ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01369745
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Moderate to severe
Sponsor: Zalicus
Start date: 2011-06-01; Completion date: 2012-09-01
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.

Detailed description:
The primary objective of the study was to demonstrate the efficacy of Z102 (2.7 mg prednisolone/360 mg dipyridamole) versus placebo on the Disease Activity Score 28 using C reactive protein (DAS28-CRP) in subjects with rheumatoid arthritis at the study endpoint of 12 weeks

Arms: arm 1: Prednisolone 2.7 mg daily for 12 weeks arm 2: Dipyridamole 360 mg daily for 12 weeks arm 3: Prednisone 5 mg daily for 12 weeks arm 4: Prednisolone 2.7 mg plus dipyridamole 360 mg daily for 12 weeks arm 5: Placebo daily for 12 weeks
Interventions: intervention 1: Prednisolone intervention 2: dipyridamole intervention 3: Prednisone intervention 4: Z102 intervention 5: placebo
Intervention descriptions: intervention 1: Prednisolone 2.7 mg daily intervention 2: dipyridamole 360 mg daily intervention 3: Prednisone 5 mg daily intervention 4: Prednisolone 2.7 mg plus dipyridamole 360 mg daily intervention 5: None

Protocol documents:
Clinical trial NCT01370460
Conditions: Acute Blood Loss Anemia Osteoarthritis, Knee
Keywords: Tranexamic Acid Blood transfusion Total knee arthroplasty
Sponsor: Henry Ford Health System
Start date: 2011-06-01; Completion date: 2012-09-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.

Detailed description:
Autologous (donor) blood transfusion is an expensive and common occurrence after total knee replacement. Published data puts this rate between 9 and 40% after primary unilateral total knee arthroplasty. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total knee replacement, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total knee arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. Furthermore, the one aforementioned randomized clinical trial used a variety of postoperative deep vein thrombosis prophylaxis after surgery and introduced a potential confounding variable. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.

Arms: arm 1: Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty. arm 2: 100mL 0.9% NS, applied topically
Interventions: intervention 1: Tranexamic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: Topical tranexamic acid (2g/100mL 0.9% saline) intervention 2: 100mL 0.9% sterile saline

Protocol documents:
Clinical trial NCT01370811
Conditions: Sialorrhoea
Keywords: oxybutynin clonidine OC Oral Solution sialorrhoea Parkinson's disease
Sponsor: Orient Pharma Co., Ltd.
Start date: 2011-08-01; Completion date: 2012-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral solution is effective in reducing saliva secretion in patients suffering from Parkinson's Disease with excessive salivation.

Detailed description:
Sialorrhea is excessive flow of saliva associated with its unintentional loss from the mouth, commonly known as drooling. Sialorrhea may result from any combination of hypersecretion, problems swallowing or sensorimotor problems containing saliva in the mouth. It is commonly found in people with neurological dysfunction such as Parkinson's Disease, leading to social isolation and embarrassment. In general, treatment options are limited because of the underlying chronic disease. The objective of the proposed low-dose, new combination drug, OC Oral solution is to develop a new treatment option that can be used to titrate saliva secretion rates to a level that is low enough to prevent unintentional loss (i.e. drooling) but not so low as to cause an uncomfortably dry mouth.

Arms: arm 1: Placebo arm 2: High dose oxybutynin and clonidine arm 3: Low dose oxybutynin and clonidine arm 4: Intermediate dose oxybutynin and clonidine
Interventions: intervention 1: oxybutynin and clonidine oral solution treatment A intervention 2: oxybutynin and clonidine oral solution treatment B intervention 3: oxybutynin and clonidine oral solution treatment C intervention 4: oxybutynin and clonidine oral solution treatment D
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Placebo

Protocol documents:
Clinical trial NCT01371565
Conditions: Cushing's Disease Cushing's Syndrome
Keywords: Cushing's Disease Cushing's Syndrome Cushings Pituitary Ectopic ACTH secretion
Sponsor: Corcept Therapeutics
Start date: 2010-11-01; Completion date: 2012-09-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a compassionate use study. In addition to providing compassionate use access to mifepristone, objectives of the study will be to evaluate the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when given on a compassionate use basis. The study will only enroll subjects whose physicians have determined that medical treatment is needed to control the symptoms or signs of hypercortisolemia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Mifepristone
Intervention descriptions: intervention 1: mifepristone at doses from 300mg/day up to 1200mg/day

Protocol documents:
Clinical trial NCT01376245
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2011-04-01; Completion date: 2012-09-01
Enrollment: 646 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate the efficacy and safety of fluticasone furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: Inhaled corticosteroid/long acting beta-agonist arm 2: matching placebo
Interventions: intervention 1: fluticasone furoate/vilanterol intervention 2: Placebo
Intervention descriptions: intervention 1: Inhaled corticosteroid/long acting beta-agonist intervention 2: matching placebo

Protocol documents:
Clinical trial NCT01376297
Conditions: Chemotherapy-Induced Nausea and Vomiting
Sponsor: Helsinn Healthcare SA
Start date: 2011-07-01; Completion date: 2012-09-01
Enrollment: 413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

Detailed description:

Arms: arm 1: Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle arm 2: Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.
Interventions: intervention 1: Netupitant and Palonosetron intervention 2: Aprepitant intervention 3: Palonosetron intervention 4: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01378104
Conditions: Sustained Virologic Response IL28B Polymorphism
Keywords: reducing dose of peginterferon chronic hepatitis c Koreans IL28B polymorphism
Sponsor: The Catholic University of Korea
Start date: 2008-10-01; Completion date: 2012-09-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1. Randomized controlled multicenter study
2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
3. IL28B polymorphism in Koreans with CHC

Detailed description:
The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.

-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).

So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.

There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.

-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a

Arms: arm 1: This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. arm 2: These group patients would be treated with standard dose 180 ug/week for 48 weeks.
Interventions: intervention 1: peginterferon alfa 2a (pegasys) intervention 2: peginterferon alfa-2a (pegasys)
Intervention descriptions: intervention 1: dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable intervention 2: These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.

Protocol documents:
Clinical trial NCT01382719
Conditions: Female Sexual Arousal Disorder Hypoactive Sexual Desire Disorder
Keywords: FSAD HSDD female sexual dysfunction FSD Female Sexual Arousal Disorder Hypoactive Sexual Desire Disorder
Sponsor: Palatin Technologies, Inc
Start date: 2011-06-01; Completion date: 2012-09-01
Enrollment: 612 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.

Detailed description:

Arms: arm 1: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product. arm 2: Low dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. arm 3: Middle dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.25 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. arm 4: High dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Interventions: intervention 1: bremelanotide
Intervention descriptions: intervention 1: Subjects will administer drug on an as needed basis, prior to anticipated sexual activity.

Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.

Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.

Protocol documents:
Clinical trial NCT01383499
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2011-08-01; Completion date: 2012-09-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.

Detailed description:

Arms: arm 1: patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler arm 2: patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler arm 3: patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler arm 4: patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler
Interventions: intervention 1: Tiotropium bromide intervention 2: Tiotropium bromide intervention 3: Tiotropium bromide intervention 4: Tiotropium bromide
Intervention descriptions: intervention 1: inhalation solution administered via Respimat in 3 different doses intervention 2: inhalation solution administered via Respimat in 3 different doses intervention 3: inhalation solution administered via Respimat in 3 different doses intervention 4: inhalation solution administered via Respimat in 3 different doses

Protocol documents:
Clinical trial NCT01384292
Conditions: Opioid-Induced Constipation
Keywords: Cancer-Related Pain Opioid-Induced Constipation OIC
Sponsor: AstraZeneca
Start date: 2011-06-01; Completion date: 2012-09-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).

Detailed description:

Arms: arm 1: Oral treatment arm 2: Oral treatment arm 3: Oral treatment
Interventions: intervention 1: NKTR-118 intervention 2: NKTR-118 intervention 3: Placebo
Intervention descriptions: intervention 1: 12.5 mg oral tablet once daily intervention 2: 25 mg oral tablet once daily intervention 3: Oral treatment

Protocol documents:
Clinical trial NCT01394185
Conditions: Marijuana Smoking
Keywords: marijuana dronabinol pharmacotherapy
Sponsor: Johns Hopkins University
Start date: 2011-02-01; Completion date: 2012-09-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.

Detailed description:

Arms: arm 1: Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order
Interventions: intervention 1: Dronabinol 120mg/day intervention 2: Placebo intervention 3: Dronabinol 240mg/day
Intervention descriptions: intervention 1: Participants receive 40mg dronabinol 3 times daily intervention 2: Participants receive placebo intervention 3: Participants receive 80mg dronabinol 3 times daily

Protocol documents:
Clinical trial NCT01417780
Conditions: Necrotizing Soft Tissue Infections
Sponsor: Atox Bio Ltd
Start date: 2011-12-01; Completion date: 2012-09-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.

Detailed description:
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections.

Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections. The efficacy domains are:

1. Clinical status domain
2. Pharmacoeconomics domain
3. Systemic and local inflammatory biomarker domain

Arms: arm 1: None arm 2: None arm 3: Normal saline (0.9% sodium chloride)
Interventions: intervention 1: AB103 intervention 2: Placebo
Intervention descriptions: intervention 1: AB103 0.25 mg/kg or 0.5 mg/kg administered as a single IV infusion intervention 2: Normal saline (0.9% sodium chloride) administered as a single IV infusion

Protocol documents:
Clinical trial NCT01422538
Conditions: Skin Laxity
Keywords: Ulthera® System Ultherapy™ treatment Ulthera, Inc. Ultrasound treatment for skin tightening Skin laxity on the face and neck.
Sponsor: Ulthera, Inc
Start date: 2011-05-01; Completion date: 2012-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.

Detailed description:
This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.

Arms: arm 1: Subjects will receive Ulthera® System alone. arm 2: Sculptra® only arm 3: Sculptra® treatment followed by Ultherapy™ treatment
Interventions: intervention 1: Ulthera® System intervention 2: Sculptra® intervention 3: Sculptra® treatment followed by Ultherapy™ treatment
Intervention descriptions: intervention 1: Focused ultrasound energy delivered below the surface of the skin on the lower face. intervention 2: Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart. intervention 3: Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

Protocol documents:
Clinical trial NCT01434121
Conditions: Sepsis Septic Shock Hypotension Acute Lung Injury
Sponsor: Virginia Commonwealth University
Start date: 2010-05-01; Completion date: 2012-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The major goal of this project is to determine whether intravenously infused ascorbic acid is safe for use as a viable therapeutic strategy in adult humans with sepsis.

Detailed description:
Evolving data from experimental animals strongly suggests that ascorbic acid potently interrupts multiple biological processes which lead to organ injury following onset of sepsis. Data presented below suggests that ascorbic acid potently attenuates lung injury produced by septic insults. Sepsis and septic shock secondary to bacterial and fungal blood stream infections are a leading cause of death in critically ill patients. At present, 28 day mortality in septic patients averages 40% in the best of ICUs. In sepsis, disseminated intravascular coagulation produces widespread systemic microvascular thrombosis that leads to multiple organ injury (i.e., lung, liver, kidney, intestinal, cardiovascular). Despite aggressive intravascular volume resuscitation and vasopressor support, appropriate antibiotic administration, and expert critical care management, mortality remains high. Only a single agent has been approved to disrupt progressive sepsis-associated microvascular thrombosis (activated protein C, \[Drodrecogin Alpha, brand name: Xigris, Lilly\]). No other non-antibiotic pharmaceutical agent is currently approved for use in sepsis. Activated protein C (APC) continuous infusion protocol spans a 96 hour period. APC infusion produces significant anticoagulation, and therefore the major risk from its use is hemorrhage. Thus, recent surgery, especially neurosurgical procedures, is a major contraindication to APC use. Finally, cost stands as an important issue for APC use. A 96 hour APC infusion in a 70 kg patient at VCUHS costs the patient over $33,000 (source VCUHS Pharmacy Services). Use of APC in sepsis remains controversial and has failed to achieve widespread acceptance. The goal of the current study is to determine the safety of ascorbic acid infusion in septic humans.

Arms: arm 1: Subject receives a high dose of infused Vitamin C arm 2: Subject receives a low dose of infused Vitamin C arm 3: Subject receives an infusion of saline
Interventions: intervention 1: Ascorbic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo intervention 2: None

Protocol documents: