ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01657162
Conditions: Postmenopausal Osteoporosis
Keywords: BA058 Abaloparatide-SC abaloparatide ACTIVExtend osteoporosis fracture bone loss
Sponsor: Radius Health, Inc.
Start date: 2012-11-20; Completion date: 2016-10-03
Enrollment: 1139 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

Detailed description:
To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

Arms: arm 1: Participants received 70 milligrams (mg) of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 micrograms (mcg) SC or abaloparatide-matching placebo daily for 18 months.
Interventions: intervention 1: Alendronate
Intervention descriptions: intervention 1: Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.

Protocol documents:
Clinical trial NCT02702011
Conditions: Diabetes Mellitus, Type 1
Sponsor: Boehringer Ingelheim
Start date: 2016-03-20; Completion date: 2016-10-03
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: empagliflozin medium dose intervention 2: empagliflozin low dose intervention 3: empagliflozin high dose intervention 4: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02606903
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-10-28; Completion date: 2016-10-04
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BI 695501 prefilled syringe intervention 2: BI 695501 autoinjector
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02682238
Conditions: Hyperhidrosis
Sponsor: Botanix Pharmaceuticals
Start date: 2016-03-08; Completion date: 2016-10-04
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.

Detailed description:
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects with Palmar Hyperhidrosis.

Participating subjects will apply either BBI-4000 15% or vehicle gel topically to the palms of both hands once daily for 4 consecutive weeks. The 4 week treatment period will be followed by a 2 week follow-up period.

Safety and tolerability will be assessed through collection of vital signs, adverse events, assessment of local skin responses, ECG, UPT and blood sampling.

Efficacy will be assessed through gravimetric sweat assessments as well as through the Hyperhidrosis Disease Severity Scale (HDSS).

Arms: arm 1: 15% BBI-4000 (sofpironium bromide) topical gel arm 2: Vehicle (placebo) gel
Interventions: intervention 1: BBI-4000, 15% intervention 2: Vehicle gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01878292
Conditions: Major Depressive Disorder
Sponsor: Forest Laboratories
Start date: 2013-07-11; Completion date: 2016-10-05
Enrollment: 529 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.

Detailed description:

Arms: arm 1: Dose-matched placebo tablets, once per day, oral administration arm 2: 15 mg vilazodone tablets, once per day, oral administration arm 3: 30 mg vilazodone tablets, once per day, oral administration
Interventions: intervention 1: Placebo intervention 2: Vilazodone intervention 3: Vilazodone
Intervention descriptions: intervention 1: Dose matched placebo tablets, once per day, oral administration. intervention 2: Vilazodone tablets, 15 mg per day, oral administration intervention 3: Vilazodone tablets, 30 mg once per day, oral administration

Protocol documents:
Clinical trial NCT01708174
Conditions: Medulloblastoma
Keywords: medulloblastoma, relapsed, pediatric, children, adults, Hh pathway inhibitor, LDE225
Sponsor: Novartis Pharmaceuticals
Start date: 2013-05-06; Completion date: 2016-10-05
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.

Detailed description:
This study was a single-arm study of the efficacy and safety of oral sonidegib in patients with Hh-pathway activated relapsed medulloblastoma. It was initially designed as a randomized, controlled, open-label phase III study of adults and children with Hh-pathway activated MB whose disease had failed standard of care therapy, including radiation therapy (RT). The original study consisted of a randomized controlled part and a non-randomized uncontrolled part. Approximately 69 patients were to be randomized in a 2:1 ratio to receive sonidegib oral suspension or the active control, temozolomide (TMZ) capsules. Randomization was to be stratified according to age, \<18 years versus ≥ 18 years. Approximately 40 patients were to receive sonidegib in the non-randomized uncontrolled part of the study. Following the enrollment of 11 patients, the study was amended to become a phase II single-arm study with only sonidegib, and the target enrollment was changed to 20 patients. Prior to the study amendment, TMZ participants whose disease progressed while on TMZ were permitted to crossover to sonidegib. After the amendment, participants receiving TMZ were crossed over to sonidegib.

Arms: arm 1: 600 mg orally for adults and 500 mg/m2 orally for children arm 2: 150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
Interventions: intervention 1: LDE225 intervention 2: TMZ
Intervention descriptions: intervention 1: Sonidegib for oral suspension was supplied in amber glass bottles. Sonidegib oral suspension was combined with the supplied reconstitution vehicle to a final concentration of 50 mg/mL. intervention 2: Temozolomide capsules were obtained locally by the Investigator

Protocol documents:
Clinical trial NCT02420262
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2015-07-26; Completion date: 2016-10-05
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/liraglutide intervention 2: insulin glargine intervention 3: insulin aspart
Intervention descriptions: intervention 1: Once daily injected s.c./subcutaneously (under the skin) in combination with metformin. intervention 2: Once daily injected s.c./subcutaneously (under the skin) in combination with metformin. intervention 3: Injected s.c./subcutaneously (under the skin) before each main meal.

Protocol documents:
Clinical trial NCT02815644
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-07-15; Completion date: 2016-10-05
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (FDC) tablet.

Detailed description:

Arms: arm 1: empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet
Interventions: intervention 1: empagliflozin/linagliptin FDC
Intervention descriptions: intervention 1: empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet

Protocol documents:
Clinical trial NCT01808144
Conditions: Gout
Keywords: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2013-03-01; Completion date: 2016-10-06
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

Detailed description:
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.

Arms: arm 1: Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015. arm 2: None
Interventions: intervention 1: lesinurad intervention 2: lesinurad intervention 3: febuxostat
Intervention descriptions: intervention 1: Tablets, 400 mg once daily (QD) intervention 2: Tablets, 200 mg QD intervention 3: Tabletsm 80 mg QD

Protocol documents:
Clinical trial NCT02616146
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2015-12-01; Completion date: 2016-10-06
Enrollment: 2016 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the contraceptive efficacy of the etonogestrel + 17β-estradiol (ENG-E2) vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of ENG-E2 vaginal ring. The levonorgestrel-ethinyl estradiol (LNG-EE) 150/30 μg combined oral contraceptive (COC) will be used as the active comparator.

Detailed description:

Arms: arm 1: Participants will receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle will consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 2: Participants will receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle will consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
Interventions: intervention 1: ENG-E2 125 μg/300 μg vaginal ring intervention 2: LNG-EE 150 μg/30 μg COC
Intervention descriptions: intervention 1: Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. intervention 2: Up to 13 cycles of LNG-EE 150 μg/30 μg administered orally, each cycle consisting of one tablet per day for 21 days, followed a 7-day tablet-free interval.

Protocol documents:
Clinical trial NCT02930005
Conditions: Psychotic Disorders Schizophrenia Schizoaffective Disorder Bipolar Disorder
Keywords: Psychotic Schizophrenia Schizoaffective Bipolar
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2015-08-07; Completion date: 2016-10-06
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the feasibility of administering meclofenamic acid or pentosan polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic disorder. Half of participants will receive meclofenamic acid, while the other half will receive polysulfate sodium.

Detailed description:
Chronic, low-grade brain inflammation is involved in the development of schizophrenia and other psychotic disorders. Medications with anti-inflammatory properties, like meclofenamic acid and pentosan polysulfate may help to reduce brain inflammation and serve as a treatment of psychotic disorders.

Arms: arm 1: 150mg meclofenamic acid daily for 8 weeks arm 2: 300mg of pentosan polysulfate sodium daily for 8 weeks
Interventions: intervention 1: Meclofenamic acid intervention 2: Pentosan polysulfate sodium
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02334800
Conditions: Healthy, Hepatic Insufficiency
Keywords: Palbociclib, PD-0332991, Hepatic Impairment
Sponsor: Pfizer
Start date: 2015-03-31; Completion date: 2016-10-09
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.

Detailed description:
This is a 4-cohort single period study. The four cohorts will consist of healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function. Each cohort will receive the same treatment consisting of a single oral 75mg dose of palbociclib administered with food. Serial PK samples will be drawn up to 120 hours post dose for the cohort consisting of healthy volunteers, and will continue until up to 192 hours post-dose for the cohorts of hepatic impairment subjects.

Arms: arm 1: Cohort of Healthy Volunteers arm 2: Cohort of mild hepatic impairment subjects meeting the criteria for Child-Pugh Class A arm 3: Cohort of moderate hepatic impairment subjects meeting the criteria for Child-Pugh Class B arm 4: Cohort of severe hepatic impairment subjects meeting the criteria for Child-Pugh Class C
Interventions: intervention 1: Palbociclib 75 mg Capsule
Intervention descriptions: intervention 1: Single oral 75 mg dose of palbociclib followed by serial PK sampling up to 192 hours post-dose (up to 120 hours post-dose for the healthy volunteer cohort).

Protocol documents:
Clinical trial NCT01185821
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: BAF312 siponimod Multiple Sclerosis Relapsing remitting Multiple Sclerosis Demyelinating Autoimmune Diseases MS RRMS inflammatory disease
Sponsor: Novartis Pharmaceuticals
Start date: 2010-08-30; Completion date: 2016-10-10
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population

Detailed description:
This study was prematurely discontinued after approximately 5 years. The decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in MS on a different population.

Arms: arm 1: 10 mg dose in Double Blind Phase and 2 mg in Open Label Phase arm 2: 2 mg dose in Double Blind Phase and 2 mg in Open Label Phase arm 3: 1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase arm 4: .5 mg dose in Double Blind Phase and 2 mg in Open Label Phase arm 5: .25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
Interventions: intervention 1: BAF312
Intervention descriptions: intervention 1: BAF312 was supplied in film-coated tablets in strengths of 5, 4 ,2, 1, .5 and .25 mg. The actual doses taken were 10, 2, 1.25, .5 and .25 mg taken orally once a day.

Protocol documents:
Clinical trial NCT01948310
Conditions: Chronic Stable Angina
Sponsor: Duke University
Start date: 2013-12-01; Completion date: 2016-10-10
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. The study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of life.

Detailed description:

Arms: arm 1: Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold. arm 2: Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
Interventions: intervention 1: Ranolazine intervention 2: Aerobic Exercise intervention 3: Placebo
Intervention descriptions: intervention 1: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day intervention 2: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test) intervention 3: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day

Protocol documents:
Clinical trial NCT01738594
Conditions: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage IA Mycosis Fungoides/Sezary Syndrome Stage IB Mycosis Fungoides/Sezary Syndrome Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage IIA Mycosis Fungoides/Sezary Syndrome Stage IIB Mycosis Fungoides/Sezary Syndrome Stage III Cutaneous T-cell Non-Hodgkin Lymphoma Stage IIIA Mycosis Fungoides/Sezary Syndrome Stage IIIB Mycosis Fungoides/Sezary Syndrome Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma Stage IVA Mycosis Fungoides/Sezary Syndrome Stage IVB Mycosis Fungoides/Sezary Syndrome
Sponsor: Northwestern University
Start date: 2013-03-22; Completion date: 2016-10-11
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase I trial studies the side effects and the best dose of carfilzomib when given together with or without romidepsin in treating patients with stage IA-IVB cutaneous T-cell lymphoma. Carfilzomib and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carfilzomib alone is more effective than when given together with romidepsin.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of carfilzomib, both as a single agent as well as in combination with romidepsin, in patients with cutaneous T-cell lymphoma (CTCL).

SECONDARY OBJECTIVES:

I. Overall response rate (ORR). II. Duration of response. III. Time to progression (TTP).

TERTIARY OBJECTIVES:

I. Measure proteasome activity concurrently in peripheral blood mononuclear cells (PBMCs) and tumor tissue biopsy specimens in order to gather pilot data on proteasome inhibition in CTCL patients treated with carfilzomib alone as well as carfilzomib with romidepsin.

OUTLINE: This is a dose-escalation study of carfilzomib. Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 2, 8, 9, 15, and 16.

ARM B: Patients receive carfilzomib as in Arm A and romidepsin IV over 4 hours on days 1, 8, and 15.

In both arms, treatment repeats every 28 days for at least 2-4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Arms: arm 1: Patients receive carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. arm 2: Patients receive carfilzomib as in Arm A and romidepsin IV over 4 hours on days 1, 8, and 15.
Interventions: intervention 1: carfilzomib intervention 2: romidepsin intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT02314052
Conditions: Hepatocellular Carcinoma
Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Start date: 2015-01-27; Completion date: 2016-10-11
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of the investigational anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid particle suspension that targets the oncogene MYC. MYC oncogene activation is important to the growth of many hematologic and solid tumor malignancies. In this study the Sponsor proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell growth.

Detailed description:
In this second study in humans, DCR-MYC will be administered by 2 hour intravenous (IV) infusion, once weekly for 2 weeks followed by a rest week (3 weeks = 1 cycle), to patients with hepatocellular carcinoma who are either sorafenib-refractory, sorafenib-intolerant despite dose reduction and best supportive care, or for whom neither sorafenib nor other suitable therapy is available. During the Phase 1b portion of the study, the highest safe dose of DCR-MYC that can be administered will be identified. In addition, the pharmacokinetic (PK) profile, potential pharmacodynamic (PD) effects, as well as the preliminary antitumor activity of DCR-MYC will be evaluated. During the Phase 2 portion of the study, up to 30 patients will be treated at the MTD identified in Phase 1b in order to further evaluate safety and tolerability, as well as assess the antitumor activity, of DCR-MYC.

Arms: arm 1: Patient groups (cohorts) will receive a single dose level of DCR-MYC; the dose level of DCR-MYC will be increased in subsequent cohorts
Interventions: intervention 1: DCR-MYC
Intervention descriptions: intervention 1: Dosing: 2 hour IV infusion on Day 1 and 8 of each 21 day cycle.

Starting dose: 0.125mg/kg/dose

Number of cycles: until progression or unacceptable toxicity develops.

PHASE 1b Dose escalation: 50% or 25% increase in subsequent cohorts depending upon toxicity until maximum tolerated dose (MTD) is identified.

PHASE 2 Cohort expansion at the MTD: Additional patients to be treated at the highest dose tolerated to assess efficacy and further assess safety

Protocol documents: