ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01634854
Conditions: Induction of Labor in Multiparous Women
Sponsor: Vanderbilt University Medical Center
Start date: 2012-07-01; Completion date: 2014-05-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.

Detailed description:
Both oxytocin and misoprostol have been demonstrated to be safe and effective methods for induction of labor. A direct comparison of efficacy and time to delivery in multiparas has not been specifically investigated. Additionally, the study will look at costs of the two drugs.Oxytocin is administered through an IV so requires more direct patient care time from the Registered Nurse, IV pump, and tubing, whereas misoprostol is a tablet, administered only once, per vagina or orally, every 4 hours. Misoprostol is also very inexpensive comparatively; if equally or more efficacious than oxytocin, this could demonstrate quite a cost and time savings to Vanderbilt University Medical Center and other institutions. Safety of either drug is not in question.

Arms: arm 1: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal arm 2: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.

Route of administration: intravenous
Interventions: intervention 1: Vaginal Misoprostol intervention 2: Intravenous Oxytocin
Intervention descriptions: intervention 1: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal intervention 2: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.

Route of administration: intravenous

Protocol documents:
Clinical trial NCT01636466
Conditions: Kidney Failure, Chronic
Keywords: Chronic allograft failure Kidney Transplantation
Sponsor: Ashtar Chami
Start date: 2013-06-01; Completion date: 2014-05-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant.

The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.

Detailed description:

Arms: arm 1: Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to take everolimus 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects will be weaned off of all other immunosuppression medicines when dialysis starts. arm 2: Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to continue on current immunosuppressive regimen. Subjects will be weaned off of all immunosuppression medicines when dialysis starts.
Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Everolimus will initially be dosed at 0.75 mg tablet taken orally twice a day. The dose will be adjusted to maintain serum trough concentrations of 5-8 ng/ml.

Protocol documents:
Clinical trial NCT01645280
Conditions: Arthritis, Rheumatoid
Keywords: Active rheumatoid arthritis Ustekinumab STELARA CNTO 1959
Sponsor: Janssen Research & Development, LLC
Start date: 2012-08-01; Completion date: 2014-05-01
Enrollment: 274 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.

Detailed description:
This is a randomized (patients assigned to treatment by chance), double-blind (study personnel and patients will not know what treatment is being assigned to patients), multicenter, placebo-controlled (a placebo is a treatment identical in appearance to the study agent, but containing no active ingredient), dose-ranging study. Approximately 250 patients will be randomly assigned to 1 of 5 treatment groups. The maximum length of study participation is 54 weeks, including a 6-week screening period. The end of the study will be the last follow-up visit of the last patient. Study visits and evaluations will occur, and patient safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo + methotrexate (MTX) (Group 1) intervention 2: Ustekinumab + MTX (Group 2) intervention 3: Ustekinumab + MTX (Group 3) intervention 4: CNTO 1959 + MTX (Group 4) intervention 5: CNTO 1959 + MTX (Group 5)
Intervention descriptions: intervention 1: Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose) intervention 2: Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose) intervention 3: Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose) intervention 4: CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose) intervention 5: CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)

Protocol documents:
Clinical trial NCT01646268
Conditions: IDIOPATHIC PARKINSON'S DISEASE
Keywords: Rotigotine Neupro phase 3 Early phase Idiopathic Parkinson's Disease
Sponsor: UCB Pharma
Start date: 2012-07-01; Completion date: 2014-05-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious in Chinese subjects with early-stage idiopathic Parkinson's disease.

Detailed description:
The study includes a maximum 4-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease 24-week Maintenance Period, a maximum 6-day De-escalation Period and 30-day Safety Follow-Up Period. The maximum study durations for an individual subject with early-stage Parkinson's disease will be 36 weeks.

Arms: arm 1: Rotigotine, daily doses, treatment group arm 2: Placebo, daily doses, placebo group
Interventions: intervention 1: Rotigotine intervention 2: Placebo Patch
Intervention descriptions: intervention 1: Transdermal Patch

Content:

2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period intervention 2: Transdermal Patch

Size:

10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2

Subjects randomized to placebo will receive matching placebo patches

Protocol documents:
Clinical trial NCT01663987
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-08-01; Completion date: 2014-05-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge 1)

Detailed description:

Arms: arm 1: Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler arm 2: Patient to receive one placebo capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Interventions: intervention 1: tiotropium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: 18 mcg once a day (QD) intervention 2: once a day (QD)

Protocol documents:
Clinical trial NCT01669811
Conditions: Refractory Reflux Esophagitis
Keywords: Refractory Reflux Esophagitis, Japanese, Nexium, twice daily, oral administration
Sponsor: AstraZeneca
Start date: 2012-08-01; Completion date: 2014-05-01
Enrollment: 1398 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

Detailed description:
A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis

Arms: arm 1: Double-blinded arm 2: Double-blinded
Interventions: intervention 1: Esomeprazole (D961H) twice daily intervention 2: Esomeprazole (D961H) once daily
Intervention descriptions: intervention 1: One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening intervention 2: One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening

Protocol documents:
Clinical trial NCT01672983
Conditions: Chronic Hepatitis C Infection
Keywords: Japanese Hepatitis C Genotype 2 Genotype 1b paritaprevir ombitasvir ritonavir VIEKIRAX Combination Tablets
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-07-01; Completion date: 2014-05-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).

Detailed description:
This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b- infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV treatment-exposed Japanese adults. The Treatment Phase evaluated the antiviral activity, safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks. The Post-treatment Phase evaluated the evolution and persistence of viral resistance to ABT-267 and ABT-450.

Arms: arm 1: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. arm 2: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. arm 3: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks. arm 4: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks. arm 5: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. arm 6: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Interventions: intervention 1: ABT-450/ritonavir, ABT-267
Intervention descriptions: intervention 1: ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)

Protocol documents:
Clinical trial NCT01681212
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2012-10-01; Completion date: 2014-05-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the survival rate after 1 year of treatment with ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or Stage IV melanoma.

Detailed description:

Arms: arm 1: During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m\^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
Interventions: intervention 1: Ipilimumab intervention 2: Dacarbazine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01732536
Conditions: Chronic Sinusitis Nasal Polyps
Keywords: corticosteroid-eluting sinus implant chronic rhinosinusitis mometasone furoate polyposis
Sponsor: Intersect ENT
Start date: 2013-01-01; Completion date: 2014-05-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.

Detailed description:
RESOLVE is a randomized (1:1), sham-controlled, parallel group, double-blind multicenter study in 100 chronic sinusitis patients who had prior endoscopic sinus surgery and presented with recurrent nasal polyps. The objective of the study was to assess the safety and efficacy of the S8 Sinus Implant, a steroid-eluting sinus implant, consisting of a bioabsorbable self-expanding sinus implant coated with 1350 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the S8 implant provides controlled release of MF to the sinus mucosa over 90 days, with the majority of drug released within 60 days.

Arms: arm 1: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Mometasone furoate nasal spray (200mcg) once daily arm 2: In-office bilateral sham procedure

Mometasone furoate nasal spray (200mcg) once daily
Interventions: intervention 1: S8 Sinus Implant intervention 2: Sham procedure intervention 3: Mometasone furoate nasal spray
Intervention descriptions: intervention 1: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses intervention 2: In-office bilateral sham procedure intervention 3: Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Protocol documents:
Clinical trial NCT01746784
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis F508del-CFTR N6022 S-Nitrosoglutathione
Sponsor: Nivalis Therapeutics, Inc.
Start date: 2014-02-01; Completion date: 2014-05-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation.

Detailed description:
This is a double-blind, randomized, placebo-controlled, multicenter, sequential dose-escalation study which will occur in two parts. All selection criteria, assessments and procedures described in this protocol will be applied to both parts. Up to 5 cohorts will be studied with a total of 67 patients at approximately 18 clinical sites in the United States.

Arms: arm 1: Subjects randomized to study drug will receive N6022 by intravenous infusion once per day for 7 days arm 2: Subjects randomized to placebo will receive normal saline administered intravenously using the same volume as the active drug group
Interventions: intervention 1: N6022 intervention 2: Normal saline
Intervention descriptions: intervention 1: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes depending on the dose intervention 2: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes depending on dose of active drug used in same cohort

Protocol documents:
Clinical trial NCT01757691
Conditions: Acute Demylelinating Optic Neuritis
Keywords: Acute demyelinating optic neuritis Optic neuritis
Sponsor: Novartis Pharmaceuticals
Start date: 2013-08-01; Completion date: 2014-05-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment

Detailed description:

Arms: arm 1: Oral capsule dose was given once daily for 48 weeks arm 2: Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
Interventions: intervention 1: Fingolimod 0.5mg/daily intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01774968
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2013-02-01; Completion date: 2014-05-01
Enrollment: 325 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.

Detailed description:

Arms: arm 1: Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks. arm 2: U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
Interventions: intervention 1: Human Regular U-500 Insulin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01783561
Conditions: Caffeine
Keywords: caffeine intubation hemodynamic
Sponsor: Sharp HealthCare
Start date: 2013-10-01; Completion date: 2014-05-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.

Detailed description:
This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants \<29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.

Arms: arm 1: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life. arm 2: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Interventions: intervention 1: Caffeine
Intervention descriptions: intervention 1: Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.

Protocol documents:
Clinical trial NCT01788358
Conditions: Hypertension
Keywords: Drug combination Nifedipine GITS Candesartan Cilexetil Hypertension Combination therapy
Sponsor: Bayer
Start date: 2013-02-14; Completion date: 2014-05-01
Enrollment: 508 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.

Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total).

Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose.

Detailed description:

Arms: arm 1: Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
Interventions: intervention 1: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) intervention 2: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) intervention 3: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) intervention 4: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention descriptions: intervention 1: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily intervention 2: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily intervention 3: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily intervention 4: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily

Protocol documents: