ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00778700
Conditions: Psoriasis
Sponsor: Incyte Corporation
Start date: 2008-10-28; Completion date: 2009-06-26
Enrollment: 199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.

Detailed description:

Arms: arm 1: Vehicle cream, applied topically, once daily from Day 1 to Week 12. arm 2: Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. arm 3: Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. arm 4: Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
Interventions: intervention 1: Placebo Cream intervention 2: Ruxolitinib Phosphate
Intervention descriptions: intervention 1: Cream with no active drug intervention 2: Ruxolitinib phosphate cream

Protocol documents:
Clinical trial NCT00799487
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Attention Deficit Hyperactivity Disorder
Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Start date: 2009-01-02; Completion date: 2009-06-26
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.

Detailed description:
The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD when compared to placebo as demonstrated using specified study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral and cognitive effects of CONCERTA (methylphenidate HCl) on older children with ADHD This means that all eligible children will receive treatment with methylphenidate HCl throughout the study (the titration and assessment periods) and inactive pill (placebo) on 1 of the 2 laboratory classroom days. On the other laboratory classroom day they will receive their regular dose of CONCERTA (methylphenidate HCl). The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. Assessments will be completed during each of the laboratory assessment days (12.5 hours). Participants will be assessed for adverse events throughout the study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a maximum of 8 weeks.

Arms: arm 1: CONCERTA (methylphenidate HCl) or placebo Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2 arm 2: CONCERTA (methylphenidate HCl) or placebo Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1
Interventions: intervention 1: CONCERTA (methylphenidate HCl) or placebo intervention 2: CONCERTA (methylphenidate HCl) or placebo
Intervention descriptions: intervention 1: Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2 intervention 2: Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1

Protocol documents:
Clinical trial NCT00837265
Conditions: Chemotherapy-induced Neutropenia
Keywords: Breast Cancer Supportive Care Neutropenia
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2008-08-21; Completion date: 2009-06-26
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

Detailed description:

Arms: arm 1: Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 2: Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 3: Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 4: Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 5: Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 6: Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 7: Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
Interventions: intervention 1: Balugrastim intervention 2: Pegfilgrastim intervention 3: Chemotherapy Regimen
Intervention descriptions: intervention 1: Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description. intervention 2: Pegfilgrastim will be administered per dose and schedule specified in the arm description. intervention 3: The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.

Protocol documents:
Clinical trial NCT00093015
Conditions: Kidney Disease Diabetes Mellitus Anemia
Sponsor: Amgen
Start date: 2004-08-01; Completion date: 2009-07-01
Enrollment: 4038 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.

Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: darbepoetin alfa
Intervention descriptions: intervention 1: Volume and dose frequency changes resembling dosing in the active treatment group intervention 2: Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL

Protocol documents:
Clinical trial NCT00095147
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2005-02-01; Completion date: 2009-07-01
Enrollment: 431 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

Detailed description:

Arms: arm 1: Days 1-365 arm 2: Days 1-365 arm 3: Days 1-197 arm 4: Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365 arm 5: Days 365 to 729 All participants receive Active Drug
Interventions: intervention 1: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB) intervention 2: Infliximab (INF) + MTX, DB intervention 3: Placebo (PLA) + MTX, DB intervention 4: PLA + MTX switched to ABA+ MTX, DB intervention 5: ABA, open-label (OL)
Intervention descriptions: intervention 1: Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months. intervention 2: Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months. intervention 3: Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. intervention 4: Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months intervention 5: Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months

Protocol documents:
Clinical trial NCT00105157
Conditions: HIV Infections Acquired Immunodeficiency Syndrome
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-03-01; Completion date: 2009-07-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.

Detailed description:

Arms: arm 1: MK0518 200 mg arm 2: MK0518 400 mg arm 3: MK0518 600 mg arm 4: Placebo
Interventions: intervention 1: Comparator: MK0518 intervention 2: MK0518 intervention 3: MK0518 intervention 4: Placebo
Intervention descriptions: intervention 1: MK0518 oral tablets 200 mg b.i.d, for 24 weeks intervention 2: MK0518 oral tablets 400 mg b.i.d, for 24 weeks intervention 3: MK0518 oral tablets 600 mg b.i.d, for 24 weeks intervention 4: Placebo to MK0518, oral tablet b.i.d, for 24 weeks

Protocol documents:
Clinical trial NCT00247416
Conditions: Stage IV Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer
Keywords: Untreated Lung Cancer non-small cell gemcitabine gemzar carboplatin dexamethasone
Sponsor: Susanne Arnold
Start date: 2005-08-01; Completion date: 2009-07-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer.

This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.

Detailed description:
Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.

Arms: arm 1: No Dexamethasone arm 2: Dexamethasone
Interventions: intervention 1: Gemcitabine intervention 2: Dexamethasone intervention 3: Carboplatin
Intervention descriptions: intervention 1: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12. intervention 2: 16 mg bid for 4 days prior to each chemotherapy start. intervention 3: AUC 6.0 intravenously over 30 minutes on day 5.

Protocol documents:
Clinical trial NCT00270634
Conditions: Kidney Diseases
Keywords: Randomized Controlled Trials Immunosuppression Adult Kidney Transplantation Treatment Outcome
Sponsor: Aurinia Pharmaceuticals Inc.
Start date: 2006-01-01; Completion date: 2009-07-01
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.

Detailed description:
Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus After Transplant (NODAT). Voclosporin is a novel calcineurin inhibitor intended for use in the prevention of organ graft rejection.

Comparison(s): Voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to tacrolimus

Arms: arm 1: Low dose voclosporin arm 2: Mid Dose Voclosporin arm 3: High Dose Voclosporin arm 4: Standard Dose Tacrolimus
Interventions: intervention 1: Voclosporin intervention 2: tacrolimus
Intervention descriptions: intervention 1: voclosporin 0.4, 0.6, 0.8 mg/kg po BID intervention 2: tacrolimus 0.05 mg/kg po BID

Protocol documents:
Clinical trial NCT00277212
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder with a recent manic or mixed episode
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2005-12-01; Completion date: 2009-07-01
Enrollment: 1169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode

Detailed description:

Arms: arm 1: Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole arm 2: Phase 2 Double-Blind Treatment: Lamotrigine + Placebo
Interventions: intervention 1: Lamotrigine + Aripiprazole intervention 2: Lamotrigine + Placebo
Intervention descriptions: intervention 1: Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks

Lamotrigine 100-200 mg/day

Aripiprazole 10-30 mg/day intervention 2: Tablets, Oral, once daily, Phase 2 - up to 52 weeks

Lamotrigine 100-200 mg/day

placebo 0 mg/day

Protocol documents:
Clinical trial NCT00289978
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple Sclerosis FTY720 Fingolimod
Sponsor: Novartis
Start date: 2006-01-01; Completion date: 2009-07-01
Enrollment: 1272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Fingolimod 1.25 mg intervention 2: Fingolimod 0.5 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Patients self-administered fingolimod 1.25 mg capsules orally once daily. intervention 2: Patients self-administered fingolimod 0.5 mg capsules orally once daily. intervention 3: Patients self-administered a fingolimod placebo capsule orally once daily.

Protocol documents:
Clinical trial NCT00378599
Conditions: Liver Transplantation Hepatitis C, Chronic Liver Cirrhosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-05-01; Completion date: 2009-07-01
Enrollment: 125 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence.

Detailed description:

Arms: arm 1: PEG-Intron plus RBV treatment for up to 48 weeks with 24-week follow up. SCH 54031 PEG-Intron 1.5 ug/kg SC per week plus SCH 18908 REBETOL twice daily (BID) PO with food, dosed as followed: Weeks 1 and 2, RBV Dose 400 mg (2 capsules, 1 AM and 1 PM). At the end of Weeks 2 and 4 of Treatment (tx), a complete blood count (CBC) was performed. An increase in RBV dose was permitted only if the hemoglobin was \>10 g/dL. At Weeks 3 and 4, RBV dose was 800 mg (4 capsules, 2 AM and 2 PM). From Weeks 5 to 48, RBV doses could be increased based on subject body weight. For subjects weighing \<65 kg, maximum dose of RBV was to be 800 mg (4 capsules, 2 AM and 2 PM), for subjects weighing 65-85 kg, max dose of RBV was 1000 mg/day (5 capsules, 2 AM and 3 PM), for subjects weighing \>85 kg, max dose of RBV was 1200 mg/day, 6 capsules, 3 AM and 3 PM).
Interventions: intervention 1: Combination of (a) pegylated interferon alfa-2b and (b) rebetol
Intervention descriptions: intervention 1: 1. Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
2. 200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks

Protocol documents:
Clinical trial NCT00467870
Conditions: Hypogonadism Primary Hypogonadism Secondary Hypogonadism
Keywords: investigational testosterone testosterone undecanoate TU Hypogonadism primary hypogonadism secondary hypogonadism
Sponsor: Endo Pharmaceuticals
Start date: 2006-03-01; Completion date: 2009-07-01
Enrollment: 531 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.

Detailed description:

Arms: arm 1: 750 mg dose of testosterone undecanoate arm 2: 1000 mg dose testosterone undecanoate
Interventions: intervention 1: Testosterone Undecanoate 750 mg intervention 2: Testosterone Undecanoate 1000 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01090323
Conditions: Sickle Cell Disease
Keywords: Deferasirox ICL670A Iron chelators Sickle Cell Disease Transfusional Hemosiderosis
Sponsor: Novartis Pharmaceuticals
Start date: 2004-07-01; Completion date: 2009-07-01
Enrollment: 185 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670 is studied in sickle cell disease patients with transfusional hemosiderosis.

Detailed description:
The treatment period started once the patient completed the core study and signed informed consent. It is continued for up to 4 years. Safety parameters were assessed every 4 weeks. Eye and Ear examinations were performed on a yearly basis. To further investigate the extent of iron overload, serum ferritin, iron, and transferrin were monitored every four weeks. The Program Safety Board monitored the safety of ICL670 during the study to evaluate and categorize any serious case reported in association with ICL670.

Arms: arm 1: None
Interventions: intervention 1: ICL670
Intervention descriptions: intervention 1: Daily doses of ICL670 were taken orally 30 minutes before breakfast. The doses range from 5-40 mg/kg and were determined based on the patient's trend in serum ferritin over time during the core study (0109) and on the frequency of blood transfusions the patient received. The treatment duration was up to 4 years.

Protocol documents:
Clinical trial NCT00003377
Conditions: Cervical Cancer
Keywords: stage III cervical cancer stage IVA cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 1999-11-01; Completion date: 2009-07-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.

Detailed description:
OBJECTIVES:

* Determine the toxicity of extended field radiotherapy with concurrent paclitaxel and cisplatin chemotherapy (as radiation sensitization) in patients with previously untreated carcinoma of the cervix metastatic to the para-aortic lymph nodes.
* Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus extended field radiotherapy in this patient population.
* Determine the effect of this treatment regimen on progression-free survival, overall survival, and site of recurrence (local vs distant) in these patients.

OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.

Patients receive external beam radiotherapy (RT) to the para-aortic nodes and the pelvis daily for 5 weeks; RT must be completed within 8 weeks of its initiation. During or after external beam RT, intracavitary radiation is administered 1-5 times. Concurrently with external beam RT, patients receive paclitaxel IV over 1 hour followed immediately by cisplatin IV on days 1, 8, 15, 22, 29, and 36.

Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until the time of recurrence or death.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 years.

Arms: arm 1: None
Interventions: intervention 1: cisplatin intervention 2: paclitaxel intervention 3: brachytherapy intervention 4: radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: