ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00531427
Conditions: Chronic Pain Osteoarthritis of the Knee
Keywords: Chronic pain, OA of the knee, opioid, transdermal
Sponsor: Purdue Pharma LP
Start date: 2007-09-01; Completion date: 2009-11-01
Enrollment: 567 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Arms: arm 1: Buprenorphine transdermal system 10 and 20 applied for 7-day wear arm 2: Placebo transdermal system to match BTDS patches, applied for 7-day wear
Interventions: intervention 1: Buprenorphine intervention 2: Placebo
Intervention descriptions: intervention 1: transdermal system 10 and 20 applied for 7-day wear intervention 2: transdermal system (placebo) applied for 7-day wear

Protocol documents:
Clinical trial NCT00536263
Conditions: Hepatitis B, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-09-01; Completion date: 2009-11-01
Enrollment: 671 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.

Detailed description:

Arms: arm 1: PegIntron 1.0 mcg/kg weekly (QW) \* 24 weeks + 24 weeks follow-up arm 2: PegIntron 1.5 mcg/kg QW \* 24 wks + 24 wks follow-up arm 3: PegIntron 1.5 mcg/kg QW \* 48 wks + 24 wks follow-up
Interventions: intervention 1: pegylated interferon alpha-2b intervention 2: pegylated interferon alpha-2b intervention 3: pegylated interferon alpha-2b
Intervention descriptions: intervention 1: 1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks intervention 2: 1.5 mcg/kg S.C. QW for 24 weeks intervention 3: 1.5 mcg/kg S.C. QW for 48 weeks

Protocol documents:
Clinical trial NCT00541671
Conditions: Nausea
Keywords: Narcotics Nausea
Sponsor: Christiana Care Health Services
Start date: 2007-02-01; Completion date: 2009-11-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We are doing this study to find out if extra medicine is needed to avoid the chance of nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea, while others do not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal is to screen all patients with pain and enroll enough subjects to reach our goal of 164 evaluable study participants.

Detailed description:
Patients will be randomized to one of two study groups. They will then be asked to rate their pain and nausea on a line graph. If the patient is a female of child bearing age, a urine pregnancy test will be done per standard of care. After this, an IV catheter will be placed in a vein in the patients arm. Pain medicine will be given through this IV per the doctor's order. With this medicine, patients will be given 10 milliliters (2 teaspoons) of either Sodium Chloride (salt water) or Phenergan mixed with Sodium Chloride (salt water). Phenergan is a medication typically used to help with nausea and is a common ingredient in prescription cough medicine.

After this is finished, patients will be asked to rate their pain and nausea in 30 minutes, and again 1, 2, and 4 hours later. If the doctor decides the patient is able to be discharged from the emergency room before the 4 hours are up, they will be asked to rate your pain and nausea again before going home, and the study will be stopped at that time.

Arms: arm 1: Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic arm 2: Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
Interventions: intervention 1: Saline intervention 2: Phenergan
Intervention descriptions: intervention 1: 10 c of saline intervention 2: Physician ordered dose

Protocol documents:
Clinical trial NCT00542386
Conditions: Chronic Kidney Disease Dialysis Hyperphosphatemia Dyslipidemia
Keywords: Chronic Kidney Disease Dialysis Hyperphosphatemia Dyslipidemia Phosphate binder
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2007-12-01; Completion date: 2009-11-01
Enrollment: 642 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MCI-196 intervention 2: Placebo
Intervention descriptions: intervention 1: 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study intervention 2: 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Protocol documents:
Clinical trial NCT00552188
Conditions: Acute Coronary Syndrome
Keywords: Atherosclerosis
Sponsor: Tallikut Pharmaceuticals, Inc.
Start date: 2007-10-01; Completion date: 2009-11-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.

Detailed description:
The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.

Arms: arm 1: VIA-2291 100mg arm 2: Matching placebo
Interventions: intervention 1: VIA-2291 intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg, oral dosing, 1 time daily for 24 weeks intervention 2: oral dosing, 1 time daily for 24 weeks

Protocol documents:
Clinical trial NCT00560508
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2007-11-01; Completion date: 2009-11-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).

Detailed description:

Arms: arm 1: patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -\> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID arm 2: patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -\> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID
Interventions: intervention 1: Pramipexole Immediate Release intervention 2: Pramipexole Extended Release
Intervention descriptions: intervention 1: titrated as individually needed (0.25 mg - 4.5 mg daily) intervention 2: titration as individually needed (0.375 mg -4.5 mg daily)

Protocol documents:
Clinical trial NCT00562718
Conditions: Breast Cancer
Keywords: stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer male breast cancer recurrent breast cancer
Sponsor: University of Texas Southwestern Medical Center
Start date: 2004-09-01; Completion date: 2009-11-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine together with radiation therapy works in treating patients with nonmetastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer.

Secondary

* To determine the effects of concurrent treatment on cosmesis and wound healing at 1 year.
* To determine the short-term (1-year) risk of recurrence of breast cancer in these patients.

OUTLINE: This is a multicenter study.

Patients undergo external-beam radiotherapy once daily, 5 days a week and concurrently receive oral capecitabine twice daily, 5 days a week Monday through Friday, for approximately 6-7 weeks.

After completion of study therapy, patients are followed at approximately 1 week, 1 month, 6 months, and 12 months.

Arms: arm 1: Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.
Interventions: intervention 1: capecitabine intervention 2: adjuvant therapy intervention 3: radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00567164
Conditions: Contraception Ovulation Inhibition Contraceptives, Oral
Keywords: Oral Contraception Birth Control pill Healthy women requesting oral contraception Contraceptive efficacy
Sponsor: Bayer
Start date: 2007-10-01; Completion date: 2009-11-01
Enrollment: 1887 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the study drug is safe and effective.

Detailed description:
The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.

Arms: arm 1: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment arm 2: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. arm 3: 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of tablets without active substance (together resulting in one cycle of 24+4 standard treatment). 13 withdrawal bleeding episodes during one year of treatment were expected.
Interventions: intervention 1: EE20/DRSP (BAY86-5300) intervention 2: EE20/DRSP (BAY86-5300) intervention 3: EE20/DRSP (YAZ, BAY86-5300)
Intervention descriptions: intervention 1: Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone intervention 2: Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone intervention 3: Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)

Protocol documents:
Clinical trial NCT00580073
Conditions: Rectal Cancer
Sponsor: University of Wisconsin, Madison
Start date: 2007-12-01; Completion date: 2009-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab, which are all medicines approved by the Food and Drug Administration (FDA) and are commercially available. This treatment regimen will possibly be combined with radiation before and/or after surgery depending on your response to the treatment. Their use in this exact combination is considered experimental. The purpose of this study is to find out how effective this combination of chemotherapy is as treatment for rectal cancer that has not spread to other parts of the body. The side effects and survival experienced by subjects receiving these drugs will also be evaluated. This is a phase II research study.

Detailed description:
Primary Objective:

\- Down-staging of the tumor

Secondary Objectives:

* Pathologic response rate
* Tumor marker response
* Incidence of sphincter sparing surgery
* Progression-free survival
* Overall Survival

Arms: arm 1: FOLFOX4 + Cetuximab
Interventions: intervention 1: FOLFOX4 intervention 2: Cetuximab
Intervention descriptions: intervention 1: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle) intervention 2: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.

Protocol documents:
Clinical trial NCT00583557
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis RA
Sponsor: Human Genome Sciences Inc.
Start date: 2005-01-01; Completion date: 2009-11-01
Enrollment: 155 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.

Detailed description:
This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).

Arms: arm 1: None
Interventions: intervention 1: belimumab
Intervention descriptions: intervention 1: IV 10mg/kg Q28 days

Protocol documents:
Clinical trial NCT00586209
Conditions: Sickle Cell Anemia Thalassemia
Keywords: sickle cell disease sickle cell anemia L-glutamine Sickle Cell Anemia (homozygous) Sickle β°-Thalassemia
Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Start date: 2004-02-06; Completion date: 2009-11-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose is to evaluate the effect of L-glutamine therapy on exercise endurance and breath by breath exercise response of sickle cell anemia patients

The secondary purpose is to assess the effect of L-glutamine on incidence of painful crises; level of chronic pain, and amount of daily requirement for narcotics.

Detailed description:
This is a phase II, prospective, randomized, double-blind, placebo-controlled, parallel-group,study to evaluate the safety and efficacy of oral L-glutamine therapy for patients with sickle cell anemia or sickle β°-thalassemia who are at least 18 years old with focus on the aspect of exercise endurance. In this study, the patients will orally take L-glutamine or placebo twice daily, and clinical and hematological parameters will be monitored. The adverse events,especially those attributable to L-glutamine therapy, will also be monitored.

The data obtained will be essential in understanding the role of L-glutamine in therapy for sickle cell anemia and sickle β°-thalassemia.

Arms: arm 1: L-glutamine group will be given at the following dosage:

17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily \>66.7 at 15 g 2X daily arm 2: Maltodextrin group will be given at the following dosage:

17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily \>66.7 at 15 g 2X daily
Interventions: intervention 1: L-Glutamine intervention 2: Placebo
Intervention descriptions: intervention 1: L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (\>66.7 kg) intervention 2: Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine

Protocol documents:
Clinical trial NCT00587847
Conditions: Chronic Lymphocytic Leukemia
Keywords: leukemia
Sponsor: Northwell Health
Start date: 2005-08-01; Completion date: 2009-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.

Detailed description:
This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.

Arms: arm 1: Single arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 weeks for 16 weeks followed by Campath 30 mg once every 3 weeks for 24 weeks. Total duration of treatment up to 48 weeks.
Interventions: intervention 1: Campath
Intervention descriptions: intervention 1: Campath 30 mg administered subcutaneously at varying intervals for up to 1 year

Protocol documents:
Clinical trial NCT00606892
Conditions: Smoking Cessation
Keywords: therapeutic effects
Sponsor: Yale University
Start date: 2007-08-01; Completion date: 2009-11-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.

Detailed description:
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment.

Arms: arm 1: Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg). arm 2: Subjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg).
Interventions: intervention 1: Varenicline intervention 2: Placebo intervention 3: IV Nic
Intervention descriptions: intervention 1: Varenicline (1 mg per day) given for 4 days prior to laboratory session intervention 2: Sugar Pill intervention 3: IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.

Protocol documents:
Clinical trial NCT00608985
Conditions: Primary Insomnia
Keywords: sleeplessness orexin receptor antagonist almorexant insomnia
Sponsor: Midnight Pharma, LLC
Start date: 2008-03-01; Completion date: 2009-11-01
Enrollment: 709 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

Detailed description:

Arms: arm 1: almorexant 200 mg arm 2: almorexant 100 mg arm 3: Placebo arm 4: zolpidem 10 mg
Interventions: intervention 1: almorexant intervention 2: almorexant intervention 3: Placebo intervention 4: zolpidem
Intervention descriptions: intervention 1: 2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem intervention 2: 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem intervention 3: 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem intervention 4: 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Protocol documents: