ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01313273
Conditions: Prostate Cancer
Sponsor: Ipsen
Start date: 2011-06-01; Completion date: 2013-06-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non metastatic castrate resistant prostate cancer patients.

Detailed description:
LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lanreotide, non steroidal anti androgens and LHRH-a intervention 2: Non steroidal anti androgens and LHRH-a
Intervention descriptions: intervention 1: Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months.

Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression. intervention 2: Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression

Protocol documents:
Clinical trial NCT01313624
Conditions: Bronchiectasis
Sponsor: Gilead Sciences
Start date: 2011-04-01; Completion date: 2013-06-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.

Detailed description:

Arms: arm 1: Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up. arm 2: Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.
Interventions: intervention 1: AZLI intervention 2: Placebo
Intervention descriptions: intervention 1: AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily intervention 2: Placebo to match AZLI administered via nebulizer three times daily

Protocol documents:
Clinical trial NCT01317901
Conditions: B-cell Small Lymphocytic Lymphoma Recurrent
Keywords: follicular lymphoma small lymphocytic lymphoma marginal zone lymphoma non-Hodgkin's lymphoma indolent lymphoma
Sponsor: Aptevo Therapeutics
Start date: 2011-05-01; Completion date: 2013-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a Phase 1 multicenter study of bendamustine, rituximab and TRU-016 (BRT) in subjects with relapsed indolent B-cell lymphoma. This was a multiple-dose escalation study to determine the maximum-tolerated dose (MTD) of TRU-016 given in combination with rituximab and bendamustine and to determine a safe dosing regimen for the combination in up to 12 subjects with relapsed indolent lymphoma.

The originally planned Phase 2 portion, an open-label, randomized study to evaluate the efficacy of BRT compared with BR, was not conducted.

Detailed description:
This study was planned to be conducted in 2 parts: a Phase 1b component designed to determine a safe dosing regimen, and a Phase 2 component designed to evaluate the efficacy of BRT compared to BR in subjects with relapsed indolent lymphoma. The Phase 2 component was not conducted.

This was an open-label, non randomized, multiple-dose escalation study to determine the MTD of BRT and to determine a safe dosing regimen for the combination in subjects with relapsed indolent lymphoma.

The study consisted of a screening period lasting up to 21 days, a treatment period lasting up to 6 cycles (28 days each), and a 60-day follow-up period. Up to 12 subjects (2 cohorts of 6 subjects each) were planned for enrollment. Two dose levels (10 and 20 mg/kg) of TRU-016 combined with rituximab 375 mg/m2 and bendamustine 90 mg/m2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.

Arms: arm 1: Two dose levels (10 and 20 mg/kg) of TRU 016 combined with rituximab 375 mg/m2 and bendamustine 90 mg/m2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
Interventions: intervention 1: TRU-016 intervention 2: Bendamustine intervention 3: Rituximab
Intervention descriptions: intervention 1: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle intervention 2: Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle. intervention 3: Rituximab by IV administration at 375 mg/m\^2 on Day 2 of each 28 day cycle.

Protocol documents:
Clinical trial NCT01318967
Conditions: Chronic Kidney Disease
Keywords: Renal blood flow Regional renal blood flow MRI
Sponsor: Wake Forest University
Start date: 2010-10-01; Completion date: 2013-06-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Comparison of renal blood flow measurements by PAH clearance and MRI

Detailed description:
The traditional measurement of renal blood flow in ml/min involves the collection of multiple blood and urine samples after an infusion of a drug called para-aminohippurate (PAH) is given. In this study, the investigators determine the ability of MRI to estimate renal blood flow. The primary hypothesis is that renal blood flow as measured by PAH clearance is similar to renal blood flow as estimated by MRI. The measurements by PAH clearance and MRI are both performed on the same day.

Arms: arm 1: PAH measure of renal blood flow is first performed on subjects prior to administration of furosemide arm 2: After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow
Interventions: intervention 1: Furosemide intervention 2: Placebo
Intervention descriptions: intervention 1: Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only. intervention 2: None

Protocol documents:
Clinical trial NCT01333956
Conditions: Primary Total Knee Arthroplasty
Sponsor: Hospital for Special Surgery, New York
Start date: 2011-05-01; Completion date: 2013-06-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Total knee arthroplasty can cause severe postoperative pain, and patients typically receive oral opioid analgesics for over 2 weeks. Side effects of pain management may impair participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems that pregabalin is very helpful to patients after total knee arthroplasty. However, pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses may not be effective, but use of high doses may increase the incidence and severity of side effects.The purpose of this study is to determine which dosage of pregabalin is the most effective at reducing pain after knee surgery.

Detailed description:

Arms: arm 1: Patients will receive 0mg of pregabalin arm 2: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16. arm 3: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16. arm 4: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Interventions: intervention 1: Pregabalin 50mg intervention 2: Pregabalin 100mg intervention 3: Pregabalin 150mg intervention 4: Placebo
Intervention descriptions: intervention 1: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16. intervention 2: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16. intervention 3: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16. intervention 4: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Protocol documents:
Clinical trial NCT01360645
Conditions: Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders
Keywords: OPC-34712 brexpiprazole Major Depressive Disorder Adjunctive Treatment
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-07-01; Completion date: 2013-06-01
Enrollment: 826 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

Detailed description:

Arms: arm 1: Drug: OPC-34712 + ADT

Drug: Placebo + ADT arm 2: Intervention: Drug: Placebo + ADT
Interventions: intervention 1: OPC-34712 + ADT intervention 2: Placebo + ADT intervention 3: Placebo + ADT
Intervention descriptions: intervention 1: Tablet, Oral, 2 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT) intervention 2: Placebo + FDA Approved Antidepressant (ADT) intervention 3: Placebo + FDA Approved Antidepressant (ADT)

Protocol documents:
Clinical trial NCT01365910
Conditions: Recurrent Colon Cancer Recurrent Rectal Cancer Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2011-06-01; Completion date: 2013-06-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well Linifanib works in treating patients with advanced, refractory colorectal cancer expressing k-Ras mutations. Linifanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To achieve an overall response rate of 15% or more.

SECONDARY OBJECTIVES:

I. Determine progression free survival. II. Determine overall survival. III. Evaluate toxicity profile of ABT 869 (linifanib) in this patient population.

OUTLINE:

Patients receive Linifanib orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years, and then every 6 months for 3 years.

Arms: arm 1: Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: linifanib
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT01366976
Conditions: Cardiopulmonary Bypass Induced Lipid Peroxidation
Keywords: oxidative stress cardiopulmonary bypass acetaminophen hemolysis
Sponsor: Vanderbilt University
Start date: 2011-07-01; Completion date: 2013-06-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Acute kidney injury is a major complication of cardiac surgery requiring cardiopulmonary bypass (CPB). Hemolysis and rhabdomyolysis frequently occur during CPB. Hemolysis leads to an increase in free hemoglobin, whereas rhabdomyolysis leads to an increase in myoglobin. Free plasma hemoglobin and myoglobin have been shown to be independent predictors of the acute kidney injury that results from CPB. When these hemeproteins are released into the plasma, they undergo redox cycling, generating radical species that initiate lipid peroxidation and a cascade of oxidative damage to cellular membranes, notably in the kidney. F2-isoprostanes and isofurans are sensitive and specific markers of oxidative stress in vivo, and are increased after CPB, particularly in those patients with acute kidney injury. Acetaminophen inhibits the lipid peroxidation catalyzed by myoglobin and hemoglobin. Moreover, in an animal model of rhabdomyolysis-induced kidney injury, acetaminophen significantly attenuated the decrease in creatinine clearance compared to control. The current proposal tests the central hypothesis that acetaminophen will attenuate the lipid peroxidation associated with the hemolysis and rhabdomyolysis that occur in patients undergoing CPB. Demonstration that acetaminophen inhibits the lipid peroxidation resulting from CPB would provide a rationale for a prospective randomized trial to test the hypothesis that acetaminophen will reduce the acute kidney injury that results from CPB.

Detailed description:

Arms: arm 1: None arm 2: Acetaminophen will ge given as 1g every 6 hours for 4 doses over a 24 hours study period
Interventions: intervention 1: Acetaminophen
Intervention descriptions: intervention 1: Acetaminophen 1g every 6 hours for 4 doses over 24 hours

Protocol documents:
Clinical trial NCT01389973
Conditions: Primary Biliary Cirrhosis
Keywords: Diseases [C] - Digestive System Diseases [C06] primary biliary cirrhosis ursodeoxycholic acid (UDCA) STELARA ustekinumab
Sponsor: Janssen Research & Development, LLC
Start date: 2011-09-01; Completion date: 2013-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.

Detailed description:
This is a multi-center, randomized (treatment will be assigned by chance), placebo-controlled (an inactive substance will be compared with the test drug to see whether the drug has a real effect), parallel-group (two or more groups of patients will receive different treatments) study that will consist of two parts. Part 1 will be an open-label (all participants will know the identity of the treatment) proof-of-concept study. Part 2 will be contingent on the results of Part 1 and will be double-blind (investigators and patients will not know what treatment is being given) and will evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis (PBC) who had an inadequate response to ursodeoxycholic acid. The duration of participation in the study for an individual participant may be up to 216 weeks. Patient safety will be monitored. Part 1: ustekinumab, 90mg subcutaneous (SC) at Weeks 0 and 4 and every 8 weeks through Week 20; Part 2: Depending on Part 1 results, either (ustekinumab 90mg or 45mg or placebo) or (ustekinumab 90mg or 180mg or placebo) SC at Weeks 0 and 4 and every 8 weeks through Week 20; Long-term Extension (including Part 1 and Part 2): beginning at Week 28, every 8 weeks with initially assigned dose until the extension dose has been selected; then every 8 weeks through Week 196 with the selected dose.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: ustekinumab 90 mg intervention 2: ustekinumab 45 mg intervention 3: ustekinumab 180 mg intervention 4: Placebo
Intervention descriptions: intervention 1: Subcutaneous injections of ustekinumb 90 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose. intervention 2: Subcutaneous injections of ustekinumb 45 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose. intervention 3: Subcutaneous injections of ustekinumb 180 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose. intervention 4: Subcutaneous injections of placebo at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.

Protocol documents:
Clinical trial NCT01392963
Conditions: Depression
Keywords: botox depression
Sponsor: Seton Healthcare Family
Start date: 2011-07-01; Completion date: 2013-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psychiatrist at every visit who will assess their depression.

Detailed description:
Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead

Arms: arm 1: At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12). arm 2: At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).
Interventions: intervention 1: botulinum toxin type A neurotoxin complex intervention 2: Placebo
Intervention descriptions: intervention 1: 29-40 U injection intervention 2: 29-40 U 0.9% NaCl injection

Protocol documents:
Clinical trial NCT01395394
Conditions: Phenylketonuria
Keywords: Phenylketonuria PKU tetrahydrobiopterin sapropterin dihydrochloride BH4 Kuvan Oxidative stress
Sponsor: Emory University
Start date: 2011-06-01; Completion date: 2013-06-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial function in patients with Phenylketonuria (PKU).

Detailed description:
Oxidative stress will be induced by having participants eat a meal in polyunsaturated fats. The investigators will see how participants respond to the meal challenge over the course of 6 hours.

* PKU participants who are currently on BH4 therapy will be evaluated while taking BH4 with the meal at a single study visit.
* PKU participants who did not responded to BH4 therapy will be evaluated twice. At the first study visit the investigators will see how you react to the meal challenge when you are not given BH4. You will be given BH4 for two weeks, then return for a second meal challenge study visit while taking BH4.
* Healthy controls will be evaluated after consuming the meal only (no BH4) at a single study visit.

Arms: arm 1: Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4. arm 2: Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4. arm 3: Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.
Interventions: intervention 1: Kuvan intervention 2: Meal Challenge
Intervention descriptions: intervention 1: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2. intervention 2: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction

Protocol documents:
Clinical trial NCT01396057
Conditions: Visual Impairment Macular Edema Branch Retinal Vein Occlusion
Keywords: Visual impairment macular edema branch retinal vein occlusion Dexamethasone implant Ranibizumab
Sponsor: Novartis Pharmaceuticals
Start date: 2011-07-01; Completion date: 2013-06-01
Enrollment: 244 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 Ranibizumab 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: Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally arm 2: Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Interventions: intervention 1: Ranibizumab intervention 2: Dexamethasone Implant intervention 3: Sham injection
Intervention descriptions: intervention 1: Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split intervention 2: Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only. intervention 3: Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration

Protocol documents: