ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02817516
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2016-06-30; Completion date: 2016-08-22
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of TAK-828 in healthy participants.

Detailed description:
The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy non-Japanese and Japanese participants in Parts 1 and 2, respectively.

The study will enroll approximately 56 participants. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TAK-828 or matching placebo. This assignment will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

Proposed doses:

* Part 1: TAK-828 15 mg, 45 mg, 75 mg, 100 mg, and placebo twice daily
* Part 2: TAK-828 45 mg, and 100 mg, and placebo twice daily

All participants will be asked to take the solution at the same time each day throughout the study.

This multi-center trial will be conducted in the United States.

Arms: arm 1: TAK-828 15 mg, solution (0.2 milligram per milliliter \[mg/mL\] or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. arm 2: TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. arm 3: TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. arm 4: TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. arm 5: TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants. arm 6: TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants. arm 7: TAK-828 placebo-matching solution, orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants. arm 8: TAK-828 placebo-matching solution, orally, twice daily on Days 1-14 in healthy Japanese participants.
Interventions: intervention 1: TAK-828 intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-828 solution. intervention 2: TAK-828 placebo-matching solution.

Protocol documents:
Clinical trial NCT01320943
Conditions: Chronic Hepatitis B
Keywords: stopping oral antiviral therapy HBsAg loss seroconversion restarting oral antiviral therapy
Sponsor: Gilead Sciences
Start date: 2011-04-26; Completion date: 2016-08-23
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF arm) compared to participants who continue TDF (Continue TDF arm).

Only participants who already are on treatment with TDF monotherapy or TDF in combination with lamivudine or emtricitabine for at least 4 years and who achieved and maintained virologic suppression (\< 400 copies/mL) for 3.5 or more years will be included in this study. One treatment arm will stop the TDF therapy while the other treatment arm will continue the TDF therapy. Participants in the Stop TDF arm will be monitored very closely with special focus on biochemical flares (especially alanine aminotransferase (ALT) increases) and virological relapses (Hepatitis B viral load increases). If any participant in the Stop TDF arm exceeds one or more predefined limits for such flares or relapses, TDF treatment will be reinstituted.

Detailed description:

Arms: arm 1: Participants randomized to this arm will stop TDF therapy at baseline. arm 2: Participants randomized to this arm will continue TDF therapy.
Interventions: intervention 1: TDF intervention 2: Stop TDF
Intervention descriptions: intervention 1: Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily intervention 2: Participants will stop TDF therapy

Protocol documents:
Clinical trial NCT02250443
Conditions: Sporadic Inclusion Body Myositis (sIBM)
Keywords: Inclusion Body Myositis (IBM)
Sponsor: Novartis Pharmaceuticals
Start date: 2014-03-11; Completion date: 2016-08-23
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an open-label, long-term study for those patients who participated in the prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term dosing. However due to lack of efficacy in patients with sIBM, the study was terminated early.

Detailed description:
This is a non-confirmatory, multicenter, open-label, non-randomized trial which will extend active treatment to those patients that participated in the preceding proof-of-concept study (CBYM338X2205) in order to collect long-term safety and tolerability data. Up to 14 patients with sIBM will be invited to enroll into the study to receive BYM338 open-label for a period of approximately 3 years or until BYM338 is commercially available, whichever comes first. The study consists of a maximum 28-day screening period, a 5-day baseline period, and a treatment period consisting of the site visits at 4-week intervals for treatment administration, safety and pharmacokinetic follow-up. All patients will be administered a medium level i.v. BYM338 dose regardless of their treatment allocation in the prior study.

Arms: arm 1: BYM338 Group
Interventions: intervention 1: BYM338 (Bimagrumab)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01705288
Conditions: Cervical Cancer Uterine Endometrial Cancer Ovarian Cancer
Keywords: laparotomy hysterectomy
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2013-01-01; Completion date: 2016-08-24
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.

Detailed description:
Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or standard of care (traditional laparatomy and supportive care).

Arms: arm 1: Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards. arm 2: Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
Interventions: intervention 1: Laparotomy intervention 2: intravenous narcotics intervention 3: standard anesthesia intervention 4: regional anesthesia intervention 5: Non-steroidal anti-inflammatory drugs
Intervention descriptions: intervention 1: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital intervention 2: given for pain management after surgery per physician orders intervention 3: inhalant or intravenous during surgery intervention 4: given by spinal or epidural infusion intervention 5: given for pain management after surgery

Protocol documents:
Clinical trial NCT01837641
Conditions: Alzheimer Disease
Sponsor: Eli Lilly and Company
Start date: 2013-05-03; Completion date: 2016-08-24
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813. Study participants will be healthy or will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD.

There will be seven groups of study participants. Five groups will receive a single dose of LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo given as an injection into a vein. Approximately 12 weeks will pass between the single dose and the first multiple dose. One group of participants will receive a single dose of LY3002813 given as an injection under the skin. One group of participants will receive a single dose of LY3002813 given as an injection into a vein.

Detailed description:

Arms: arm 1: 0.1 milligram per kilogram (mg/kg) single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks intravenously (IV) arm 2: 0.3 mg/kg single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV arm 3: 1 mg/kg single dose LY3002813 given once by IV infusion. arm 4: 1 mg/kg single dose then 1 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV arm 5: 3 mg/kg single dose then 3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV arm 6: 10 mg/kg single dose then 10 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV arm 7: Placebo given once, then every 4 weeks for up to 16 weeks IV arm 8: Up to 3 mg/kg LY3002813 given once subcutaneously (SC) arm 9: Up to 3mg/kg LY3002813 given once intravenously (IV)
Interventions: intervention 1: LY3002813-IV intervention 2: LY3002813-SC intervention 3: Placebo-IV
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered SC intervention 3: Administered IV

Protocol documents:
Clinical trial NCT02474589
Conditions: Smallpox
Keywords: Treatment orthopoxvirus smallpox
Sponsor: SIGA Technologies
Start date: 2015-06-19; Completion date: 2016-08-24
Enrollment: 449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.

Detailed description:
Pharmacokinetics and safety and tolerability data will be collected.

Arms: arm 1: 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects arm 2: matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects
Interventions: intervention 1: tecovirimat intervention 2: Placebo
Intervention descriptions: intervention 1: Study is based on Animal Regulatory Rule intervention 2: Does not apply

Protocol documents:
Clinical trial NCT01886378
Conditions: Long-chain Fatty Acid Oxidation Disorders (LC-FAOD) Carnitine Palmitoyltransferase (CPT II) Deficiency Very Long Chain Acyl-CoA Dehydrogenase (VLCAD) Deficiency Longchain 3-hydroxy-acyl-CoA Dehydrogenase (LCHAD) Deficiency Trifunctional Protein (TFP) Deficiency
Keywords: FAOD VLCAD CPT II CPT2 CPT 2 LCHAD UX007 Triheptanoin TFP C7
Sponsor: Ultragenyx Pharmaceutical Inc
Start date: 2014-02-06; Completion date: 2016-08-25
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to evaluate the impact of UX007 on acute clinical pathophysiology associated with LC-FAOD following 24 weeks of treatment.

Detailed description:

Arms: arm 1: UX007 dosing titrated to a target dose of 25-35% of total caloric intake or maximum tolerated dose. Participants are followed to evaluate the effects of UX007 over 24 weeks (Treatment Period), then continued treatment in the Extension Period for an additional 54 weeks for a total of 78 weeks of treatment.
Interventions: intervention 1: UX007
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02149108
Conditions: Colorectal Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2014-09-25; Completion date: 2016-08-25
Enrollment: 768 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nintedanib (BIBF 1120) intervention 2: Placebo intervention 3: BSC intervention 4: BSC
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02413346
Conditions: Acne Vulgaris
Sponsor: Almirall, S.A.
Start date: 2015-03-20; Completion date: 2016-08-26
Enrollment: 490 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with moderate to severe facial acne vulgaris.

Detailed description:

Arms: arm 1: Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(kg) sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks). arm 2: Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
Interventions: intervention 1: Sarecycline
Intervention descriptions: intervention 1: Administered based on participant's body weight.

Protocol documents:
Clinical trial NCT02661126
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2016-01-19; Completion date: 2016-08-26
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of MK-3682B, a fixed dose combination (FDC) tablet containing uprifosbuvir (MK-3682) + grazoprevir (MK-5172) + ruzasvir (MK-8408) in participants with moderate (Part 1) and severe (Part 2) renal insufficiency (RI) to plasma PK in healthy participants.

Detailed description:

Arms: arm 1: Participants with an estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73m\^2 to \<60 mL/min/1.73m\^2 take 2 MK-3682B FDC tablets on Day 1 after fasting for 10 hours. arm 2: Participants with an eGFR of ≥15 mL/min/1.73m\^2 to \<30 mL/min/1.73m\^2 take 2 MK-3682B FDC tablets on Day 1 after fasting for 10 hours. arm 3: Healthy participants (creatinine clearance \[CLcr\] ≥80 mL/min) take 2 MK-362B FDC tablets on Day 1 after fasting for 10 hours. Healthy participants are matched to RI participants based on mean age, body mass index (BMI) and gender.
Interventions: intervention 1: MK-3682B
Intervention descriptions: intervention 1: FDC oral tablet containing 225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir.

Protocol documents:
Clinical trial NCT02695290
Conditions: Carcinoma, Non-Small-Cell Lung ErbB Receptors
Sponsor: Boehringer Ingelheim
Start date: 2016-03-17; Completion date: 2016-08-26
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Afatinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01496807
Conditions: Melanoma
Keywords: unresectable stage 3 stage 4 autoimmune antibodies
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2012-02-17; Completion date: 2016-08-29
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the patient's blood that recognize their own tissues, known as "autoimmune" antibodies. Investigators also want to find out how likely it is that their tumor will shrink.

Detailed description:

Arms: arm 1: Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
Interventions: intervention 1: Sylatron intervention 2: Yervoy
Intervention descriptions: intervention 1: Sylatron - Once per week for 12 weeks, given as an injection under the skin. intervention 2: Yervoy - Once every 3 weeks for 12 weeks (4 times total), given over a 90-minute intravenous infusion (through the vein).

Protocol documents:
Clinical trial NCT01930162
Conditions: Single Umbilical Cord Blood Transplantation Non-myeloablative Conditioning Acute Lymphocytic Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia
Keywords: HSC835 single umbilical cord blood transplantation non-myeloablative conditioning regimen Umbilical cord blood UCB transplantation
Sponsor: Novartis Pharmaceuticals
Start date: 2014-10-07; Completion date: 2016-08-29
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.

Detailed description:

Arms: arm 1: Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
Interventions: intervention 1: HSC835
Intervention descriptions: intervention 1: HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).

Protocol documents:
Clinical trial NCT01939223
Conditions: Colorectal Neoplasms
Keywords: Stage IV colorectal cancer / Liver Metastasis
Sponsor: Bayer
Start date: 2013-12-02; Completion date: 2016-08-29
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.

Detailed description:

Arms: arm 1: 4 regorafenib tablets taken orally in the morning daily, followed by a low fat meal for 3 weeks on off treatment followed by 1 week off without treatment,Treatment 21 days. arm 2: 4 placebo tablets taken orally in the morning daily,followed by a low fat meal for 3 weeks on off treatment followed by 1 week off without treatment,Treatment 21 days.
Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506) intervention 2: Placebo
Intervention descriptions: intervention 1: Four tablets of 40mg taken orally daily in the morning, dose of 160 mg for 21 days of treatment followed by 7 days without treatment intervention 2: Four tablets taken in the morning orally daily for 21 days of treatment followed by 7 days without treatment

Protocol documents:
Clinical trial NCT02130193
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Efficacy Danirixin EXACT-PRO COPD Safety RD CXCR2 inhibitor EXACT-RS PK HCRU exacerbations PD
Sponsor: GlaxoSmithKline
Start date: 2014-02-13; Completion date: 2016-08-29
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this First Time in Patient study is to obtain initial information on the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of repeat daily administration of danirixin in subjects with symptomatic chronic obstructive pulmonary disease (COPD) having mild to moderate airflow limitation and are at high risk for future COPD exacerbations.

The study will be conducted in two parts. Part A will be a two week open label, single arm study in patients with COPD to obtain pharmacokinetic data and safety information of repeat dosing of danirixin in the population of interest. Approximately 10 subjects will be enrolled in Part A of the study. Progression to and dose selection for Part B will occur following review of the data collected in Part A. Part B will be a 52-week, randomized, double-blind (sponsor unblind), placebo-controlled on top of standard of care, parallel group study. Part B will evaluate several clinical efficacy assessments related to exacerbations and respiratory symptoms. Approximately 100 subjects will be enrolled with a target of 80 subjects completing 52 weeks of danirixin administration.

Detailed description:

Arms: arm 1: Subjects will receive 50 mg danirixin twice daily (BID) orally for 14 days. If the exposure to danirixin is lower than expected, after 14 days of dosing, then the dose may be increased to 75 mg BID for Part B. arm 2: Subjects will be randomized to receive either danirixin BID or placebo BID treatment along with standard care of treatment for 52 weeks. Subjects completing Part A and meeting the eligibility criteria for Part B could also be randomized in Part B.
Interventions: intervention 1: Danirixin intervention 2: Placebo
Intervention descriptions: intervention 1: Danirixin is available as 50 or 75 mg white, film coated immediate release tablet. intervention 2: Subjects will receive danirixin matching placebo

Protocol documents: