ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02689804
Conditions: Contraception
Keywords: Emergency contraception
Sponsor: Columbia University
Start date: 2015-07-10; Completion date: 2017-02-03
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The investigators propose a study to compare serum LNG and UPA levels after administration of a single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no difference in PK parameters between women with normal BMI and obese women.

Detailed description:
Eligible women will present to the division research office, at which time a history and physical exam will be completed. Each participant's BMI will be confirmed and she will be assigned to one of two BMI groups (18.5-24.9 versus 30-39.9). At the conclusion of the enrollment visit, the research coordinator will randomize each woman to receive a single-dose pill of either levonorgestrel 1.5mg (like Plan B One-Step® or its generic formulations) or ulipristal acetate 30mg (ellaOne®) on two separate occasions.

Arms: arm 1: Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order. arm 2: Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
Interventions: intervention 1: LNG-EC intervention 2: UPA-EC
Intervention descriptions: intervention 1: FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg intervention 2: FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Protocol documents:
Clinical trial NCT02487030
Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 4 (GT-4) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Sofosbuvir ledipasvir Hepatitis C Hepatitis C, Chronic Liver Diseases Virus Diseases Antiviral Agents
Sponsor: Gilead Sciences
Start date: 2015-09-07; Completion date: 2017-02-04
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: LDV/SOF for 8 weeks (treatment-naive (TN)) arm 2: LDV/SOF+RBV for 8 weeks (treatment-naive) arm 3: LDV/SOF for 12 weeks (treatment-naive) arm 4: LDV/SOF+RBV for 12 weeks (treatment-naive) arm 5: Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks. arm 6: LDV/SOF for 12 weeks (treatment-experienced) arm 7: LDV/SOF+RBV for 12 weeks (treatment-experienced)
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily intervention 2: Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01692756
Conditions: Anterior Cruciate Ligament (ACL) Tears
Sponsor: Cale Jacobs
Start date: 2013-03-01; Completion date: 2017-02-05
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University.

The purpose of this research is to gather information on how safe and effective Kenalog® is in alleviating knee pain following ACL rupture.

Detailed description:
Injury to the knee during sports participation often involves partial of full detachment of the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood.

In this research study, we hope to prevent and reduce the initial post-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL injuries by treating them within 1-2 days after their injury.

Arms: arm 1: Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. arm 2: Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury. arm 3: Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® arm 4: subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.
Interventions: intervention 1: Kenalog or placebo intervention 2: Kenalog then Placebo intervention 3: Kenalog intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02564029
Conditions: Reflex Epilepsy, Photosensitive
Sponsor: Pfizer
Start date: 2015-12-16; Completion date: 2017-02-07
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
PF-06372865 in subjects with photosensitive epilepsy

Detailed description:

Arms: arm 1: 17.5 milligram (mg) single dose arm 2: 52.5 mg single dose arm 3: Single dose arm 4: 2mg single dose
Interventions: intervention 1: PF-06372865 intervention 2: Placebo intervention 3: Lorazepam
Intervention descriptions: intervention 1: Single dose intervention 2: Placebo for PF-06372865 and placebo for lorazepam intervention 3: 2 mg single oral dose

Protocol documents:
Clinical trial NCT01212770
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis Psoriasis Arthritis inflammation skin condition inflammatory cells apremilast CC-10004 phosphodiesterase type 4
Sponsor: Amgen
Start date: 2010-09-30; Completion date: 2017-02-09
Enrollment: 505 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Detailed description:
Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Arms: arm 1: 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase arm 2: 30 mg Apremilast tablets administered twice a day for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice a day for up to 4.5 years in the active treatment / long-term safety phase orally twice daily arm 3: Placebo + 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 20 mg Apremilast twice daily at Week 16 arm 4: Placebo + 30 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 30 mg Apremilast twice daily at Week 16.
Interventions: intervention 1: Apremilast 20mg intervention 2: Apremilast 30mg intervention 3: Placebo
Intervention descriptions: intervention 1: Apremilast 20 mg twice daily, orally intervention 2: Apremilast 30 mg twice daily, orally intervention 3: None

Protocol documents:
Clinical trial NCT02707952
Conditions: Chronic Hepatitis C Virus Hepatitis C Virus
Keywords: Compensated cirrhosis Non-cirrhotic Renal impairment Hepatitis C virus (HCV) Hepatitis C Chronic Hepatitis C Hepatitis C Genotype 1 Hepatitis C Genotype 2 Hepatitis C Genotype 3 Hepatitis C Genotype 4 Hepatitis C Genotype 5 Hepatitis C Genotype 6 DAA-experienced
Sponsor: AbbVie
Start date: 2016-02-22; Completion date: 2017-02-09
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve, and DAA treatment-experienced Japanese adult subjects.

Detailed description:
The study consisted of two sub-studies that enrolled in parallel. Substudy 1 was randomized, open-label, and active-controlled, wherein HCV treatment-naïve or interferon (IFN)-experienced (i.e., DAA treatment-naïve), genotype (GT)1-infected participants without cirrhosis were enrolled. Substudy 2 was non-randomized, open label, and enrolled special populations of HCV-infected participants \[GT1- or GT2-infected subjects with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected subjects (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected subjects who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), HCV GT1- or GT2-infected subjects with severe renal impairment (with compensated cirrhosis or without cirrhosis)\].

Arms: arm 1: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype(GT)1 -infected, DAA treatment-naïve participants without cirrhosis. arm 2: Ombitasvir (25 mg)/paritaprevir (150 mg)/ritonavir (100mg) (OBV/PTV/r) QD for 12 weeks in HCV GT1 infected, DAA treatment-naïve participants without cirrhosis. arm 3: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120mg) QD for 12 weeks in HCV GT1- or GT2-infected participants with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected participants (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected participants who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), and HCV GT1- or GT2-infected participants with severe renal impairment and compensated cirrhosis. arm 4: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in GT1- or GT2-infected participants with severe renal impairment and without cirrhosis.
Interventions: intervention 1: ABT-493/ABT-530 intervention 2: OBV/PTV/r
Intervention descriptions: intervention 1: Co-formulated tablet intervention 2: Co-formulated tablet

Protocol documents:
Clinical trial NCT01417000
Conditions: Metastatic Pancreatic Cancer
Keywords: Cancer Cancer vaccine Listeria monocytogenes Listeria-based vaccines GVAX Cyclophosphamide Cytoxan T regulatory cells Heterologous Prime-Boost Immunotherapy Mesothelin Pancreatic cancer
Sponsor: Aduro Biotech, Inc.
Start date: 2011-09-21; Completion date: 2017-02-10
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.

Detailed description:

Arms: arm 1: 200 mg per square meter (mg/m\^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units \[CFU\]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16. arm 2: 200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
Interventions: intervention 1: GVAX Pancreas intervention 2: CRS-207 intervention 3: Cyclophosphamide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02642432
Conditions: Hepatitis C Virus Infection Chronic Hepatitis C Compensated Cirrhosis
Keywords: HCV Genotype 1 HCV Genotype 4 HCV Genotype 2 Cirrhotic Interferon-Free Compensated Cirrhosis HCV Genotype 5 Hepatitis C HCV Genotype 6
Sponsor: AbbVie
Start date: 2015-12-07; Completion date: 2017-02-10
Enrollment: 146 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.

Detailed description:

Arms: arm 1: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Interventions: intervention 1: ABT-493/ABT-530
Intervention descriptions: intervention 1: Tablet; ABT-493 coformulated with ABT-530

Protocol documents:
Clinical trial NCT01637961
Conditions: Recurrent Uterine Corpus Sarcoma Uterine Corpus Leiomyosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2012-08-01; Completion date: 2017-02-11
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well alisertib works in treating patients with leiomyosarcoma of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the clinical activity of MLN8237 (alisertib) in patients with recurrent or persistent leiomyosarcoma of the uterus who have received one or two prior cytotoxic therapies and the frequency of patients who survive progression-free for at least 6 months after initiating therapy or have objective tumor response.

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) among women with leiomyosarcoma treated with MLN8237.

II. To determine the distribution of progression-free survival (PFS) and overall survival (OS).

TERTIARY OBJECTIVES:

I. To determine the relationship of Aurora A Kinase expression, measured by immunohistochemistry, with objective response, PFS at 6 months, survival, and progression-free survival.

OUTLINE:

Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Alisertib intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01534260
Conditions: Acute Myeloid Leukemia
Sponsor: Hamid Sayar
Start date: 2012-02-10; Completion date: 2017-02-13
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research is being done because treatment options are very limited and usually unsuccessful for Acute Myeloid Leukemia (AML) in older individuals, or younger people with disease that has relapsed and/or proven resistant to standard therapy. Subjects are invited to participate in this study that will examine the use of three drugs called Sorafenib (Nexavar), Vorinostat (Zolinza) and Bortezomib (Velcade) for treating acute myeloid leukemia.

Detailed description:

Arms: arm 1: Escalating cohorts of sorafenib, vorinostat and bortezomib
Interventions: intervention 1: sorafenib, vorinostat and bortezomib
Intervention descriptions: intervention 1: Escalating dose cohorts of sorafenib, vorinostat and bortezomib. The first cohort will receive sorafenib from day 1 to 14, vorinostat will be given on days 1-4 and 8-12, and bortezomib will be given on days 1 and 8. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.

Protocol documents:
Clinical trial NCT01218048
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Carcinoma Head and Neck Cetuximab Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor: Robert Ferris
Start date: 2011-02-01; Completion date: 2017-02-14
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There are currently no useful tests to identify patients who will respond to cetuximab therapy, notably because EGFR levels do not correlate with the clinical responses observed. Thus, the investigators are investigating the role of cellular immunity and immune escape mechanisms to explain the differential clinical response to cetuximab.

Detailed description:
This prospective phase II clinical trial of preoperative, single-agent cetuximab treated patients is being conducted in order to obtain specimens before and after 4 weeks of cetuximab for immune biomarker studies. Stage III/IV HNC patients will be treated with definitive surgical resection and observed for disease recurrence. Cetuximab will be administered for a 3-4 week preoperative period to study biomarker modulation in correlation clinical response by CT scan and tumor apoptosis/proliferation after tumor excision, immediately after neoadjuvant cetuximab but before surgery. We will biopsy the skin/acneiform rash in all patients to correlate rash with biomarker modulation and clinical response. Cetuximab may also be given in the adjuvant setting. A primary scientific hypothesis will be tested: does short term pre-operative exposure to cetuximab modulate blood immune biomarkers and is immune modulation associated with anti-tumor effect? Forty (n=40) patients with complete specimens (tumor, peripheral blood mononuclear cells (PBMC) and serum) are necessary to enable adequate statistical power to be reached using paired specimens. A secondary set of hypotheses will evaluate the association between pre-operative biomarker levels and modulation with disease recurrence. The proposed trial will accrue stage II, III or IV surgical candidates without distant metastasis.

Arms: arm 1: Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation + Cisplatin (or Carboplatin)

NOTE: Based the results of surgery if the treating physician feels patient is not a candidate for chemotherapy, radiation can be given alone or with cetuximab.
Interventions: intervention 1: Cetuximab intervention 2: Surgery intervention 3: Post-surgical radiation intervention 4: Cisplatin or carboplatin
Intervention descriptions: intervention 1: Pre-Surgery: IV, 400 mg/m2 day 1 then 250 mg/m2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT intervention 2: Surgery for tumor intervention 3: Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery intervention 4: Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy

Protocol documents:
Clinical trial NCT01932970
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Sponsor: Amgen
Start date: 2013-08-12; Completion date: 2017-02-14
Enrollment: 158 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

Detailed description:

Arms: arm 1: Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Interventions: intervention 1: Etelcalcetide
Intervention descriptions: intervention 1: Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.

Protocol documents:
Clinical trial NCT01361113
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma RCC Votrient Pazopanib Nephrectomy Neoadjuvant Phase II LCCC 1028 Lineberger Comprehensive Cancer Center
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2011-06-01; Completion date: 2017-02-15
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will be a single arm phase II clinical trial of 8 weeks of daily, oral neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically confirmed localized renal cell carcinoma (RCC).

Detailed description:
The primary objective of this study is to determine the objective response rate Complete Response + Partial Response(CR+PR) associated with neoadjuvant pazopanib at 8 weeks as defined via Response Evaluation Criteria in Solid Tumors (RECIST1.1). The investigators will also estimate the recurrence free survival (RFS), specifically the 1 and 2 year rates, with recurrence defined via RECIST1.1, and characterize the safety issues. Finally, this study also includes a number of exploratory analyses designed to evaluate potential correlations between RFS and; serum levels of cytokine and angiogenesis factor (CAF).

Arms: arm 1: Pazopanib 800 mg PO once daily for 8 weeks
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: 800 mg orally once daily for 8 weeks, prior to nephrectomy

Protocol documents: