ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01569828
Conditions: Pharmacokinetics Renal Impaired Healthy Volunteer
Keywords: LCZ696 pharmacokinetics
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2009-09-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function

Detailed description:

Arms: arm 1: once daily administration of 400 mg LCZ696 for 5 days arm 2: once daily administration of 400 mg LCZ696 for 5 days
Interventions: intervention 1: LCZ696A intervention 2: LCZ696A
Intervention descriptions: intervention 1: None intervention 2: once daily administration of 400 mg LCZ696 for 5 days

Protocol documents:
Clinical trial NCT02015676
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2001-07-01; Completion date: 2009-09-01
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m\^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m\^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression. arm 2: Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m\^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.
Interventions: intervention 1: trastuzumab intervention 2: paclitaxel intervention 3: Myocet
Intervention descriptions: intervention 1: Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression intervention 2: 60 mg/m\^2 IV weekly; dose increased to 70 mg/m\^2, and subsequently 80 mg/m\^2, after 2 treatment cycles with no evidence of DLT until disease progression intervention 3: 40 mg/m\^2 IV weekly; dose increased to 50 mg/m\^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles

Protocol documents:
Clinical trial NCT00662818
Conditions: Migraine Disorders Heart Disease Cerebrovascular Accident TIA (Transient Ischemic Attack) Vascular Diseases Peripheral Vascular Diseases
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-03-17; Completion date: 2009-09-02
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.

Detailed description:

Arms: arm 1: Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned. arm 2: Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Interventions: intervention 1: Telcagepant intervention 2: Acetaminophen/Paracetamol intervention 3: Placebo to Telcagepant intervention 4: Placebo to Acetaminophen/Paracetamol
Intervention descriptions: intervention 1: Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets) intervention 2: Acetaminophen/Paracetamol (500 mg X 2 dosage units) intervention 3: Placebo 300 mg soft gel capsules or placebo 280 mg tablet. intervention 4: Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Protocol documents:
Clinical trial NCT00832624
Conditions: Diabetes Mellitus Non-insulin-dependent
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-11-26; Completion date: 2009-09-02
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.

Detailed description:

Arms: arm 1: sitagliptin
Interventions: intervention 1: sitagliptin
Intervention descriptions: intervention 1: Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks

Protocol documents:
Clinical trial NCT00647296
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS Amyotrophic Lateral Sclerosis Lou Gehrig Lou Gehrig's Lou Gehrig's disease Motor Neuron Disease Nervous System Diseases KNS-760704 BIIB050
Sponsor: Knopp Biosciences
Start date: 2008-04-09; Completion date: 2009-09-04
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a 2-part study of dexpramipexole in patients with ALS.

Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of dexpramipexole vs. placebo for 12 weeks.

Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole for up to 72 weeks.

Detailed description:
This study was a two-part, multicenter, double-blind study in subjects with ALS to evaluate the safety and tolerability of dexpramipexole treatment, as well as the preliminary effects on measures of clinical function and mortality of dexpramipexole treatment.

In part 1, 102 subjects with ALS were randomized at 20 US sites to receive placebo, dexpramipexole at 50 mg/day; dexpramipexole at 150 mg/day; or dexpramipexole at 300 mg/day for 12 weeks. Participants who completed Part 1 were eligible to enroll into Part 2.

Part 2 was a randomized, double-blind, 2-arm, parallel-group, extension study evaluating the longer-term safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole. In part 2, following a 4-week, placebo washout, continuing subjects received dexpramipexole at 50 mg/day or 300 mg/day as double-blind treatment for up to 72 additional weeks (Part 2 duration was up to a total of 76 weeks, including the 4 week placebo portion).

Arms: arm 1: During Part 1, subjects received twice daily doses of dexpramipexole (50 mg/day, 150 mg/day, or 300 mg/day) or matching placebo for approximately 12 weeks. arm 2: At the beginning of Part 2, subjects received twice daily doses of placebo for approximately 4 weeks. arm 3: Following the Part 2 placebo washout, subjects received dexpramipexole (50 mg/day or 300 mg/day), subjects received twice daily doses of placebo for up to 18 months.
Interventions: intervention 1: Placebo intervention 2: Dexpramipexole 50 mg/day intervention 3: Dexpramipexole 150 mg/day intervention 4: Dexpramipexole 300 mg/day
Intervention descriptions: intervention 1: Placebo: 2 tablets taken orally twice daily intervention 2: Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily intervention 3: Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily intervention 4: Dexpramipexole: 2 x 75 mg tablets taken orally twice daily

Protocol documents:
Clinical trial NCT00151892
Conditions: Ulcerative Colitis
Sponsor: Shire
Start date: 2005-04-08; Completion date: 2009-09-07
Enrollment: 829 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

Detailed description:

Arms: arm 1: Mesalazine arm 2: None
Interventions: intervention 1: SPD476 intervention 2: Asacol
Intervention descriptions: intervention 1: 2.4 g/day Once Daily (QD) intervention 2: 1.6g/day administered 800 mg Twice Daily (BID)

Protocol documents:
Clinical trial NCT00733304
Conditions: Macular Degeneration
Keywords: age-related macular degeneration (AMD) choroidal neovascularization (CNV) vascular endothelial growth factor (VEGF) pazopanib angiogenesis
Sponsor: GlaxoSmithKline
Start date: 2008-06-25; Completion date: 2009-09-09
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months.

Detailed description:

Arms: arm 1: eligible participants received 5 mg/ml Pazopanib eye drops three times daily (TID) arm 2: eligible participants received 2 mg/ml Pazopanib eye drops three times daily arm 3: eligible participants received 5 mg/ml Pazopanib eye drops once daily (QD)
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: 5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD

Protocol documents:
Clinical trial NCT00737464
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-08-26; Completion date: 2009-09-12
Enrollment: 132 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.

Protocol documents:
Clinical trial NCT00497796
Conditions: Cytomegalovirus Infections
Keywords: cytomegalovirus CMV prophylaxis liver liver transplant
Sponsor: Shire
Start date: 2007-07-23; Completion date: 2009-09-14
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.

Detailed description:
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 14 weeks following orthotopic liver transplantation.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: maribavir intervention 2: ganciclovir
Intervention descriptions: intervention 1: 100mg twice a day for 14 weeks. intervention 2: 1000mg three times per day for 14 weeks.

Protocol documents:
Clinical trial NCT00392171
Conditions: Glioma Astrocytoma Oligodendroglioma Glioblastoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-06-09; Completion date: 2009-09-15
Enrollment: 120 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m\^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m\^2).

Detailed description:

Arms: arm 1: Temozolomide will be administered at a dose of 50 mg/m\^2 for cycles of 28 days for 12 months or until progression.
Interventions: intervention 1: Temozolomide
Intervention descriptions: intervention 1: Subjects will receive temozolomide 50 mg/m\^2 for cycles of 28 days for 12 months or until progression

Protocol documents:
Clinical trial NCT00490776
Conditions: Cutaneous T-Cell Lymphoma
Keywords: Cutaneous T-Cell Lymphoma adults Mycosis Fungoides Sézary Syndrome CTCL
Sponsor: Novartis Pharmaceuticals
Start date: 2007-07-05; Completion date: 2009-09-22
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the safety and efficacy of LBH589B in adult participants with refractory/resistant Cutaneous T-Cell Lymphoma and prior Histone Deacetylase (HDAC) inhibitor therapy.

Detailed description:

Arms: arm 1: Participants received panobinostat, 20 milligrams (mg), capsules, orally, thrice weekly on alternate Days 1, 3, and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression, and/or physician's discretion to discontinue the treatment.
Interventions: intervention 1: Panobinostat
Intervention descriptions: intervention 1: Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly.

Protocol documents:
Clinical trial NCT00419666
Conditions: Chronic Plaque Psoriasis
Keywords: Calcitriol Psoriasis PK Adolescents
Sponsor: Galderma R&D
Start date: 2006-08-01; Completion date: 2009-09-24
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.

Detailed description:

Arms: arm 1: Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Interventions: intervention 1: Calcitriol 3mcg/g
Intervention descriptions: intervention 1: Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.

Protocol documents:
Clinical trial NCT00712296
Conditions: Asthma
Keywords: Asthma alternative medicine complementary medicine herbal therapy
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2008-08-01; Completion date: 2009-09-29
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics

Detailed description:
Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown limited benefits. Patients have increasingly turned to complementary and alternative medicine (CAM) for treatment of their asthma, despite the uncertainty of its benefits due a lack of well-controlled scientific studies.

We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to be a safe and effective alternative to prednisone for treating asthma and exhibited a beneficial effect on TH1 and TH2 balance. Additionally, a Phase I study conducted in the United States showed good tolerability to ASHMI. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in patients with asthma.

Arms: arm 1: ASHMI 4 capsules twice a day arm 2: ASHMI 12 capsules twice a day arm 3: Placebo 6 capsules twice a day
Interventions: intervention 1: ASHMI 4 intervention 2: ASHMI 12 intervention 3: Placebo
Intervention descriptions: intervention 1: 4 capsules orally twice a day intervention 2: 12 capsules orally twice a day intervention 3: Placebo 6 capsules twice a day

Protocol documents:
Clinical trial NCT00803400
Conditions: Panic Disorder
Keywords: Panic disorder Exercise Alprazolam Aerobic
Sponsor: University of Buenos Aires
Start date: 2008-10-01; Completion date: 2009-09-30
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone.

Detailed description:
We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments that those who did not. There are also some scientific studies that included physical exercise in the treatment for panic disorder and compared them to other single pharmacological treatments.

So our objective will be to compare the efficacy of a pharmacological monotherapy (alprazolam), that is one of the options for the pharmacological treatment of panic disorder, with other treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response.

Arms: arm 1: Patients assigned to the pharmacological plan arm 2: Patients assigned to mix plan
Interventions: intervention 1: Alprazolam intervention 2: Alprazolam + Aerobic exercise
Intervention descriptions: intervention 1: The patients assigned to the pharmacological plan will receive 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they have their first baseline psychiatric control, where all the patients are tested.

Then, at the same visit, all the patients are indicated 4 mg of alprazolam. The dose is gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12. intervention 2: The patients assigned to exercise have to pass an ergometric test to determine their functional capacity expressed in METs for future exercise indication.

Two weeks after the first interview they have their first baseline psychiatric control and at the same time they are indicated a 4 mg dose of alprazolam, gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12.

Then they follow a protocolized aerobic exercise plan for this study during 12 weeks.

The type of selected exercise consists of a rapid walk for 30 minutes divided in stages.

After each stage the patient has to control his own heart frequency that has to be between 50 and 75% of their maximum to assure an aerobic condition (American Cardiological Association).

Protocol documents:
Clinical trial NCT00048568
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2002-12-01; Completion date: 2009-10-01
Enrollment: 1250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.

Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.

Detailed description:

Arms: arm 1: Short Term: Abatacept was dosed by weight with participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. Participants continued treatment with methotrexate (MTX) either orally or parenterally at a minimum dose of 15 mg. arm 2: Short Term: Participants received a placebo solution intravenously and methotrexate at the dose employed prior to study enrollment and a minimum of 15 mg. arm 3: Open Label: Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
Interventions: intervention 1: Abatacept intervention 2: Methotrexate intervention 3: Placebo
Intervention descriptions: intervention 1: Intravenous (IV) Solution, - Weight Titered (500 mg \< 60 kg); (750 mg 60-100 kg), )1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year intervention 2: Tablets, Oral, \>= 15 mg, weekly, 1 year intervention 3: IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year

Protocol documents: