ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00556894
Conditions: Rheumatoid Arthritis
Sponsor: Can-Fite BioPharma
Start date: 2008-02-01; Completion date: 2009-04-01
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months.

Detailed description:
This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for \>=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, or placebo given orally q12h for 12 weeks. Screening examinations will occur within 1 month prior to dosing. Washout of other disease-modifying antirheumatic drugs (DMARDs) (with the exception of hydroxychloroquine), including biological agents, will occur prior to dosing; if washout is necessary, patients must re-qualify for inclusion following the washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids must be stable for \>=1 month prior to dosing and remain so during protocol participation. Disease activity will be assessed using swollen and tender joint counts, physician and patient global assessments (by visual analog scale, VAS), patient reported pain (by VAS), a Health Assessment Questionnaire (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP) levels. Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, and 12.

Arms: arm 1: CF101 0.1 mg was given orally q12h arm 2: CF101 1 mg was given orally q12h arm 3: Matched placebo was given orally q12h
Interventions: intervention 1: CF101 intervention 2: Placebo
Intervention descriptions: intervention 1: orally q12h intervention 2: orally q12h

Protocol documents:
Clinical trial NCT00573157
Conditions: Lupus Nephritis
Keywords: nephritis atacicept
Sponsor: EMD Serono
Start date: 2007-12-01; Completion date: 2009-04-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International; operational oversight was provided by ZymoGenetics.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atacicept intervention 2: Mycophenolate mofetil intervention 3: Placebo intervention 4: Corticosteroids
Intervention descriptions: intervention 1: Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. intervention 2: MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion. intervention 3: Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks. intervention 4: High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.

Protocol documents:
Clinical trial NCT00573937
Conditions: Neoplasms Pain
Keywords: Neoplasms Pain Methadone Morphine
Sponsor: Mayo Clinic
Start date: 2007-08-01; Completion date: 2009-04-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.

Detailed description:
Treatment of cancer pain is based on the World Health Organization (WHO) step ladder approach to the use of analgesic drugs. Medication potency increases at each step of the WHO ladder, from nonopioid (step 1; e.g., aspirin and nonsteroidal anti-inflammatory drugs) through weak opioids (step 2; e.g. codeine) plus a nonopioid to strong opioids (step 3; e.g., morphine) plus a nonopioid analgesic. Morphine is considered the gold standard for the treatment of moderate to severe pain, but this is based on level C criteria. Research has discovered that methadone is a potent opioid that operates at several levels which are important for pain control. The primary aim is to compare morphine versus methadone as a first-line analgesic in patients with moderate to severe cancer pain. Patients will be randomized to receive either oral slow-release morphine (15 mg) every 8 hours and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain or oral methadone 2.5 mg every 8 hours and methadone 2.5 mg every 4 hours as needed for breakthrough pain. Our hypothesis is that methadone will provide equivalent pain control efficacy after 4 weeks of therapy. We postulate that methadone will be as preferable as morphine as an analgesic. We will compare the two drugs via adverse effects and compare stability of analgesia via comparison of the number of breakthrough pain episodes. The study will attempt to establish equivalency of methadone as a first-line analgesic for moderate to severe cancer pain.

Arms: arm 1: Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain. arm 2: Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
Interventions: intervention 1: Methadone intervention 2: Morphine
Intervention descriptions: intervention 1: Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain. intervention 2: Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.

Protocol documents:
Clinical trial NCT00577512
Conditions: Multiple Myeloma
Sponsor: University of Arkansas
Start date: 2007-04-01; Completion date: 2009-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done in an attempt to improve the remission rate and the survival time for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used chemotherapy drugs and by giving courses closer together (before the myeloma comes back or gets worse), subjects in this study will have better outcomes.

Detailed description:
This study has the following goals:

* To find out how many subjects treated with high dose DTPACE (Dexamethasone, Thalidomide, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide. (HD DTPACE) on this protocol will have a complete response or near complete response that lasts for 6 months or longer.
* In subjects achieving a response, to find out how long the response will last.
* To learn more about the side effects of this treatment.

Up to 75 subjects, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at the University of Arkansas for Medical Sciences (UAMS) only.

The treatment in this study is divided into 3 parts

* High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored.
* High dose DTPACE and stem cell re-infusion.
* Velcade, Thalidomide, Dexamethasone (sometimes known as VTD) Maintenance therapy.

Arms: arm 1: DTPACE
Interventions: intervention 1: DTPACE
Intervention descriptions: intervention 1: * Dexamethasone 200 mg Intravenous Infusion "Piggy-Back" (IVPB) Days 1-7
* Thalidomide 200 mg by mouth (PO) Days 1-7
* Cisplatin 15mg/m2 Days 1-4 (modify for renal insufficiency)
* Adriamycin 15 mg/m2 Days 1-4
* Cyclophosphamide 600 mg/m2 Days 1-4
* Etoposide 60 mg/m2 Days 1-4

Protocol documents:
Clinical trial NCT00580814
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Brookhaven ADHD Dopamine methylphenidate PET
Sponsor: University of California, Irvine
Start date: 2006-02-01; Completion date: 2009-04-01
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.

Detailed description:

Arms: arm 1: intervention is methylphenidate once daily for 12 months, doses individually titrated arm 2: no methylphenidate treatment for non ADHD
Interventions: intervention 1: Experimental: methylphenidate treatment
Intervention descriptions: intervention 1: subjects received mehtylphenidate treatment for 12 months

Protocol documents:
Clinical trial NCT00581139
Conditions: Care, Postoperative Pain, Postoperative Surgical Procedures, Operative Otorhinolaryngologic Surgical Procedures Tonsillectomy Adenoidectomy
Sponsor: University of California, Irvine
Start date: 2003-04-01; Completion date: 2009-04-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Preoperative Preparation Program (Child Life Specialist) intervention 2: Midazolam intervention 3: Parental Presence during Induction of Anesthesia intervention 4: PPIA preparation program PLUS Midazolam premedication
Intervention descriptions: intervention 1: This group will receive the standard preoperative visit to the hospital with Child Life intervention intervention 2: 0.5 mg/kg oral midazolam intervention 3: One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program. intervention 4: Subjects in this group will receive both interventions 2 and 3.

Protocol documents:
Clinical trial NCT00584012
Conditions: Any Cancer Breast Cancer
Keywords: Any cancer Breast cancer Lovastatin Docetaxel
Sponsor: Susan L Roeder
Start date: 2004-04-01; Completion date: 2009-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This purpose of this study is to evaluate the use of two medications, docetaxel and lovastatin to determine the highest dose of lovastatin and docetaxel that can be given safely as well as the safety of combining the two drugs and the effect on the subject's tumor. Subjects can have any cancer.

Detailed description:
The primary objective of this study is to determine the maximum tolerated dose (MTD) of lovastatin and docetaxel in patients with various different cancers.

Arms: arm 1: Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
Interventions: intervention 1: Lovastatin intervention 2: Docetaxel
Intervention descriptions: intervention 1: Given PO intervention 2: Given IV

Protocol documents:
Clinical trial NCT00613730
Conditions: Cancer of Pancreas Cancer of the Pancreas Pancreas Cancer Pancreatic Cancer
Sponsor: Amgen
Start date: 2007-01-01; Completion date: 2009-04-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in the United States. In approximately 55 centers, approximately 75 eligible locally advanced unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line therapy of gemcitabine and panitumumab.

Detailed description:
Enrollment closed after 3 patients were enrolled. This voluntary action was prompted by the announcement that the Southwest Oncology Group (SWOG) S0205 trial (NCT00075686), A Phase III Randomized Open Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer, did not meet its primary endpoint of improving overall survival).

Arms: arm 1: Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
Interventions: intervention 1: Gemcitabine intervention 2: panitumumab
Intervention descriptions: intervention 1: Intravenous administration intervention 2: Intravenous administration

Protocol documents:
Clinical trial NCT00628862
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD
Sponsor: AstraZeneca
Start date: 2007-12-01; Completion date: 2009-04-01
Enrollment: 613 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Detailed description:

Arms: arm 1: Formoterol 4.5 ug twice daily (bid) arm 2: Formoterol 9.0 ug bid arm 3: Placebo
Interventions: intervention 1: Formoterol Turbuhaler® 4.5mg intervention 2: Formoterol Turbuhaler® 9 mg intervention 3: Turbuhaler® placebo
Intervention descriptions: intervention 1: 4.5 mg inhaled twice daily intervention 2: 9 mg inhaled twice daily intervention 3: placebo inhaled twice daily

Protocol documents:
Clinical trial NCT00632931
Conditions: Advanced Cancer Relapsed Advanced Cancer Refractory
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-01; Completion date: 2009-04-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

Detailed description:
Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

Arms: arm 1: Arm A: Drug/Placebo arm 2: Arm B: Placebo/Drug
Interventions: intervention 1: vorinostat intervention 2: Comparator: placebo (unspecified)
Intervention descriptions: intervention 1: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity. intervention 2: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).

Protocol documents:
Clinical trial NCT00634322
Conditions: Osteosarcoma
Keywords: osteosarcoma high dose methotrexate leucovorin
Sponsor: BTG International Inc.
Start date: 2008-10-01; Completion date: 2009-04-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV

Detailed description:

Arms: arm 1: HDMTX-LV with glucarpidase arm 2: HDMTX-LV with placebo arm 3: compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
Interventions: intervention 1: glucarpidase intervention 2: leucovorin
Intervention descriptions: intervention 1: IV dose based on weight, two doses given for 5 minutes, 24 hours apart intervention 2: IV or po given every 6 hours

Protocol documents:
Clinical trial NCT00640926
Conditions: Community-Acquired Pneumonia (CAP)
Sponsor: Melinta Therapeutics, Inc.
Start date: 2007-10-01; Completion date: 2009-04-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether RX-1741, an oxazolidinone antibiotic, is safe and effective in the treatment of mild to moderate community acquired pneumonia (CAP).

Detailed description:

Arms: arm 1: Radezolid 300 mg arm 2: Radezolid 450 mg arm 3: Radezolid 450 mg BID
Interventions: intervention 1: Radezolid intervention 2: Radezolid intervention 3: Radezolid
Intervention descriptions: intervention 1: 300 mg/day, orally for 7-10 days intervention 2: 450 mg/day orally for 7-10 days intervention 3: 900 mg/day orally for 7-10 days

Protocol documents:
Clinical trial NCT00647270
Conditions: Rheumatoid Arthritis
Sponsor: Abbott
Start date: 2007-12-01; Completion date: 2009-04-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

Detailed description:
The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow as measured by ACR20 response criteria at Week 12.

Arms: arm 1: Placebo 12 weeks, 40mg adalimumab remaining 12 weeks arm 2: 40 mg every other week arm 3: 80 mg monthly
Interventions: intervention 1: adalimumab intervention 2: Placebo intervention 3: adalimumab
Intervention descriptions: intervention 1: Pre-filled syringe. See arm for more detail intervention 2: Pre-filled syringe. See arm for more detail intervention 3: Pre-filled syringe. See arm for more detail

Protocol documents:
Clinical trial NCT00660010
Conditions: Puberty, Precocious
Keywords: CPP central precocious puberty pediatrics suppression of LH Lupron leuprolide acetate depot formulation GnRHa GnRH agonist GNRH analog LH Tanner staging
Sponsor: Abbott
Start date: 1991-01-01; Completion date: 2009-04-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.

Detailed description:
This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old.

At the treatment visits, efficacy assessments are Tanner staging (suppression of breast development in females and genital development in males), gonadotropins (LH and FSH), sex steroids (estradiol in females and testosterone in males), ratio of bone age to chronological age, adult height compared to a standard population and predicted mature height, and age and time to regular menses in females. This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.

Arms: arm 1: None
Interventions: intervention 1: Lupron (leuprolide acetate)
Intervention descriptions: intervention 1: Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.

Protocol documents:
Clinical trial NCT00660075
Conditions: Diabetes Mellitus Postprandial Lipemia
Keywords: Diabetes mellitus Postprandial Hyperlipidemia Atherosclerosis
Sponsor: Laval University
Start date: 2008-02-01; Completion date: 2009-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated improvements in islet function. Although clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-4 inhibitor treatment, animal studies suggested that DPP-4 inhibition reduce intestinal triglyceride (TG) absorption and apolipoprotein production and increased chylomicron catabolism. Therefore, the present study was designed to examine the effects of sitagliptin on postprandial lipemia in patients with type 2 diabetes. A possible reduction in postprandial atherogenic triglyceride-rich lipoproteins (TRL) levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg/d for 6 weeks arm 2: Placebo for 6 weeks
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Sitagliptin 100 mg/d for 6 weeks intervention 2: Placebo for 6 weeks

Protocol documents:
Clinical trial NCT00662532
Conditions: Periodontitis
Keywords: Peri-implantitis; antibiotic
Sponsor: OraPharma
Start date: 2008-04-01; Completion date: 2009-04-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

Detailed description:
At Visit 1, the dentist will:

* do an oral exam
* ask some questions
* decide if the person qualifies for being in the study
* make an appointment for Visit 2 if they qualify

At Visit 2 (Baseline), the dentist will:

* do a special cleaning of the implants
* examine the whole mouth
* collect some fluid
* take x-rays
* put the people into one of two groups (taking into account whether or not they smoke)

  1. one group will have the study antibiotic put on all the areas in their mouth with gum problems
  2. the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.

At Visit 4 (about 3 months later), the dentist will:

* collect fluid samples
* examine the whole mouth
* apply the antibiotic again for people in that group

At Visit 5 (about 6 months later), the dentist will:

* collect fluid samples
* examine the whole mouth
* take x-rays

Arms: arm 1: 1 mg microspheres of minocycline hydrochloride arm 2: Control group receiving no drug intervention
Interventions: intervention 1: Minocycline HCl
Intervention descriptions: intervention 1: 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial

Protocol documents: