ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01461824
Conditions: Weight Gain Disorder of Bone Density and Structure, Unspecified Uterine Bleeding
Keywords: Birth Control Contraceptive Methods Female Contraception Weight Gain Bone Density
Sponsor: Nationwide Children's Hospital
Start date: 2011-09-01; Completion date: 2016-07-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.

Detailed description:
Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When receiving the birth control shot some girls gain a lot of weight while others do not. Some girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and thickness of the bones.

In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm. The 150mg dose is approved for use in this age group by the Food and Drug Administration (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the FDA only when given under the skin therefore it is considered experimental. The 75mg dose is also considered experimental as this dose is not FDA approved regardless of how it is given.

Arms: arm 1: Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM arm 2: Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM arm 3: Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM
Interventions: intervention 1: Depot medroxyprogesterone acetate (DMPA)
Intervention descriptions: intervention 1: 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months

Protocol documents:
Clinical trial NCT01477320
Conditions: Gastrointestinal Hemorrhage Clostridium Difficile Colitis
Keywords: Enteral Nutrition Stress Ulcer Prophylaxis Critically Ill Patients Overt and significant GI bleeding Stress gastropathy Clostridium Difficile pseudomembranous colitis Vital AF Small peptide fish oil structured lipids Fructose oligosaccharide
Sponsor: Mohamed Saad
Start date: 2013-09-01; Completion date: 2016-07-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pantoprazole 40 mg IV daily and tube feed. intervention 2: Placebo and tube feed
Intervention descriptions: intervention 1: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily. intervention 2: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.

Protocol documents:
Clinical trial NCT01513174
Conditions: Non Small Cell Lung Cancer
Keywords: GOAL Lung Non small cell lung cancer EGFR mutations
Sponsor: Spanish Lung Cancer Group
Start date: 2011-08-01; Completion date: 2016-07-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer.

Detailed description:
GOAL is a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease. Patients were randomly allocated (1:1) to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), response rate, safety and tolerability.

Arms: arm 1: Gefitinib will be administered once daily, continuously, in 28-day cycles, as a fixed dose of 250 mg/day. arm 2: Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase I study) twice a day, continuously, in 28-day cycles.
Interventions: intervention 1: Gefitinib intervention 2: Olaparib
Intervention descriptions: intervention 1: Gefitinib 250 mg once a day, continuously, in 28-day cycles, until progression intervention 2: Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase Ib study) twice a day, continuously, in 28-day cycles.

Protocol documents:
Clinical trial NCT01527487
Conditions: HER2 Negative Breast Cancer
Keywords: breast cancer eribulin Halaven taxotere
Sponsor: SCRI Development Innovations, LLC
Start date: 2012-06-01; Completion date: 2016-07-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose a randomized phase II study evaluating the pCR and toxicity profiles of combination eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC) as neoadjuvant therapy for locally advanced HER2-negative breast cancer.

Detailed description:

Arms: arm 1: Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard arm 2: Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard
Interventions: intervention 1: Eribulin intervention 2: Cyclophosphamide intervention 3: Docetaxel
Intervention descriptions: intervention 1: 1.4 mg/m2 IV (Days 1 \& 8), given short (≤15 minute) IV infusion, per institutional standard intervention 2: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard. intervention 3: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks.

Protocol documents:
Clinical trial NCT01535573
Conditions: Cocaine Dependence
Keywords: Cocaine citalopram treatment serotonin
Sponsor: Joy Schmitz
Start date: 2010-12-01; Completion date: 2016-07-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.

Detailed description:

Arms: arm 1: Citalopram 20 mg arm 2: Citalopram 40 mg arm 3: Placebo
Interventions: intervention 1: Citalopram intervention 2: Citalopram intervention 3: Placebo
Intervention descriptions: intervention 1: 20 mg once per day for 9 weeks intervention 2: 40 mg per day for 9 weeks intervention 3: 0 mg per day for 9 weeks

Protocol documents:
Clinical trial NCT01587118
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD Posttraumatic Stress Disorder Asenapine Adjunctive antidepressant neuroleptic
Sponsor: Lori Davis, MD
Start date: 2012-06-01; Completion date: 2016-07-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label pilot study of adjunctive asenapine for the treatment of Posttraumatic Stress Disorder (PTSD) in veterans who have not fully remitted to an adequate trial of standard antidepressant treatment.

Detailed description:
Consenting Veterans with the diagnosis of PTSD who have not fully remitted to an adequate trial of standard antidepressant treatment (sertraline, citalopram, escitalopram, fluoxetine, venlafaxine, or mirtazapine) are treated with the addition of open-label asenapine for 12-weeks.

Arms: arm 1: adjunctive asenapine
Interventions: intervention 1: Adjunctive asenapine
Intervention descriptions: intervention 1: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.

Protocol documents:
Clinical trial NCT01594762
Conditions: Diabetic Foot Infection
Keywords: Diabetic Foot Ulcer Infection
Sponsor: Dipexium Pharmaceuticals, Inc.
Start date: 2014-06-01; Completion date: 2016-07-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.

Detailed description:

Arms: arm 1: Drug: Topical placebo cream arm 2: Drug: Topical pexiganan cream 0.8%
Interventions: intervention 1: Topical pexiganan cream 0.8% intervention 2: Topical placebo cream intervention 3: Standard wound care
Intervention descriptions: intervention 1: 14 days of treatment intervention 2: 14 days of treatment intervention 3: 14 days of treatment

Protocol documents:
Clinical trial NCT01625455
Conditions: Sezary Syndrome Pruritus
Keywords: Sezary Syndrome Pruritus Aprepitant Neurokinin-1
Sponsor: Vanderbilt University Medical Center
Start date: 2012-02-01; Completion date: 2016-07-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this randomized, double-blinded, placebo-controlled study is to test the hypothesis that administration of aprepitant will decrease the severity of pruritus in patients with Sèzary Syndrome.

Detailed description:

Arms: arm 1: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days. arm 2: Matching placebo will be given in place of aprepitant
Interventions: intervention 1: Aprepitant intervention 2: Placebo
Intervention descriptions: intervention 1: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days. intervention 2: Placebo will be given orally for a total of 7 days.

Protocol documents:
Clinical trial NCT01673828
Conditions: Traumatic Brain Injury Posttraumatic Epilepsy
Keywords: Brain Injuries Pregnanolone Epilepsy
Sponsor: Michael A. Rogawski, MD, PhD
Start date: 2013-04-01; Completion date: 2016-07-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.

Detailed description:
This is a double-blind, placebo-controlled, randomized, dose-finding, two-stage adaptive, clinical trial study comparing allopregnanolone to placebo when administered intravenously for 5 days beginning within 8 hours after injury. Test products to be administered are low and high dose allopregnanolone (Products L and H, respectively) and placebo (Product P) intravenous solutions. The products are administered during a 4-day treatment period followed by a 1-day dose de-escalation period. Stage 1 of the study will assess safety and confirm that dosing with Products L and H achieve the target steady-state plasma concentrations set for each of these products. Dosing will be adjusted in Stage 1, if necessary. Stage 2 will initially allocate subjects equally to Products L, H and P but will then use adaptive randomization to allocate subjects between Products L and H to optimized the probability of yielding a better 3-month Glasgow Outcome Score Extended (GOS-E) score.

Arms: arm 1: Allopregnanolone injection (intravenous solution) continuous infusion for 5 days arm 2: Placebo injection (intravenous solution) continuous infusion for 5 days
Interventions: intervention 1: Allopregnanolone injection intervention 2: Placebo injection
Intervention descriptions: intervention 1: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium intervention 2: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium

Protocol documents:
Clinical trial NCT01703091
Conditions: Non-small Cell Lung Cancer Metastatic
Sponsor: Eli Lilly and Company
Start date: 2012-12-01; Completion date: 2016-07-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of ramucirumab in combination with docetaxel in participants with Stage IV non-small cell lung cancer who have had disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy for advanced/metastatic disease.

Detailed description:

Arms: arm 1: Ramucirumab 10 milligram per kilogram (mg/kg) on Day 1 of every 21 day cycle, administered as an intravenous (IV) infusion over approximately 60 minutes. Docetaxel 60 milligram per square meter (mg/m2) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes. arm 2: Placebo (administered at a volume equivalent to a dose of milligram per kilogram (mg/kg)) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes. Docetaxel 60 mg/m2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
Interventions: intervention 1: Ramucirumab intervention 2: Placebo intervention 3: Docetaxel
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered IV intervention 3: Administered IV

Protocol documents:
Clinical trial NCT01751971
Conditions: Sleep Apnea
Sponsor: Brigham and Women's Hospital
Start date: 2012-11-01; Completion date: 2016-07-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study seeks to employ advanced methods to estimate the individual factors contributing to sleep apnea from standard recordings made during routine clinical sleep studies. This study focuses on breathing control or "loop gain" as one of the factors contributing to sleep apnea. Increased levels of oxygen in the air is known to make breathing more stable by lowering "loop gain". Here, our goal is to use a new method capable of detecting a reduction in loop gain with oxygen. The investigators also aim to test whether a high loop gain measured at baseline/placebo predicts a greater improvement in sleep apnea with oxygen therapy.

Detailed description:
In a single-blinded randomized crossover study, inspired oxygen/air (40%/21%) is delivered on two separate nights. Loop gain is measured from routine polysomnography using a novel mathematical method. A value of loop gain \>1 reflects unstable breathing, and a value less than but approaching 1 denotes a system more prone to oscillate. Loop gain is measured as the changes in ventilatory drive/effort that arises subsequent to changes in ventilation (e.g. due to obstructive apnea). A simple chemoreflex model (gain, time constant, delay) is fit to surrogate ventilation data (derived from airflow) during sleep. The best model is one that best matches the elevated ventilatory drive (measured as ventilation in the absence of airflow obstruction) based on the prior apneic/hypopneic fall in ventilation. Loop gain is calculated from this model. We aim to use loop gain measured on and off oxygen to determine whether a strong response (reduction in apnea severity) can be predicted by a higher loop gain (in the sham arm) using our method. We also assessed whether assessing upper airway anatomy/collapsibility, dilator muscle responsiveness, and the arousal threshold helped to predict responses to treatment.

Arms: arm 1: Participants breathe air with additional inspired oxygen (40%) for 1 night during an overnight sleep study (15 L/min via venturi mask). 1 week later participants will crossover to Sham (sham comparator). arm 2: Participants breathe air without additional inspired oxygen for 1 night during sleep (15 L/min via Venturi mask). 1 week later participants will crossover to Inspire Oxygen (active intervention).
Interventions: intervention 1: Inspired oxygen (40%) intervention 2: Sham
Intervention descriptions: intervention 1: Supplemental oxygen at 40% inspired via venturi mask (15 L/min). Equivalent to 5 L/min via nasal cannula. intervention 2: Medical air with 21% oxygen via venturi mask (15 L/min).

Protocol documents:
Clinical trial NCT01789047
Conditions: Idiopathic Parkinson's Disease Drug Induced Dyskinesia
Keywords: Parkinson's disease dyskinesia Indonesia amantadine
Sponsor: Rush University Medical Center
Start date: 2013-03-01; Completion date: 2016-07-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine.

Detailed description:
We conducted a randomized placebo controlled trial of topiramate in PD dyskinetic subjects already on amantadine but with continuing dyskinesia. Topiramate or placebo was introduced in blinded fashion with a gradual titration (topiramate 25-150 mg/d) over 6 weeks and then a maintenance period of 8 weeks. The primary outcome of interest was change from baseline to end of study in total Unified Dyskinesia Rating Scale (UDysRS) score using Intention to Treat analysis.

Arms: arm 1: Topiramate as adjunct to amantadine. arm 2: Placebo
Interventions: intervention 1: Topiramate intervention 2: Placebo intervention 3: Amantadine
Intervention descriptions: intervention 1: Topiramate as adjunct to amantadine intervention 2: Placebo control intervention 3: Existing treatment for all participants

Protocol documents:
Clinical trial NCT01827332
Conditions: Marijuana Dependence
Keywords: marijuana substance abuse drug abuse marijuana dependence drug addiction
Sponsor: Medical University of South Carolina
Start date: 2013-03-01; Completion date: 2016-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the impact of a medication called oxytocin on marijuana use and therapy response in people who frequently use marijuana.

Detailed description:
Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential additive effects with a therapy intervention have not been explored in marijuana-dependent individuals. In the proposed study, the impact of intranasal oxytocin on therapy effectiveness and marijuana use outcomes following a brief therapy intervention will be investigated. It is hypothesized that oxytocin administration (vs. placebo) will improve treatment satisfaction and decrease marijuana use.

Arms: arm 1: intranasal administration arm 2: intranasal administration
Interventions: intervention 1: Oxytocin intervention 2: Saline
Intervention descriptions: intervention 1: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET. intervention 2: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.

Protocol documents:
Clinical trial NCT01831089
Conditions: Breast Cancer Ovarian Cancer Gynecological Cancer Head and Neck Carcinoma Non-small Cell Lung Cancer Small Cell Lung Cancer Non-squamous Cell Lung Cancer
Sponsor: PharmaMar
Start date: 2013-09-01; Completion date: 2016-07-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors

Detailed description:
Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a selected cohort of patients to characterize the safety profile and feasibility of this combination, to obtain preliminary information on antitumor activity, to obtain preliminary information on quality of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to detect major drug-drug PK interactions and PK(pharmacokinetic)/PD(pharmacodynamic) correlation and to conduct an exploratory pharmacogenomic(PGx) analysis in patients with selected advanced solid tumors.

Arms: arm 1: PM01183 + paclitaxel +/- bevacizumab
Interventions: intervention 1: PM01183 + paclitaxel +/- bevacizumab
Intervention descriptions: intervention 1: PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion

paclitaxel: 6 mg/ml concentrate for solution for infusion

bevacizumab: 25 mg/ml concentrate for solution for infusion

Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients

Protocol documents: