ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02753816
Conditions: Tranexamic Acid Burn Major Surgery
Keywords: Tranexamic Acid Burn Surgery Tangential Excision
Sponsor: Spectrum Health Hospitals
Start date: 2016-04-01; Completion date: 2019-12-03
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your stay.

In this study, prior to each surgical procedure to treat the participants burn injury, the participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid that looks like the tranexamic acid medicine, but does not have any active ingredient in it. In this study, both the tranexamic acid and the placebo are considered research.

Detailed description:
Neither the participant nor the study doctor will choose what treatment the participant gets. The participant will have an equal chance of being given the tranexamic acid or the placebo. Neither the participant nor the study doctor will know which treatment the participant is receiving.

The participant will receive one 1 gram dose of either tranexamic acid or placebo immediately before surgery. The dose of tranexamic acid or placebo will be given in the participants vein over a 10-minute period.

Information from the participants medical record related to their surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with the participants study number instead of their name.

Arms: arm 1: 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery arm 2: Placebo given over 10 minutes into the vein once prior to surgery
Interventions: intervention 1: Tranexamic Acid intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00669578
Conditions: Chronic Myeloproliferative Disorders Secondary Myelofibrosis
Keywords: secondary myelofibrosis polycythemia vera essential thrombocythemia primary myelofibrosis
Sponsor: Mayo Clinic
Start date: 2008-05-01; Completion date: 2019-12-12
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. CC-4047 may also stop the growth of cancer cells by blocking blood flow to the cancer.

PURPOSE: This trial is studying the side effects and best dose of CC-4047 and to see how well it works in treating patients with myelofibrosis.

Detailed description:
OBJECTIVES:

Phase I:

Primary

* To determine the Maximum Tolerated Dose of CC-4047 in the treatment of Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF, post-PV MF, or post-ET MF).

Phase II:

Primary

* Best overall response as determined by International Working Group Criteria over the first 6 cycles (168 days) of study treatment.

Secondary

* Safety (type, frequency, severity \[National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0\] of adverse events (AEs), and relationship of AEs to CC-4047.
* Duration of response.
* Time to response.
* Best overall response as determined by International Working Group Criteria over the first 12 cycles (336 days) of study treatment.

OUTLINE: Patients receive oral CC-4047. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28 days and then every 6 months for up to 3 years.

Arms: arm 1: None
Interventions: intervention 1: CC-4047
Intervention descriptions: intervention 1: CC-4047: taken orally each day in a 28 day cycle.

Protocol documents:
Clinical trial NCT00376688
Conditions: Recurrent Breast Carcinoma Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7
Sponsor: National Cancer Institute (NCI)
Start date: 2006-07-11; Completion date: 2019-12-16
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well temsirolimus works in treating patients with breast cancer that has spread to other places in the body. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the overall activity (as defined by complete response \[CR\] + partial response \[PR\] + stable disease \[SD\] for \>= 24 weeks) of a weekly 25 mg intravenous dose of temsirolimus in patients with locally advanced or metastatic breast cancer.

II. To compare the activity of temsirolimus in patients with locally advanced or metastatic breast cancer whose primary tumors have mutations in the PIK3CA or PTEN gene with those whose tumors do not have a mutation in the PIK3CA gene.

III. To examine correlations between antitumor activity of temsirolimus and alterations in expression of genes in the PI3K pathway in primary tumor biopsy specimens.

OUTLINE:

Patients receive temsirolimus intravenously (IV) over 30 minutes weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive temsirolimus IV over 30 minutes weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Temsirolimus
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given IV

Protocol documents:
Clinical trial NCT01774786
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2013-06-10; Completion date: 2019-12-31
Enrollment: 780 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram \[mg/kg\] intravenously \[IV\] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.

Detailed description:

Arms: arm 1: Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. arm 2: Participants will receive placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Interventions: intervention 1: 5-Fluorouracil intervention 2: Capecitabine intervention 3: Cisplatin intervention 4: Pertuzumab intervention 5: Placebo intervention 6: Trastuzumab
Intervention descriptions: intervention 1: Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m\^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles. intervention 2: Participants will receive capecitabine 1000 mg/m\^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles. intervention 3: Participants will receive cisplatin 80 mg/m\^2 IV q3w for 6 cycles. intervention 4: Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. intervention 5: Participants will receive placebo (matched to pertuzumab) IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason. intervention 6: Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

Protocol documents:
Clinical trial NCT03380000
Conditions: Postmenopausal Women
Keywords: Dietary nitrate supplementation Beetroot juice
Sponsor: Penn State University
Start date: 2014-09-12; Completion date: 2020-01-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this study the investigators will test the hypothesis that acute consumption of inorganic nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal women. Understanding and improving artery function and blood pressure regulation in women is important because they undergo accelerated arterial stiffening after menopause and have much larger increases in blood pressure when they exercise compared with either premenopausal women or men of similar age.

Detailed description:
Postmenopausal women have stiff central arteries and exaggerated blood pressure (BP) responses during exercise compared with either premenopausal women or men of similar age. Arterial stiffness and exaggerated BP responses to exercise are prognostic for heart wall thickening, future hypertension, adverse cardiovascular events, and mortality. Previous studies have reported that acute consumption of nitrate-rich beetroot juice can lower resting and exercising BP responses in older adults. However, these studies included both sexes and did not compare the effects of beetroot juice to a nitrate-depleted placebo (a true control). Thus, the potential BP lowering effects of nitrate supplementation per se have not been established in postmenopausal women. The present study examines the acute (single dose) effects of nitrate-rich beetroot juice on resting hemodynamics (peripheral and central BP, arterial wave properties, etc), and physiological responses to handgrip exercise in metabolically healthy post-menopausal women.

Arms: arm 1: Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing. arm 2: Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Interventions: intervention 1: Beetroot juice intervention 2: Beetroot juice placebo
Intervention descriptions: intervention 1: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK). intervention 2: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).

Protocol documents:
Prot_SAP_000.pdf: 





















































ICF_001.pdf:
Clinical trial NCT01639001
Conditions: NSCLC (Non-small Cell Lung Cancer)
Keywords: Crizotinib ALK positive ALK Anaplastic Lymphoma Kinase NSCLC Non-Small Cell Lung Cancer Frontline 1L Previously Untreated East Asian Non-Squamous
Sponsor: Pfizer
Start date: 2012-09-29; Completion date: 2020-01-08
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer Patients. The objective of the study is to demonstrate that Crizotinib is superior to first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma Kinase) gene locus.

Detailed description:

Arms: arm 1: Crizotinib arm 2: Chemotherapy \[Option at Investigator's Choice\]
Interventions: intervention 1: Crizotinib intervention 2: Pemetrexed/Cisplatin intervention 3: Pemetrexed/Carboplatin
Intervention descriptions: intervention 1: 250 mg two times daily \[BID\], oral, on a continuous daily dosing schedule. Cycles are defined in 21 day periods. intervention 2: Option 1: Pemetrexed/Cisplatin; Pemetrexed, 500 mg/m\^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Cisplatin, 75 mg/m\^2 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and cisplatin will be repeated every 3 weeks for a maximum of 6 cycles. intervention 3: Option 2: Pemetrexed/Carboplatin. Pemetrexed, 500 mg/m\^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Carboplatin, at a dose calculated to produce an AUC of 5 or 6 mg.min/mL will be administered by infusion according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and carboplatin will be repeated every 3 weeks for a maximum of 6 cycles.

Protocol documents:
Clinical trial NCT03198715
Conditions: Acute Ischemic Stroke
Keywords: Fibrinolysis enhancer TAFIa inhibitor Developmental Phase I
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2017-07-30; Completion date: 2020-01-19
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.

Detailed description:

Arms: arm 1: Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours arm 2: Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours arm 3: Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours arm 4: Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours arm 5: Participants receive saline by intravenous infusion over six hours
Interventions: intervention 1: DS1040b intervention 2: Placebo
Intervention descriptions: intervention 1: DS-1040b in solution for intravenous infusion intervention 2: Saline solution for intravenous infusion

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01945021
Conditions: Non Small Cell Lung Cancer ROS1 Proto Oncogene Crizotinib
Keywords: Non small cell lung cancer NSCLC ROS1 ROS1 positive ROS1 proto oncogene c ros tyrosine kinases ROS1 positive NSCLC ROS1 lung cancer ALK negative Lung Carcinoma Neoplasm Crizotinib Xalkori Previously treated or untreated North East Asian
Sponsor: Pfizer
Start date: 2013-09-30; Completion date: 2020-01-22
Enrollment: 129 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation

Detailed description:

Arms: arm 1: Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
Interventions: intervention 1: Crizotinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT04982874
Conditions: Drug Use
Keywords: bioequivalence furosemide Indonesian healthy volunteers
Sponsor: PT. Kimia Farma (Persero) Tbk
Start date: 2019-12-13; Completion date: 2020-01-29
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.

Detailed description:
Twenty four healty volunteers were given a single dose of Furosemide 40 mg Tablet or Lasix® 40 mg Tablet with 240 mL of water beneath fasting condition. Then the blood samples for Furosemide were drawn and analyzed using UPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Arms: arm 1: volunteers received Furosemide 40 mg tablet with 240 mL of water arm 2: volunteers received Lasix® 40 mg tablet with 240 mL of water
Interventions: intervention 1: Furosemide 40 mg intervention 2: Lasix® 40 mg Tablet
Intervention descriptions: intervention 1: Administered with 240 mL of water intervention 2: Administered with 240 mL of water

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01224210
Conditions: Portopulmonary Hypertension
Keywords: portopulmonary hypertension portal hypertension esophageal or gastric varices right heart catheterization transpulmonary gradient Endothelin Receptor Antagonist Ambrisentan Letairis pulmonary hemodynamics
Sponsor: Tufts Medical Center
Start date: 2010-03-01; Completion date: 2020-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an Open Label, Multicenter, pilot clinical trial to assess the efficacy and safety of an oral selective Endothelin Receptor Antagonist (ambrisentan) in patients with portopulmonary hypertension.

Preliminary evidence suggests that ambrisentan is safe and effective in patients with portopulmonary hypertension. The goal of therapy for these patients is to improve symptoms of dyspnea and to improve pulmonary hemodynamics to a mean pulmonary artery pressure \<35 mm Hg in order to make patients eligible for liver transplantation. Therefore, the primary endpoints for this study will include 6 minute walk distance (6MWD) and pulmonary vascular resistance (PVR).

Eligible subjects will receive 5 mg ambrisentan once-daily for the first 4 weeks. After the initial 4-week period, investigators will increase study drug dose to 10 mg once daily (both 5 mg and 10 mg doses are FDA approved). If 10 mg is not tolerated in the opinion of investigator, then the investigator may decrease the dose back to 5 mg once daily. Primary outcome is a change in both the 6 Minute Walk Distance and in Pulmonary Vascular Resistance from baseline to Week 24. Subjects will be monitored with liver function tests (LFT) every 2 weeks for the first 8 weeks, then every 4 weeks thereafter. These safety laboratory tests may be performed at a local phlebotomy laboratory or at the Investigator clinic. In addition, the Investigator will assess each subject for safety and efficacy at Week 4, Week 12, and Week 24. Following Week 24, subjects will be assessed for safety and efficacy every 12 weeks. Patients will be followed for a total of 1 year. After 1 year, if the Investigator feels that continuing the treatment will be beneficial to the patients, they will be provided with ambrisentan by Gilead Pharmaceuticals, free of charge.

Detailed description:

Arms: arm 1: Open Label Ambrisentan
Interventions: intervention 1: Ambrisentan
Intervention descriptions: intervention 1: Ambrisentan once-daily in the morning with or without food. The adult dose selected for this study will be 5 mg for the first 4 weeks. After the initial 4 weeks the dose will be increased to 10mg (available doses are 5, and 10 mg) based on tolerance safety. Subjects will remain on 10mg until they complete the study. Dose adjustments may be made based on side effects.

Protocol documents:
Clinical trial NCT04016077
Conditions: Hepatic Impairment Healthy Participants
Keywords: PF-06651600 Pharmacokinetics Hepatic impairment
Sponsor: Pfizer
Start date: 2019-07-19; Completion date: 2020-03-05
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this study.

Detailed description:

Arms: arm 1: This arm includes participants with moderate hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10. arm 2: This arm includes healthy adult participants who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10. arm 3: This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met.

The arm includes participants with mild hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
Interventions: intervention 1: PF-06651600 30 mg
Intervention descriptions: intervention 1: PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.

Protocol documents:
Prot_000.pdf: 







































































































































































SAP_001.pdf:
Clinical trial NCT02504268
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2015-09-03; Completion date: 2020-03-19
Enrollment: 994 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

Detailed description:
Subcutaneous (SC)

Arms: arm 1: Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week arm 2: Methotrexate at least 15mg per week tablet or capsule orally arm 3: Placebo for Abatacept subcutaneous injection once per week arm 4: Placebo to match Methotrexate capsule orally once per week
Interventions: intervention 1: Abatacept intervention 2: Methotrexate intervention 3: Abatacept Placebo intervention 4: Methotrexate Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: