ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00377429
Conditions: Ovarian Cancer
Keywords: Epithelial Cancer Epithelial Carcinoma Epithelial Ovarian Cancer Epithelial Ovarian Carcinoma Fallopian Tube Cancer Fallopian Tube Carcinoma Ovarian Cancer Ovarian Carcinoma Ovarian Epithelial Cancer Ovarian Epithelial Carcinoma Peritoneal Cancer Peritoneal Carcinoma Advanced Epithelial Ovarian Cancer
Sponsor: Neovii Biotech
Start date: 2006-09-01; Completion date: 2008-02-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.

Detailed description:
A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter or port. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 4 months (includes the baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months follow-up), with post-study follow-up every 3 months for 2 years.

Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule (EpCAM) on tumor cells and CD3 (cluster of differentiation 3) on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells \[DCs\] and natural killer \[NK\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Arms: arm 1: None
Interventions: intervention 1: catumaxomab
Intervention descriptions: intervention 1: Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).

Protocol documents:
Clinical trial NCT00387881
Conditions: Migraine, Without Aura
Keywords: sumatriptan succinate, naproxen sodium, parallel group, double-blind, placebo-controlled, Combination product, migrainous headache Probable migraine, a sub-type of Migraine probable migraine,
Sponsor: GlaxoSmithKline
Start date: 2006-09-01; Completion date: 2008-02-01
Enrollment: 679 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sumatriptan succinate / naproxen sodium intervention 2: Placebo
Intervention descriptions: intervention 1: sumatriptan 85mg / naproxen sodium 500mg intervention 2: Placebo to match Treximet tablets

Protocol documents:
Clinical trial NCT00390858
Conditions: Transfusional Iron Overload β-thalassemia Major Pediatric Rare Anemia
Keywords: β-thalassemia major iron overload deferasirox pediatric rare anemia
Sponsor: Novartis Pharmaceuticals
Start date: 2003-09-01; Completion date: 2008-02-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.

Detailed description:

Arms: arm 1: Initial dose of 10 mg/kg, dose modifications of ± 5 or 10 mg/kg were based on participant response.
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: Deferasirox in children from 1 to 18 years old was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters and on increasing or decreasing Liver Iron Concentration (LIC), and serum ferritin. Deferasirox was available as 125 mg, 250 mg and 500 mg tablets.

Protocol documents:
Clinical trial NCT00392288
Conditions: Asthma
Keywords: Bronchial Asthma
Sponsor: AstraZeneca
Start date: 2006-09-01; Completion date: 2008-02-01
Enrollment: 528 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.

Secondary objective: To assess the safety and tolerability of ciclesonide.

Detailed description:

Arms: arm 1: double-blind arm 2: double-blind arm 3: double-blind
Interventions: intervention 1: Ciclesonide intervention 2: Ciclesonide intervention 3: Placebo
Intervention descriptions: intervention 1: Ciclesonide MDI 40 µg BID over twelve weeks intervention 2: Ciclesonide MDI 80 µg BID over twelve weeks intervention 3: Placebo MDI over twelve weeks

Protocol documents:
Clinical trial NCT00394251
Conditions: Breast Cancer
Keywords: Adjuvant therapy Bevacizumab Abraxane Early stage breast cancer
Sponsor: Celgene
Start date: 2006-08-01; Completion date: 2008-02-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m\^2 or Taxol 175 mg/m\^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.

Detailed description:

Arms: arm 1: Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m\^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46). arm 2: Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m\^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
Interventions: intervention 1: Adriamycin and Cytoxan (AC) intervention 2: ABI-007 intervention 3: Taxol intervention 4: Bevacizumab intervention 5: pegfilgrastim
Intervention descriptions: intervention 1: Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m\^2 intravenous, plus Cytoxan 600 mg/m\^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8). intervention 2: 260 mg/m\^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16) intervention 3: 175 mg/m\^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16) intervention 4: 10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46). intervention 5: 6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary.

Protocol documents:
Clinical trial NCT00401258
Conditions: Irritable Bowel Syndrome
Keywords: IBS irritable bowel syndrome irritable bowel
Sponsor: Mclean Hospital
Start date: 2006-11-01; Completion date: 2008-02-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.

During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be treated with open-label duloxetine.

Detailed description:
IBS is a chronic gastrointestinal disorder characterized by abdominal pain, altered bowel habits, and abdominal bloating for which no organic cause can be determined. Duloxetine has demonstrated efficacy in the treatment of depression as well as in several pain syndromes including diabetic peripheral neuropathy and fibromyalgia. We hypothesize that it will be a safe and efficacious treatment for the symptoms of IBS, in particular abdominal pain.

We plan to study 15 male and female subjects between the ages of 18 and 65 years who have had gastrointestinal symptoms at least 2 days/week for greater than six months and who have been diagnosed with IBS by a physician. During the 12-week study, subjects will receive open-label duloxetine titrated up to 60mg/day. Subjects will be asked to complete a total of ten study visits during the 12-week study period. All study visits will be conducted at McLean Hospital.

Arms: arm 1: 12-week, open-label trial of duloxetine in subjects with IBS.
Interventions: intervention 1: duloxetine
Intervention descriptions: intervention 1: 30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician.

Protocol documents:
Clinical trial NCT00401830
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia Syndrome Lacosamide Vimpat Harkoseride
Sponsor: UCB Pharma
Start date: 2006-10-01; Completion date: 2008-02-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

Detailed description:
This was a proof-of-concept study and not powered for statistical comparisons.

The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Arms: arm 1: None arm 2: Lacosamide Tablet 400mg daily
Interventions: intervention 1: Lacosamide intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg intervention 2: Matching placebo tablet administered twice daily

Protocol documents:
Clinical trial NCT00402337
Conditions: Chronic Constipation
Keywords: Constipation Chronic Constipation Microbia linaclotide linaclotide acetate MD-1100
Sponsor: Ironwood Pharmaceuticals, Inc.
Start date: 2006-11-01; Completion date: 2008-02-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: linaclotide acetate intervention 2: Matching placebo
Intervention descriptions: intervention 1: oral, once daily. intervention 2: oral, once daily

Protocol documents:
Clinical trial NCT00412529
Conditions: Hepatitis B Chronic Hepatitis B
Keywords: HBeAg-positive, chronic hepatitis B telbivudine entecavir viral kinetics
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2008-02-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Entecavir intervention 2: Telbivudine
Intervention descriptions: intervention 1: Entecavir 0.5 mg once daily for 12 weeks. intervention 2: Telbivudine 600 mg once daily for 12 weeks.

Protocol documents:
Clinical trial NCT00424294
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer
Start date: 2006-06-01; Completion date: 2008-02-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

Detailed description:
Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.

Arms: arm 1: Celecoxib with placebo therapy. arm 2: Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms. arm 3: CP-195,543 and Celecoxib dual therapy.
Interventions: intervention 1: CP-195,543 intervention 2: celecoxib intervention 3: Methotrexate
Intervention descriptions: intervention 1: CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor. intervention 2: Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States \[US\] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis. intervention 3: Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.

Protocol documents:
Clinical trial NCT00428389
Conditions: Alzheimer's Disease
Keywords: Dementia, Alzheimer's, Rivastigmine, donepezil
Sponsor: Novartis
Start date: 2007-01-01; Completion date: 2008-02-01
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm\^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period.

Detailed description:

Arms: arm 1: Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm\^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm\^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm\^2 patch and continued on their best tolerated dose for the remainder of the study. arm 2: Patients randomized to the delayed switch group were switched to 5 cm\^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm\^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm\^2 patch and continued on their best tolerated dose for the remainder of the study.
Interventions: intervention 1: Rivastigmine 5 cm^2 transdermal patch intervention 2: Rivastigmine 10 cm^2 transdermal patch
Intervention descriptions: intervention 1: Rivastigmine 5 cm\^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours. intervention 2: Rivastigmine 10 cm\^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours.

Protocol documents:
Clinical trial NCT00431041
Conditions: Overactive Bladder
Keywords: Solifenacin succinate Oxybutynin immediate release Xerostomia Overactive bladder
Sponsor: Astellas Pharma Inc
Start date: 2006-12-01; Completion date: 2008-02-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Detailed description:
This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Arms: arm 1: Solifenacin succinate: 5 mg tablets, taken orally, once daily arm 2: Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
Interventions: intervention 1: solifenacin intervention 2: oxybutynin immediate release
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT00431951
Conditions: Healthy
Keywords: Healthy Volunteers
Sponsor: SIGA Technologies
Start date: 2007-02-01; Completion date: 2008-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.

Detailed description:
This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 30 healthy volunteers ages 18-50 years, randomized to receive either active drug (8 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (250, 400 or 800mg groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1 placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each dose group. Dose groups completed the study treatment approximately 5 weeks prior to the start of the following dose group. Study procedures included several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiograms.

Arms: arm 1: 250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days arm 2: Placebo to match ST-246
Interventions: intervention 1: ST-246 intervention 2: Placebo
Intervention descriptions: intervention 1: 250 mg, 400 mg or 800 mg capsules given once daily for 21 days intervention 2: Capsules to match experimental drug

Protocol documents:
Clinical trial NCT00441766
Conditions: Irritable Bowel Syndrome
Sponsor: Allergan
Start date: 2007-03-01; Completion date: 2008-02-01
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Detailed description:

Arms: arm 1: Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks arm 2: Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks arm 3: Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks arm 4: Part A: Placebo capsule every 12 hours for 4 weeks
Interventions: intervention 1: AGN 203818 intervention 2: AGN 203818 intervention 3: AGN 203818 intervention 4: placebo
Intervention descriptions: intervention 1: Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks intervention 2: Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks intervention 3: Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks intervention 4: Part A: placebo capsule every 12 hours for 4 weeks

Protocol documents:
Clinical trial NCT00443040
Conditions: Post-Operative Ileus
Sponsor: Tioga Pharmaceuticals
Start date: 2007-01-01; Completion date: 2008-02-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.

Detailed description:
This randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and tolerability of two dose levels of asimadoline on the duration of post-operative ileus in subjects undergoing laparoscopic or hand-assisted laparoscopic colon resections. Subjects meeting entry criteria were randomized in a 1:1:1 ratio to receive either asimadoline 1.0 mg, asimadoline 3.0 mg or a placebo. One hundred and fourteen subjects were planned, and in the event that a subject was converted from a laparoscopic surgery to an open surgery (laparotomy), that subject would be discontinued from the trial and followed for safety only. The protocol allowed subjects converted to open procedures to be replaced. The first dose was administered approximately 90 minutes pre-operatively, and subsequent dosing was b.i.d. for up to 10 post-operative doses. Subjects were dosed with study drug only while in the hospital. After discharge, they were followed for an additional 28 days. Total study duration for each patient was approximately 5 to 6 weeks.

Arms: arm 1: None arm 2: Asimadoline 1.0 mg b.i.d. arm 3: Asimadoline 3.0 mg b.i.d.
Interventions: intervention 1: Asimadoline intervention 2: Placebo
Intervention descriptions: intervention 1: Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose. intervention 2: Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.

Protocol documents: