ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00553254
Conditions: Carcinoma, Non Small Cell Lung
Sponsor: Pfizer
Start date: 2008-02-05; Completion date: 2014-07-17
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-00299804
Intervention descriptions: intervention 1: Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent

Protocol documents:
Clinical trial NCT01831791
Conditions: Alopecia
Keywords: male pattern hair loss hair growth hair restoration Dutasteride Androgenetic alopecia safety efficacy
Sponsor: GlaxoSmithKline
Start date: 2013-04-14; Completion date: 2014-07-19
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of 0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who completes the full course of study treatment and the final study visit (Week 52; Visit 7) will be considered as study completion.

Detailed description:

Arms: arm 1: Subjects will receive 1 capsule of Dutasteride 0.5 mg orally once daily for 52 weeks (12 months).
Interventions: intervention 1: Dutasteride 0.5 mg
Intervention descriptions: intervention 1: Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of Dutasteride and it will be packaged in high-density polyethylene (HDPE) bottles with plastic child-resistant closures.

Protocol documents:
Clinical trial NCT01514864
Conditions: Carcinoma, Non-small Cell Lung
Sponsor: Bristol-Myers Squibb
Start date: 2012-05-31; Completion date: 2014-07-23
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib.

Detailed description:

Arms: arm 1: Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred arm 2: Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression

Protocol documents:
Clinical trial NCT00545077
Conditions: Breast Cancer
Keywords: endocrine therapy bevacizumab breast cancer first-line therapy
Sponsor: Spanish Breast Cancer Research Group
Start date: 2007-11-06; Completion date: 2014-07-24
Enrollment: 380 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Locally advanced or metastatic breast cancer in postmenopausal women with negative Human Epidermal Growth Factor Receptor 2 (HER2), who are candidates for hormone treatment and who have not received previous chemotherapy or hormonotherapy for the metastatic disease.

Detailed description:
The main endpoint of the study is progression-free survival (PFS). It has been calculated that 378 patients will need to be included, according to the following assumptions:

* Recruitment period of 21 months.
* Minimum follow-up period of 9 months.
* PFS of 9 months in the control arm (letrozole in monotherapy). Using a two-sided log-rank test, for a 5% α level, 344 patients (172 in each treatment arm) will be required for 270 events to occur, which will provide an 80% power for detecting a hazard ratio of 0.69 (corresponding to a PFS median of 13 months in the bevacizumab arm). This sample size has been adjusted for an intermediate analysis when 2/3 of the total of required events have occurred. This intermediate analysis can be avoided if, at the time in which it must be carried out, it is estimated that the final analysis will be carried out in 4 months.

Taking into account a 10% percentage of losses, 378 patients are expected to be included in the study.

An intermediate safety evaluation will be carried out when 63 patients have finished their treatment in each treatment arm.

A multicenter, randomized phase III clinical trial. After verifying the selection criteria, the patients will be randomized to receive letrozole alone or in combination with bevacizumab. Before randomization, the patients will be stratified according to the following prognosis factors:

* Estrogen Receptor (ER)+ / Progesterone Receptor (PgR)+ vs the other options (ER+/PgR- vs ER-/PgR+)
* Previous adjuvant hormonotherapy (yes/no)
* Status: locally advanced vs metastatic.
* Measurable vs non measurable disease
* Visceral disease (yes/no)
* PFS.

Arms: arm 1: Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent. arm 2: Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.
Interventions: intervention 1: Letrozole intervention 2: Bevacizumab intervention 3: Fulvestrant
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01743807
Conditions: Relapsed Acute Lymphoblastic Leukemia Relapsed Acute Myelogenous Leukemia
Keywords: Relapsed Minimal Residual Disease MRD Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia ALL AML GNKG168 Pediatric Childhood
Sponsor: Therapeutic Advances in Childhood Leukemia Consortium
Start date: 2014-03-26; Completion date: 2014-07-28
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who are in morphologic remission but are positive for Minimum Residual Disease (MRD).

Detailed description:
GNKG168 is a Toll-like receptor (TLR) agonist. TLR agonists are a novel approach to stimulate an effective anti-tumor immune response as they are able to stimulate both innate and adaptive immune responses. There will be two strata i.e patients who have received hematopoietic stem cell transplant (HSCT) and patients who have never undergone HSCT. GNKG168 will be administered as a 60 min iv infusion. One 14-day cycle consists of 5-day treatment followed by 9 day-rest. Patients will receive 2 cycles before evaluation. The primary objective is to determine the maximum tolerated dose of GNKG168 in relapsed ALL and AML patients. The completion of this study and the correlative studies will provide a solid foundation for subsequent phase 2 study and the development of clinical applications of CpG-ODN-based immune therapy as a treatment of childhood leukemia. If safety and efficacy of GNKG168 is proven, it will be intriguing to explore its role to maintain CR in a randomized manner.

Arms: arm 1: Patients who have a history of hematopoetic stem cell transplantation (HSCT). GNKG168 will be administered as a 60 minute intravenous infusion daily for 5 consecutive days. It may be repeated every 14 days. Patients should receive minimum 2 courses and up to 6 courses may be administered. Dose will be assigned at study entry. arm 2: Patients who have never undergone HSCT. GNKG168 will be administered as a 60 minute intravenous infusion daily for 5 consecutive days. It may be repeated every 14 days. Patients should receive minimum 2 courses and up to 6 courses may be administered. Dose will be assigned at study entry.
Interventions: intervention 1: GNKG168
Intervention descriptions: intervention 1: GNKG168 will be given intravenously over 1 hour on days 1 through 5 followed by 9 days of rest. Dose will be assigned at study entry.

Dose Level 0: 0.15 mg/kg Dose Level 1: 0.25 mg/kg Dose Level 2: 0.75 mg/kg Dose Level 3: 1.5 mg/kg

The starting dose level for the trial will be 0.25 mg/kg. If that dose level proves to be intolerable, the dose will be reduced to 0.15 mg/kg (dose level 0). If the 0.15 mg/kg dose level is intolerable due to DLTs, TACL, the Principal Investigator, and Medical Monitor will then decide the best course of action for subsequent administration of GNKG168.

Protocol documents:
Clinical trial NCT01808261
Conditions: Cerebrovascular Accident
Keywords: Ischemic Stroke
Sponsor: GlaxoSmithKline
Start date: 2013-05-18; Completion date: 2014-07-28
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study MAG104615, a Proof of Concept Study for GSK249320 versus placebo in Stroke Patients.

Detailed description:
Myelin-associated glycoprotein (MAG) is one of the key proteins known to inhibit neuronal regeneration when released from oligodendrocytes in conditions of neuronal injury, such as stroke. GSK249320 is a humanised monoclonal antibody (mAb) that binds with high specificity to MAG and antagonises or neutralises MAG-mediated inhibition and has been shown to improve functional recovery after stroke in pre-clinical models, possibly by promoting neuroregeneration and plasticity. The present study (MAG104615) is designed to establish Proof of Concept (PoC) for GSK249320 in ischemic stroke patients. MAG104615 will be a placebo-controlled, double-blind, multicenter, randomized, repeat dose, Bayesian design study. PoC will be achieved by demonstrating a clinically meaningful improvement in lower limb motor recovery, specifically by evaluating changes in gait velocity from baseline to Day 90/Month 3. Subjects will also be followed out to Day 180/Month 6 to further evaluate longer term motor recovery and safety. Additional secondary efficacy measures of motor recovery will be evaluated to further demonstrate and characterize the extent and duration of overall motor recovery after treatment with GSK249320. Changes in disability and neurological impairment will be characterized after treatment with GSK249320 and explored for how they relate to motor recovery. This PoC study will also further characterize the safety, PK, and immunogenicity of GSK249320 will explore pharmacodynamic (PD) markers, and will explore use of actigraphy to measure motor recovery. Subjects will be stratified by gait velocity at baseline for randomization (1:1 allocation) into one of two treatment groups: 15mg/kg GSK249320, or placebo. Each subject will receive 2 repeat IV doses of GSK249320 or placebo.

Arms: arm 1: Placebo is a clear, colorless solution (50mM acetate buffer, pH 5.5 containing 0.02% (w/v) polysorbate-80 and made isotonic with 111.2 mM sodium chloride). Placebo is for intravenous (IV) use only. arm 2: Clear to opalescent, colorless to pale yellow or pale brown, and is supplied as a sterile, concentrated solution (1000mg/vial). GSK249320 is for IV use only.
Interventions: intervention 1: GSK249320 100/mg intervention 2: Placebo
Intervention descriptions: intervention 1: Clear to opalescent, colorless to pale yellow or pale brown, and is supplied as a sterile, concentrated solution (1000mg/vial). GSK249320 is for IV use only. intervention 2: Placebo is a clear, colorless solution (50mM acetate buffer, pH 5.5 containing 0.02% (w/v) polysorbate-80 and made isotonic with 111.2 mM sodium chloride). Placebo is for intravenous (IV) use only.

Protocol documents:
Clinical trial NCT04080297
Conditions: Vasomotor Symptoms (VMS)
Keywords: Vasomotor Symptoms, Breast Cancer, Hot Flashes, Tamoxifen, Aromatase Inhibitors, Estrogen Antagonists, Hormone Antagonists, Hormones, Hormone Substitutes Hormone Antagonists, Physiological Effects of Drugs, Antineoplastic Agents, Hormonal Antineoplastic, Selective Estrogen Receptor Modulators Estrogen Receptor Modulators, Bone Density Conservation Agents, Steroid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
Sponsor: Que Oncology
Start date: 2014-01-10; Completion date: 2014-07-28
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.

Detailed description:
Vasomotor symptoms are significant in postmenopausal women with the most effective medications for relief being hormonal preparations. Non-hormonal medications have demonstrated efficacy but at a far lower level than estrogen replacement therapy. For women with a history of breast cancer hormone replacement therapy is problematic especially if their therapeutic regime involves an aromatase inhibitor. Therefore, this study will explore the effect of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.

The study is an open-label, two dose study (Group 1: 100 mg once daily and Group 2: 200 mg once daily) of Q-122, over a 4 week treatment period. As eligible subjects are enrolled, they will be assigned to Group 1 until Group 1 is fully enrolled. Dose escalation to the 200 mg level will only occur following a review of the safety experience of at least 6 subjects treated with 100 mg Q-122 once daily for at least 2 weeks. Once Group 1 is fully enrolled, eligible subjects will be enrolled into Group 2.

A two-week screening phase will be used to establish a stable baseline of vasomotor symptoms and to establish study eligibility. Qualified subjects will be treated with Q-122 for four weeks either at 100 mg/day dose or the 200 mg/day dose, during which time they will be evaluated for safety, tolerability, and pharmacokinetics of Q-122 and tamoxifen levels; subjects will continue to record their hot flashes in identical fashion to the screening period. Following the 28 day treatment, period subjects who complete the study will continue to record their hot flashes for a two week follow up period.

Arms: arm 1: 10 patients treated with Q-122, 100 mg. Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days. arm 2: 11 patients treated with Q-122, 200 mg. Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days.
Interventions: intervention 1: oral capsule of Q-122
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00580047
Conditions: Renal Insufficiency
Keywords: bone density osteopenia transplant zoledronic acid alendronate
Sponsor: University of Nebraska
Start date: 2003-12-01; Completion date: 2014-07-29
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.

Detailed description:
The aims are to determine baseline bone mineral density (BMD) in kidney and kidney/pancreas transplant patients who will be randomized to weekly alendronate, annual zoledronic acid infusions or placebo (calcium with Vitamin D). These patients will be followed for two years with annual bone density testing as well as biochemical markers. A secondary aim is to evaluate the compliance.

Arms: arm 1: Zoledronic Acid 4mg intravenously once a year for 2 years arm 2: Alendronate 70mg orally once a week for 2 years arm 3: Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily
Interventions: intervention 1: Zoledronic Acid intervention 2: Calcium with vitamin D intervention 3: Alendronate
Intervention descriptions: intervention 1: 4mg IV Annually intervention 2: 1200 mg Calcium with 800 International Units of vitamin D intervention 3: 70mg weekly

Protocol documents:
Clinical trial NCT01208181
Conditions: Arthritis, Rheumatoid
Sponsor: Organon and Co
Start date: 2010-09-27; Completion date: 2014-07-29
Enrollment: 1404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-part (6 weeks duration for each part), randomized, double-blind, placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.

Detailed description:

Arms: arm 1: The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and Part 2 of the study. arm 2: The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 2 of the study. arm 3: The etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study. arm 4: The placebo treatment sequence will receive matching placebo to etoricoxib tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study.
Interventions: intervention 1: Etoricoxib 60 mg intervention 2: Etoricoxib 90 mg intervention 3: Placebo to Etoricoxib 60 mg intervention 4: Placebo to Etoricoxib 90 mg
Intervention descriptions: intervention 1: One tablet orally once daily for 6 weeks. intervention 2: One tablet orally once daily for 6 weeks. intervention 3: One tablet orally once daily for 6 weeks. intervention 4: One tablet orally once daily for 6 weeks

Protocol documents:
Clinical trial NCT01553591
Conditions: Irritable Bowel Syndrome
Sponsor: Furiex Pharmaceuticals, Inc
Start date: 2012-05-29; Completion date: 2014-07-29
Enrollment: 1282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.

Detailed description:

Arms: arm 1: Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period. arm 2: Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period. arm 3: Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Interventions: intervention 1: Eluxadoline intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablets twice daily intervention 2: Oral tablets twice daily

Protocol documents:
Clinical trial NCT01584440
Conditions: Agitation Alzheimer's Disease
Keywords: AVP-923-20 AVP-923-30 AVP-923 Dextromethorphan Quinidine Neuropsychiatric Inventory Aggression Efficacy Safety
Sponsor: Avanir Pharmaceuticals
Start date: 2012-08-13; Completion date: 2014-07-30
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).

Detailed description:
Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.

This is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study, consisting of 10 weeks of treatment.

Up to 200 participants will be enrolled at approximately 30-40 centers in the US.

Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening must occur within within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Arms: arm 1: Participants will receive placebo during Stage 1 and Stage 2 of the study. arm 2: Participants will receive AVP-923-20 and AVP-923-30 in a sequential manner during Stage 1 and Stage 2 of the study. arm 3: Participants will receive placebo in Stage 1 followed by AVP-923 in Stage 2.
Interventions: intervention 1: AVP-923-20 intervention 2: Placebo intervention 3: AVP-923-30
Intervention descriptions: intervention 1: AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine intervention 2: Placebo capsule intervention 3: AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine

Protocol documents:
Clinical trial NCT01178073
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Arterial Hypertension Ambrisentan Sponsor Rest of World: GSK Tadalafil PAH Sponsor US: Gilead
Sponsor: GlaxoSmithKline
Start date: 2010-10-01; Completion date: 2014-07-31
Enrollment: 610 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.

Detailed description:

Arms: arm 1: ambrisentan + tadalafil arm 2: ambrisentan arm 3: tadalafil
Interventions: intervention 1: ambrisentan intervention 2: tadalafil
Intervention descriptions: intervention 1: ambrisentan (target dose: 10mg) intervention 2: tadalafil (target dose: 40mg)

Protocol documents:
Clinical trial NCT01324947
Conditions: Multiple Myeloma
Keywords: Myeloma Multiple Myeloma Relapsed Multiple Myeloma Relapsed and Refractory Multiple Myeloma Refractory Myeloma Resistant Multiple Myeloma Treatment-resistant Multiple Myeloma Pomalidomide Lenalidomide-resistant Bortezomib-resistant Companion
Sponsor: Celgene
Start date: 2011-03-01; Completion date: 2014-07-31
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.

Detailed description:

Arms: arm 1: Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity
Interventions: intervention 1: pomalidomide
Intervention descriptions: intervention 1: Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity

Protocol documents: