start date: 2014-03-01; Completion date: 2015-11-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase 2 trial studies how well ixazomib(MLN9708) works in treating study participants with relapsed or refractory acute myeloid leukemia. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVE:

Determine the best response including complete remission (CR), CR with incomplete recovery (CRi), and partial remission (PR) after 3 cycles of treatment with MLN9708 (ixazomib) in participants with nucleophosmin (NPM)1-mutated acute myeloid leukemia (AML) (following the LeukemiaNet1 guidelines for response criteria).

SECONDARY OBJECTIVES:

* Determine the duration of remission in all responders after treatment with MLN9708 defined as the time of documented remission until relapse.
* Determine the 1 year overall survival, which will be measured from time of study entry to the earlier of death from any cause or end of follow up at 1 year.
* Establish toxicity and tolerability of MLN9708 treatment in AML, including non-hematologic toxicities grade 3 or above as specified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

OUTLINE:

Participants receive ixazomib orally (PO) on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Participants receive ixazomib PO (orally) on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Ixazomib
Intervention descriptions: intervention 1: Given orally (PO)

Protocol documents:
Clinical trial NCT02052011
Conditions: Microvascular Angina
Keywords: Chest Pain Microvascular Angina Ranolazine Emergency department PET
Sponsor: Yale University
Start date: 2014-04-01; Completion date: 2015-11-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of Ranolazine for the treatment chest pain from disease of small vessels of the heart also known as 'microvascular angina'.

Detailed description:
The Yale Chest Pain Center (CPC) is a unique clinical lab that provides an integrated interdisciplinary research team, access to high volume of chest pain patients largely free of coronary disease (93%) as well state of the art diagnostics including cardiac PET and a sophisticated system for serum processing and banking facilities. The CPC cohort represents a unique population with unrecognized microvascular disease and is often only accessible through the ED. We propose a one-year pilot study to understand the mechanisms of angina relief by Ranolazine (n=20) in patients with microvessel disease in the ED population as compared to controls (n=10) at baseline and at 1-month. In addition, changes in pain scores and function as measured by Seattle Angina Questionnaire (SAQ), recidivism and costs will be measured and correlated with changes in coronary flow reserve (CFR). Serum samples will be obtained and banked for future marker analysis as intermediate surrogates of outcomes.

Primary aim: To compare changes in coronary flow reserve as measured by cardiac PET in patients receiving Ranolazine versus controls.

Secondary aim: To determine if Ranolazine changes Seattle Angina Questionnaire (SAQ) scores in association with changes in Coronary Flow Reserve (CFR) versus controls.

Exploratory aim: To compare composite rate of return visits (office, emergency department and hospitalization) for chest pain within 4-weeks of enrollment between patients with and without Ranolazine.

Arms: arm 1: Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin). arm 2: Subjects will take placebo pill twice daily for 4 weeks.
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will take the extended-release Ranolazine for a total of 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin). intervention 2: None

Protocol documents:
Clinical trial NCT02070991
Conditions: Pulmonary Hypertension
Keywords: pre- and post-capillary pulmonary hypertension CpcPH
Sponsor: Actelion
Start date: 2014-07-01; Completion date: 2015-11-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.

Detailed description:

Arms: arm 1: oral tablet, 10 mg once daily. arm 2: Matching placebo, once daily.
Interventions: intervention 1: Macitentan intervention 2: Placebo
Intervention descriptions: intervention 1: oral tablet, 10 mg once daily intervention 2: matching placebo

Protocol documents:
Clinical trial NCT02074059
Conditions: Respiratory Distress Syndrome
Sponsor: Windtree Therapeutics
Start date: 2014-02-01; Completion date: 2015-11-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.

Detailed description:

Arms: arm 1: 25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP arm 2: 50 mg TPL/kg: Lucinactant for inhalation with nCPAP arm 3: 75 mg TPL/kg: Lucinactant for inhalation with nCPAP arm 4: 100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met. arm 5: 150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met. arm 6: nCPAP therapy alone
Interventions: intervention 1: Lucinactant for Inhalation intervention 2: nCPAP alone
Intervention descriptions: intervention 1: Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) intervention 2: nCPAP therapy

Protocol documents:
Clinical trial NCT02074514
Conditions: Chronic HCV Infection
Sponsor: Gilead Sciences
Start date: 2014-03-01; Completion date: 2015-11-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks. arm 2: Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: RBV
Intervention descriptions: intervention 1: 400 mg tablet administered orally once daily intervention 2: 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT02081690
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH-SYMPACT psychometric instrument
Sponsor: Actelion
Start date: 2014-03-01; Completion date: 2015-11-01
Enrollment: 160 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study.

Primary objectives: To evaluate the psychometric characteristics of reliability and construct validity of the French, Italian and Spanish versions of the PAH-SYMPACT™.

To evaluate the ability of the French, Italian and Spanish versions of the PAH SYMPACT™ to detect change.

Secondary objective: To assess the safety of macitentan in patients with pulmonary arterial hypertension (PAH).

Exploratory objective: To explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT™) in patients with PAH in France, Italy and Spain.

Detailed description:

Arms: arm 1: Macitentan tablet, dose of 10 mg, once daily
Interventions: intervention 1: Macitentan
Intervention descriptions: intervention 1: Macitentan tablet, dose of 10 mg, once daily

Protocol documents:
Clinical trial NCT02086591
Conditions: Adult Diffuse Large B-Cell Lymphoma Mantle Cell Lymphoma Recurrent Lymphoma, Follicular Marginal Zone B-Cell Lymphoma Malignant Lymphoma - Lymphoplasmacytic Waldenstrom Macroglobulinemia Small Lymphocytic Lymphoma Chronic Lymphocytic Leukemia (CLL) T-Cell Lymphoma
Keywords: Non Hodgkin Lymphoma Doxycycline
Sponsor: University of Rochester
Start date: 2014-03-01; Completion date: 2015-11-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether doxycycline is effective in the treatment of relapsed Non Hodgkin Lymphomas (NHL).

Detailed description:
The long-term objective of this proposal is to develop more effective and less toxic therapeutic approaches for relapsed and refractory Non Hodgkin Lymphomas (NHL). Given the incurability of indolent lymphomas, innovative strategies for treatment are needed. For aggressive lymphomas such as Diffuse Large B Cell Lymphoma (DLBCL), novel treatments are particularly relevant since one third of patients have disease that will relapse or is refractory to standard therapy. Outcomes for this remaining group of patients are very poor. To address this unmet need, we have identified the antimicrobial agent doxycycline as a novel drug repurposed for lymphoma treatment based on results from a small molecule screen against Diffuse Large B Cell Lymphoma (DLBCL). Through preclinical work in his laboratory, my basic science collaborator Dr. Jiyong Zhao has found that doxycycline inhibits proliferation and survival in both activated B cell (ABC) type and germinal center B (GCB) type Diffuse Large B Cell Lymphoma (DLBCL) cell lines, as well as in Burkitt lymphoma (BL) and follicular lymphoma (FL) cell lines. Based on this preliminary data, we propose an open label, single center phase II study of doxycycline in patients with relapsed Non Hodgkin Lymphomas (NHL). We have selected a dose and schedule (200 mg BID by mouth daily) based on maximum antimicrobial dose use, and acceptance of tolerability in several studies. The planned correlative studies should help to identify potential biomarkers for response to doxycycline, such as plasma matrix metalloproteinase 9 (MMP9), and provide further insight into potential mechanisms of doxycyline action hypothesized from results of prior laboratory studies.

Arms: arm 1: Doxycycline 200 mg twice daily
Interventions: intervention 1: Doxycycline
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02104427
Conditions: Multiple Myeloma Non-Hodgkin Lymphoma Hodgkin Disease
Sponsor: GPCR Therapeutics, Inc.
Start date: 2015-02-01; Completion date: 2015-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.

Detailed description:

Arms: arm 1: 1\. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal
Interventions: intervention 1: TG-0054 combined with G-CSF
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02110225
Conditions: Retinitis Pigmentosa
Keywords: Cone-Rod Degenerations Cone-Rod Dystrophy Cone-Rod Dystrophy 2 Cone-Rod Retinal Dystrophy Pigmentary Retinopathy Retinal Cone-Rod Dystrophy Rod Cone Dystrophies Rod-Cone Dystrophy Tapetoretinal Degeneration
Sponsor: Dompé Farmaceutici S.p.A
Start date: 2014-01-01; Completion date: 2015-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the safety and tolerability of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution administered over 6 months versus a vehicle control in patients with typical retinitis pigmentosa. The secondary objective of this study is to attempt to show a dose response by assessing the potential efficacy of the rhNGF dose regimens for improving or slowing the deterioration of visual function outcomes at 3 and 6 months. During a 6 month follow-up period patients will be monitored to determine if there is evidence of a persistent biological effect after discontinuation of the study treatment.

Detailed description:
This is a 24-week phase Ib/II, multicenter, randomized, double-masked, vehicle controlled, parallel-group, dose-ranging study with a 24-week follow-up period to evaluate the safety and potential efficacy of two doses (60 μg/ml and 180 μg/ml) of recombinant human nerve growth factor (rhNGF) eye drops solution versus vehicle in patients with typical retinitis pigmentosa (RP).

Arms: arm 1: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes arm 2: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes. arm 3: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes.
Interventions: intervention 1: rhNGF 60 µg/ml eye drops solution intervention 2: rhNGF 180 µg/ml eye drops solution intervention 3: Placebo
Intervention descriptions: intervention 1: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes intervention 2: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes intervention 3: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes

Protocol documents:
Clinical trial NCT02116972
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2014-04-01; Completion date: 2015-11-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

Detailed description:
This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The study was conducted in male and female patients ≥40 years of age with OA of the knee.

Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:

* 16 mg FX006,
* 32 mg FX006, or
* normal saline (placebo).

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \[Baseline\], Weeks 4, 8, 12, 16, 20, and 24).

The study was expected to enroll over approximately 6 to 7 months.

Arms: arm 1: Single 5 mL intra-articular (IA) injection Extended-release formulation arm 2: Single 5 mL intra-articular (IA) injection Extended-release formulation arm 3: Normal Saline Single 5 mL intra-articular (IA) injection
Interventions: intervention 1: FX006 32 mg intervention 2: Placebo intervention 3: FX006 16 mg
Intervention descriptions: intervention 1: Single 5 mL IA injection intervention 2: Single 5 mL IA injection intervention 3: Single 5 mL IA injection

Protocol documents:
Clinical trial NCT02117310
Conditions: Skull Base Neoplasms
Sponsor: Ohio State University
Start date: 2015-03-01; Completion date: 2015-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a feasibility study in which indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal flap harvest will be necessary. The research entails administering ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

Detailed description:
This study is being done to determine if it is feasible to use angiography during endo-nasal surgery. During the angiography indocyanine green (ICG) will be injected into the patients IV tubing to help see the arteries. ICG is routinely used in vascular surgeries on the brain but not for endo-nasal surgery. The purpose of this study is to see how well intraoperative angiography using ICG can be done during endonasal surgery.

Arms: arm 1: Angiography with administered ICG
Interventions: intervention 1: indocyanine green
Intervention descriptions: intervention 1: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

Protocol documents:
Clinical trial NCT02120027
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: Irritable Bowel Syndrome Colon, irritable Bowel disease Diarrhea
Sponsor: Menarini Group
Start date: 2014-02-01; Completion date: 2015-11-01
Enrollment: 558 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 24-week treatment period.

Detailed description:
The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 24 weeks in comparison with placebo in female IBS-D patients. Randomisation to ibodutant and placebo will be 1:1. Efficacy is evaluated in terms of weekly response for abdominal pain intensity and stool consistency over 24 weeks of treatment in at least 50% of the weeks of treatment.

The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period (treatment-free) for IBS severity assessment, a first 24-week double-blind treatment period, a second 28-week re-randomised double-blind treatment period and a 2-week safety follow-up, resulting in a maximum 58-week overall duration of the study for each patient.

Patients report their IBS-related symptoms daily in a telephone-based electronic diary from run-in until end of treatment.

Arms: arm 1: Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 . arm 2: Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.
Interventions: intervention 1: Ibodutant 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablet, to be given once daily. intervention 2: Oral tablet (identical in appearance and weight to ibodutant tablets) to be given once daily.

Protocol documents:
Clinical trial NCT02129062
Conditions: Adult B Acute Lymphoblastic Leukemia Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1 Recurrent Adult Acute Lymphoblastic Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2014-04-01; Completion date: 2015-11-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well ibrutinib works in treating patients with B-cell acute lymphoblastic leukemia that has come back after treatment or has not responded to other treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the efficacy of ibrutinib in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) as measured by objective response rate (ORR).

SECONDARY OBJECTIVES:

I. To evaluate the global safety profile of ibrutinib in patients with relapsed or refractory B-ALL.

II. To assess response duration. III. To assess Bruton's tyrosine kinase (BTK) target inhibition, biomarkers, and gene expression profiles in B-ALL patient samples before and during treatment with ibrutinib.

OUTLINE:

Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Arms: arm 1: Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Ibrutinib intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given orally 560 mg daily (dispensed as 4 x 140-mg capsules) intervention 2: Correlative studies

Protocol documents: