ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01396083
Conditions: Visual Impairment Macular Edema Central Retinal Vein Occlusion
Keywords: Visual impairment macular edema Central retinal vein occlusion Dexamethasone implant Ranibizumab
Sponsor: Novartis Pharmaceuticals
Start date: 2011-08-01; Completion date: 2014-01-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ranibizumab intervention 2: Dexamethasone implant and sham injections
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01396421
Conditions: Acute Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-07-01; Completion date: 2014-01-01
Enrollment: 636 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

Detailed description:
Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Arms: arm 1: Higher Dose, tablet, once daily, for six weeks arm 2: Middle Dose, tablet, once daily, for six weeks arm 3: Lower Dose, tablet, once daily, for six weeks arm 4: Placebo, once daily, for six weeks
Interventions: intervention 1: OPC-34712 [Brexpiprazole] High Dose intervention 2: Experimental: OPC-34712 [Brexpiprazole] Middle Dose intervention 3: Experimental: OPC-34712 [Brexpiprazole] Low Dose intervention 4: Placebo
Intervention descriptions: intervention 1: Higher dose, tablet, once daily, for six weeks intervention 2: Middle dose, tablet, once daily, for six weeks intervention 3: Lower dose, tablet, once daily, for six weeks intervention 4: Placebo, once daily, for six weeks

Protocol documents:
Clinical trial NCT01424241
Conditions: Acromegaly
Keywords: Sandostatin LAR
Sponsor: Columbia University
Start date: 2006-10-01; Completion date: 2014-01-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF-1) normalization into current IGF-I normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.

Detailed description:
A major goal of treatment of acromegaly is to normalize serum IGF-1 levels. Recently developed new normative data for serum IGF-1 levels has lowered the upper limit of normal for this hormone level. Octreotide, an analog of somatostatin, a synthetic form of the hypothalamic hormone somatostatin, which inhibits growth hormone (GH) release by blocking somatostatin receptors in the pituitary and on the tumor, is now available in a long acting depot formulation, Sandostatin LAR, that suppresses tumoral GH secretion and normalizes GH and IGF-1 levels in about 60% of patients. Although sandostatin LAR is Food and Drug Administration (FDA) approved for the therapy of acromegaly and is used clinically, its efficacy with respect to new normative IGF-1 ranges has not been studied. In addition, an important goal of therapy of acromegaly is to treat co-morbidities of the disease such as insulin resistance, which is common in acromegaly. Other important morbidities in acromegaly are hypertension and cardiovascular disease such as left ventricular hypertrophy (LVH). In this study the investigators will assess the effect of LAR therapy on biochemical parameters as well as important clinical endpoints of therapy of acromegaly.

Arms: arm 1: Nine months of open label dose escalation Sandostatin LAR therapy.
Interventions: intervention 1: Sandostatin LAR
Intervention descriptions: intervention 1: Open label dose escalation of Sandostatin LAR 10 mg, 20 mg, 30 mg, up to 40 mg if necessary.

Protocol documents:
Clinical trial NCT01427738
Conditions: HIV-1 Infection
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2011-06-01; Completion date: 2014-01-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to see which one of two medicines (topical gentian violet \[GV\] or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC). This was measured by whether the study participant still had OC or sores in his/her mouth after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment of OC were assessed.

Detailed description:
A5265 was a phase III, open-label (both the researchers and participants know which treatment was being administered) clinical trial to compare the safety and efficacy of topical GV to that of oral nystatin suspension. Male and female HIV-1 positive participants ≥ 18 years of age were randomized (as if by the toss of a coin) with equal probability and stratified by CD4+ T-cell counts and the use of antiretroviral therapy at the time of study entry to receive either topical GV solution (5 mL swish and gargle for 1 minute and spit two times daily) or nystatin oral suspension (5 mL swish for 1 minute and swallow four times daily) for 14 days. Therapy was considered as failed if participants have no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Evaluation of signs and symptoms of oral candidiasis was done by an evaluator who was blinded to the treatment assignment. A total of 494 participants was expected to enroll in the study but due to early study closure only 221 enrolled; and participants are expected to be on the study for about 13 weeks.

Arms: arm 1: Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days arm 2: Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Interventions: intervention 1: Gentian Violet intervention 2: Nystatin oral suspension
Intervention descriptions: intervention 1: Participants were administered topical Gentian violet solution, orally, twice daily for 14 days. intervention 2: Participants were administered Nystatin oral suspension 4 times a day for 14 days.

Protocol documents:
Clinical trial NCT01429259
Conditions: Cystic Fibrosis Pneumonia Pseudomonas Aeruginosa Infection
Keywords: Cystic Fibrosis Acute Pulmonary Exacerbations Pseudomonas aeruginosa
Sponsor: Joseph Kuti
Start date: 2012-02-01; Completion date: 2014-01-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour infusion will be measured.

Detailed description:
This study will be conducted at 7 pediatric hospitals in the United States (Columbia University Medical Center, New York, New York; University of North Carolina, Chapel Hill, North Carolina; St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, Connecticut Children's Medical Center, Hartford, Connecticut, Riley Hospital for Children, Indianapolis, Indiana, Nationwide Hospital for Children, Columbus, Ohio, and Children's Medical Center, Dallas, Texas). Cystic Fibrosis children (age 6-17 years) admitted to one of these enrolling sites with an acute exacerbation of his or her pulmonary infection who require antibiotic therapy with meropenem will be eligible. Meropenem will be administered as a 3 hour prolonged infusion and blood concentrations will be measured to determine the population pharmacokinetics in 30 patients, the safety of prolonged infusion meropenem, and the practicality as measured be treatment burden using a questionaire. The population pharmacokinetic model developed will be utilized to determine the optimal dose of meropenem to administer to children with Cystic Fibrosis, and define an exposure response relationship for the drug in this population.

Arms: arm 1: All 30 participants will receive meropenem as a 3 hour infusion.
Interventions: intervention 1: meropenem
Intervention descriptions: intervention 1: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.

Protocol documents:
Clinical trial NCT01447225
Conditions: Solid Tumors
Keywords: Advanced-stage Solid Tumors MM-121 Carboplatin Pemetrexed Gemcitabine Cabazitaxel ErbB3 Phase I Cancer
Sponsor: Merrimack Pharmaceuticals
Start date: 2011-10-01; Completion date: 2014-01-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

Detailed description:
This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 in combination with certain anticancer therapies. The dose-escalation portion of the study employed a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of MM-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. Doses of MM-121 and/or the anticancer therapy were escalated until either the MTD is identified or the combination was shown to be tolerable at the highest planned doses.

Arms: arm 1: escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle arm 2: carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle arm 3: pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle arm 4: escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle
Interventions: intervention 1: MM-121 intervention 2: Carboplatin intervention 3: Pemetrexed intervention 4: Cabazitaxel intervention 5: Gemcitabine
Intervention descriptions: intervention 1: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV intervention 2: administered at AUC 6 intervention 3: administered IV at 500 mg/m2 intervention 4: administered IV at 20 mg/m2 or 25 mg/m2 intervention 5: administered IV at 1000 mg/m2 or 1250 mg/m2

Protocol documents:
Clinical trial NCT01448044
Conditions: Hepatitis C
Keywords: hepatitis C virus
Sponsor: Bristol-Myers Squibb
Start date: 2011-12-01; Completion date: 2014-01-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Detailed description:

Arms: arm 1: * BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks
* PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response
* Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response arm 2: * Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks
* PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks
* Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks
Interventions: intervention 1: BMS-790052 (NS5A Replication Complex Inhibitor) intervention 2: Placebo matching BMS-790052 intervention 3: Pegylated-interferon alfa 2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01448213
Conditions: Fuchs' Dystrophy Bullous Keratopathy
Keywords: DMEK Rejection Corticosteroid
Sponsor: Price Vision Group
Start date: 2011-10-01; Completion date: 2014-01-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The investigators hope to determine if one is more effective at preventing rejection or if both are equally effective.

Detailed description:
Graft rejection is one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used after transplant surgery. The steroid eye drop dosing regimen varies from surgeon to surgeon, because no studies have been done to determine the optimum dosing regimen.

Arms: arm 1: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study. arm 2: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Interventions: intervention 1: Prednisolone acetate intervention 2: Fluorometholone
Intervention descriptions: intervention 1: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study. intervention 2: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Protocol documents:
Clinical trial NCT01451411
Conditions: Hyponatremia
Keywords: Serum Sodium Euvolemia Hypervolemia Vaprisol® Conivaptan YM087
Sponsor: Cumberland Pharmaceuticals
Start date: 2012-02-01; Completion date: 2014-01-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.

Detailed description:
A 3:1 randomization between conivaptan and placebo will be implemented and randomization will be further stratified in a 1:1:2 ratio for age groups: 2-5 years, 6-10 years, and 11-17 years.

Subjects will need to remain hospitalized for the 48-hour Treatment Period through Hour 96 (Day 4). There will be a follow-up safety visit on Day 9 or day of hospital discharge, whichever occurs first. There is a final follow-up phone call at Day 32 to assess if any serious adverse events have occurred since hospital discharge.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Conivaptan hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous intervention 2: Intravenous

Protocol documents:
Clinical trial NCT01455428
Conditions: Postherpetic Neuralgia ( PHN )
Keywords: Pregabalin Postherpetic Neuralgia ( PHN )
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-12-01; Completion date: 2014-01-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lyrica (pregabalin) intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, 300 mg/d, BID, 8 weeks treatment intervention 2: Capsule, 300 mg/d, BID, 8 weeks treatment

Protocol documents:
Clinical trial NCT01459913
Conditions: Hepatitis C, Chronic
Keywords: VX-950 INCIVEK INCIVO
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2011-11-01; Completion date: 2014-01-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

Detailed description:

Arms: arm 1: Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus \[HCV\] Ribonucleic Acid \[RNA\] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment. arm 2: Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. arm 3: Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. arm 4: Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
Interventions: intervention 1: Telaprevir intervention 2: Pegylated Interferon Alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: Tablet intervention 2: Subcutaneous Injection intervention 3: Tablet

Protocol documents:
Clinical trial NCT01471015
Conditions: Hypoxic Ischemic Encephalopathy
Keywords: Hypoxic Ischemic Encephalopathy Cooling Therapy HIE
Sponsor: University of Utah
Start date: 2012-09-01; Completion date: 2014-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Selective head cooling or whole body hypothermia has become the standard of care for neonatal hypoxia-ischemia encephalopathy (HIE). Despite early intervention death or major neurodevelopmental disability still occurs in nearly 50% of infants ≥ 36 weeks gestational age (GA) treated with cooling. No additional therapies have proven to be efficacious in further reducing brain injury and impairment for these high risk infants. Neuroprotective strategies aimed at improving early childhood outcomes are still needed. An important area of study includes therapies that may complement the neuroprotective effects of hypothermia and promote neuronal regeneration, recovery and neurovascular remodeling. Among these therapies, erythropoiesis stimulating agents (ESA) have been shown to provide neuroprotection, improving short and long-term neurologic outcome in brain injury and HIE in neonatal and adult animal models. Parallel with neuroprotective effects in experimental settings, recent small clinical studies suggest improved outcomes after ESA administration in patients with severe traumatic brain injury and HIE. ESA may work through several important mechanisms including reduced inflammation, limited oxidative stress, decreased apoptosis and white matter injury, as well as via pro-angiogenic and neurogenic properties.

Darbepoetin alfa (Darbe), a recombinant human erythropoietin (EPO)-derived molecule, has an extended circulating half life and comparable biological activity to EPO, including activation of the EPO receptor. The proposed study is a Phase I/II dose safety and pharmacokinetic trial of early Darbe administered concurrent with hypothermia in human newborn infants with moderate to severe birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants with HIE who survive beyond the newborn period.

Detailed description:

Arms: arm 1: 10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days arm 2: 2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old. arm 3: Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old
Interventions: intervention 1: Darbepoetin alfa intervention 2: Darbepoetin alfa intervention 3: Placebo
Intervention descriptions: intervention 1: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old. intervention 2: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old. intervention 3: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old

Protocol documents: