ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00278863
Conditions: Gastric Cancer
Keywords: Stomach cancer Palliative chemotherapy Capecitabine S-1
Sponsor: Asan Medical Center
Start date: 2004-11-01; Completion date: 2007-01-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: S-1 intervention 2: Capecitabine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00304356
Conditions: Clostridium Enterocolitis Pseudomembranous Colitis
Keywords: Clostridium difficile Associated Diarrhea
Sponsor: Daniel M. Musher MD
Start date: 2004-01-01; Completion date: 2007-01-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.

Detailed description:
Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and a mortality that may be around 2-3%. There has been an enormous increase in this disease at the VA Medical Center during the past two years, just as has occurred at other hospitals throughout the United States.

Currently recommended therapy for this condition is metronidazole, given orally. About 15-20% of patients fail to respond to initial therapy with metronidazole, and another 20% relapse after treatment. Relapses may be treated with another course of metronidazole; about one-half will respond to this therapy. The failures are treated with oral vancomycin, but this drug also has a failure rate of 10-20%. There is, at present, no other accepted therapy (although some articles in the literature favor vancomycin with ingested bacteria from benign species). Furthermore, there is a strong risk to the emergence of resistant bacteria when hospitalized patients are treated with oral vancomycin.

Nitazoxanide is an FDA approved drug that is marketed in the U.S. and has been widely used throughout the world to treat parasitic diseases of the gastrointestinal tract; several million children have been treated with this drug during the past decade. Nitazoxanide has been approved as an antiprotozoal agent for oral administration in pediatric patients, ages 1 through 11, with diarrhea. The drug acts by interfering with anaerobic metabolic pathways, and it has been shown to have excellent in vitro activity against C. difficile. We hypothesized that this drug was both safe and effective as an alternative in patients who have diarrheal disease caused by C. difficile. The IRB approved a double-blind protocol to compare metronidazole with nitazoxanide, and we have treated a total of 16 patients so far under this protocol.

In our IRB-approved double blind study (by design, two thirds of the subjects have been randomized to the nitazoxanide), our patients have appeared to have a good response rate -- so good, in fact, that we think that nitazoxanide may be a better drug to treat this infection than either metronidazole or vancomycin.

Arms: arm 1: 500 mg nitazoxanide bid given to patient
Interventions: intervention 1: Nitazoxanide
Intervention descriptions: intervention 1: 500 mg bid

Protocol documents:
Clinical trial NCT00354484
Conditions: Postpartum Anemia
Keywords: anemia postpartum
Sponsor: American Regent, Inc.
Start date: 2006-05-01; Completion date: 2007-01-01
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.

Detailed description:
This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.

Arms: arm 1: Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. arm 2: 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate tablets
Intervention descriptions: intervention 1: Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. intervention 2: 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

Protocol documents:
Clinical trial NCT00375934
Conditions: Pain, Postoperative
Keywords: Bunionectomy Bunion surgery Post-operative pain
Sponsor: Xanodyne Pharmaceuticals
Start date: 2006-09-01; Completion date: 2007-01-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: diclofenac potassium (XP21L) intervention 2: Placebo
Intervention descriptions: intervention 1: 25 mg capsule, every 6 hours intervention 2: Oral placebo capsule, every 6 hours

Protocol documents:
Clinical trial NCT00405067
Conditions: Hypercholesterolemia
Keywords: Cholesterol
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2006-05-01; Completion date: 2007-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.

Detailed description:
Subjects will participate in this study for approximately 14-17 weeks. This study has 2 periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other characteristics will be evaluated to determine study eligibility. This period also includes a 4-week washout for patients on prior lipid-lowering therapies; and 2) a 12-week treatment period with interim visits at weeks 4 and 8.

85 subjects were randomized into one of 3 treatment arms with equal probability. In treatment arm 1, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe placebo. In treatment arm 2, subjects will receive BMS-201038 (AEGR-733) placebo plus 10 mg of ezetimibe. In treatment arm 3, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe 10 mg. After 4 weeks of treatment, subjects in arms 1 and 3 will be force-titrated to BMS-201038 (AEGR-733) 7.5 mg. After another 4 weeks of treatment, subjects in arms 1 and 3 will then be force-titrated to BMS-201038 (AEGR-733) 10 mg for 4 more additional weeks of treatment. Subjects in arm 2 will continue to receive BMS-201038 (AEGR-733) matching placebo for the entire 12 weeks of treatment. Subjects randomized to ezetimibe 10 mg in arms 2 and 3 and ezetimibe placebo in arm 1 will remain on these doses for the entire 12-week treatment period.

Interventions: intervention 1: BMS-201038 (AEGR-733) intervention 2: Ezetimibe
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00422812
Conditions: Migraine Headache Aura
Keywords: Migraine, Staccato Prochlorperazine Migraine headache with or without aura.
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2006-04-01; Completion date: 2007-01-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been initiated to assess the efficacy and safety in outpatients with migraine headache with or without aura.

Detailed description:

Arms: arm 1: Inhaled Staccato Placebo arm 2: Inhaled Staccato Prochlorperazine 5 mg arm 3: Inhaled Staccato Prochlorperazine 7.5 mg arm 4: Inhaled Staccato Prochlorperazine 10 mg
Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled PCZ 5 mg intervention 3: Inhaled PCZ 7.5 mg intervention 4: Inhaled PCZ 10 mg
Intervention descriptions: intervention 1: Inhaled Staccato Placebo intervention 2: Inhaled Staccato Prochlorperazine 5 mg intervention 3: Inhaled Staccato Prochlorperazine 7.5 mg intervention 4: Inhaled Staccato Prochlorperazine 10 mg

Protocol documents:
Clinical trial NCT00577720
Conditions: Postmenopausal Women
Sponsor: Warner Chilcott
Start date: 2006-07-01; Completion date: 2007-01-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Detailed description:
To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.

Arms: arm 1: 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks arm 2: 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks arm 3: 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks arm 4: 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
Interventions: intervention 1: risedronate intervention 2: risedronate intervention 3: risedronate intervention 4: risedronate
Intervention descriptions: intervention 1: 35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks intervention 2: 35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks intervention 3: 50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks intervention 4: 50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

Protocol documents:
Clinical trial NCT00753987
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis Hypertonic Saline Infants
Sponsor: The Hospital for Sick Children
Start date: 2006-03-01; Completion date: 2007-01-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the study is to determine whether or not inhalation of hypertonic saline will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung function.

Detailed description:
Cystic fibrosis lung disease is characterized by mucous retention which favors secondary bacterial infection and inflammation, which leads to lung damage and ultimately respiratory failure. Classically, therapeutic interventions are aimed to improve mucociliary clearance, to reduce both bacterial load and lower airway inflammation.

Hypertonic saline (HS) has been used for the induction of sputum production in all age groups to obtain secretions from the lower respiratory for diagnostic purposes. Hypertonic saline is also used in older children with CF, who do not produce sputum spontaneously, to obtain representative samples for microbiology.

There is evidence from studies in patients with cystic fibrosis that HS can improve mucociliary clearance. The improvement was more impressive in areas that were well ventilated, making it likely that HS will work better in patients with relatively preserved pulmonary function. Newer evidence also suggests that the osmotic effect on the airway surface that was expected to be short lived, may actually persist for longer time periods (up to 8 hours). All these data indicate that HS may be a useful agent in the treatment of CF patients.

As the effect on mucociliary clearance was found to be better in areas with adequate ventilation, it is logical to assume that treatment with HS may be most efficacious when initiated early in the disease process. So far, no data on the tolerability of inhalation of HS are available for infants with cystic fibrosis. However, evidence from infants with AIDS as well as recent studies in infants with bronchiolitis suggest that hypertonic saline can be safely administered by inhalation in infants. Nevertheless, proof of tolerability in CF infants is a prerequisite for longer term studies of HS in this age group. In older children, tolerability has been tested by measuring pulmonary function both before and after inhalation of HS saline. Similar data are not yet available for infants.

Arms: arm 1: Administration of a single dose of 7% hypertonic saline
Interventions: intervention 1: Hypertonic Saline
Intervention descriptions: intervention 1: 5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.

Protocol documents:
Clinical trial NCT01340625
Conditions: Bioequivalence
Keywords: Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2006-12-01; Completion date: 2007-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 \* 0.4 mg/35 mcg chewable tablets) in healthy female adult volunteers administered under fasting conditions.

Detailed description:

Arms: arm 1: Norethindrone/Ethinyl Estradiol 0.4 mg/35 mcg Chewable Tablets (Teva) arm 2: Ovcon® 35 Fe 0.4 mg/35 mcg Chewable Tablets (Warner Chilcott)
Interventions: intervention 1: Norethindrone/Ethinyl Estradiol intervention 2: Ovcon® 35 Fe
Intervention descriptions: intervention 1: 0.4 mg/35 mcg Chewable Tablets intervention 2: 0.4 mg/35 mcg Chewable Tablets

Protocol documents:
Clinical trial NCT00249808
Conditions: Psoriasis
Keywords: Candidates for systemic therapy for psoriasis
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-12-13; Completion date: 2007-01-25
Enrollment: 1266 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of differentiation \[CD\] 11a recombinant human monoclonal antibody) in participants with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen and ultraviolet A phototherapy (PUVA).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Efalizumab - anti-CD11a recombinant human monoclonal antibody
Intervention descriptions: intervention 1: Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment \[FT\]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.

Protocol documents:
Clinical trial NCT00473694
Conditions: Anesthesia, General
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-11-28; Completion date: 2007-01-29
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.

Detailed description:

Arms: arm 1: Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. arm 2: Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate. arm 3: Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. arm 4: Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Interventions: intervention 1: sugammadex intervention 2: neostigmine intervention 3: vecuronium intervention 4: rocuronium intervention 5: glycopyrrolate
Intervention descriptions: intervention 1: Administered as an intravenous (IV) infusion intervention 2: Administered as an IV infusion intervention 3: Administered as an IV infusion intervention 4: Administered as an IV infusion intervention 5: Administered as an IV infusion

Protocol documents:
Clinical trial NCT01112358
Conditions: Ovarian Stimulation
Keywords: Lutropin alfa Fertilization in vitro Intracytoplasmic sperm injection Reproductive techniques, assisted
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-12-07; Completion date: 2007-01-30
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.

Detailed description:

Arms: arm 1: Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist. arm 2: Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.
Interventions: intervention 1: r-FSH intervention 2: r-hLH intervention 3: Analogous GnRH antagonist intervention 4: r-hCG intervention 5: Progesterone
Intervention descriptions: intervention 1: r-FSH will be administered as specified in the arm description. intervention 2: r-hLH will be administered as specified in the arm description. intervention 3: Analogous GnRH antagonist will be administered as specified in the arm description. intervention 4: r-hCG will be administered as specified in the arm description. intervention 5: Progesterone will be administered as specified in the arm description.

Protocol documents:
Clinical trial NCT00087516
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-06-01; Completion date: 2007-02-01
Enrollment: 741 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d ) arm 2: Phase A and B: Oral tablets of sitagliptin 200 mg q.d arm 3: Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d. arm 4: Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.
Interventions: intervention 1: Sitagliptin (MK0431) intervention 2: Sitagliptin intervention 3: Placebo intervention 4: Placebo intervention 5: Metformin - Rescue
Intervention descriptions: intervention 1: Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks. intervention 2: Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks. intervention 3: Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks. intervention 4: Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks. intervention 5: Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Protocol documents: