ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02402933
Conditions: Hypoglycemia Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2015-03-01; Completion date: 2015-08-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at time of enrolment will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of Nasal Glucagon (LY900018) in treating episodes of hypoglycemia.

Detailed description:
This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of moderate or severe hypoglycemia in persons with T1D.

This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.

Arms: arm 1: A single dose of 3mg glucagon nasal powder administered using a nasal powder delivery device for the treatment of moderate or severe hypoglycemic events; a maximum of 4 events per participant during the study.
Interventions: intervention 1: Nasal Glucagon
Intervention descriptions: intervention 1: 3 mg nasal glucagon powder

Protocol documents:
Clinical trial NCT02408692
Conditions: Contraception Body Weight
Keywords: Emergency contraception Obese BMI Normal BMI
Sponsor: Oregon Health and Science University
Start date: 2015-02-01; Completion date: 2015-08-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.

Detailed description:
To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations.

We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.

Arms: arm 1: 5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG arm 2: 5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG arm 3: 5 obese women (BMI \>30 kg/m2) taking 3mg LNG
Interventions: intervention 1: ECx1 intervention 2: ECx2
Intervention descriptions: intervention 1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation. intervention 2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)

Protocol documents:
Clinical trial NCT02436577
Conditions: Bioequivalence Healthy Japanese Subjects Pharmacokinetics
Keywords: ticagrelor orodispersible tablet ticagrelor immediate-release tablet bioequivalence Phase I healthy Japanese subjects
Sponsor: AstraZeneca
Start date: 2015-06-01; Completion date: 2015-08-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be an open-label, randomised, three-period, three-treatment, crossover study in healthy Japanese male and female of non-childbearing potential subjects, performed at a single study centre.

The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD) tablets when administered with water and without water and ticagrelor immediate-release (IR) tablets.

Detailed description:
Study to evaluate the bioequivalence of ticagrelor orodispersible (OD) tablets administered with water and without water and ticagrelor immediate-release (IR) tablets.

Arms: arm 1: Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3 arm 2: Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 arm 3: Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 arm 4: Treatment A in Period 1, Treatment C in Period 2 and Treatment B in Period 3 arm 5: Treatment B in Period 1, Treatment A in Period 2 and Treatment C in Period 3 arm 6: Treatment C in Period 1, Treatment B in Period 2 and Treatment A in Period 3
Interventions: intervention 1: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water intervention 2: Ticagrelor OD tablet (90 mg single dose) administered without water intervention 3: Ticagrelor IR tablet (90 mg) administered with 150 mL of water
Intervention descriptions: intervention 1: Ticagrelor 90 mg OD tablet, single dose intervention 2: Ticagrelor 90 mg OD tablet, single dose intervention 3: Ticagrelor 90 mg IR tablet, single dose

Protocol documents:
Clinical trial NCT02440633
Conditions: Bacterial Enteritis
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2015-05-01; Completion date: 2015-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.

Detailed description:

Arms: arm 1: Suspension containing 50 mg of 14C-OPS-2071
Interventions: intervention 1: 14C-OPS-2071
Intervention descriptions: intervention 1: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.

Protocol documents:
Clinical trial NCT02455050
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2014-12-01; Completion date: 2015-08-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.

Detailed description:

Arms: arm 1: 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks. arm 2: 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. arm 3: 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. arm 4: 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks.
Interventions: intervention 1: Carboxymethylcellulose Sodium Based Eye Drops intervention 2: Systane® Gel Drops intervention 3: Genteal® Lubricant Gel Drops
Intervention descriptions: intervention 1: 1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye. intervention 2: 1 to 2 drops of Systane® Gel Drops in each eye. intervention 3: 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.

Protocol documents:
Clinical trial NCT02461992
Conditions: Hemophilia A
Keywords: FVIII activity
Sponsor: Pfizer
Start date: 2015-07-01; Completion date: 2015-08-01
Enrollment: 13 participants; Allocation: ; Intervention model: 

Brief summary:
An open-label, single dose pharmacokinetic study of Xyntha (Moroctocog Alfa (AF-CC), Recombinant Factor VIII) in male Chinese subjects with hemophilia A

Detailed description:
The purpose of this study is to obtain pharmacokinetic profiles of FVIII:C after Xyntha administration in Chinese patients with severe hemophilia A, which is in support of the continued registration of Xyntha in China

Arms: arm 1: observation arm
Interventions: intervention 1: Intravenous infusions of Xyntha
Intervention descriptions: intervention 1: A single dose 50IU/kg dose of Xyntha administered by intravenous infusion within 10 minutes on Day 1

Protocol documents:
Clinical trial NCT02465489
Conditions: Healthy
Keywords: deferiprone deferiprone extended release formulation pharmacokinetics
Sponsor: ApoPharma
Start date: 2015-06-01; Completion date: 2015-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended release tablets) under fed and fasting conditions.

Detailed description:
This is a single-center, open-label, randomized, 5-period, 5-sequence study of the pharmacokinetics of a new formulation of deferiprone, extended release tablets, in twenty healthy volunteers. In each study period, blood samples for pharmacokinetics assessment will be collected pre-dose and over 24 hours post-dose. Safety will be assessed throughout the study.

Arms: arm 1: A single 1000 mg dose of deferiprone extended release tablet formulation administered under fasting conditions arm 2: A single 1000 mg dose of deferiprone extended release tablet formulation administered under fed conditions arm 3: A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered under fed conditions arm 4: A single 1000 mg dose of deferiprone immediate release tablet formulation administered under fasting conditions arm 5: A single 1000 mg dose of deferiprone immediate release tablet formulation administered under fed conditions
Interventions: intervention 1: Deferiprone extended release intervention 2: Deferiprone immediate release
Intervention descriptions: intervention 1: Deferiprone 1000 mg extended release tablet formulation intervention 2: Ferriprox (deferiprone) 500 mg immediate release tablet formulation

Protocol documents:
Clinical trial NCT02476422
Conditions: Post Operative Dental Pain
Keywords: Diclofenac potassium Post-operative dental pain Moderate to severe pain
Sponsor: Novartis Pharmaceuticals
Start date: 2015-04-01; Completion date: 2015-08-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.

Detailed description:

Arms: arm 1: Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method. arm 2: Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
Interventions: intervention 1: Diclofenac potassium intervention 2: Ibuprofen intervention 3: Placebo to ibuprofen intervention 4: Placebo to diclofenac potassium
Intervention descriptions: intervention 1: Single dose of diclofenac 50 mg soft gelatin capsule intervention 2: Single dose of ibuprofen 400 mg tablet intervention 3: Single dose of placebo to ibuprofen 400 mg tablet intervention 4: Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule

Protocol documents:
Clinical trial NCT02530554
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Sponsor: Medline Industries
Start date: 2015-07-01; Completion date: 2015-08-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG

Detailed description:
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.

Arms: arm 1: 3 min application time arm 2: Marketed 2% CHG
Interventions: intervention 1: CHG
Intervention descriptions: intervention 1: Single application

Protocol documents:
Clinical trial NCT02541864
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori Hybrid therapy Bismuth containing quadruple therapy Eradication
Sponsor: Kaohsiung Veterans General Hospital.
Start date: 2013-07-01; Completion date: 2015-08-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing quadruple therapy was suggested to be the first choice for eradication therapy of Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line treatment.

Detailed description:
For this randomly assigned to receive either a 14-day hybrid therapy (a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days) or a 14-day bismuth containing quadruple therapies (pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days).at a 1:1 ratio. Our primary outcomes was the eradication rate by intention-to-treat and per- protocol analyses

Arms: arm 1: pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days arm 2: (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)
Interventions: intervention 1: Bismuth quadruple therapy intervention 2: Hybrid therapy
Intervention descriptions: intervention 1: pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days intervention 2: (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)

Protocol documents:
Clinical trial NCT02682498
Conditions: Arthroplasty, Replacement, Knee
Keywords: Knee Arthroplasty, Total Liposomal Bupivicaine
Sponsor: University of California, Irvine
Start date: 2013-10-01; Completion date: 2015-08-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study) group will use less opioid in the first 48 hours post-operatively than the control group.

Detailed description:
Opioids have been prescribed with increasing frequency for non-acute, non-cancer pain in the last 15 years. Because of this, opioid tolerance in the general population has grown markedly, and opioid tolerant patients can be especially difficult to manage in the perioperative period. In general, they require much higher doses of opioids to obtain similar levels of pain-control compared to opioid-naïve patients and are susceptible to respiratory depression and other adverse events. This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty.

Arms: arm 1: Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours. arm 2: A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
Interventions: intervention 1: (Bupivacaine Liposome Injectable Suspension) intervention 2: Standard Preparation
Intervention descriptions: intervention 1: Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery. intervention 2: A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.

Protocol documents:
Clinical trial NCT01653028
Conditions: Myxofibrosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Leiomyosarcoma Recurrent Liposarcoma Recurrent Malignant Peripheral Nerve Sheath Tumor Recurrent Undifferentiated Pleomorphic Sarcoma Stage III Soft Tissue Sarcoma AJCC v7 Stage IV Soft Tissue Sarcoma AJCC v7
Sponsor: National Cancer Institute (NCI)
Start date: 2012-08-22; Completion date: 2015-08-02
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib 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 response rate (complete response \[CR\] + partial response \[PR\]) assessed for patients within each cohort: liposarcoma (cohort 1); leiomyosarcoma (non-uterine) (cohort 2); undifferentiated sarcoma (including pleomorphic undifferentiated sarcoma, formerly known as malignant fibrous histiocytoma, and myxofibrosarcoma) (cohort 3); malignant peripheral nerve sheath tumor (cohort 4); and other sarcomas (cohort 5).

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival (OS) for patients treated with MLN8237 (alisertib) in each cohort.

II. To assess the adverse events associated with patients treated with MLN8237 in each cohort.

TERTIARY OBJECTIVES:

I. To correlate potential clinical benefit with markers of aurora kinase inhibition in pre- and post-treatment tumor biopsies.

II. To correlate clinical outcome with change in fluorine F 18 fluorothymidine (FLT)-positron emission tomography (PET) uptake at baseline versus after one week of treatment (ie, week 2 of cycle 1).

OUTLINE:

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

After completion of study treatment, patients are followed up every 6 months for 18 months.

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

Protocol documents:
Clinical trial NCT00511992
Conditions: Advanced Ovarian Carcinoma Primary Peritoneal Carcinoma Ovarian Carcinosarcoma
Keywords: Ovarian Cancer Gynecologic Cancer Ovarian Carcinoma Peritoneal Carcinoma IP chemotherapy Intraperitoneal Avastin Bevacizumab
Sponsor: University of Oklahoma
Start date: 2007-07-01; Completion date: 2015-08-03
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Detailed description:
Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.

Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Arms: arm 1: None
Interventions: intervention 1: Avastin intervention 2: Paclitaxel intervention 3: Cisplatin
Intervention descriptions: intervention 1: Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)

Consolidation Treatment:

Avastin 15mg/kg IV every 21 days x 12 cycles intervention 2: Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles intervention 3: 75mg/m2 IP day 2 every 21 days x 6 cycles

Protocol documents: