ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01566630
Conditions: Pre-eclampsia
Keywords: human recombinant RLX030 Pre-eclampsia hemodynamics Pharmacokinetics
Sponsor: Novartis Pharmaceuticals
Start date: 2013-05-01; Completion date: 2014-08-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed in two parts. Part 1 will assess the safety and tolerability of different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can prolong pregnancy in women with pre-eclampsia.

Detailed description:

Arms: arm 1: In part 1, within each cohort, two (2) patients per cohort will be treated open label with RLX030 and two (2) patients will be treated double blind with RLX030 as intravenous infusion for 72 hours. There will be 3 cohorts in part 1 with different doses of RLX030.

In part 2, there is no open label treatment on RLX030. In part 2, patients will be randomized in a double-blind fashion to this arm with the optimal dose of RLX030 as intravenous infusion for 72 hours as determined from part 1. arm 2: In part 1, equal number of subjects will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours in 3 cohorts.

In part 2, patients will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours
Interventions: intervention 1: Placebo intervention 2: RLX030
Intervention descriptions: intervention 1: Placebo to RLX030 as intravenous infusion for 72 hours intervention 2: RLX030 1 mg/mL vials

Protocol documents:
Clinical trial NCT01569815
Conditions: Mild and Moderate Renal Impairment
Keywords: Renal Impairment, LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2009-02-01; Completion date: 2014-08-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.

Detailed description:

Arms: arm 1: LCZ696 400 mg once daily for 5 days
Interventions: intervention 1: LCZ696
Intervention descriptions: intervention 1: LCZ696 400 mg once daily

Protocol documents:
Clinical trial NCT01575275
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: Michael Vogelbaum, MD, PhD
Start date: 2012-05-01; Completion date: 2014-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the safety and performance of an investigational agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for visualizing a tumor during surgery. It is also being studied to determine if there are differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance imaging (MRI)

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the volume of residual enhancing tumor after a 5-ALA guided resection of a glioblastoma multiforme (GBM).

II. Determine the volume of tissue removed compared to the measured enhancing tumor evaluated on a pre-operative MRI.

SECONDARY OBJECTIVES:

I. Evaluate the time to tumor progression. II. Evaluate the overall survival.

OUTLINE:

Patients receive aminolevulinic acid orally (PO) 2-4 hours before surgery.

After completion of study treatment, patients are followed up for 2 weeks.

Arms: arm 1: Patients receive aminolevulinic acid PO 2-4 hours before surgery.
Interventions: intervention 1: aminolevulinic acid intervention 2: therapeutic conventional surgery
Intervention descriptions: intervention 1: Given PO intervention 2: Undergo surgery

Protocol documents:
Clinical trial NCT01594047
Conditions: Post Operative Pain Hyperalgesia
Keywords: hyperalgesia Patient controlled analgesia morphine methadone ketamine
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Start date: 2009-12-01; Completion date: 2014-08-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia after abdominal surgery.

Detailed description:
not desired

Arms: arm 1: Patient received a standard balance anaesthesia and morphine for post operative pain. arm 2: Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery. arm 3: Methadone PCA arm 4: Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery.

Methadone administered by a PCA system (dose 2 mg, lock-out 12min.).
Interventions: intervention 1: ketamine infusion intervention 2: Methadone PCA
Intervention descriptions: intervention 1: Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery intervention 2: Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)

Protocol documents:
Clinical trial NCT01595438
Conditions: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Keywords: Ceftazidime, Avibactam, Doripenem, Ciprofloxacin, sulfamethoxazole/trimethoprim, Anti-Infective Agents, Complicated Urinary Tract Infection,Acute Pyelonephritis
Sponsor: Pfizer
Start date: 2012-10-01; Completion date: 2014-08-01
Enrollment: 598 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

Detailed description:
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Arms: arm 1: IV treatment arm 2: IV treatment
Interventions: intervention 1: Ceftazidime - Avibactam ( CAZ-AVI) intervention 2: Doripenem intervention 3: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) intervention 4: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Intervention descriptions: intervention 1: Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes intervention 2: 500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes intervention 3: Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement intervention 4: Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

Protocol documents:
Clinical trial NCT01599806
Conditions: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Keywords: Ceftazidime, Avibactam, Doripenem, Ciprofloxacin, sulfamethoxazole/trimethoprim, Anti-Infective Agents, Complicated Urinary Tract Infection,Acute Pyelonephritis
Sponsor: Pfizer
Start date: 2012-10-01; Completion date: 2014-08-01
Enrollment: 641 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

Detailed description:
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Arms: arm 1: IV treatment arm 2: IV treatment
Interventions: intervention 1: Ceftazidime - Avibactam ( CAZ-AVI) intervention 2: Doripenem intervention 3: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) intervention 4: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Intervention descriptions: intervention 1: Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes intervention 2: 500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes intervention 3: Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement intervention 4: Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

Protocol documents:
Clinical trial NCT01621672
Conditions: Multiple Myeloma
Keywords: Revlimid progression free Lenalidomide
Sponsor: University of Arkansas
Start date: 2010-04-01; Completion date: 2014-08-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine in a phase II trial, whether further maintenance therapy with Revlimid can extend the duration of progression-free survival and the duration of complete or near complete response compared to no further therapy beyond the TT3 protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years with VTD (2003-33) or VRD (2006-66).

Detailed description:
Determine the associated toxicities in qualitative and quantitative terms using NCI CTCAE(NCI common terminology for adverse events)

Arms: arm 1: Revlimid dosing will be in the morning at the same time each day arm 2: No treatment control.
Interventions: intervention 1: Revlimid
Intervention descriptions: intervention 1: 10 mg/day in the morning same time each day

Protocol documents:
Clinical trial NCT01642277
Conditions: Overactive Bladder
Keywords: Overactive Bladder OAB Urinary Tract Infection UTI Microbiome Bacteria Solifenacin 16S rRNA sequence
Sponsor: Loyola University
Start date: 2012-07-01; Completion date: 2014-08-01
Enrollment: 134 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown that female urine, even in the absence of culture evidence of bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine and sequenced to identify bacterial species present in urine. From this the investigators can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a difference in the bacterial communities in the urine of women who respond to Solifenacin, a drug used to treat OAB, versus those that do not.

Detailed description:
This is a prospective study with two groups: Women who have accepted a clinical recommendation for OAB treatment with solifenacin and a comparator (control) group of women unaffected by OAB. All women will have a baseline urine assessment with bacterial genome sequencing. Solifenacin treated patients will also have urine assessments with bacterial genomic sequencing at 4 and 12 weeks on treatment.

Arms: arm 1: Solifenacin treated women: Women with OAB who are prescribed solifenacin arm 2: Women without OAB who are not prescribed solifenacin.
Interventions: intervention 1: Solifenacin
Intervention descriptions: intervention 1: 5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks

Protocol documents:
Clinical trial NCT01647945
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH WHO group 1
Sponsor: Edda Spiekerkoetter
Start date: 2012-07-01; Completion date: 2014-08-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Mutations in bone morphogenetic protein receptor 2 (BMPR2) are present in \>80% of familial and \~20% of sporadic pulmonary arterial hypertension (PAH) patients. Furthermore dysfunctional BMP signaling is a general feature of pulmonary hypertension even in non-familial PAH.

We therefore hypothesized that increasing BMP signaling might prevent and reverse the disease. We screened \> 3500 FDA approved drugs for their propensity to increase BMP signaling and found FK506 (Tacrolimus) to be a strong activator of BMP signaling. Tacrolimus restored normal function of pulmonary artery endothelial cells, prevented and reversed experimental PAH in mice and rats.

Given that Tacrolimus is already FDA approved with a known side-effect profile, it is an ideal candidate drug to use in patients with pulmonary arterial hypertension.

The aims of our trial are:

1. Establish the Safety of FK506 in patients with PAH.
2. Evaluate the Efficacy of FK506 in PAH
3. Identify ideal candidates for future FK506 phase III clinical trial.

Detailed description:
Study Design:

Randomized, placebo-controlled, four arm clinical trial.

Sample Size: 10 subjects in each arm, Total enrollment = 40 patients.

1. 10 patients: FK-506 blood level: 3 - 5 ng/ml
2. 10 patients: FK-506 blood level: 2 - 3 ng/ml
3. 10 patients: FK-506 level: \< 2.0 ng/ml
4. 10 patients: Placebo

Study Duration:

16 weeks

Primary Endpoints:

1\) Safety of low-dose FK506 in PAH

Secondary Objectives/Endpoints:

1. Combined Clinical Events/Time to Clinical Worsening @ 16 weeks:

   * All cause mortality
   * Transplantation
   * Atrial septostomy
   * Need for escalation of therapies as deemed by site investigator
   * Worsening of NYHA/WHO classification by at least 1 point.
   * Hospitalization for right heart failure.
2. Change in 6MWD at 16 weeks
3. Change in NT-Pro-BNP at 16 weeks
4. Change in Uric Acid at 16 weeks
5. Change in DLCO at 16 weeks
6. Change in novel RV parameters by transthoracic echocardiography: Change in RV size, RA size, RV function, TAPSE, RVSP

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: FK506 level < 2 ng/ml intervention 3: FK506 level 2-3 ng/ml intervention 4: FK506 level 3-5 ng/ml
Intervention descriptions: intervention 1: placebo pill intervention 2: FK506 goal trough blood level \< 2 ng/ml intervention 3: FK506 goal trough blood level 2-3 ng/ml intervention 4: FK506 goal trough blood level 3-5 ng/ml

Protocol documents:
Clinical trial NCT01650246
Conditions: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2012-08-01; Completion date: 2014-08-01
Enrollment: 143 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

Detailed description:
This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.

Arms: arm 1: None
Interventions: intervention 1: lesinurad
Intervention descriptions: intervention 1: Tablets, 400 mg QD

Protocol documents:
Clinical trial NCT01652716
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Start date: 2013-01-01; Completion date: 2014-08-01
Enrollment: 377 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Exenatide suspension 2 mg weekly subcutaneous injection arm 2: Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
Interventions: intervention 1: Exenatide once weekly suspension intervention 2: Exenatide twice daily
Intervention descriptions: intervention 1: Exenatide suspension 2 mg weekly subcutaneous injection intervention 2: 5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks

Protocol documents:
Clinical trial NCT01658020
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Acute exacerbation of Chronic obstructive pulmonary disease Acute Exacerbation Chronic obstructive pulmonary disease(COPD) Zabofloxacin Moxifloxacin
Sponsor: Dong Wha Pharmaceutical Co. Ltd.
Start date: 2012-08-01; Completion date: 2014-08-01
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.

Detailed description:
A Phase 3, Multicenter, Double Blind, Active Controlled, Randomized Study to Evaluate the Efficacy and Safety of Zabofloxacin for Patients with acute bacterial exacerbation of Chronic obstructive pulmonary disease.

Arms: arm 1: Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days arm 2: Moxifloxacin 400mg tablet P.O. once daily for 7days
Interventions: intervention 1: Zabofloxacin intervention 2: Moxifloxacin
Intervention descriptions: intervention 1: Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days intervention 2: Moxifloxacin 400mg tablet P.O. once daily for 7days

Protocol documents:
Clinical trial NCT01687270
Conditions: Recurrent Chronic Hepatitis C Virus Post Liver Transplant
Sponsor: Gilead Sciences
Start date: 2012-11-01; Completion date: 2014-08-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

Detailed description:

Arms: arm 1: Participants will receive sofosbuvir+RBV for 24 weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.

Protocol documents:
Clinical trial NCT01691885
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2012-11-01; Completion date: 2014-08-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the study is to test the hypothesis that lung hyperinflation contributes to cardiac dysfunction in COPD and that the treatment of lung deflation with FF/VI Inhalation Powder 100/25 mcg administered once daily (QD) will result in the reversal of this cardiac dysfunction compared with placebo. This will be assessed by measures of right and left global and regional systolic and diastolic cardiac function as assessed using a 30 minute CMR.

A secondary objective will be to investigate the effect of FF/VI inhalation powder 100/25mcg QD on measures of arterial stiffness in the form of pulse wave analysis and distensability in the pulmonary and systemic circulation.

Detailed description:
This will be a Phase IIIb, randomised, double-blind, placebo-controlled, cross-over, single-centre study to investigate the acute effects of FF/VI inhalation powder 100/25mcg QD in lung deflation on cardiac biventricular function and arterial stiffness in adults with COPD.

Subjects will visit the clinic a minimum of 4 times over a 28-day period with a further contact which can be either a telephone contact or clinic visit (Visit/Contact 4). A 7-day run-in period will be followed by two 7-day (maximum 14-day) treatment periods separated by a 7(±2) day wash-out period. The first dose of treatment will be taken the day after randomisation. A safety Follow-up contact (either visit or telephone) will occur 7(±2) days post the last treatment day.

Subjects will be prescribed appropriate COPD therapy at the end of Treatment Visit 5, if required. There are no plans to provide the study drug for compassionate use following study completion.

It is planned to have 44 completed evaluable subjects. Subjects who withdraw early will be replaced. In order to ensure 44 evaluable subjects, assuming a 10% protocol deviation rate, 49 subjects will be randomised. The total duration of subject participation, including the follow-up period, will be approximately 36 days.

Arms: arm 1: Placebo followed by Fluticasone Furoate Vilanterol Combination arm 2: Fluticasone Furoate Vilanterol Combination followed by Placebo
Interventions: intervention 1: Fluticasone Furoate intervention 2: Vilanterol
Intervention descriptions: intervention 1: 100mcg Once daily intervention 2: 25mcg Once daily

Protocol documents:
Clinical trial NCT01704495
Conditions: Asthma
Keywords: Uncontrolled Asthma, Exacerbation, Safety
Sponsor: AstraZeneca
Start date: 2012-11-01; Completion date: 2014-08-01
Enrollment: 1147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Detailed description:
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Arms: arm 1: AZD5069 oral capsules self-administered twice daily arm 2: AZD5069 oral capsules self-administered twice daily arm 3: AZD5069 oral capsules self-administered twice daily arm 4: Placebo oral capsules self-administered twice daily
Interventions: intervention 1: AZD5069 intervention 2: Placebo
Intervention descriptions: intervention 1: AZD5069 oral capsules self-administered twice daily. intervention 2: Placebo oral capsules self-administered twice daily.

Protocol documents: