ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01659255
Conditions: Non Hodgkins Lymphoma Chronic Lymphocytic Leukaemia
Sponsor: Gilead Sciences
Start date: 2012-08-17; Completion date: 2016-01-11
Enrollment: 90 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Detailed description:

Arms: arm 1: Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily. arm 2: Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily. arm 3: Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily. arm 4: Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily. arm 5: Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily. arm 6: Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. arm 7: Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. arm 8: Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily. arm 9: Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. arm 10: Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily. arm 11: Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily. arm 12: Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily. arm 13: Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily. arm 14: Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily. arm 15: Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. arm 16: Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily. arm 17: Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
Interventions: intervention 1: Tirabrutinib
Intervention descriptions: intervention 1: Capsules administered orally

Protocol documents:
Clinical trial NCT02550106
Conditions: CHRONIC SPONTANEOUS URTICARIA
Keywords: CHRONIC SPONTANEOUS URTICARIA OMALIZUMAB URTICARIA CONTROL TEST IGE025
Sponsor: Novartis Pharmaceuticals
Start date: 2015-04-22; Completion date: 2016-01-11
Enrollment: 136 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate the proportion of patients with an urticaria control test \[UCT\] score of greater than or equal to 12 at Week 12.

Detailed description:

Arms: arm 1: sub cutaneous injections of 300 mg every 4 weeks until Week 8.
Interventions: intervention 1: OMALIZUMAB
Intervention descriptions: intervention 1: sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Protocol documents:
Clinical trial NCT01965652
Conditions: Opioid-induced Constipation
Keywords: Opioid Induced Constipation
Sponsor: Shionogi
Start date: 2013-09-24; Completion date: 2016-01-12
Enrollment: 1246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

Detailed description:

Arms: arm 1: Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks. arm 2: Participants received matching placebo tablets orally once daily for 52 weeks.
Interventions: intervention 1: Naldemedine intervention 2: Placebo
Intervention descriptions: intervention 1: Naldemedine 0.2 mg tablet taken orally once a day intervention 2: Placebo tablet taken orally once a day

Protocol documents:
Clinical trial NCT02255110
Conditions: Soft Tissue Sarcoma
Keywords: Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma TH-302 Doxorubicin Evofosfamide
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2014-12-10; Completion date: 2016-01-12
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, single-arm, Japanese multicenter trial to evaluate the safety, tolerability, and efficacy of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma (STS).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TH-302 intervention 2: Doxorubicin
Intervention descriptions: intervention 1: TH-302 will be administered at a dose of 300 milligram per square meter (mg/m\^2) by intravenous infusion over 30 minutes on Days 1 and 8 of every 21-day cycle until the evidence of significant treatment-related toxicity or progressive disease. intervention 2: Doxorubicin will be administered at a dose of 75 mg/m\^2 by intravenous injection (over at least 5 minutes) or by intravenous infusion over 6-96 hours on Day 1 of every 21-day cycle starting 2 to 4 hours after completion of TH-302 administration until the evidence of significant treatment-related toxicity or progressive disease.

Protocol documents:
Clinical trial NCT01606761
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, Rheumatoid Active rheumatoid arthritis despite anti-TNF-alpha therapy Sirukumab Human Anti-IL-6 monoclonal antibody
Sponsor: Janssen Research & Development, LLC
Start date: 2012-08-06; Completion date: 2016-01-12
Enrollment: 878 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

Detailed description:
Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 68 weeks, which includes 52 weeks of treatment. Participants who complete participation in the study will be eligible for inclusion into the long term extension study if enrollment at a participating site is available to them. If they do not participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 24, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.

Arms: arm 1: Patients will receive placebo every 2 weeks from Week 0 through Week 22, followed by a subcutaneous (SC) sirukumab dose regimen every 2 weeks through Week 52. arm 2: Patients will receive sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52. arm 3: Patients will receive sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC administrations will be made at Weeks 2, 6, and every 4 weeks through Week 52.
Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: Sirukumab intervention 4: Sirukumab intervention 5: Sirukumab
Intervention descriptions: intervention 1: Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22. intervention 2: Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52. intervention 3: Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52. intervention 4: Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52. intervention 5: Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.

Protocol documents:
Clinical trial NCT02299635
Conditions: Triple Negative Breast Neoplasms
Keywords: PF-03084014 Notch Alterations
Sponsor: Pfizer
Start date: 2015-02-03; Completion date: 2016-01-14
Enrollment: 19 participants; Allocation: ; Intervention model: 

Brief summary:
This study is designed to evaluate the preliminary anti-tumor activity and tolerability of PF-03084014 when administered as a single agent in the treatment of patients with advanced triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for genomic alterations in Notch receptors (NA-)

Detailed description:

Arms: arm 1: PF-03084014 will be administered orally, continuously, twice daily at 150 mg, but the dose can be reduced to 100 mg or 80 mg.
Interventions: intervention 1: PF-03084014 intervention 2: PF-03084014 intervention 3: PF-03084014
Intervention descriptions: intervention 1: Tablet, 10 mg, twice a day. intervention 2: Tablet, 50 mg, twice a day intervention 3: Tablet, 100 mg, twice a day

Protocol documents:
Clinical trial NCT02202759
Conditions: Adenocarcinoma of the Stomach Gastroesophageal Junction Expressing Guanylyl Cyclase C
Keywords: Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2014-08-04; Completion date: 2016-01-15
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in patients with recurrent or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the stomach or gastroesophageal junction.

Detailed description:
The drug being tested in this study is called MLN0264. MLN0264 is being tested to treat tumors in people who have metastatic or recurrent gastric or gastroesophageal junction malignancies expressing guanylyl cyclase C (GCC). Participants will be analyzed in cohorts based on GCC expression: low=combined H-score 10-109, intermediate=combined H-score 110-249, high=combined IHC H-score \>250. This study will assess tumor size reduction in patients who are administered MLN0264.

The study enrolled 38 patients. All participants will be administered MLN0264 at 1.8 mg/kg as a single, 30-minute, intravenous (IV) infusion on Day 1 of each 3-week treatment cycle, followed by a rest period of 20 days. Participants will continue to receive MLN0264 for up to 1 year or until disease progression or unacceptable toxicity occurs.

This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 19 months. Participants will make 3 to 6 visits to the clinic per treatment cycle, an end-of-treatment visit 30 days after the last dose of study medication, and follow-up assessments every 12 weeks until death or 6 months after the last patient completes treatment - whichever occurs first.

Arms: arm 1: MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
Interventions: intervention 1: MLN0264
Intervention descriptions: intervention 1: MLN0264 IV infusion

Protocol documents:
Clinical trial NCT02202785
Conditions: Pancreatic Adenocarcinoma
Keywords: Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2014-07-02; Completion date: 2016-01-15
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in patients with advanced or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the pancreas.

Detailed description:
The drug being tested in this study is called MLN0264. MLN0264 is being tested to treat tumors in people who have metastatic adenocarcinoma of the pancreas expressing guanylyl cyclase C (GCC). This study will assess tumor size reduction in patients who are administered MLN0264.

The study will enroll 42 to 81 patients. All participants will be administered MLN0264 at 1.8 mg/kg as a single, 30-minute, intravenous (IV) infusion on Day 1 of each 3-week treatment cycle, followed by a rest period of 20 days. Participants will continue to receive MLN0264 for up to 1 year or until disease progression or unacceptable toxicity occurs.

This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 19 months. Participants will make 3 to 6 visits to the clinic per treatment cycle, an end-of-treatment visit will occur 30 days after the last dose of study medication, and follow-up assessments will occur every 12 weeks until death or 6 months after the last patient completes treatment - whichever occurs first.

Arms: arm 1: MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
Interventions: intervention 1: MLN0264
Intervention descriptions: intervention 1: MLN0264 IV infusion

Protocol documents:
Clinical trial NCT01866306
Conditions: Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-22; Completion date: 2016-01-18
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB) in healthy and asthmatic participants, and to identify an appropriate dosage of RV16UB in order to study biomarkers in asthmatic participants. The study is divided into 2 parts. Part 1 is a dose-finding study where healthy participants, and asthmatic participants, who were either treated or not treated with a class of long-acting beta antagonists (LABA) will be recruited to undergo nasal challenge with increasing doses of RV16UB. Part 2 is a biomarker study where mild to moderate asthmatics undergo challenge with the most appropriate dose of RV16UB identified in Part 1, based on tolerability and viral effects. .

Detailed description:

Arms: arm 1: Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril. arm 2: Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. arm 3: Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. arm 4: Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. arm 5: Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. arm 6: Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. arm 7: Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
Interventions: intervention 1: RV16UB intervention 2: LABA
Intervention descriptions: intervention 1: RV16UB is administered by spraying an atomized viral suspension into a single nostril. Planned doses of RV16UB in Part 1 are 10 Tissue Culture Infective Dose 50 (TCID50), 100 TCID50, 1000 TCID50 and 10,000 TCID50. intervention 2: Asthmatic participants were treated with LABA as part of their standard of care

Protocol documents:
Clinical trial NCT01698775
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-10-02; Completion date: 2016-01-19
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of omarigliptin in participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end stage renal disease on dialysis with inadequate glycemic control. The primary hypothesis of the study is that omarigliptin compared to placebo produces greater reduction in glycosylated hemoglobin (A1C) after 24 weeks.

Detailed description:

Arms: arm 1: Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54). arm 2: Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Interventions: intervention 1: Omarigliptin intervention 2: Placebo to omarigliptin intervention 3: Glipizide intervention 4: Placebo to glipizide intervention 5: Insulin
Intervention descriptions: intervention 1: Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week intervention 2: Matching placebo to omarigliptin capsule administered orally once a week intervention 3: Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54). intervention 4: Matching placebo to glipizide daily intervention 5: Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.

Protocol documents:
Clinical trial NCT01911546
Conditions: Highly-sensitized Kidney Transplant Recipients
Sponsor: Joseph Kahwaji, MD, MPH
Start date: 2013-06-01; Completion date: 2016-01-19
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A growing number of patients on the kidney transplant waiting list are broadly human leukocyte antigen (HLA) sensitized (HS). These patients are unlikely to have a compatible donor. Therefore they wait longer and have increased morbidity and mortality. Desensitization with intravenous immune globulin (IVIG) and rituximab with alemtuzumab induction improves transplant rates and achieves good allograft outcomes. However, HS patients are at risk for viral infections after transplant. We have previously shown an increased incidence of BKV infections after desensitization with HS patients having higher peak viral loads. Cytomegalovirus (CMV) and polyomavirus BK (BKV) infections place HS renal transplant recipients at particular risk. Allograft rejection is associated with both CMV and BKV infection. This is of particular concern for HS patients as they are at an increased risk of rejection at baseline. Furthermore, the frequent development of leukopenia after transplantation often requires the CMV prophylactic agent to be discontinued along with lowering immunosuppression. This increases the risk of CMV infection and allograft rejection.

Everolimus was approved for rejection prophylaxis in combination with calcineurin inhibitors (CNI). CNI used in the study that led to drug's approval was cyclosporine. There are several trials nearing it's completion that utilize low dose tacrolimus instead. In 2012 Novartis published data from several trials showing superior outcomes using everolimus + low dose tacrolimus. This combination is currently approved in EU. It is also a combination that is standard of care (SOC) at our center for patients on everolimus.

This study aims to demonstrate that use of everolimus as part of a maintenance immunosuppression regimen may decrease viral infections without lowering overall immunosuppression thus improving allograft function and survival.

Detailed description:

Arms: arm 1: Patients receiving everolimus will be on low dose tacrolimus.
Interventions: intervention 1: everolimus + low-dose tacrolimus
Intervention descriptions: intervention 1: Patients are supplied everolimus (Zortress) + prograf

Protocol documents:
Clinical trial NCT02611154
Conditions: Abuse of Anabolic Steroids
Keywords: Healthy Volunteers Sports Medicine Men's Health Athletes Anti-Doping
Sponsor: University of Utah
Start date: 2015-11-18; Completion date: 2016-01-19
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic profile during anti-doping testing, which is different than the profile seen when testosterone is administered into muscle, on skin or under the tongue.

Objective: The investigators aim to characterize the unique steroid doping profile following administration of intranasal testosterone to healthy, active volunteer subjects.

Detailed description:
Testosterone is a substance commonly abused in the sporting world despite being banned by all American sports leagues, international federations, and the World Anti-Doping Agency. Current methods employed to detect exogenously administered testosterone include direct detection using isotope ratio mass spectrometry (IRMS) and indirect detection using the athlete biological passport (ABP). However, different formulations of testosterone (oral, transdermal, sublingual, etc) are expected to result in characteristic IRMS profiles, affect the ABP readings in unique ways, and differ in their windows of detection. In 2014, a new formulation of testosterone, Natesto, which is administered intranasally, was FDA approved. Though only approved for medical use, it is expected athletes may use this product, and its effect on steroid doping markers has yet to be determined. Characterization of this detection profile is necessary for confirmation of the exact product being administered in an anti-doping setting. In this study, the investigators aim to understand the effects on the steroid doping profile following a single administration of Natesto to healthy, active volunteers. Windows of detection will be determined for the standard dosing of Natesto, and the effects on ABP markers and IRMS profiles will also be established.

Arms: arm 1: All participants will be receiving intranasal testosterone and will follow the same study procedures.
Interventions: intervention 1: Testosterone
Intervention descriptions: intervention 1: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.

Protocol documents: