ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00094653
Conditions: Melanoma Metastases
Keywords: melanoma metastatic melanoma skin cancer
Sponsor: Bristol-Myers Squibb
Start date: 2004-09-01; Completion date: 2009-10-01
Enrollment: 1783 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

Detailed description:
Melanoma accounts for approximately 5% of all skin cancers in the United States, but it accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic melanoma). First line treatments for metastatic melanoma, usually IL-2, dacarbazine and/or temozolomide, are associated with significant toxicities. MDX-010 (anti-CTLA4) antibodies are designed to keep the immune system running by blocking CTLA-4 from down-regulating T cell activation. MDX-1379 is made up of two peptides that are pieces of a bigger melanoma protein (gp100). These peptides bind to HLA-A2 which is then recognized by T cells.

Arms: arm 1: Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo arm 2: MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine) arm 3: MDX-010 (ipilimumab) + Placebo
Interventions: intervention 1: MDX-010 (anti-CTLA4) monoclonal antibody intervention 2: MDX-1379 (gp100) Melanoma Peptide Vaccine
Intervention descriptions: intervention 1: 3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses intervention 2: 2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.

Protocol documents:
Clinical trial NCT00097981
Conditions: Multiple Myeloma
Keywords: Multiple myeloma Newly diagnosed multiple myeloma Thalidomide Dexamethasone DOXIL Pegylated liposomal hydrochloride doxorubicin injection
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2005-01-01; Completion date: 2009-10-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.

Detailed description:
This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone versus DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4 to 12 treatment cycles, depending on the response of their multiple myeloma to the treatment (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection). Maximum duration of study participation for each participant will be 48 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Thalidomide intervention 2: Dexamethasone intervention 3: DOXIL
Intervention descriptions: intervention 1: Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles. intervention 2: Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20. intervention 3: DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.

Protocol documents:
Clinical trial NCT00190684
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2000-08-01; Completion date: 2009-10-01
Enrollment: 1553 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).

Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.

Detailed description:

Arms: arm 1: Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Interventions: intervention 1: atomoxetine
Intervention descriptions: intervention 1: 0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years

Protocol documents:
Clinical trial NCT00190775
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2004-09-01; Completion date: 2009-10-01
Enrollment: 502 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.

Detailed description:
The initial study was 34 weeks long; however, the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks (38 weeks total).

Arms: arm 1: Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally arm 2: Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.
Interventions: intervention 1: Atomoxetine Hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally intervention 2: Placebo is administered QD, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.

Protocol documents:
Clinical trial NCT00261443
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder with a recent manic or mixed episode
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2005-09-01; Completion date: 2009-10-01
Enrollment: 1270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

Detailed description:

Arms: arm 1: /Active Comparator arm 2: None
Interventions: intervention 1: Lithium or Valproate with placebo (PBO) intervention 2: Lithium or Valproate with Aripiprazole
Intervention descriptions: intervention 1: Tablets, Oral, once daily

lithium 250-2100 mg/day

valproate 250-2500mg/day

Placebo once daily intervention 2: Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)

lithium 250-2100 mg/day

valproate 250-2500mg/day

aripiprazole 15-30 mg/day

Protocol documents:
Clinical trial NCT00394355
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-09-01; Completion date: 2009-10-01
Enrollment: 566 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus montelukast (ML) 10 mg daily in the evening.

Detailed description:

Arms: arm 1: MF DPI 400 mcg once a day (QD) in the evening (PM) arm 2: MF DPI 200 mcg QD PM arm 3: Fluticasone propionate (FP) metered dose inhaler (MDI) 250 mcg twice a day (BID) arm 4: ML 10 mg QD PM
Interventions: intervention 1: mometasone furoate dry powder inhaler intervention 2: mometasone furoate dry powder inhaler intervention 3: fluticasone propionate hydrofluoroalkane (HFA) intervention 4: montelukast
Intervention descriptions: intervention 1: 400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year. intervention 2: 200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year. intervention 3: 250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year intervention 4: 10 mg given once daily in the evening by mouth for 1 year.

Protocol documents:
Clinical trial NCT00407537
Conditions: Hypertension Hypercholesterolemia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-03-01; Completion date: 2009-10-01
Enrollment: 1531 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.

Detailed description:

Arms: arm 1: Open label caduet added to usual care regimen followed by investigators.
Interventions: intervention 1: Amlodipine besylate/atorvastatin calcium single pill combination
Intervention descriptions: intervention 1: Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion

Protocol documents:
Clinical trial NCT00522275
Conditions: Partial Epilepsies
Keywords: Adjunctive treatment in epilepsy add-on treatment for epilepsy partial seizures AEDs antiepileptic drugs seizures
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2004-10-01; Completion date: 2009-10-01
Enrollment: 308 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy

Detailed description:

Arms: arm 1: Up to 800 mg/day lacosamide (flexible dosing)
Interventions: intervention 1: lacosamide
Intervention descriptions: intervention 1: 50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

Protocol documents:
Clinical trial NCT00739934
Conditions: Candidiasis Candidemia
Keywords: Open-Label Pharmacokinetics Intravenous to oral switch Safety Voriconazole Immunocompromise Children High Risk For Systemic Fungal Infection.
Sponsor: Pfizer
Start date: 2008-12-01; Completion date: 2009-10-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.

Detailed description:

Arms: arm 1: Immunocompromised children aged 2 to \<12 years who are at high risk for systemic fungal infection.
Interventions: intervention 1: voriconazole (Vfend)
Intervention descriptions: intervention 1: Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h

Notes:

1. If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
2. Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.

(IV = Intravenous; POS = Powder for oral suspension)

Protocol documents:
Clinical trial NCT00777023
Conditions: Hot Flashes
Keywords: Hot Flashes Hot Flushes Postmenopausal symptoms Vasomotor symptoms
Sponsor: Depomed
Start date: 2008-10-01; Completion date: 2009-10-01
Enrollment: 565 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women

Detailed description:
The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:

G-ER 1200mg daily (single evening dose)

G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg PM)

compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a stable dose, compared with the baseline week.

Arms: arm 1: Gabapentin extended-release (G-ER) 1200 mg arm 2: Gabapentin extended-release (G-ER) 1800 mg arm 3: Placebo 1200 mg or 1800 mg
Interventions: intervention 1: Gabapentin Extended-Release (G-ER) 1200 mg intervention 2: Gabapentin Extended-Release (G-ER) 1800 mg intervention 3: Placebo
Intervention descriptions: intervention 1: G-ER 1200 mg daily dosage given as two 600-mg tablets. intervention 2: G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening. intervention 3: Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).

Protocol documents:
Clinical trial NCT00001151
Conditions: Hypocalcemia Rickets
Keywords: Calciferol Hypocalcemia Rickets
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 1976-03-01; Completion date: 2009-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Vitamin D in the diet undergoes changes in the liver and kidneys to several forms. Patients suffering from disorders with Vitamin D resistance are unable to absorb calcium from food. Patients diagnosed with these disorders will be evaluated and treated with high doses of another form of Vitamin D (1,25-dihydroxyvitamin D3). Patients will be monitored and observed throughout the study to avoid experiencing side effects from the medication.

Detailed description:
Patients with extreme resistance to 1,25-dihydroxyvitamin D will be evaluated and treated with high doses of 1,25-dihydroxyvitamin D3.

Plan: In previously untreated patients the study will be divided into a control and one or more treatment periods. During the control period, parathyroid status will be assessed by parameters nos. 1\& 2 (below). In previously treated patients maintenance vitamin D will be gradually replaced with 1,25(OH)2D3. This will be accomplished by withdrawal of vitamin D and institution of 1,25(OH)2D3 when the serum calcium shows a downward trend.

1,25(OH)2D3 as 0.25 or 0.5 ug capsules (though IND 20,889) or as a solution of I microgram per ml will be administered orally. In most cases, because of consideration of time and expense, the cooperation of the patient's local physician will be enlisted. The following will be monitored:

1. Serum calcium, phosphorus,alkaline phosphatase,creatinine at twice weekly intervals. After a maintenance dose has been established, this will be decreased to a monthly, and subsequently 3-6 monthly interval.
2. Urine calcium, phosphorus,creatinine and cAMP before therapy and, when appropriate, during therapy.

The dose of 1,25(OH)2D3 will be 0.125 to 50.0 ug/day. Serum calcium will not be allowed to rise above the normal range (2.0 -2.4 mM at NIH). Should hypercalcemia occur, appropriate treatment will be initiated and the drug dosage will be decreased.

Arms: arm 1: 1,25-Dihydroxycholecalciferol 5 ug orally per day for 2 years
Interventions: intervention 1: 1,25-Dihydroxycholecalciferol
Intervention descriptions: intervention 1: Usual doses of 1,25-dihydroycholecalciferol are 0.25-1 ug per day. All patients in this study received very high doses or 5-20 ug per day.

Protocol documents:
Clinical trial NCT00006164
Conditions: Chronic Hepatitis c Cirrhosis, Liver Fibrosis, Liver Hepatic Cirrhosis
Keywords: liver disease hepatitis c virus antiviral agent cirrhosis
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2000-06-01; Completion date: 2009-10-01
Enrollment: 1050 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.

Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.

The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.

The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.

Detailed description:

Arms: arm 1: Peg-interferon alfa-2a 90 mcg/week arm 2: Standard of care followup
Interventions: intervention 1: Peginterferon alfa-2a + Ribavirin intervention 2: Peginterferon alfa-2a
Intervention descriptions: intervention 1: Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight \<75 kg, \>75 kg) daily in two divided doses for 24 weeks intervention 2: 90 mcg/week injection, for 3.5 years

Protocol documents:
Clinical trial NCT00022672
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2001-01-01; Completion date: 2009-10-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Detailed description:

Arms: arm 1: Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase. arm 2: 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Interventions: intervention 1: trastuzumab (Herceptin®) intervention 2: anastrazole (Arimidex®)
Intervention descriptions: intervention 1: 4mg/kg iv loading dose, followed by 2mg/kg iv weekly intervention 2: 1 mg tablet taken orally daily

Protocol documents:
Clinical trial NCT00062751
Conditions: Breast Neoplasms
Keywords: breast neoplasms
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2002-12-01; Completion date: 2009-10-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Letrozole / Temsirolimus (CCI-779) intervention 2: Letrozole / Temsirolimus (CCI-779) intervention 3: Letrozole
Intervention descriptions: intervention 1: Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily intervention 2: Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks intervention 3: Letrozole 2.5 mg daily

Protocol documents: