ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00913510
Conditions: Bladder Dysfunction Multiple Sclerosis
Sponsor: Wellspect HealthCare
Start date: 2009-12-01; Completion date: 2012-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aims of this prospective, randomized study are:

* To assess the effect of clean intermittent catheterization (CIC)
* To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when using CIC in combination with anticholinergic drugs
* To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves bladder control and QoL
* To increase the evidence of CIC, and support clinical guidelines of bladder management in MS patients

Detailed description:

Arms: arm 1: Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device. arm 2: Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
Interventions: intervention 1: CIC using LoFric Primo intervention 2: Anticholinergic medication
Intervention descriptions: intervention 1: Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, and start of CIC using LoFric Primo catheters, i.e. Drug + Device. intervention 2: Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.

Protocol documents:
Clinical trial NCT00925587
Conditions: Anemia Chronic Kidney Disease
Keywords: CKD Anemia correction darbepoetin alfa
Sponsor: Amgen
Start date: 2009-06-01; Completion date: 2012-05-01
Enrollment: 358 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.

Detailed description:

Arms: arm 1: Q2W administration of darbepoetin alfa. arm 2: QM administration of darbepoetin alfa
Interventions: intervention 1: darbepoetin alfa
Intervention descriptions: intervention 1: Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.

Protocol documents:
Clinical trial NCT00926575
Conditions: Acute Gastrointestinal Graft vs Host Disease
Keywords: BDP orBec GVHD beclomethasone dipropionate bone marrow transplant hematopoietic cell transplant HCT stem cell transplant marrow transplant SCT beclomethasone 17,21-dipropionate
Sponsor: Soligenix
Start date: 2009-10-01; Completion date: 2012-05-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

Detailed description:

Arms: arm 1: Investigational drug arm 2: Control
Interventions: intervention 1: oral beclomethasone 17,21-dipropionate intervention 2: Placebo
Intervention descriptions: intervention 1: Two tablets QID for 50 days intervention 2: Two tablets QID for 50 days

Protocol documents:
Clinical trial NCT00947661
Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: glaucoma latanoprost
Sponsor: Sun Pharma Advanced Research Company Limited
Start date: 2010-07-01; Completion date: 2012-05-01
Enrollment: 578 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.

Detailed description:

Arms: arm 1: Test drug arm 2: Reference drug
Interventions: intervention 1: SPARC0912 intervention 2: Reference0912
Intervention descriptions: intervention 1: Eye drops, once daily, 12 weeks intervention 2: Eye drops, once daily, 12 weeks

Protocol documents:
Clinical trial NCT00973102
Conditions: Hemorrhagic Shock
Sponsor: University of Texas Southwestern Medical Center
Start date: 2009-07-01; Completion date: 2012-05-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Based on encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with hemorrhagic shock will safely reduce secondary injury, and improve survival.

Detailed description:
Annually in the United States, approximately 30 million people require treatment for traumatic injuries in emergency departments. Two million of these patients require hospitalization, with several hundred thousand ultimately dying, often due to extreme blood loss. Importantly, these traumatic injuries are the leading cause of death and disability for children and young adults under the age of 44, with the total cost of trauma in the U.S. approaching $260 billion each year.

Despite advances in pre-hospital care, early resuscitation, surgical interventions and intensive care monitoring aimed at the primary traumatic injury, many survivors never recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in the first few hours after the severe traumatic event.

In spite of the current bleak outlook for many of these patients, a series of animal investigations have uncovered a promising solution to the problem of the secondary injury seen in hemorrhagic shock and other similar processes, namely the early administration of estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound.

Based on encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with hemorrhagic shock will safely reduce secondary injury, and improve survival.

Arms: arm 1: Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV. arm 2: Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.
Interventions: intervention 1: Premarin IV intervention 2: Placebo
Intervention descriptions: intervention 1: One time dose of Premarin IV intervention 2: One time dose of placebo.

Protocol documents:
Clinical trial NCT00976391
Conditions: Diabetes Mellitus, Type 2
Keywords: open-label albiglutide insulin glargine preprandial insulin
Sponsor: GlaxoSmithKline
Start date: 2009-09-01; Completion date: 2012-05-01
Enrollment: 586 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

Detailed description:
This randomized, open-label, active-controlled, parallel-group, multicenter study evaluates the safety and efficacy of a weekly subcutaneously injected dose of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes. Subjects with a historical diagnosis of type 2 diabetes who are inadequately controlled despite the use of insulin glargine or other intermediate- or long-acting insulins for \>/= 6 months but \< 5 years, with or without oral antidiabetic medications, who are unable to achieve a glycosylated hemoglobin value of \< 7% will be recruited into the study. Subjects must also be willing and capable of pursuing an intensive regimen of both basal and preprandial insulin.

Arms: arm 1: albiglutide in combination with insulin glargine arm 2: insulin glargine in combination with preprandial lispro insulin
Interventions: intervention 1: albiglutide + insulin glargine intervention 2: insulin glargine + preprandial lispro insulin
Intervention descriptions: intervention 1: albiglutide in combination with insulin glargine intervention 2: insulin glargine in combination with preprandial lispro insulin

Protocol documents:
Clinical trial NCT00981526
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Cognition Metabolism Antipsychotics Psychopathology
Sponsor: University of Massachusetts, Worcester
Start date: 2009-03-01; Completion date: 2012-05-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80 mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy expenditure, and body composition. In addition, the study will examine insulin's effects on psychopathology and cognition.

Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. Approximately 70 subjects will be enrolled.

Detailed description:
The specific aims include:

Primary Aims:

1. Examine the efficacy of telmisartan added to regular doses of clozapine or olanzapine in improving insulin resistance.
2. Examine the efficacy of telmisartan in reducing fasting triglycerides.

Secondary Aims:

1. Examine the effects of telmisartan on negative symptoms, positive symptoms, and cognitive function.
2. Examine telmisartan's effects on lipids, body composition, and waist/hip ratio.
3. Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein (CRP) and interleukin 6 (IL-6).

Arms: arm 1: (existing Clozapine or Olanzapine treatment) + (Telmisartan) arm 2: (existing Clozapine or Olanzapine treatment) + (Placebo)
Interventions: intervention 1: Telmisartan intervention 2: Placebo intervention 3: Clozapine intervention 4: Olanzapine
Intervention descriptions: intervention 1: Telmisartan 40mg/day for the first 2 weeks.

Telmisartan 80mg/day for the next 10 weeks. intervention 2: Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks. intervention 3: Clozapine (plus telmisartan or placebo) for 12 weeks. intervention 4: Olanzapine (plus telmisartan or placebo) for 12 weeks.

Protocol documents:
Clinical trial NCT01004159
Conditions: Colorectal Cancer
Keywords: Colorectal cancer KRAS wild type tumors
Sponsor: Roswell Park Cancer Institute
Start date: 2009-09-01; Completion date: 2012-05-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being performed to test if the use of high dose of cetuximab in combination with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan in patients with wild type KRS tumors that have advanced colon or rectal cancer

Detailed description:
Cetuximab is a manufactured antibody-antibodies are proteins that can be found circulating in your blood stream. The growth of colorectal cancer may be affected by the interaction of a growth factor known as "epidermal growth factor" (EGF) with its receptor.

Cetuximab is a antibody directed against the receptor for EGF and has been shown to turn off the activity of the receptor and to stop the growth of cancer cells in many laboratory tests. Cetuximab has been recently approved by the Food and Drug Administration in the treatment of patients with advanced colorectal cancer and who failed standard chemotherapy. Cetuximab has been shown to delay the progression of colorectal cancer when given alone in patients who have failed standard chemotherapy and when given with a chemotherapy drug called irinotecan in patients who have failed irinotecan.

Arms: arm 1: None
Interventions: intervention 1: cetuximab with irinotecan
Intervention descriptions: intervention 1: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment

Protocol documents:
Clinical trial NCT01034163
Conditions: Hodgkin's Lymphoma
Keywords: Phase III randomized double blind placebo controlled multi-center study panobinostat Hodgkin's lymphoma at risk for relapse autologous stem cell transplant
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-01; Completion date: 2012-05-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.

Detailed description:

Arms: arm 1: Participants received 45 mg orally 3 times a week (TIW), every other week (QOW), arm 2: Participants received matching placebo to PAN TIW, QOW.
Interventions: intervention 1: Panobinostat intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo

Protocol documents:
Clinical trial NCT01049217
Conditions: Neuropathy
Keywords: neuropathy pain HIV-1 HIV Infections
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-04-01; Completion date: 2012-05-01
Enrollment: 377 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.

Detailed description:
Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: Pregabalin 75 mg-300mg twice daily during the course of the study. intervention 2: Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.

Protocol documents:
Clinical trial NCT01062763
Conditions: Arterial Hypertension Hypertension, Resistant to Conventional Therapy Diabetes Mellitus
Keywords: hypertension spironolactone antihypertensive treatment Type-2 diabetes
Sponsor: Ib Abildgaard Jacobsen
Start date: 2010-03-01; Completion date: 2012-05-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.

Detailed description:
The primary object of the study is to estimate the effect of addition of low dose spironolactone to antihypertensive treatment with at least three antihypertensive drugs in patients with type-2 diabetes and blood pressure over 130/80 mmHg.

Secondary aims are to estimate how many of these patients have their blood pressure controlled by the addition of spironolactone, to investigate whether the addition of spironolactone affects insulin sensitivity and urinary protein secretion and to estimate the incidence of adverse effects of the aldosterone antagonist.

Arms: arm 1: spironolactone is added to previous antihypertensive treatment arm 2: Addition of placebo
Interventions: intervention 1: spironolactone intervention 2: placebo
Intervention descriptions: intervention 1: 25 to 50 mg once daily intervention 2: addition of placebo 1 to 2 tablets daily

Protocol documents:
Clinical trial NCT01068652
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-03-01; Completion date: 2012-05-01
Enrollment: 403 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa. The aim of this clinical trial is to investigate the effect of 50 weeks of treatment with different intensified insulin administrations (all in combination with a fixed dose of metformin) on blood sugar control in subjects with type 2 diabetes inadequately controlled by oral anti-diabetic drugs (OADs).

Detailed description:

Arms: arm 1: Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. \[under the skin\]) if treatment target of HbA1c below 7.0% was not reached. arm 2: Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
Interventions: intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: biphasic insulin aspart 30 intervention 4: metformin
Intervention descriptions: intervention 1: Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin). intervention 2: Pending evaluation of HbA1c every 3 months, insulin aspart was added to the insulin detemir treatment (up to three does daily, injected s.c. (under the skin) intervention 3: Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin). Pending evaluation of HbA1c every 3 months, the dose will intensified up to 3 doses daily intervention 4: 1000-2000 mg/day in combination with insulin treatment

Protocol documents:
Clinical trial NCT01068912
Conditions: Influenza
Keywords: Influenza
Sponsor: MDVI, LLC
Start date: 2010-02-01; Completion date: 2012-05-01
Enrollment: 530 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.

Detailed description:
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by 400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1 day, followed by 800 mg favipiravir BID for 4 days).

Arms: arm 1: Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days arm 2: High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days arm 3: Placebo
Interventions: intervention 1: Favipiravir intervention 2: Favipiravir intervention 3: Placebo comparator
Intervention descriptions: intervention 1: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days intervention 2: High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days intervention 3: Placebo BID x 1 day, and Placebo BID x 4 days

Protocol documents:
Clinical trial NCT01082328
Conditions: Phenylketonuria
Keywords: Phenylketonuria (PKU) Hyperphenylalaninemia (HPA) Kuvan® Sapropterin dihydrochloride Kuvan responder Tetrahydrobiopterin (BH4)
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2010-05-01; Completion date: 2012-05-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to evaluate the proportion of responders (that is, greater than or equal to \[\>=\] 30 percent reduction from Baseline in blood phenylalanine \[Phe\] level) to treatment with Kuvan® (sapropterin dihydrochloride) 20 milligram per kilogram per day (mg/kg/day) for 28 days.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Kuvan®
Intervention descriptions: intervention 1: Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) will be given once daily for 28 +/- 1 days.

Protocol documents: