ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03578146
Conditions: Healthy Volunteers
Sponsor: Portola Pharmaceuticals
Start date: 2012-12-01; Completion date: 2015-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

Detailed description:
A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in healthy volunteers.

Arms: arm 1: 210 mg andexanet IV bolus administered over 7 minutes (\~30 mg/min) arm 2: 420 mg andexanet IV bolus administered over 14 minutes (\~30 mg/min) arm 3: 600 mg andexanet IV bolus administered over 20 minutes (\~30 mg/min) arm 4: 720 mg IV bolus administered over 24 minutes \[\~30 mg/min\] followed by 240 mg continuous IV infusion \[4 mg/min over 60 min) arm 5: 800 mg IV bolus administered over 26.7 minutes \[\~30 mg/min\] followed by 960 mg continuous IV infusion \[8 mg/min over 120 min\] arm 6: Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous fusion.
Interventions: intervention 1: PRT064445/Rivaroxaban intervention 2: Placebo/Rivaroxaban intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00756236
Conditions: Myocardial Ischemia
Sponsor: University of Oklahoma
Start date: 2008-10-01; Completion date: 2015-09-02
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We will compare three study groups receiving metoprolol, esmolol, or placebo. Level of anesthesia will be titrated to achieve the same range of BIS value in all groups. Our hypothesis is that the metoprolol and esmolol groups will require a lower level of anesthetic agent to achieve the targeted BIS range, compared to the placebo group.

Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac protection, decreases anesthetic requirement.

Detailed description:
Beta-receptor antagonists are commonly used in the perioperative setting. These agents have been shown to decrease the incidence of perioperative myocardial ischemia and are recommended by a recent practice guideline in certain patient groups.1 Besides protection from ischemia, there are other situations where beta-receptor antagonists are used intraoperatively such as control of the sympathetic response to tracheal intubation and certain types of surgical stimuli.

There is new evidence suggesting that administration of esmolol, a short-acting beta-receptor antagonist, might reduce the actual anesthetic requirement. This was initially shown by studies in which esmolol decreased the amount of anesthetic required to prevent movement after skin incision.2;3 Subsequent studies used bispectral index (BIS) as an endpoint and demonstrated decreased BIS values in subjects receiving esmolol during general anesthesia. 4;5

This anesthetic-sparing effect observed with esmolol has not been prospectively studied with other beta-receptor antagonists. Since perioperative beta-blockade is commonly achieved using longer acting agents such as metoprolol or atenolol, it is clinically relevant to understand the effects of these medications on anesthetic requirement. We aim to conduct a prospective, randomized, controlled, double-blind study to compare the anesthetic-sparing effect of metoprolol and esmolol administered intraoperatively.

Arms: arm 1: Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment. arm 2: Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment. arm 3: Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml \& 5ml syringes.
Interventions: intervention 1: Metoprolol intervention 2: Esmolol intervention 3: P-Group
Intervention descriptions: intervention 1: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration intervention 2: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl intervention 3: 0.9%NaCl dispensed in 60ml \& 5ml syringes

Protocol documents:
Clinical trial NCT02092350
Conditions: Hepatitis C Virus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-03-17; Completion date: 2015-09-02
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be \>45%.

Detailed description:

Arms: arm 1: Participants receive grazoprevir 100 mg tablet, orally, once per day (QD) + elbasvir 50 mg tablet, orally, QD, for 12 weeks. arm 2: Participants receive placebos to both grazoprevir and elbasvir for 12 weeks, and after a 4-week break, grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks. arm 3: Participants receive grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks with intensive PK testing.
Interventions: intervention 1: Grazoprevir intervention 2: Elbasvir intervention 3: Placebo to Grazoprevir intervention 4: Placebo to Elbasvir
Intervention descriptions: intervention 1: Grazoprevir 100 mg tablet intervention 2: Elbasvir 50 mg tablet intervention 3: Placebo tablet matched to grazoprevir intervention 4: Placebo tablet matched to elbasvir

Protocol documents:
Clinical trial NCT01354964
Conditions: Insulin Resistance
Keywords: Glucose Metabolism Disorders Insulin Resistance Endocrine System Vitamin D
Sponsor: Albert Einstein College of Medicine
Start date: 2009-03-13; Completion date: 2015-09-03
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to study the effects of Vitamin D supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation, and on specific cells and processes in fat tissue.

Detailed description:
Over the last several years, studies have shown that low vitamin D levels may increase risk of developing Type 2 Diabetes. The investigators will administer vitamin D3 (cholecalciferol) to non-diabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels \<20 ng/ml) to increase the level of vitamin D3. The investigators will study the effects of increased Vitamin D on insulin action, adipose tissue inflammation, and on certain cells and processes in fat tissue.

Investigators will study participants with a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Adipose tissue inflammation will be measured using the following inflammatory markers: IL-6, PAI-1, TNF-alpha, and iNOS.

Arms: arm 1: Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to six months. arm 2: Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months.
Interventions: intervention 1: Vitamin D intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02128932
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-08-04; Completion date: 2015-09-03
Enrollment: 1089 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: semaglutide intervention 2: insulin glargine
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks. intervention 2: Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.

Protocol documents:
Clinical trial NCT02105012
Conditions: Asthma
Keywords: Mild moderate persistent Adult
Sponsor: Pearl Therapeutics, Inc.
Start date: 2014-04-01; Completion date: 2015-09-04
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.

Detailed description:
This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.

Arms: arm 1: Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID arm 2: BD MDI 160 µg (PT008) administered as 2 inhalations BID arm 3: BD MDI 80 µg (PT008) administered as 2 inhalations BID arm 4: BD MDI 40 µg (PT008) administered as 2 inhalations BID arm 5: Placebo MDI administered as 2 inhalations BID
Interventions: intervention 1: BD MDI 320 µg intervention 2: BD MDI 160 µg intervention 3: BD MDI 80 µg intervention 4: BD MDI 40 µg intervention 5: Placebo MDI
Intervention descriptions: intervention 1: Budesonide Inhalation Aerosol administered as 2 inhalations BID intervention 2: Budesonide Inhalation Aerosol administered as 2 inhalations BID intervention 3: Budesonide Inhalation Aerosol administered as 2 inhalations BID intervention 4: Budesonide Inhalation Aerosol administered as 2 inhalations BID intervention 5: Placebo MDI administered as 2 inhalations BID

Protocol documents:
Clinical trial NCT03256552
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Pearl Therapeutics, Inc.
Start date: 2015-01-28; Completion date: 2015-09-05
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

Detailed description:
This was a randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center study to assess the efficacy and safety of 3 doses of GP MDI (28.8, 14.4, and 7.2 μg ex-actuator, BID) in Japanese subjects with moderate to severe COPD.

Subjects who met the entry criteria had their maintenance therapy for COPD adjusted, as specified in the protocol. To allow for an adequate washout of previous maintenance medications, subjects underwent a washout period of at least 7 days, but not greater than 28 days duration prior to returning to the clinic for Visit 2 (Randomization Visit; Day 1 of Treatment Period 1).

The 4 study treatments were GP MDI 28.8, 14.4, and 7.2 μg ex-actuator, and Placebo MDI BID. Subjects were randomly assigned to 1 of the following 4 treatment sequences (ABCD, BDAC, CADB, DCBA) in a 1:1:1:1 ratio using an Interactive Web Response System where each letter represented 1 of the 4 treatments included in the study by random assignment.

Subjects were to complete 7 days of dosing in each of the 4 Treatment Periods, with each Treatment Period separated by a washout period of 5 to 21 days.

Arms: arm 1: Glycopyrronium Metered Dose Inhaler 28.8 micrograms arm 2: Glycopyrronium Metered Dose Inhaler 14.4 micrograms arm 3: Glycopyrronium Metered Dose Inhaler 7.2 micrograms arm 4: Placebo Inhalation Aerosol
Interventions: intervention 1: Glycopyrronium MDI 28.8 micrograms intervention 2: Glycopyrronium MDI 14.4 micrograms intervention 3: Glycopyrronium MDI 7.2 micrograms intervention 4: Placebo MDI
Intervention descriptions: intervention 1: Glycopyrronium MDI 28.8 micrograms intervention 2: Glycopyrronium MDI 14.4 micrograms intervention 3: Glycopyrronium MDI 7.2 micrograms intervention 4: Placebo Inhalation Aerosol

Protocol documents:
Clinical trial NCT02105467
Conditions: Chronic Hepatitis C Virus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-06-05; Completion date: 2015-09-06
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment or deferred treatment (placebo control). The primary efficacy hypothesis was that the proportion of participants receiving combination therapy in the Immediate Treatment Arm who achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is superior to 73%.

Detailed description:

Arms: arm 1: Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period arm 2: Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was continued for an additional 24 weeks.
Interventions: intervention 1: Grazoprevir 100mg / Elbasvir 50 mg FDC intervention 2: Placebo to Grazoprevir / Elbasvir 50 mg FDC
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00902018
Conditions: Immune Thrombocytopenia
Keywords: ITP
Sponsor: Weill Medical College of Cornell University
Start date: 2009-01-01; Completion date: 2015-09-07
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to further evaluate the effects that eltrombopag (and romiplostim) have on platelets in subjects with chronic ITP. Eltrombopag is approved by the Food and Drug Administration (FDA) for the treatment of low platelets in patients with chronic ITP. It is being further studied by GlaxoSmithKline (now Novartis) in other conditions associated with low platelets. This research study is being done because eltrombopag has been shown to increase platelet counts in a different way than other therapies for ITP. The investigators want to further study how eltrombopag and romiplostim affect subjects and their platelets to determine how the study drug should best be used in ITP treatment.

Detailed description:
The B-cell lymphoma extra large (Bcl-xL/Bak) balance has been identified as an intrinsic mechanism that is critical in determining platelet lifespan (Mason, Cell 2007). There is evidence that Bcl-xL protein expression in megakaryocytes is regulated by Thrombopoietin (TPO) mediated activation of Akt pathways mediated by Jak2 and Stat 5 (possibly by Stat 3 as well). (e.g., Kozuma et. al., Journal of Thrombosis and Haemostasis). Little is known about the Bcl-xL / Bak axis in patients with ITP, or the effect of TPO-R stimulation on platelet survival in patients with ITP. The TPO effect may be a result of stimulation of thrombopoietin-receptor (TPO-R) signalling in megakaryocytes altering the packaging of Bcl-xl into platelets, or be a direct effect of platelet TPO-R stimulation as described above.

Arms: arm 1: 10 ITP patients were treated with daily oral eltrombopag 75mg for 2 weeks and complete testing was done at weekly intervals 3 times they then were allowed to receive long-term eltrombopag arm 2: 3 of the patients who received eltrombopag were also treated with romiplostim 10 micrograms/kg weekly for 2 weeks with the same complete testing done at weekly intervals three times after a washout period \> 1 month they then resumed long-term eltrombopag arm 3: no intervention single blood draw with complete studies
Interventions: intervention 1: Eltrombopag intervention 2: Romiplostim intervention 3: healthy controls
Intervention descriptions: intervention 1: The 10 subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times, weekly, for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months. intervention 2: three of the patients treated with eltrombopag will be treated with weekly romiplostim at a dose of 10 micrograms/kg weekly for 2 weeks with testing at weekly intervals for 3 times intervention 3: single blood draw for all measures included in the intervention arms

Protocol documents:
Clinical trial NCT01163786
Conditions: Bronchiolitis Obliterans
Keywords: Bortezomib GVHD Bronchiolitis Obliterans
Sponsor: Northwestern University
Start date: 2010-10-07; Completion date: 2015-09-09
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Approximately 10,000 allogeneic hematopoietic stem cell transplants (HSCT) are performed annually in the US for various indications. Bronchiolitis obliterans (BO) is the most common late noninfectious complication following allogeneic hematopoietic stem cell transplant. Prognosis of BO in the allogeneic HSCT setting is dismal and there are no therapies proven to be consistently effective. The exact incidence is not clear but may be as high as 30%2 . Risk factors include new or ongoing chronic graft versus host disease (cGVHD), age, antecedent obstructive airways disease and viral infections1. BO is characterized physiologically by progressive irreversible airflow obstruction and pathologically by luminal occlusion of the distal airways due to progressive scarring3. The pathogenesis is not completely understood but the cytokine transforming growth factor-beta 1 (TGF-b1), important for both tissue repair and fibrosis, is thought to play a pivotal role. Bortezomib, an FDA approved proteasomal inhibitor inhibits TGF-b1 signaling in vitro and protects against lung injury/fibrosis in bleomycin mouse model as well as in a mouse model for skin fibrosis. This is consistent with other data in the literature that proteasomal inhibition can prevent the development of fibrosis. Thus the investigators propose to test the safety, tolerability and efficacy of bortezomib in chronic pulmonary GVHD (BO).

Detailed description:

Arms: arm 1: Patients will Receive 2 4week cycles of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib wil be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.

Protocol documents:
Clinical trial NCT02170727
Conditions: Hepatitis C Virus
Sponsor: Bristol-Myers Squibb
Start date: 2014-06-26; Completion date: 2015-09-09
Enrollment: 199 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

Detailed description:
US National Institutes of Health Division of AIDs (DAIDS)

Arms: arm 1: DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Interventions: intervention 1: DCV/ASV/BMS-791325
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01974687
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C virus HCV
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-31; Completion date: 2015-09-11
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with Hepatitis C virus (HCV) genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will be evaluated. The antiviral activity of uprifosbuvir will also be assessed in HCV-infected participants.

Detailed description:

Arms: arm 1: Healthy participants will receive sequentially higher doses of uprifosbuvir (10 mg - 300 mg) capsules or matching placebo capsules once daily (QD) on Day 1 (Cohorts 1a-3a, 5a), Days 1 and 7 (Cohort 4a), or Day 1 - Day 7 (Cohort 6a). Dosing of next cohort will be based on review of available safety and PK data. Dosing will occur under fasted conditions with the exception of Cohort 4a, in which drug administration will occur under both fasted and fed conditions. arm 2: HCV GT1 participants with no prior direct-acting antiviral (DAA) exposure will receive a single dose of uprifosbuvir (10 mg - 300 mg) for 1 day across sequential dose cohorts. Dosing will commence following review of available safety and PK data from respective dose cohorts in Group A. All dosing will occur under fasted conditions. arm 3: HCV GT1 participants will receive uprifosbuvir (50 mg - 400 mg in capsules or 300 mg or 450 mg in tablets) or matching placebo capsules QD for 7 days. Dosing will commence following review of available safety and PK data of Group A. Fed vs. fasted dosing will be dependent on food effect results from Group A. arm 4: HCV GT2 - GT6 participants will receive uprifosbuvir (50 mg - 300 mg) capsules QD for 7 days. Dosing will commence following review of available safety and PK data from Group A. Fed vs. fasted dosing will be dependent on food effect results from Group A. arm 5: HCV GT1 participants with mildly impaired hepatic function will receive uprifosbuvir (150 mg - 450 mg) capsules QD for 1 or 7 days. Dosing of subsequent cohorts will be based on review of available safety and PK data. Fed vs. fasted dosing will be dependent on food effect results from Group A. arm 6: HCV GT1 participants will receive itraconazole 200 mg twice daily (BID) on Day -5 and itraconazole 200 mg QD from Day -4 to Day 11. Participants will also be co-administered uprifosbuvir 300 mg from Day 1 to Day 7.
Interventions: intervention 1: Uprifosbuvir intervention 2: Placebo intervention 3: Itraconazole
Intervention descriptions: intervention 1: Uprifosbuvir 5 mg, 25 mg, or 50 mg capsule, or 150 mg tablet, administered by mouth. intervention 2: Matching placebo to uprifosbuvir capsule administered by mouth. intervention 3: Itraconazole is supplied as 10 mg/mL oral solution or 100 mg capsules administered by mouth.

Protocol documents: