ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00452543
Conditions: Major Depressive Disorder Alcohol Abuse Alcohol Dependence
Keywords: Major depressive disorder Alcoholism Alcohol abuse Alcohol dependence
Sponsor: Massachusetts General Hospital
Start date: 2007-03-01; Completion date: 2010-05-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence. The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.

Detailed description:
Depression and alcohol use disorders contribute to a significant proportion of the burden of disease, in the United States and abroad. Patients who suffer from co-morbid depression and alcohol abuse/dependence have illnesses that are more severe, persistent and costly than people with either depression or an alcohol use disorder alone. The treatment of these patients remains controversial. Several studies have demonstrated that antidepressants can be safe and efficacious in the treatment of depression in people who continue to drink, and it is now considered the standard of care to provide such treatment. Other studies have shown that pharmacotherapy with naltrexone or acamprosate can help reduce drinking in alcoholics without co-morbid depression. A logical extension of these findings would be to study the treatment of depressed alcoholics with dual pharmacotherapy, combining an anti-depressant with a medication aimed at treating the alcohol use disorder. We will conduct a randomized, double-blind, placebo controlled trial of escitalopram plus acamprosate and behavioral treatment vs. escitalopram plus placebo and behavioral treatment in 20 depressed alcoholics. Outcome measures will include depression, alcohol use and global functioning.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: acamprosate intervention 2: escitalopram intervention 3: Medical management intervention 4: Placebo
Intervention descriptions: intervention 1: Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks. intervention 2: Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD. intervention 3: Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks). intervention 4: Placebo, 2 capsules PO TID, for 12 weeks

Protocol documents:
Clinical trial NCT00453336
Conditions: Head and Neck Cancer Precancerous/Nonmalignant Condition
Keywords: recurrent squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the oropharynx oral leukoplakia
Sponsor: University of Miami
Start date: 2003-06-01; Completion date: 2010-05-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, precancerous cells and cancer cells are killed.

PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.

Detailed description:
OBJECTIVES:

* Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions, carcinoma in situ, select superficial squamous cell carcinoma of the oral cavity, oropharynx, or larynx, or condemned mucosa syndrome in the upper aerodigestive tract.
* Determine the safety of this regimen in these patients.

OUTLINE: Patients are stratified according to disease condition (benign vs malignant).

Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4.

After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: Porfimer Sodium intervention 2: Photodynamic Therapy
Intervention descriptions: intervention 1: Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home. intervention 2: Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.

Protocol documents:
Clinical trial NCT00461773
Conditions: Hormone-Sensitive Breast Cancer Breast Cancer
Keywords: Neoadjuvant treatment
Sponsor: Yale University
Start date: 2007-03-01; Completion date: 2010-05-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the objective response rate of a combination of letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients with hormone sensitive breast cancer.

Detailed description:

Arms: arm 1: brief exposure bevacizumab arm 2: brief exposure bevacizumab and letrozole
Interventions: intervention 1: Letrozole intervention 2: Bevacizumab
Intervention descriptions: intervention 1: Letrozole 2.5 mg po qd intervention 2: bevacizumab 10 mg/kg IV

Protocol documents:
Clinical trial NCT00510809
Conditions: High Cholesterol
Sponsor: James Backes, PharmD
Start date: 2007-07-01; Completion date: 2010-05-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the effects of policosanol on the cholesterol profile.

Detailed description:
The primary objectives of this study are to determine the changes in the lipid profile \[LDL-C, HDL-C, triglycerides, total cholesterol\] and the emerging risk factor, Lp(a), when policosanol is added to statin therapy. Additionally, one more primary objective is to evaluate the safety of the combination regimen.

Arms: arm 1: Policosanol 20mg daily arm 2: None arm 3: Policosanol 20mg daily Plus Statin Therapy Already In Use
Interventions: intervention 1: Policosanol intervention 2: Placebo intervention 3: Policosanol Plus Already In Use Statin Therapy
Intervention descriptions: intervention 1: Policosanol 20 mg daily intervention 2: Placebo daily intervention 3: Policosanol 20 mg daily Statin Therapy

Protocol documents:
Clinical trial NCT00517413
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-10-01; Completion date: 2010-05-01
Enrollment: 163 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta \[Mircera\]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms sc or iv monthly, starting dose

Protocol documents:
Clinical trial NCT00518973
Conditions: Anorexia Nervosa
Sponsor: University of California, San Diego
Start date: 2006-07-01; Completion date: 2010-05-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study is being held at UCSD to determine whether the medication Quetiapine helps people suffering from anorexia nervosa by reducing core eating disorders symptoms. This study will see if the medication Quetiapine helps symptoms of anxiety, depression, and obsessionality, in addition to increasing BMI. Men and women between the ages of 18-65 and are currently suffering from anorexia nervosa are needed.

Detailed description:

Arms: arm 1: The primary outcome was to determine the effect of quetiapine compared with placebo in terms of reducing core eating disorder symptoms on the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) and the Eating Disorder Inventory-2 (EDI-2). arm 2: Secondary outcomes were to determine if quetiapine is superior to placebo in reducing anxiety, depression and obsessionality assessed with the State Trait Anxiety Inventory (STAI), Hamilton Depression Rating Scale (HAM D) and Yale-Brown Obsessive Compulsive Scale, respectively. In addition, another secondary goal was to determine if quetiapine is superior to placebo in terms of weight gain. Adverse events were also determined.
Interventions: intervention 1: Quetiapine intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects. intervention 2: Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.

Protocol documents:
Clinical trial NCT00528879
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Metformin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs
Sponsor: AstraZeneca
Start date: 2007-09-01; Completion date: 2010-05-01
Enrollment: 915 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks arm 2: Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks arm 3: Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks arm 4: Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo intervention 3: Metformin
Intervention descriptions: intervention 1: Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks intervention 2: Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks intervention 3: Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

Protocol documents:
Clinical trial NCT00533910
Conditions: Hepatic Encephalopathy
Keywords: Minimal hepatic encephalopathy
Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Start date: 2007-10-01; Completion date: 2010-05-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized, blinded, placebo-controlled trial.

Detailed description:

Arms: arm 1: Will be given placebo and follow the exact procedures as the experimental section arm 2: None
Interventions: intervention 1: Rifaximin intervention 2: placebo
Intervention descriptions: intervention 1: 550mg BID rifaximin for 8 weeks intervention 2: same as the experimental arm

Protocol documents:
Clinical trial NCT00552760
Conditions: Bipolar Disorder
Sponsor: Lehigh Valley Hospital
Start date: 2007-11-01; Completion date: 2010-05-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.

Detailed description:
Patients with euthymic bipolar disorder, although free of significant mood symptoms, often have continued sleep disturbances. Improving patients' sleep by also normalizing the circadian rhythm will lead to fewer mood exacerbations. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for bipolar patients will improve sleep and will cause fewer mood exacerbations.

Patients with bipolar disorder often experience frequent mood alterations that are attempted to be controlled by mood stabilizing agents and anti-psychotic agents. Both classes of medications have numerous significant side effects. Establishing that ramelteon is helpful in the sleep of patients with bipolar disorder and helpful in mood stability will increase the number of treatment options for bipolar patients.

Arms: arm 1: 8 mg arm 2: None
Interventions: intervention 1: Ramelteon intervention 2: Placebo
Intervention descriptions: intervention 1: one 8 mg tablet at bedtime for up to 6 months intervention 2: one tablet at bedtime for up to 6 months

Protocol documents:
Clinical trial NCT00558792
Conditions: Coronary Artery Disease
Sponsor: Bracco Diagnostics, Inc
Start date: 2007-11-01; Completion date: 2010-05-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.

Detailed description:

Arms: arm 1: iopamidol injection 370, 70 mL arm 2: iopamidol injection 370, 80 mL arm 3: iopamidol injection 370, 90 mL
Interventions: intervention 1: Isovue 370, 70 mL intervention 2: Isovue 370, 80 mL intervention 3: Isovue 370, 90 mL
Intervention descriptions: intervention 1: 70 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second intervention 2: 80 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second intervention 3: 90 mL of iopamidol injection 370 injected at a rate of \>=4 mL/second

Protocol documents:
Clinical trial NCT00564395
Conditions: Type 1 Diabetes Mellitus
Keywords: blood sugar glycemic
Sponsor: Montefiore Medical Center
Start date: 2007-08-01; Completion date: 2010-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.

Detailed description:
One of the barriers to good glycemic control in children with type 1 diabetes is multiple daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in the same syringe would decrease the number of injections and may improve adherence

This study hypothesized that slow-acting insulin detemir mixed with aspart would have equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes.

Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited. However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose values over time were calculated as area under the curve (AUC), index of blood glucose control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)

Arms: arm 1: Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days. arm 2: Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days.
Interventions: intervention 1: Insulin Detemir mixed with RAI injection intervention 2: Insulin Detemir and RAI injection
Intervention descriptions: intervention 1: Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection intervention 2: Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection

Protocol documents:
Clinical trial NCT00581945
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Novartis
Start date: 2007-01-01; Completion date: 2010-05-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD

Detailed description:

Arms: arm 1: Participants received an initial dose of 1 mg/kg canakinumab (ACZ885) via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period. arm 2: Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
Interventions: intervention 1: Canakinumab intervention 2: Placebo
Intervention descriptions: intervention 1: The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion. intervention 2: Matching placebo to ACZ885 administered via intravenous infusion.

Protocol documents:
Clinical trial NCT00584935
Conditions: Ocular Cicatricial Pemphigoid
Keywords: Pemphigoid Blistering Diseases Blindness Autoimmune Rituximab
Sponsor: University of Alabama at Birmingham
Start date: 2006-01-01; Completion date: 2010-05-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cicatricial pemphigoid is an autoimmune blistering disease which affects the skin, mucous membranes, and, in a small subset of patients, the eye. Progressive ocular disease can lead to irreversible damage and blindness. Conventional treatments include systemic steroids, dapsone, and immunosuppressive agents. These treatments, however, are not successful with all patients. Rituximab has been very effective in the treatment of other autoimmune disorders, and has recently been shown to be effective for autoimmune blistering pemphigus. We propose that it will also be effective in the treatment of cicatricial pemphigoid.

Detailed description:
Cicatricial pemphigoid is an autoimmune blistering disease which can affect the skin, mucous membranes, and, in a small subset of patients, the eyes. Progressive ocular disease can lead to irreversible damage and blindness. Conventional treatments have included high dose systemic steroids, dapsone, and immunosuppressive agents such as azathioprine, methotrexate, cyclophosphamide, and mycophenolate mofetil. However, there are a subgroup of patients who fail to respond to these treatments, develop intolerable side effects, or have contraindications to their use. Patients may also develop resistance to these conventional treatment modalities. For these reasons, alternative treatment modalities are needed. Rituximab has been very effective in the treatment of other autoimmune disorders. It has recently been shown to be effective in the treatment of another autoimmune blistering disorder known as pemphigus. We thus propose that Rituximab will be effective in the treatment of cicatricial pemphigoid.

Arms: arm 1: The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15).

Protocol documents: