ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00841100
Conditions: Phenylketonuria
Keywords: PKU Kuvan BH4 tetrahydrobiopterin
Sponsor: University of Miami
Start date: 2008-12-01; Completion date: 2011-07-19
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness in the same patients with PKU when their blood phenylalanine concentrations are altered by diet.

Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will increase the frequency of Kuvan responsiveness.

Detailed description:

Arms: arm 1: Participants will receive one dose of Kuvan 20 mg/kg on Day 1 and assessed for Acute 24 hour Kuvan response. arm 2: After completion of acute 24 hour component, participants can enroll in Phase 1 and will receive Kuvan 20 mg/kg by mouth once daily for 28 consecutive days arm 3: Participants in Phase 1 that was not responsive will continue on to the Phase 2 of the study. Positive response is defined as a decrease of blood phenylalanine of 30% or greater from baseline taken from morning blood serum. The Phase 2 component of the study will be a 2 week period of dietary restriction. arm 4: Participants in Phase 2 that achieves a fasting blood phenylalanine of less than 600 umol/l after 2 week dietary restriction will be retreated with Kuvan 20 mg/kg by mouth once daily for a period of 28 consecutive days.
Interventions: intervention 1: Kuvan intervention 2: Diet
Intervention descriptions: intervention 1: 20mg/kg by mouth once daily intervention 2: Phenylalanine-restricted diet (4-10 mg/kg/day phenylalanine) using the prescribed phenylalanine-free medical formula and low protein foods tested with the patients for taste and acceptance to lower blood phenylalanine levels below 600 umol/l.

Protocol documents:
Clinical trial NCT01144364
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2004-01-19; Completion date: 2011-07-21
Enrollment: 234 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [Mabthera/Rituxan]
Intervention descriptions: intervention 1: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00951275
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-10-31; Completion date: 2011-07-22
Enrollment: 105 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)
Intervention descriptions: intervention 1: 8mg/kg iv every 4 weeks for 6 months intervention 2: As prescribed

Protocol documents:
Clinical trial NCT00970593
Conditions: Diabetes Mellitus
Sponsor: Pfizer
Start date: 2009-09-02; Completion date: 2011-07-25
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects with type 2 diabetes who are taking metformin for their diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: OAP-189 intervention 2: placebo comparator
Intervention descriptions: intervention 1: Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) Group 6: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) intervention 2: Group 1 \& 2: PBO x 7 days BID Group 3: PBO QD x 14 days Group 4: PBO QD x 14 days Group 5: PBO QD x 14 days Group 6: PBO QD x 14 days

Protocol documents:
Clinical trial NCT00737477
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-09-30; Completion date: 2011-07-31
Enrollment: 96 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.

Detailed description:

Arms: arm 1: Participants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.

Protocol documents:
Clinical trial NCT00451451
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: relapsing multiple sclerosis oral remitting
Sponsor: Biogen
Start date: 2007-06-01; Completion date: 2011-08-01
Enrollment: 1417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

Detailed description:
Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Arms: arm 1: Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) arm 2: Participants received two 120 mg BG00012 capsules orally three times daily (TID) arm 3: Participants received two placebo capsules orally three times daily (TID) arm 4: Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
Interventions: intervention 1: BG00012 intervention 2: Placebo intervention 3: Glatiramer Acetate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00481871
Conditions: Relapsed or Refractory Lymphoproliferative Malignancies Hodgkin's Lymphoma Peripheral T-cell Lymphoma B-cell Lymphoma Waldenstrom's Macroglobulinemia
Keywords: Lymphoproliferative malignancies Lymphoma Hodgkin's lymphoma (HL) Non-Hodgkin's lymphoma (NHL) PTCL T/NK-cell leukemia/lymphoma T-cell lymphoma/leukemia (HTLV 1+) Angioimmunoblastic T-cell lymphoma Blastic NK lymphoma Anaplastic large cell lymphoma T/NK-cell lymphoma Enteropathy-type intestinal lymphoma Hepatosplenic T-cell lymphoma Extranodal peripheral T/NK-cell lymphoma Subcutaneous panniculitis T-cell lymphoma Transformed mycosis fungoides PDX Pralatrexate Gemcitabine Gemzar Vitamin B12 Folic acid
Sponsor: Acrotech Biopharma Inc.
Start date: 2007-05-01; Completion date: 2011-08-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's macroglobulinemia.

This study is being done to find doses of the combination of pralatrexate and gemcitabine with vitamin B12 and folic acid that can be safely given to patients with these types of lymphoma and explore the effectiveness of the treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pralatrexate Injection intervention 2: Gemcitabine Hydrochloride intervention 3: Vitamin B12 intervention 4: Folic Acid
Intervention descriptions: intervention 1: Intravenous (IV) push administration over 30 seconds to 5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).

Sequential Dosing: 10 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met.

Same Day Dosing: 15 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met. intervention 2: Gemcitabine will be prepared and administered as an IV infusion as per manufacturer instructions.

Sequential Dosing: 400 mg/m2 every 2 weeks (days 2 and 16) of a 4-week cycle until criteria for discontinuation per the protocol are met.

Same Day Dosing: 600 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met. intervention 3: 1 mg intramuscular injection

Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate. intervention 4: 1 mg orally

Administered daily for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days after last dose of pralatrexate.

Protocol documents:
Clinical trial NCT00665847
Conditions: HIV-1
Keywords: HIV-1 TMC125-TiDP35-C213 TMC125-C213
Sponsor: Tibotec Pharmaceuticals, Ireland
Start date: 2008-11-01; Completion date: 2011-08-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.

Detailed description:
The study design is a single arm treatment (all patients assigned to receive etravirine), open label (patients will know the identity of the treatments they are receiving) safety and antiviral activity of Etravirine (TMC125) in treatment-experienced, HIV infected children and adolescents 6 to 17 years of age. Etravirine is a new drug belonging to the NNRTI (a non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the human immunodeficiency virus (HIV). This drug has been tested for safety and effectiveness in adults, however, there is no data on the drug's long-term safety and antiviral activity in children and adolescents. This study will last for a maximum of 48 weeks. A total of 100 ptients will receive etravirine tablets based on body weight and an investigator selected optimized background regimen (OBR) of at least 2 antiretrovirals (ARVs), consisting of a boosted protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor(s) (NRTI\[s\]). Use of enfuvirtide is optional. Safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Etravirine (TMC125) intervention 2: Optimized background regimen (OBR)
Intervention descriptions: intervention 1: Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks. intervention 2: An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir \[LPV\], darunavir \[DRV\], atazanavir \[ATV\] or saquinavir \[SQV\]) in combination with nucleos(t)ide reverse transcriptase inhibitor(s) (N\[t\]RTIs) to be dosed according to the drugs individual package inserts for 48 weeks.

Protocol documents:
Clinical trial NCT00957996
Conditions: Seasonal Influenza Cough Sore Throat Nasal Congestion Myalgia Headache Fatigue
Keywords: influenza hospitalized flu antiviral
Sponsor: BioCryst Pharmaceuticals
Start date: 2009-10-01; Completion date: 2011-08-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.

Detailed description:

Arms: arm 1: Peramivir 300 mg twice daily arm 2: Peramivir 600 mg once daily
Interventions: intervention 1: Peramivir intervention 2: Peramivir
Intervention descriptions: intervention 1: 300 mg twice daily intervention 2: 600 mg once daily

Protocol documents:
Clinical trial NCT00981682
Conditions: Nocturia
Keywords: decrease in the number of nocturic episodes for patients with nocturia
Sponsor: Serenity Pharmaceuticals, Inc.
Start date: 2009-08-01; Completion date: 2011-08-01
Enrollment: 376 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SER120
Intervention descriptions: intervention 1: once a day treatment of nocturia

Protocol documents:
Clinical trial NCT00982007
Conditions: Iron Deficiency Anemia
Keywords: IDA
Sponsor: American Regent, Inc.
Start date: 2009-09-01; Completion date: 2011-08-01
Enrollment: 997 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.

Detailed description:

Arms: arm 1: Intravenous (IV) iron arm 2: Oral iron - Ferrous Sulfate tablets arm 3: Other IV iron arm 4: Intravenous (IV) iron
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate Tablets intervention 3: IV Iron (standard of care) intervention 4: Ferric Carboxymaltose (FCM)
Intervention descriptions: intervention 1: A total maximum cumulative dose of 1500 mg administered on Days 0 and 7. intervention 2: 325 mg Ferrous Sulfate tablets taken orally three times a day intervention 3: IV standard of care (other IV iron) per the Investigator's discretion intervention 4: A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Protocol documents:
Clinical trial NCT01348165
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-05-01; Completion date: 2011-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers

Detailed description:
As a transition from preclinical investigations to clinical development in this first-in-man trial, safety, tolerability, and pharmacokinetics of BI 137882 will be assessed in healthy male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 137882 in the indication of COPD.

Healthy male subjects aged 21 - 50 years will be recruited for this study. They provide a relatively stable physiological, biochemical and hormonal basis (steady state) for studying drug effects, they show no disease-related variation and they are not taking concomitant medication.

Within each dose group, all actively treated individuals will receive the same BI 137882 dose. The next higher dose will only be administered if the treatment in the preceding dose group was safe and well tolerated.

Arms: arm 1: Powder for oral solution arm 2: Powder for oral solution arm 3: Powder for oral solution arm 4: Powder for oral solution arm 5: Powder for oral solution arm 6: Powder for oral solution arm 7: Powder for oral solution arm 8: Powder for oral solution arm 9: Powder for oral solution arm 10: Powder for oral solution
Interventions: intervention 1: BI 137882 intervention 2: Placebo
Intervention descriptions: intervention 1: Powder for oral solution intervention 2: Powder for oral solution

Protocol documents:
Clinical trial NCT00090363
Conditions: Prostate Cancer
Keywords: rising PSA bone metastases Clinical study pain-free or mildly symptomatic
Sponsor: AstraZeneca
Start date: 2004-07-01; Completion date: 2011-08-01
Enrollment: 447 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

Detailed description:

Arms: arm 1: Matching placebo oral tablet once daily, with best supportive care arm 2: ZD4054 10 mg oral tablet once daily, with best supportive care arm 3: ZD4054 15 mg oral tablet once daily, with best supportive care
Interventions: intervention 1: ZD4054 15 mg intervention 2: Placebo intervention 3: ZD4054 10 mg
Intervention descriptions: intervention 1: 15 mg oral tablet once daily intervention 2: None intervention 3: 10mg oral tablet once daily

Protocol documents:
Clinical trial NCT00123162
Conditions: Dysmenorrhea
Keywords: Sildenafil
Sponsor: Milton S. Hershey Medical Center
Start date: 2007-05-01; Completion date: 2011-08-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a higher improvement rate when compared to placebo in the treatment of moderate to severe primary dysmenorrhea.

Detailed description:
It is well established that excess prostaglandin production in primary dysmenorrhea leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid anti-inflammatory drugs (NSAIDS) being the most effective with the overall success rate of more than 75%. Sildenafil citrate (Viagra) is an inhibitor that augments the vasodilatory effects of nitric oxide by preventing the degradation of Cyclic guanosine monophosphate (cGMP) in the uterine muscle. Sildenafil is commonly used in the treatment of male erectile dysfunction, pulmonary hypertension in children and adults, and in vitro fertilization. To date it has not been used in the treatment of primary dysmenorrhea.

Arms: arm 1: A single vaginal dose of Viagra 100 mg. arm 2: A single vaginal dose of placebo.
Interventions: intervention 1: Sildenafil Citrate intervention 2: Placebo
Intervention descriptions: intervention 1: A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours. intervention 2: A single vaginal dose of placebo and monitored for 4 hours.

Protocol documents:
Clinical trial NCT00147537
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: non-small cell lung cancer chemotherapy figitumumab insulin-like growth 1 factor receptor IGF-IR monoclonal antibody
Sponsor: Pfizer
Start date: 2005-02-01; Completion date: 2011-08-01
Enrollment: 282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.

Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Detailed description:

Arms: arm 1: CP-751,871 + paclitaxel + carboplatin arm 2: 1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin
2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib
Interventions: intervention 1: CP-751,871 intervention 2: paclitaxel intervention 3: carboplatin intervention 4: CP-751,871 intervention 5: paclitaxel intervention 6: carboplatin intervention 7: erlotinib
Intervention descriptions: intervention 1: Phase 2 Arm A:

CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles intervention 2: Phase 2 Arm A:

Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

Phase 2 Arm B:

Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles intervention 3: Phase 2 Arm A:

Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

Phase 2 Arm B:

Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles intervention 4: Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) intervention 5: Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) intervention 6: Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) intervention 7: Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)

Protocol documents: