ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00786643
Conditions: Colorectal Cancer
Keywords: Gamma Interferon 5-FU LV
Sponsor: Accelerated Community Oncology Research Network
Start date: 2006-02-01; Completion date: 2010-03-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.

Detailed description:

Arms: arm 1: Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. arm 2: Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
Interventions: intervention 1: 5-Fluorouracil intervention 2: Leucovorin (LV) intervention 3: Gamma-Interferon-1b (IFN-γ) intervention 4: Bevacizumab
Intervention descriptions: intervention 1: 5-FU bolus was administered at 400mg/m\^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m\^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle. intervention 2: Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle. intervention 3: Gamma-Interferon 150 mcg/m\^2 was administered by subcutaneous injection on day 1 of each cycle immediately before treatment with 5-FU and LV, and on day 3 of each cycle immediately after treatment with 5-FU and LV. intervention 4: Bevacizumab 5mg/kg was only added to the treatment regimen of patients in stratum 1 who demonstrated stable disease on imaging repeated prior to the 5th cycle of treatment. Bavacizumab was administered on day 4 of each cycle.

Protocol documents:
Clinical trial NCT00789074
Conditions: Tobacco Dependence Smoking Cessation
Keywords: Smoking cessation Tobacco dependence Varenicline Preloading
Sponsor: Queen Mary University of London
Start date: 2009-07-01; Completion date: 2010-03-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping.

The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as indicated by standard prescribing practice), followed by a 12-week open label treatment period where all participants will receive varenicline.

Detailed description:

Arms: arm 1: Participants will use varenicline (1mg BD) 4-weeks prior to quitting arm 2: Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Varenicline 1mg twice daily intervention 2: Placebo 1mg BD

Protocol documents:
Clinical trial NCT00790296
Conditions: Cancer-related Fatigue
Keywords: cancer fatigue
Sponsor: UConn Health
Start date: 2006-12-01; Completion date: 2010-03-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the study is to evaluate thyrotropin releasing hormone (TRH) as a treatment for cancer-related fatigue.

The central hypothesis of this pilot study is that TRH is more efficacious than placebo in alleviating cancer-related fatigue in patients with breast or prostate cancer.

Detailed description:

Arms: arm 1: TRH arm 2: Placebo
Interventions: intervention 1: Thyrotropin releasing hormone (TRH) intervention 2: Placebo
Intervention descriptions: intervention 1: 0.5mg and 1.5mg intervention 2: Saline

Protocol documents:
Clinical trial NCT00790582
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS Amyotrophic Lateral Sclerosis Lou Gehrig's Disease Lithium Lithium Carbonate
Sponsor: Forbes Norris MDA/ALS Research Center
Start date: 2008-05-01; Completion date: 2010-03-01
Enrollment: 109 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease. Since there is no placebo in this study, all patients will be taking lithium carbonate.

Detailed description:
This is a Phase II Screening study. There is no placebo (inactive or 'fake' drug) in this study, meaning that all participants will be taking lithium carbonate. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease.

A recent article was published in a highly regarded medical journal that showed a positive effect of lithium carbonate on an ALS type mouse. The researchers then studied a very small number of people with ALS, giving 16 people lithium carbonate with riluzole and giving 28 people only riluzole. The people who took lithium remained stronger for a considerably longer period of time. However, the study was very small and we cannot really tell if lithium works unless a larger study is performed. It is not well understood why lithium carbonate might be helpful but it is believed that it may play a role in protecting the motor nerves from the damage of ALS.

If you choose to participate, you will need to go to your study clinic for research study visits 7 times in one year and you will have 4 telephone interviews during that time. These visits and phone calls could take up to 17 hours in total.

Caution: Lithium is an FDA approved drug used for some psychiatric disorders. It is not FDA approved for ALS. Lithium has many potentially serious side effects and must only be taken under close supervision of your physician.

Arms: arm 1: None
Interventions: intervention 1: lithium carbonate
Intervention descriptions: intervention 1: The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.

Protocol documents:
Clinical trial NCT00809328
Conditions: Community Acquired Pneumonia (CAP)
Sponsor: Pfizer
Start date: 2009-02-01; Completion date: 2010-03-01
Enrollment: 102 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.

Detailed description:

Arms: arm 1: Azithromycin switch therapy (switch from intravenous to oral)
Interventions: intervention 1: Azithromycin
Intervention descriptions: intervention 1: The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.

Protocol documents:
Clinical trial NCT00810069
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD Depression
Sponsor: Eli Lilly and Company
Start date: 2008-11-01; Completion date: 2010-03-01
Enrollment: 840 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.

Two hypothesis will be tested:

1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.

Detailed description:

Arms: arm 1: Escitalopram 10 milligrams per day for 4 weeks (one 10 milligram \[mg\]-capsule) followed by Duloxetine flexible dose (60 or 120 mg daily) for 12 weeks. arm 2: Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule) followed by Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule\[s\]). Then, non-responders switched to Duloxetine 60 or 120 mg per day for 8 weeks , and responders continued on Escitalopram 10 to 20 mg per day for 8 weeks.
Interventions: intervention 1: Duloxetine Hydrochloride intervention 2: Escitalopram
Intervention descriptions: intervention 1: Flexible dose of 60 or 120 mg daily intervention 2: 10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.

Protocol documents:
Clinical trial NCT00811642
Conditions: Fungal Infection
Keywords: refractory or first line medication intolerable invasive fungal infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-11-01; Completion date: 2010-03-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI

Detailed description:

Arms: arm 1: Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks
Interventions: intervention 1: Posaconazole
Intervention descriptions: intervention 1: 400mg BID oral suspension for 12 weeks

Protocol documents:
Clinical trial NCT00815633
Conditions: Pityriasis Rubra Pilaris
Keywords: PRP Pityriasis Rubra Pilaris Amevive Alefacept Biologic Immunosuppressant Severe skin disease
Sponsor: Joshua Zeichner
Start date: 2008-12-01; Completion date: 2010-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the biologic medication alefacept (Amevive) is effective and safe in the treatment of Pityriasis Rubra Pilaris.

Detailed description:
Pityriasis Rubra Pilaris (PRP) is a therapeutic challenge, and many different medication regimens exist to treat the condition. Clinical response is variable, and no single treatment has emerged as a leading therapy. Biologic agents have emerged as effective treatments for many skin diseases, including psoriasis. Given the clinical overlap between PRP and psoriasis, it is logical to attempt to use these agents for PRP. Since the majority of patients with PRP are unresponsive to current therapies, new treatment modalities must be evaluated. This study will evaluate the treatment of adult 30 years or older with a diagnosis of PRP, either subtypes 1 or 2. In this study, the safety and efficacy of alefacept will be evaluated in adult patients with PRP refractory to current treatments. Alefacept is a dimeric fusion protein containing the CD2 extracellular binding region of human leukocyte function antigen-3 (LFA-3) linked to the Fc portion of human IgG1. The drug binds to the T-lymphocyte antigen CD2 and blocks its interaction with LFA-3 on antigen presenting cells in the body. The CD2/LFA-3 interaction is a key co-stimulatory signal in the activation of T-lymphocytes central to the pathophysiology of psoriasis. It is theorized this interaction plays a role in the pathophysiology of PRP. Alefacept is currently approved for the treatment of adults with moderate to severe, chronic, plaque-type psoriasis. The medication is administered as weekly intramuscular injections for 12 week courses. In this study, a dose of 15mg alefacept will be administered intramuscularly at weekly intervals for 12 weeks. This is the dosing regimen currently approved for the treatment of psoriasis. Patients will be followed for a total of 24 weeks.

Arms: arm 1: Treatment Group (only one group)
Interventions: intervention 1: Alefacept
Intervention descriptions: intervention 1: 15mg intramuscular injection weekly for 12 weeks

Protocol documents:
Clinical trial NCT00815659
Conditions: Metabolic Syndrome
Keywords: plasma lipid profile metabolic syndrome
Sponsor: AstraZeneca
Start date: 2008-12-01; Completion date: 2010-03-01
Enrollment: 97 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.

Detailed description:

Arms: arm 1: medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Interventions: intervention 1: rosuvastatin
Intervention descriptions: intervention 1: medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Protocol documents:
Clinical trial NCT00816907
Conditions: Schizophrenia
Keywords: Schizoaffective Disorder
Sponsor: National Institute of Mental Health (NIMH)
Start date: 2009-01-01; Completion date: 2010-03-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications.

Detailed description:
Schizophrenia is a chronic mental disorder that is characterized, in part, by psychotic symptoms. Psychotic symptoms include hallucinations and delusions, in which a person has abnormal experiences or beliefs, and are commonly treated with antipsychotic medications. Unfortunately, a side effect of many antipsychotics is unwanted weight gain, which can lead to physical illness. Use of the drug metformin has resulted in weight loss among diabetics. Metformin has also been shown to cause weight loss in preliminary studies of people taking atypical antipsychotics-a newer, second generation of antipsychotic medications. Metformin is currently approved by the Food and Drug Administration to treat only people with diabetes. This study will test the usefulness of prescribing metformin as a second medication to treat people with schizophrenia or schizoaffective disorder who are overweight and taking antipsychotics. The study will also provide important feasibility information for future larger studies.

Participation in this study will last 16 weeks. After undergoing baseline assessments, participants will be randomly assigned to receive either metformin or placebo, both of which will be taken twice daily for the duration of the study. All participants will also receive behavioral therapy that will teach them about reducing their weight through diet and exercise. Participants will undergo assessments at 11 study visits: the first 2 will include screening and baseline testing, the next 2 visits will take place after the first and second weeks of receiving treatment, and the last 7 visits will take place every 2 weeks until the end of the study. Assessments will include measurements of body weight, waist-to-hip ratio, and vital signs; clinical interviews about medication adherence, side effects, and alcohol use; and monthly blood tests to assess levels of lipids, glucose, insulin, and hemoglobin A1c.

Arms: arm 1: Encapsulated metformin 1000-2000 mg/day arm 2: Matching placebo capsules 2-4 daily
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mg to 1,000 mg taken twice daily for 16 weeks intervention 2: 1 to 2 placebo capsules taken twice daily for 16 weeks

Protocol documents:
Clinical trial NCT00824382
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2009-01-01; Completion date: 2010-03-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.

Detailed description:

Arms: arm 1: 2 puffs of 2.5 Âµg/actuation arm 2: 2 puffs of 5 Âµg/actuation arm 3: 2 puffs arm 4: 2 puffs of 1 Âµg/actuation
Interventions: intervention 1: BI 1744 CL 2 Âµg intervention 2: BI 1744 CL 5 Âµg intervention 3: BI 1744 CL 10 Âµg intervention 4: Placebo
Intervention descriptions: intervention 1: 2 puffs of 1 Âµg/actuation delivered by the RespimatÂ® inhaler intervention 2: 2 puffs of 2.5 Âµg/actuation delivered by the RespimatÂ® inhaler intervention 3: 2 puffs of 5 Âµg/actuation delivered by RespimatÂ® intervention 4: 2 puffs delivered by the RespimatÂ® inhaler

Protocol documents:
Clinical trial NCT00824460
Conditions: Chronic Kidney Disease
Keywords: Hemodialysis
Sponsor: Vifor Pharma
Start date: 2008-12-01; Completion date: 2010-03-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: 1.25 g PA21 (250 mg iron) intervention 2: 5.0 g PA21 (1,000 mg iron) intervention 3: 7.5 g PA21 (1,500 mg iron) intervention 4: 10.0 g PA21 (2,000 mg iron) intervention 5: 12.5 g PA21 (2,500 mg iron) intervention 6: Sevelamer hydrochloride
Intervention descriptions: intervention 1: Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day. intervention 2: Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day). intervention 3: Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day). intervention 4: Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day). intervention 5: Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day). intervention 6: Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).

Protocol documents:
Clinical trial NCT00833040
Conditions: Cancer Pain
Keywords: Cancer breakthrough pain
Sponsor: Talphera, Inc
Start date: 2009-04-01; Completion date: 2010-03-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.

Detailed description:

Arms: arm 1: During the Titration Phase, patients titrated to the effective dosage of sublingual sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sublingual sufentanil NanoTab™ was taken as needed for breakthrough pain.

During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active doses of sublingual sufentanil (dosage determined in Titration Phase) and three placebo doses taken in random order. One NanoTab™ was taken as needed for breakthrough pain.
Interventions: intervention 1: Sublingual sufentanil NanoTabs™ and placebo NanoTabs™
Intervention descriptions: intervention 1: During the Titration Phase, patients titrated to the dose of sufentanil that provided adequate pain relief without intolerable side effects. Dosages were 20, 30, 40, 60 and 80 mcg. During the Double Blind Phase, patients were randomized to one of six sequences and took 7 doses of sufentanil (dosage determined in the titration phase, and 3 doses of placebo.

Protocol documents:
Clinical trial NCT00833859
Conditions: Pancreatic Neoplasms
Keywords: stereotactic radiosurgery borderline resectable pancreatic cancer gastrointestinal pancreas
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely.

Detailed description:
* Cycle 1 and 2:

  * Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m\^2 intravenous piggy back (IVPB) over 30 min
  * Days 4, 11 and 25, 32 ....docetaxel 30 mg/m\^2 IVPB over 1 hour
  * Days 1-14 and 22-35 ....capecitabine 750 mg/m\^2 oral twice daily
  * Each cycle is 21 days long
* SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume
* Cycle 3 and 4:

  * Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m\^2 IVPB over 30 min
  * Days 54, 61 and 75, 82 ....docetaxel 30 mg/m\^2 IVPB over 1 hour
  * Days 51-64 ....capecitabine 750 mg/m\^2 oral twice daily
  * Each cycle is 21 days long
* Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.

Arms: arm 1: GTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS)
Interventions: intervention 1: GTX (gemcitabine, docetaxel and capecitabine) intervention 2: stereotactic body radiation therapy
Intervention descriptions: intervention 1: GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14 intervention 2: stereotactic body radiation therapy (SBRT) 25

Protocol documents:
Clinical trial NCT00845897
Conditions: Diabetes Mellitus Peripheral Neuropathy Plantar Ulcers
Keywords: Diabetes mellitus plantar ulcers peripheral neuropathy
Sponsor: Washington University School of Medicine
Start date: 2005-03-01; Completion date: 2010-03-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this grant is to collect pilot data to assess the amount of botulinum toxin that needs to be injected into the calf muscles of subjects with diabetes mellitus, peripheral neuropathy, and a plantar ulcer to decrease muscle strength. We hypothesize that a decrease in plantar flexor muscle strength will temporarily decrease plantar pressure. The decrease in plantar pressure will provide temporary protection to the new tissue as it gains tolerance to high stress with the long term potential outcome as a decrease in the ulcer recurrence rate.

Detailed description:
Please read "Brief Summary"

Arms: arm 1: Placebo (saline) injections into 6 sites in the calf muscle arm 2: Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. arm 3: 300 units of botulinum toxin injected into 6 sites in the calf muscle
Interventions: intervention 1: Botulinum Toxin intervention 2: Saline
Intervention descriptions: intervention 1: 200 units of botulinum toxin, and 300 units of botulinum toxin. Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus intervention 2: Placebo (saline) (3cc). Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus

Protocol documents: