ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01680159
Conditions: Plaque Psoriasis Psoriatic Arthritis Pustular Psoriasis (Excluding a Localized) Psoriatic Erythroderma
Keywords: Infliximab REMICADE TA-650 psoriasis
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-07-01; Completion date: 2015-03-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.

Detailed description:
* Patients with plaque psoriasis or psoriatic arthritis:

  1. Screening Period:

     TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours.
  2. Increased Dose Period:

     If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours.
* Patients with pustular psoriasis or psoriatic erythroderma:

TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours.

Arms: arm 1: None
Interventions: intervention 1: TA-650
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01685021
Conditions: Acute Lymphoblastic Leukemia
Keywords: B-ALL CD19 MOR208 MOR00208 Xmab5574 B-cell acute lymphoblastic leukemia Fc-optimized Anti-CD19 Antibody
Sponsor: MorphoSys AG
Start date: 2013-04-01; Completion date: 2015-03-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)

Detailed description:

Arms: arm 1: intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
Interventions: intervention 1: MOR00208 (formerly Xmab5574)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01689532
Conditions: Arthritis, Rheumatoid
Keywords: Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine Sirukumab Human Anti-IL-6 Monoclonal Antibody
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2012-11-01; Completion date: 2015-03-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).

Detailed description:
This is a randomized (patients will be assigned to treatment by chance), double-blind (study personnel and patients will not know what treatments are being given), multicenter study. The expected duration of the study is 68 weeks. This will include 52 weeks of treatment with study agent with dosing every 2 weeks and 16 weeks of safety follow-up after the last dose. Disease-modifying antirheumatic drugs (DMARDs), including MTX and SSZ, are not permitted from 4 weeks before the first dosing with study agent until Week 24. The use of DMARDs is discouraged at or any time after Week 24; however, patients who have less than 20% improvement from baseline in both swollen and tender joint counts at Week 24 will be allowed to take DMARDs. At or any time after Week 16, the initiation and/or adjustment of oral corticosteroids will be allowed for patients who have less than 20% improvement from baseline in both swollen and tender joint counts at Week 16.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sirukumab 100 mg intervention 2: Sirukumab 50 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52. intervention 2: Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. intervention 3: Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.

Protocol documents:
Clinical trial NCT01709578
Conditions: Rheumatoid Arthritis
Sponsor: Sanofi
Start date: 2012-10-01; Completion date: 2015-03-01
Enrollment: 546 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for:

* reduction of signs and symptoms at Week 24 and
* improvement of physical function at Week 12

in participants with active rheumatoid arthritis (RA) who were inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists.

Secondary Objectives:

The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in participants with active RA who were inadequate responders or intolerant to TNF-α antagonists, for:

* Reduction of signs and symptoms at Week 12;
* Improvement in physical function at Week 24;
* Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24;
* Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24.

To assess the exposure of sarilumab added to DMARD therapy in this population.

To assess the safety of sarilumab in this population.

Detailed description:
Total study duration was up to 34 weeks: screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, participant were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).

Arms: arm 1: Placebo matched to sarilumab once every 2 weeks (q2w) was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks. arm 2: Sarilumab 150 mg q2w was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks. arm 3: Sarilumab 200 mg q2w was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.
Interventions: intervention 1: Sarilumab intervention 2: placebo intervention 3: hydroxychloroquine intervention 4: methotrexate intervention 5: sulfasalazine intervention 6: leflunomide
Intervention descriptions: intervention 1: Pharmaceutical form:solution Route of administration: subcutaneous intervention 2: Pharmaceutical form:solution Route of administration: subcutaneous intervention 3: Dispensed according to the local practice. intervention 4: Dispensed according to the local practice. intervention 5: Dispensed according to the local practice. intervention 6: Dispensed according to the local practice.

Protocol documents:
Clinical trial NCT01726023
Conditions: Complicated Intra-abdominal Infection
Keywords: Ceftazidime-avibactam, Metronidazole, Meropenem, Anti-Bacterial Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Physiological Effects of Drugs
Sponsor: Pfizer
Start date: 2013-01-01; Completion date: 2015-03-01
Enrollment: 486 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

Detailed description:
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ceftazidime-avibactam intervention 2: metronidazole intervention 3: Meropenem
Intervention descriptions: intervention 1: Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg intervention 2: Metronidazole 500mg/100ml solution for infusion intervention 3: Meropenem powder for solution for infusion 1000mg

Protocol documents:
Clinical trial NCT01746862
Conditions: Idiopathic Short Stature
Keywords: Saizen® Recombinant human growth hormone (r-hGH) Idiopathic short stature Height velocity Bone age
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2012-12-01; Completion date: 2015-03-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose, for 12 months (12 months of treatment in the test group, and 6 months of no treatment and then 6 months of treatment in the control group).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Saizen® intervention 2: Saizen®
Intervention descriptions: intervention 1: Subjects in the Saizen test group will receive Saizen (recombinant-human growth hormone \[r-hGH\]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months. intervention 2: Subjects in the Saizen control group will receive no treatment for the first 6 months and thereafter will receive Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.

Protocol documents:
Clinical trial NCT01748955
Conditions: Depression Suicidal Ideation
Keywords: Major Depressive Disorder MDD Reward BOLD signal Suicide
Sponsor: New York State Psychiatric Institute
Start date: 2010-06-01; Completion date: 2015-03-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study uses functional magnetic resonance imaging (fMRI) to investigate the effects of two different antidepressant medications (Paxil CR versus Wellbutrin XL) on reward processing in depressed patients who have attempted suicide or are currently experiencing suicidal thoughts.

Detailed description:
Major depressive disorder (MDD) is a common and serious psychiatric illness. It is among the leading causes of disability and is the psychiatric disorder most often associated with suicide. The treatment of MDD with antidepressant medication remains largely trial and error. Little empirical evidence exists to guide the treatment of MDD when suicide risk is a major factor.

The study uses functional magnetic resonance imaging (fMRI) to compare the effects of paroxetine, an SSRI, versus bupropion, a non-SSRI, on brain activity in depressed patients with a past suicide attempt and/or current suicidal thoughts. Participants are randomly assigned to either paroxetine or bupropion treatment for 8 weeks, with fMRI scans involving a reward processing task at baseline and Week 8. Weekly study visits include interviews with a psychologist, self-report scales, and medication monitoring. All participants will then be offered 4 additional months of open clinical treatment. If original medication assignments prove to be ineffective, participants will have the option to switch to another medication. After completing the study, participants will be referred for ongoing treatment.

Arms: arm 1: Participants will receive bupropion XL for 8 weeks. arm 2: Participants will receive Paroxetine CR for 8 weeks.
Interventions: intervention 1: Paroxetine CR for Major Depressive Episode intervention 2: Bupropion XL for Major Depressive Episode
Intervention descriptions: intervention 1: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment. intervention 2: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.

Protocol documents:
Clinical trial NCT01778049
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2013-01-01; Completion date: 2015-03-01
Enrollment: 708 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

Detailed description:

Arms: arm 1: Empagliflozin open label treatment period arm 2: Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in arm 3: Empagliflozin / Linagliptin 25/5 mg Dose FDC active arm 4: Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo arm 5: Empagliflozin / Linagliptin 10/5 mg Dose FDC active arm 6: Empagliflozin open label treatment period arm 7: Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo arm 8: Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
Interventions: intervention 1: BI 10773 intervention 2: BI 10773 Placebo intervention 3: BI 10773 / BI 1356 intervention 4: BI 10773 intervention 5: BI 10773 / BI 1356 intervention 6: BI 10773 / BI 1356 Placebo intervention 7: BI 10773 intervention 8: BI 10773 intervention 9: BI 10773 intervention 10: BI 10773 / BI 1356 Placebo intervention 11: BI 10773 Placebo intervention 12: BI 10773 / BI 1356 Placebo intervention 13: BI 10773 intervention 14: BI 10773 / BI 1356 Placebo
Intervention descriptions: intervention 1: Empagliflozin active intervention 2: Empagliflozin placebo intervention 3: Empagliflozin / Linagliptin 25/5 mg Dose FDC active intervention 4: Empagliflozin active intervention 5: Empagliflozin / Linagliptin 10/5 mg Dose FDC active intervention 6: Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC intervention 7: Empagliflozin active intervention 8: Empagliflozin active intervention 9: Empagliflozin active intervention 10: Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo intervention 11: Empagliflozin placebo intervention 12: Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo intervention 13: Empagliflozin active intervention 14: Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Protocol documents:
Clinical trial NCT01789320
Conditions: Uveitis Intermediate Uveitis Posterior Uveitis Panuveitis Noninfectious Uveitis
Keywords: uveitis intermediate uveitis posterior uveitis panuveitis noninfectious uveitis microneedle suprachoroidal space SCS inflammation ocular inflammatory conditions triamcinolone acetonide TA Triesence injection IVT intravitreal corticosteroid sympathetic ophthalmia temporal arteritis vitreous haze
Sponsor: Clearside Biomedical, Inc.
Start date: 2013-02-01; Completion date: 2015-03-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.

Detailed description:
This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.

Arms: arm 1: TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)
Interventions: intervention 1: triamcinolone acetonide (Triesence®)
Intervention descriptions: intervention 1: 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space

Protocol documents:
Clinical trial NCT01794455
Conditions: Depression Hypertension
Keywords: Depression Depressive Disorder Geriatrics Hypertension
Sponsor: Vanderbilt University
Start date: 2013-05-01; Completion date: 2015-03-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This pilot proposal will test the hypothesis that altered cerebral vessel reactivity and cerebral hypoperfusion (decreased blood flow to the brain) is a core mechanism underlying the relationship between vascular disease and depression in older adults. The long-term objective of this line of research is to: A) determine the relationship between vascular reactivity, cerebral hypoperfusion and the persistence of late-life depression and B) determine if improving cerebral perfusion with angiotensin receptor blockers (ARBs) improves depression outcomes.

Detailed description:
This study will examine how magnetic resonance imaging (MRI) measures of cerebral perfusion relate to antidepressant response. There are two phases to the study. In the first phase, we will examine how cerebral perfusion is related to response to sertraline, a commonly used antidepressant. In the second phase, we will examine individuals who do not respond to sertraline or other selective serotonin reuptake inhibitors (SSRI). We will examine if candesartan, an ARB, improves depression and if it does so by improving cerebral perfusion.

After providing informed consent, participants will undergo medical and psychiatric screening. Participants determined to be eligible at the screen will proceed to a baseline evaluation, which will include brief cognitive neuropsychological testing and MRI. Participants will then begin open-label sertraline for eight weeks (baseline to week 8). Dosing will begin at 50mg daily and, based on response and tolerability, can increase up to the FDA approved maximum dose of 200mg daily.

After the eight weeks, participants will be re-evaluated and complete another MRI. Those who respond to sertraline and experience remission of their depression will end their study participation. Those who do not experience remission will continue to the phase 2 open-label candesartan arm.

The candesartan arm will last for 12 weeks (week 8 to week 20). Dosing will begin at 4mg daily and can increase to a maximum dose of 32mg, based on tolerability and response. Participants will be monitored closely, and other antihypertensive medications adjusted to avoid low blood pressure. At the end of the 12-week trial, participants will again complete MRI and neuropsychological testing. Their study participation will then end.

Arms: arm 1: Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily. arm 2: For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.
Interventions: intervention 1: Sertraline intervention 2: Candesartan
Intervention descriptions: intervention 1: 50mg - 200mg daily intervention 2: 4mg - 32mg daily

Protocol documents:
Clinical trial NCT01806857
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic lateral sclerosis ALS Nuedexta Bulbar function motor neurons
Sponsor: Center for Neurologic Study, La Jolla, California,
Start date: 2013-04-01; Completion date: 2015-03-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).

Detailed description:
Muscle weakness, the cardinal feature of ALS, leads to progressive loss of motor function affecting the limbs, tongue, respiratory and pharyngeal muscles. Symptomatic treatments such as the placement of a feeding tube, can compensate for the inability to swallow. Riluzole, the only approved treatment for ALS, may slow disease progression but no treatment is curative and none have improved function.

Unexpectedly, Nuedexta®, approved for the treatment of labile emotionality that occurs in association with ALS and other neurological disorders, has been observed to improve bulbar function, primarily speech and swallowing, in a number of neurological disorders, including ALS. The basis for this is conjectural but likely due to a direct effect of the drug on motor neurons in the part of the brain that controls speech and swallowing. The same part of the brain appears to modulate the expression of emotions and interestingly the site of action of the drug is the same as a site that has been implicated in a juvenile form of ALS.

This is a multicenter, randomized double-blind, placebo controlled, cross over study evaluating the palliative effect of Nuedexta® on bulbar dysfunction. It is expected that approximately 60 ALS patients from 7 clinical centers in the US will be enrolled.

Arms: arm 1: Subjects in this arm will receive treatment with Nuedexta first for 28 days (±3 days) and then crossed over to receive treatment with matching placebo for 28 days (±3 days). arm 2: Subjects in this arm will receive treatment with matching placebo first for 28 days (±3 days) and then crossed over to receive treatment with Nuedexta for 28 days (±3 days).
Interventions: intervention 1: Nuedexta intervention 2: Matching Placebo
Intervention descriptions: intervention 1: Nuedexta PO (by mouth) for 28 ± 3 days intervention 2: matching placebo PO (by mouth) for 28 ± 3 days

Protocol documents: