ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00085423
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma stage IV melanoma
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2004-02-01; Completion date: 2010-02-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the objective response rate in lymphodepleted patients with metastatic melanoma treated with cyclophosphamide, fludarabine, and high-dose interleukin-2.
* Determine the feasibility of this regimen in these patients.

Secondary

* Determine the quality and quantity of lymphocyte recovery in these patients during and after treatment with this regimen.
* Determine time to disease progression and survival in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days 1 and 2 and fludarabine IV over 30 minutes on days 3-7. Patients then receive high-dose interleukin-2 IV every 8 hours (14 doses) on days 8-12 and 22-26. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 8 and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.

Arms: arm 1: Aldesleukin (IL-2), cyclophosphamide, fludarabine phosphate, sargramostim
Interventions: intervention 1: aldesleukin intervention 2: sargramostim intervention 3: cyclophosphamide intervention 4: fludarabine phosphate
Intervention descriptions: intervention 1: ‡Interleukin-2 (aldesleukin) IV (600,000 U/kg; Chiron, Emeryville, CA): two 5-day courses on days 8 and 22. Interleukin-2 was given over 15 minutes every 8 hours. Goal is 14 doses/5-day course intervention 2: GM-CSF was given subcutaneously daily from day 8 until absolute granulocyte count exceeds 5,000 cells/mL for 2 consecutive days. intervention 3: Cyclophosphamide (60 mg/kg/d; Baxter, Deerfield, IL) intravenously (IV) for 2 days with sodium 2- mercaptoethanesulfonate (Mesna; Sicor, Irvine, CA) at 20% of cyclophosphamide dose IV 15 minutes before and 40% of the cyclophosphamide dose orally at 2 and 6 hours after the initiation of chemotherapy. intervention 4: Fludarabine IV (25 mg/M2/day)-five daily doses from Day 3

Protocol documents:
Clinical trial NCT00100659
Conditions: Chronic Hepatitis C
Keywords: pediatric hepatitis children HCV PEG PEG-2a peginterferon alfa-2a Pegylated Interferon RV ribavirin Pegasys CHC chronic hepatitis C chronic hepatitis C virus hepatitis c pediatric hepatitis pediatric HCV
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2004-12-01; Completion date: 2010-02-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.

The purpose of this study is also to determine whether PEG-2a in combination with RV or PEG-2a alone will result in a longer response rate in children with CHC.

Detailed description:

Arms: arm 1: Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.

Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets. arm 2: Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
Interventions: intervention 1: Pegylated Interferon/ribavirin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00106691
Conditions: Preneoplastic Conditions Prostatic Intraepithelial Neoplasia
Keywords: neoplasia chemoprevention cancer premalignant precancerous Chemoprophylaxis Intraepithelial Prostatic Neoplasia Neoplasia, Prostatic Intraepithelial
Sponsor: GTx
Start date: 2005-01-01; Completion date: 2010-02-01
Enrollment: 1589 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).

Detailed description:
The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy.

Arms: arm 1: The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days). arm 2: The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days
Interventions: intervention 1: Toremifene 20 mg intervention 2: Placebo
Intervention descriptions: intervention 1: The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days). intervention 2: The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

Protocol documents:
Clinical trial NCT00118131
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2003-12-01; Completion date: 2010-02-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the antitumor activity of docetaxel and cisplatin, as measured by tumor response rate, in patients with chemotherapy-naïve stage IIIB or IV non-small cell lung cancer.

Secondary

* Determine the duration of response in patients treated with this regimen.
* Determine time to disease progression in patients treated with this regimen.
* Determine the 1-year survival rate in patients treated with this regimen.
* Determine the median survival time in patients treated with this regimen.
* Correlate aneuploidy (as determined by DNA histograms) and immunohistochemical expression of stathmin, Aurora-A, and survivin with response in patients treated with this regimen.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour once on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 13-19 months.

Arms: arm 1: A cycle is defined as an interval of 28 days.

Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).

Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).

Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
Interventions: intervention 1: cisplatin intervention 2: docetaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00121641
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Start date: 2005-07-01; Completion date: 2010-02-01
Enrollment: 1035 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

Detailed description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) \> 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Arms: arm 1: Metformin 500-2000 mg (as needed for rescue) arm 2: Metformin 500-2000 mg (as needed for rescue) arm 3: Metformin 500-2000 mg (as needed for rescue) arm 4: Metformin 500-2000 mg (as needed for rescue) arm 5: Saxagliptin 10 mg

Metformin 500-2000 mg (as needed for rescue)
Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Placebo matching Saxagliptin intervention 5: Metformin intervention 6: Placebo matching Metformin intervention 7: Saxagliptin intervention 8: Metformin
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\]) intervention 2: Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT) intervention 3: Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) intervention 4: Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT) intervention 5: Tablets, Oral, 500 mg, daily (42 months LT) intervention 6: Tablets, Oral, 0 mg, daily (42 months LT) intervention 7: Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label intervention 8: Tablets, Oral, 500-2000 mg (as needed for rescue)

Protocol documents:
Clinical trial NCT00121667
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Start date: 2005-08-01; Completion date: 2010-02-01
Enrollment: 1462 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone

Detailed description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitizone added onto their blinded study medication

Arms: arm 1: Pioglitazone 15-45 mg (as needed for rescue) arm 2: Pioglitazone 15-45 mg (as needed for rescue) arm 3: Pioglitazone 15-45 mg (as needed for rescue) arm 4: Pioglitazone 15-45 mg (as needed for rescue)
Interventions: intervention 1: Saxagliptin + Metformin intervention 2: Saxagliptin + Metformin intervention 3: Saxagliptin + Metformin intervention 4: Placebo + Metformin intervention 5: Pioglitazone
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) intervention 2: Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) intervention 3: Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) intervention 4: Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT) intervention 5: Tablets, Oral, 15 - 45 mg (as needed for rescue)

Protocol documents:
Clinical trial NCT00129376
Conditions: Breast Cancer
Keywords: Stage II and IIIA breast Cancer. Neoadjuvant chemotherapy. Weekly docetaxel.
Sponsor: Spanish Breast Cancer Research Group
Start date: 2003-02-01; Completion date: 2010-02-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).

The pathological complete response rate obtained in previous studies is around 12%. The expected pathological complete response rate in this study is 25%. With an alpha error of 0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed initially. With 2 pathological complete responses, patient recruitment will continue until approximately 61 patients are recruited. Twelve pathological complete responses are needed to confirm the study hypothesis.

Detailed description:
Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176). Adjuvant chemotherapy and radiotherapy were delivered according to the protocol of each participating center. Hormonal treatment was started after the last chemotherapy infusion in all patients with positive estrogen and/or progesterone receptor tumors and was continued for five years.

Semiquantitative determination of three molecular markers was carried out by immunocytochemical methods. Tissue samples were taken prior to initiation of chemotherapy from the core of the primary tumors. Specimens were sent to a central laboratory for analysis of Topo II, survivin and p27.

Arms: arm 1: Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles. Later, docetaxel (36 mg/m2) was administered an intravenous infusion, weekly for six weeks followed by a 2-week resting period (8-week cycle).
Interventions: intervention 1: Doxorubicin intervention 2: Cyclophosphamide intervention 3: Docetaxel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00143819
Conditions: Psoriasis Eczema
Keywords: psoriasis dry skin eczema atopic dermatitis
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2005-09-01; Completion date: 2010-02-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of Neuroskin Forte in relieving the symptoms of dry skin in adults with psoriasis or eczema.

Detailed description:
Subjects will apply study drug and placebo sprays 3 times a day to the assigned, randomized sides of the body. They are allowed to continue using prescription medications, but not moisturizers. Assessments will be performed every other week. Total duration of the study is 10 weeks (8 weeks of treatment and a follow-up visit 2 weeks later).

Arms: arm 1: bilateral comparison arm 2: bilateral comparison
Interventions: intervention 1: Neuroskin Forte intervention 2: Placebo Application
Intervention descriptions: intervention 1: Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks intervention 2: Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks

Protocol documents:
Clinical trial NCT00193479
Conditions: Non-Hodgkins Lymphoma
Sponsor: SCRI Development Innovations, LLC
Start date: 2003-04-01; Completion date: 2010-02-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.

Detailed description:
Upon determination of eligibility, patients will receive:

* Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab

Patients that are not considered candidates for anthracycline therapy will not receive mitoxantrone. Patients with objective response (partial or complete response) or stable disease will receive Rituximab maintenance therapy.

Arms: arm 1: All patients receive three courses of combination chemotherapy/rituximab followed by pegfilgrastim, administered at 21-day intervals. Treatment administered is as follows: cyclophosphamide 500mg/m2 IV day 1; mitoxantrone 10mg/m2 IV day 1; vincristine 1.0mg/m2 (maximum 2mg) IV day 1; prednisone 80mg PO days 1 - 5; rituximab 375mg/m2 IV day 1.
Interventions: intervention 1: Cyclophosphamide intervention 2: Mitoxantrone intervention 3: Vincristine intervention 4: Prednisone intervention 5: Rituximab
Intervention descriptions: intervention 1: Cyclophosphamide intervention 2: Mitoxantrone intervention 3: Vincristine intervention 4: Prednisone intervention 5: Rituximab

Protocol documents:
Clinical trial NCT00218036
Conditions: Cocaine Abuse Opiate Dependence
Keywords: Cocaine Abuse Opiate Abuse
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2006-07-01; Completion date: 2010-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.

Detailed description:
This is a 24-week, randomized, double-blind, placebo-controlled study examining two doses of modafinil (200 and 400 mg) and citalopram (20 and 40 mg) in the treatment of methadone maintained cocaine dependent individuals.

Participants will first be given methadone to determine its tolerated and effective doses. Most participants will be able to reach a stable dose of methadone within 7 to 10 days of methadone initiation. When 80% of the projected dose of methadone has been achieved, participants will begin the medication regimen of modafinil or citalopram. Modafinil will be given over a 7-day period. Dosing of modafinil will begin at 200 mg and, depending on the individual, may increase to 400 mg. Citalopram will be given in increasing doses, starting at 20 mg and increasing to 40mg.

Arms: arm 1: Modafinil 200mg / Methadone Maintenance (1.2mg/kg) arm 2: Modafinil 400mg/ Methadone Maintenance (1.2mg/kg) arm 3: Citalopram 20/ Methadone Maintenance 1.2mg/kg arm 4: Citalopram 40/ Methadone Maintenance 1.2 mg/kg arm 5: Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study
Interventions: intervention 1: Modafinil 200mg intervention 2: Modafinil 400mg intervention 3: Citalopram 20mg intervention 4: Citalopram 40mg intervention 5: Placebo
Intervention descriptions: intervention 1: 10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days. intervention 2: 10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days. intervention 3: 10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days. intervention 4: 10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days. intervention 5: Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg

Protocol documents:
Clinical trial NCT00241176
Conditions: Tourette's Syndrome Tic Disorders
Keywords: Psychiatric Clinical Trial Pediatrics Tourette's Disorder Tic Disorder
Sponsor: NYU Langone Health
Start date: 2005-09-01; Completion date: 2010-02-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if Abilify will reduce tics (repetitive, uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with Tourette's Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable movements or vocalizations).

Detailed description:
The aims of this study are to obtain systematic data regarding dosing and safety of aripiprazole (Abilify) in the treatment of youth with Tourette's Disorder (TD). Tourette's Disorder is characterized by multiple motor (more than one uncontrollable movement) and vocal tics (vocal outbursts) which have been present for more than 1 year, with onset before the age of 18. The disorder causes marked distress in social, occupational or other important areas of functioning. Abilify has been approved by the United States Food and Drug Administration (FDA) to treat adults with schizophrenia but has not been approved to treat Tourette's Disorder (TD) so it is considered experimental or investigational in this study.

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Baseline Visit 2: Subjects btw 25-50kg start on 1.25mg/day, btw 50-70kg start on 2.5mg/day, greater than 70kg start on 5mg/day Visit 3: Titrated based on YGTSS \& CGI-TS ratings at investigator discretion. Subjects who show evidence of response (reduction in CGI-TS by 1-2 points) may remain on same dose. Subjects who show no response may increase as follows: btw 25-50kg increase to 2.5mg/day, btw 50-70kg increase to 3.75mg/day, greater than 70kg increase to 7.5mg/day Visit 5: Subjects who show no response may increase as follows: btw 25-50kg increase to 3.75mg/day, btw 50-70kg increase to 5mg/day, greater than 70kg increase to 10mg/day Visit 6: Subjects who show no response may be increase as follows: btw 25-50kg increase to 5mg/day, btw 50-70kg increase to 7.5mg/day, greater than 70kg increase to 12.5mg/day Visit 7: Subjects who how no response may be increase as follows: btw 25-50kg increase to 7.5mg/day, btw 50-70kg increase to 10mg/day, greater than 70kg increase to 15mg/day

Protocol documents: