ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02300558
Conditions: Long QT Syndrome Type 3
Keywords: Type 3 long QT syndrome (LQT3) Long QT syndrome Congenital long QT Sudden cardiac death
Sponsor: Gilead Sciences
Start date: 2014-12-17; Completion date: 2017-02-15
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension (OLE) phase.

Detailed description:

Arms: arm 1: Eleclazine and/or eleclazine placebo up to Week 24 arm 2: Eligible participants will continue to receive open-label eleclazine until this drug is commercially available for the treatment of patients with LQT3, or until Gilead terminates development of eleclazine for the treatment of patients with LQT3, or the investigator deems it no longer in the participant's best interest.
Interventions: intervention 1: Eleclazine intervention 2: Eleclazine placebo
Intervention descriptions: intervention 1: Tablets administered orally intervention 2: Tablets administered orally

Protocol documents:
Clinical trial NCT01211262
Conditions: Malignant Melanoma
Keywords: Melanoma Phase I Biologic
Sponsor: Immunocore Ltd
Start date: 2010-09-28; Completion date: 2017-02-16
Enrollment: 84 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The drug is designed to target melanoma cells and stimulate immune cells to kill them. This trial is designed to establish the level of drug that can be given to a patient that is tolerable. It also designed to establish the best dosing schedule for the drug and to look for signals that the drug is working as intended.

Detailed description:
IMCgp100 is a bispecific biologic incorporating an engineered T cell receptor (TCR) specific for a peptide antigen derived from the protein gp100 presented in the context of HLA A2 on the surface of melanoma cells. The TCR is fused to an anti-CD3 antibody single-chain variable fragment (scFv) that recruits and activates non-melanoma specific T cells (killer T cells) in physical contact with the cancer T cell. This is a Phase I study designed to assess the safety profile and establish a tolerable dose of IMCgp100 in HLA A2 positive malignant melanoma patients. The study has two treatment arms with different treatment schedules, weekly or daily dosing. Each treatment arm in the study has two parts. In the first part, dose escalation, the safety and tolerability of the drug are examined and the optimal dose of drug is established. In the second part of the trial, participants will receive an extended course of treatment with a view to assessing the effect of the drug on disease.

Arms: arm 1: Weekly intravenous (IV) infusions of IMCgp100 over treatment cycles of 8 weeks each. arm 2: Daily IV infusions of IMCgp100 administered on days 1 to 4 and days 22 to 25 of a six-week treatment cycle.
Interventions: intervention 1: IMCgp100
Intervention descriptions: intervention 1: For each arm, the study will be divided into two parts: In part 1, dose escalation, the MTD or RP2D for each dosing regimen will be established. In part 2, dose expansion, a cohort of participants will be treated at the RP2D or MTD.

Protocol documents:
Clinical trial NCT01986101
Conditions: Bipolar Depression
Sponsor: Sumitomo Pharma Co., Ltd.
Start date: 2014-02-19; Completion date: 2017-02-16
Enrollment: 525 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Detailed description:
The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day) monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.

Arms: arm 1: once daily orally arm 2: once daily orally arm 3: once daily orally
Interventions: intervention 1: Placebo intervention 2: SM-13496 intervention 3: SM-13496
Intervention descriptions: intervention 1: Placebo comparator intervention 2: SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6 intervention 3: SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6

Protocol documents:
Prot_000.pdf: 























































































































































SAP_001.pdf:
Clinical trial NCT02485353
Conditions: Leukemia, Myeloid, Acute
Keywords: Vosaroxin Cytarabine Remission Induction Safety Progression-Free Survival Mortality Rate Length of Stay
Sponsor: Hamid Sayar
Start date: 2015-10-20; Completion date: 2017-02-16
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the treatment of adults 60 years of age or older with previously untreated acute myeloid leukemia. A total of 17 evaluable patients are planned to be treated on the study.

Detailed description:
Primary objective: rate of complete remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) Secondary objectives: (1) safety of this combination in induction therapy of older patients previously unexposed to intensive chemotherapy; (2) progression-free survival; (3) length of stay in hospital for induction; (4) 30- and 60-day mortality rate.

The treatment period will include up to 4 cycles of treatment (induction 1, induction 2, consolidation 1, and consolidation 2). In each cycle, the first day of study treatment will be considered day 1.

* Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L.
* Up to 2 cycles of consolidation treatment may be completed by eligible patients in remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) if safety parameters are met.

Arms: arm 1: None
Interventions: intervention 1: Vosaroxin and Cytarabine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02493517
Conditions: Acromegaly
Sponsor: Ipsen
Start date: 2014-10-01; Completion date: 2017-02-16
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.

Detailed description:

Arms: arm 1: Lanreotide Autogel 90mg from day 1 to week 13, 1 injection every 4 weeks (4 in total), titrated to 60mg, 90mg, or 120mg at week 17, then from week 17 to week 29 each group receives 1 injection every 4 weeks (4 in total/group). arm 2: Lanreotide PR 40mg from day 1 to week 15, 1 injection every 10 days, then at dose titration (week 16) injection frequency will either remain at 10 days or increase to 14 days or decrease to 7 days up until week 30 or 31.
Interventions: intervention 1: Lanreotide Autogel® intervention 2: Lanreotide Acetate
Intervention descriptions: intervention 1: Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate). intervention 2: Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection (provided as a sterile injectable lyophilisate of lanreotide acetate).

Protocol documents:
Clinical trial NCT01376908
Conditions: Phenylketonuria
Keywords: Phenylketonuria (PKU) Kuvan® (Sapropterin) Phe-restricted diet Paediatric <4 years old responders to BH4 Phe tolerance
Sponsor: BioMarin Pharmaceutical
Start date: 2011-06-01; Completion date: 2017-02-17
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with phenylketonuria (PKU).

Detailed description:

Arms: arm 1: Subjects will be treated with Kuvan® tablets once daily along with Phe-restricted diet therapy. arm 2: Subjects will follow a Phe-restricted diet alone.
Interventions: intervention 1: Kuvan® intervention 2: Phenylalanine (Phe)-restricted diet
Intervention descriptions: intervention 1: Kuvan® (sapropterin dihydrochloride) tablets will be administered orally at the dose of 10 mg/kg/day and will be escalated to 20 mg/kg/day if after 4 weeks a subject's Phe tolerance is not increased by at least 20% versus baseline. intervention 2: Phe intake will be adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.

Protocol documents:
Clinical trial NCT02949973
Conditions: Lupus Nephritis
Keywords: lupus nephritis calcineurin inhibitors voclosporin
Sponsor: Aurinia Pharmaceuticals Inc.
Start date: 2015-06-01; Completion date: 2017-02-17
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in patients with active lupus nephritis

Detailed description:
Voclosporin is a novel calcineurin inhibitor (CNI) intended for use in the prevention of organ graft rejection and for the treatment of autoimmune diseases. The aim of the current development program is to investigate whether voclosporin added to the standard of care treatment in active Lupus Nephritis (LN) is able to reduce disease activity, as measured by a reduction in proteinuria. The background therapy will be mycophenolate mofetil (MMF) 2 g daily, initial treatment with IV methylprednisolone followed by a reducing course of oral corticosteroids. Patients with active, flaring LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria (American College of Rheumatology) and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria while demonstrating an acceptable safety profile.

Arms: arm 1: Voclosporin, oral, 23.7 mg twice daily (BID)
Interventions: intervention 1: voclosporin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02338843
Conditions: Catecholamine-resistant Hypotension (CRH) Distributive Shock High Output Shock Sepsis
Sponsor: La Jolla Pharmaceutical Company
Start date: 2015-03-01; Completion date: 2017-02-18
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.

Detailed description:
Catecholamine-resistant hypotension (CRH) is an often fatal condition resulting from an underlying cause such as septic shock, inflammation due to trauma, or severe drug reactions. When these conditions occur, most patients will respond to either volume expansion or vasopressor treatment. However, some patients will require excessive doses of vasopressors and will be deemed to be resistant.

Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of patients with catecholamine-resistant hypotension (CRH).

This is a multi-site, randomized, double-blind, placebo-controlled study. Adult patients with CRH, who are hospitalized in an ICU setting, may be eligible to participate. Approximately 315 patients will be enrolled.

Arms: arm 1: Treatment arm arm 2: Placebo arm
Interventions: intervention 1: LJPC-501 intervention 2: Placebo
Intervention descriptions: intervention 1: Treatment arm intervention 2: PBO

Protocol documents:
Clinical trial NCT01691794
Conditions: HIV, Pediatric
Sponsor: Bristol-Myers Squibb
Start date: 2012-11-30; Completion date: 2017-02-20
Enrollment: 108 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.

Detailed description:

Arms: arm 1: Participants with baseline weight of 15 to \<20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years. arm 2: Participants with baseline weight of 20 to \<40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years. arm 3: Participants with baseline weight ≥ 40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
Interventions: intervention 1: Atazanavir intervention 2: Ritonavir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01559090
Conditions: Systemic Lupus Erythematosus
Keywords: Japan Phase2 Safety Tolerability Systemic Lupus Erythematosus SLE, MEDI-546
Sponsor: AstraZeneca
Start date: 2012-04-20; Completion date: 2017-02-21
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.

Detailed description:
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)

Arms: arm 1: MEDI-546 100 mg IV arm 2: MEDI-546 300 mg IV arm 3: MEDI-546 1000 mg IV
Interventions: intervention 1: MEDI-546 intervention 2: MEDI-546 intervention 3: MEDI-546
Intervention descriptions: intervention 1: Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks intervention 2: Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks intervention 3: Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.

Protocol documents:
Clinical trial NCT02871011
Conditions: Tinea Pedis
Keywords: Tinea Bronchodilator Agents Tinea Pedis Nitric Oxide Dermatomycoses Endothelium-Dependent Relaxing Factors Infectious Infection Mycoses Skin Diseases Foot Dermatoses Foot Diseases Pruritus Skin Manifestations Signs and Symptoms
Sponsor: Nitric Solutions Inc.
Start date: 2016-08-13; Completion date: 2017-02-21
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing solution footbath and it's effect on the clinical signs and symptoms associated with Tinea Pedis

Detailed description:
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject \& Assessor) Primary Purpose: Treatment

Arms: arm 1: Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. arm 2: Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.
Interventions: intervention 1: Nitric Oxide intervention 2: Water
Intervention descriptions: intervention 1: Delivered as a footbath intervention 2: Delivered as a footbath

Protocol documents:
Clinical trial NCT01868997
Conditions: Thyroid Associated Ophthalmopathies Thyroid-Associated Ophthalmopathy
Keywords: Thyroid Eye Disease, Graves Orbitopathy, Thyroid Associated Ophthalmopathy
Sponsor: Amgen
Start date: 2013-07-01; Completion date: 2017-02-22
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED.

"Funding Source - FDA OOPD"

Detailed description:
Study with completed results acquired from Horizon in 2024.

Arms: arm 1: A placebo infusion (normal saline) administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. arm 2: Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants start treatment at a dose of 10 mg/kg. At Week 3, the dose is escalated to 20 mg/kg and kept constant for the remainder of the study.
Interventions: intervention 1: teprotumumab intervention 2: normal saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02237950
Conditions: Bacterial Vaginosis
Sponsor: Starpharma Pty Ltd
Start date: 2014-10-13; Completion date: 2017-02-22
Enrollment: 586 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.

Detailed description:
Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.

The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.

Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.

Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.

Arms: arm 1: Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks arm 2: Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Interventions: intervention 1: Metronidazole oral tablets 500mg intervention 2: 1% SPL7013 Gel intervention 3: Placebo gel
Intervention descriptions: intervention 1: One tablet taken orally twice daily for seven consecutive days intervention 2: 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks. intervention 3: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Protocol documents:
Clinical trial NCT02083185
Conditions: Prostate Cancer
Keywords: Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2014-03-26; Completion date: 2017-02-23
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (\<50 ng/dL).

Detailed description:
The drug being tested in this study is called relugolix (TAK-385). Relugolix is being tested to treat people who have prostate cancer. This study will look at achieving and maintaining testosterone suppression (\<50 ng/dL).

The study enrolled 136 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Relugolix 80 mg
* Relugolix 120 mg
* Leuprorelin 22.5 mg

Relugolix was administered starting with a 320 mg (loading dose), followed by relugolix 80 mg or 120 mg tablets, for 48 weeks plus an optional 48-week extension at the investigator's discretion. Patients randomized to leuprorelin were administered 22.5 mg subcutaneously on Day 1 and every 12 weeks for 4 injections.

This multicenter trial was conducted in the United States and Canada. The overall time to participate in this study was 114.4 weeks. Participants made multiple visits to the clinic and at 12 weeks after last dose of study drug for a follow-up assessment.

Arms: arm 1: Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. arm 2: Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. arm 3: Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
Interventions: intervention 1: Relugolix intervention 2: Leuprorelin
Intervention descriptions: intervention 1: Relugolix tablets intervention 2: Leuprorelin subcutaneous injection

Protocol documents: