ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03447821
Conditions: Infectious Diarrhoea
Keywords: Infectious diarrhoea rifamycin SV rifamycin SV MMX MMX
Sponsor: Cosmo Technologies Ltd
Start date: 2008-02-01; Completion date: 2008-07-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX technology (CB-01-11) in the treatment of infectious diarrhoea.

Detailed description:
To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMXTM technology (CB-01-11) in the treatment of infectious diarrhoea.

Primary end points to determine:

• The safety and preliminary efficacy data of the three doses of the new rifamycin SV formulation tested based upon the time elapsed from the ingestion of the 1st dose of study medication to the passage of the last unformed stool (TLUS), in compliance with the relevant guidelines

Secondary end-points to determine:

* The number of patients showing improvement in diarrhoea during a 24-h interval, i.e. \>50 % reduction of bowel movements.
* The number of unformed stools passed per 24-h interval, after dosing.
* The number of patients who are declared to be "well". Wellness is defined as the patient having 48 hours with no unformed stools, a maximum of two soft stools and no clinical symptoms of infectious diarrhoea.
* The number of treatment failures. A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose.
* The number and percentage of patients recovered from diarrhoea. Patients were considered to have recovered if fewer than three unformed stools were passed in the previous 24 hours and no symptom of enteric infection were present.

Arms: arm 1: Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos. arm 2: Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos. arm 3: Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
Interventions: intervention 1: 400 mg Rifamycin SV dosage intervention 2: 800 mg Rifamycin SV dosage intervention 3: 1200 mg Rifamycin SV dosage
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00651742
Conditions: Locally Advanced or Metastatic Pancreatic Cancer
Sponsor: Taiho Oncology, Inc.
Start date: 2006-01-09; Completion date: 2008-07-08
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether S-1 is effective in slowing tumor activity in participants with locally advanced or metastatic pancreatic cancer who have not had chemotherapy. The study is also looking at the safety of S-1.

Detailed description:
Locally advanced or metastatic pancreatic cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione \[FT\]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine \[CDHP\]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.

Arms: arm 1: Participants received 30 milligrams per meter square (mg/m\^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.
Interventions: intervention 1: S-1
Intervention descriptions: intervention 1: All participants received S-1 orally at a dose of 30 mg/m2 BID for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial was planned to proceed to the second stage only if sufficient efficacy was demonstrated in Stage 1.

Protocol documents:
Clinical trial NCT00423137
Conditions: Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2007-01-17; Completion date: 2008-07-09
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis

Detailed description:

Arms: arm 1: Twice daily (b.i.d.) arm 2: Twice daily (b.i.d.) arm 3: Twice daily (b.i.d.) arm 4: Twice daily (b.i.d.)
Interventions: intervention 1: BIBW 2948 BS intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule intervention 2: Capsule

Protocol documents:
Clinical trial NCT00265148
Conditions: Alzheimer's Disease
Keywords: rosiglitazone cognition cerebral glucose metabolism positron emission tomography (PET) Alzheimer's Disease
Sponsor: GlaxoSmithKline
Start date: 2004-05-18; Completion date: 2008-07-10
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a placebo-controlled study evaluating the effects of rosiglitazone on functional brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).

Detailed description:

Arms: arm 1: 4 mg once a day for 1 month increasing to 8 mg once a day (Extended Released Tablets) arm 2: Placebo dummy to match
Interventions: intervention 1: Rosiglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: Extended Release Tablets intervention 2: Placebo dummy to match

Protocol documents:
Clinical trial NCT00832390
Conditions: Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-02-14; Completion date: 2008-07-11
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
After 24 weeks of treatment evaluate the efficacy and security.

Detailed description:

Arms: arm 1: sitagliptin
Interventions: intervention 1: sitagliptin phosphate
Intervention descriptions: intervention 1: Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets

Protocol documents:
Clinical trial NCT00383188
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis Rheumatoid
Sponsor: Pfizer
Start date: 2006-12-15; Completion date: 2008-07-16
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: placebo intervention 2: PH-797804 intervention 3: PH-797804 intervention 4: PH-797804 intervention 5: PH-797804
Intervention descriptions: intervention 1: Capsule, once daily (QD) for 12 weeks intervention 2: Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks intervention 3: Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks intervention 4: Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks intervention 5: Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks

Protocol documents:
Clinical trial NCT00623363
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease motor complications dyskinesia Motor complications associated with Parkinson's
Sponsor: Daiichi Sankyo
Start date: 2007-07-13; Completion date: 2008-07-17
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.

Detailed description:

Arms: arm 1: Participants will be randomized to receive two 12-hour intravenous (IV) infusions of piclozotan administered at a plasma level of 30 ng/mL over 2 inpatient days. arm 2: Participants will be randomized to receive two 12-hour intravenous (IV) infusions of 0.9 % sodium chloride (normal saline) administered at a plasma level of 30 ng/mL over 2 inpatient days.
Interventions: intervention 1: piclozotan intervention 2: 0.9% sodium chloride (normal saline)
Intervention descriptions: intervention 1: piclozotan, intravenous (IV) infusion intervention 2: 0.9% sodium chloride (normal saline) intravenous (IV) infusion

Protocol documents:
Clinical trial NCT00157014
Conditions: Heart Diseases Heart Transplantation
Keywords: Antirejection Treatment Outcome Immunosuppression Treatment Effectiveness Anti-rejection therapy
Sponsor: Astellas Pharma Inc
Start date: 2004-05-10; Completion date: 2008-07-18
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.

Detailed description:
Subcellular markers will be assessed in relationship to cellular acute rejection in de novo cardiac transplant recipients receiving either tacrolimus or cyclosporine as their primary immunosuppressant

Two parallel active arms.

Arms: arm 1: Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant arm 2: Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant arm 3: Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant arm 4: Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
Interventions: intervention 1: Tacrolimus intervention 2: Cyclosporine intervention 3: Mycophenolate mofetil intervention 4: Methylprednisolone intervention 5: Prednisone
Intervention descriptions: intervention 1: Oral intervention 2: Oral intervention 3: Intravenous and Oral intervention 4: Intravenous intervention 5: Oral

Protocol documents:
Clinical trial NCT00778999
Conditions: Infertility
Sponsor: Organon and Co
Start date: 2006-10-01; Completion date: 2008-07-24
Enrollment: 442 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation to provide adequate numbers of good quality oocytes and embryos. This optimization is mainly valuable to a group of infertility patients (9%-24%) who respond poorly to Controlled Ovarian Stimulation(COS). It is also important for an additional 2.6% of the infertility patients who manifest a high response to gonadotropin and are at risk for hyperstimulation syndrome, a life-threatening situation. Extensive research was carried out and led to the introduction of GnRH antagonist, as an alternative to Gonadotropin Releasing Hormone (GnRH) agonist, for the prevention of premature Luteinizing Hormone (LH) surges. Further research to optimize the GnRH antagonist regimen concluded that a daily treatment with 200 IU of recombinant Follicle Stimulating Hormone (recFSH) in a GnRH antagonist regimen is safe, well tolerated and results in a good clinical outcome. This protocol is now frequently applied in the US and Europe.

Predicting a woman's response (based on the assessment of ovarian reserve) to COS is useful in determining individualized clinical management strategies for low and high responders and thus avoiding cancellation. Such prediction when based on reliable scientific evidence is valuable in consulting patients about their chances of success. A large number of studies have been performed, which used certain clinical, ultrasonographic and hormonal markers (called predictive factors), to try to optimize a COS protocol for patients who were down-regulated with a long GnRH agonist protocol. Prospective trials of predictive models have also been used to adjust the starting dose of FSH to prevent a too low or too high ovarian response. To date, however, none have been performed for women undergoing ovarian stimulation with a GnRH antagonist protocol.

The primary objective of this randomized, open-label, multicenter clinical trial was to identify one or more factors capable of predicting ovarian response in women treated with a daily dose of 200 IU recFSH in a GnRH antagonist protocol. Since many ART centers now use oral contraceptives as a means to schedule patients stimulated with recFSH and a GnRH antagonist for assisted reproduction, the trial evaluated also whether intervention with oral contraceptives affects the accuracy of predictive models for ovarian response.

Detailed description:

Arms: arm 1: Use of oral contraceptive pills prior to controlled ovarian stimulation arm 2: No use of oral contraceptive pills prior to controlled ovarian stimulation
Interventions: intervention 1: Marvelon
Intervention descriptions: intervention 1: oral contraceptive 1 tablet daily for 14 to 21 days

Protocol documents:
Clinical trial NCT00441545
Conditions: Chronic Kidney Disease, Stage 5
Sponsor: Shire
Start date: 2007-01-05; Completion date: 2008-07-31
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Detailed description:
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Arms: arm 1: Fosrenol (Lanthanum carbonate) arm 2: Sevelamer hydrochloride
Interventions: intervention 1: Fosrenol (Lanthanum Carbonate) intervention 2: Sevelamer hydrochloride
Intervention descriptions: intervention 1: The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets. intervention 2: The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.

Protocol documents:
Clinical trial NCT00450333
Conditions: Anemia Kidney Failure
Keywords: Chronic
Sponsor: Shire
Start date: 2006-10-30; Completion date: 2008-07-31
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

Detailed description:

Arms: arm 1: Erythropoietin(EPO)-naive BIW arm 2: EPO-naive QW arm 3: EPO QW arm 4: EPO Q2W
Interventions: intervention 1: Dynepo (Epoetin delta) intervention 2: Dynepo intervention 3: Dynepo intervention 4: Dynepo
Intervention descriptions: intervention 1: subcutaneous, BIW for 24 weeks intervention 2: subcutaneous, QW for 24 weeks intervention 3: subcutaneous, QW for 24 weeks intervention 4: subcutaneous, Q2W for 24 weeks

Protocol documents:
Clinical trial NCT00514813
Conditions: Anemia Kidney Failure, Chronic
Sponsor: Shire
Start date: 2007-06-06; Completion date: 2008-07-31
Enrollment: 152 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

Detailed description:

Arms: arm 1: Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject
Interventions: intervention 1: Dynepo
Intervention descriptions: intervention 1: Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject

Protocol documents:
Clinical trial NCT00065156
Conditions: Myelodysplastic Syndromes
Keywords: MDS CC-5013 Revlimid Celgene
Sponsor: Celgene
Start date: 2003-06-01; Completion date: 2008-08-01
Enrollment: 148 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: lenalidomide
Intervention descriptions: intervention 1: 10 mg orally once daily for 21 days out of a 28-day cycle (syncopated); subsequently amended (Amendment 1, dated 27 August 2003) to employ a continuous dosage regimen in which 10 mg was taken once daily for 28 day cycles (continuous). Subjects who initially began a syncopated regimen and who did not experience a dose-limiting adverse event were allowed to switch to the continuous regimen.

Protocol documents:
Clinical trial NCT00112294
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2004-12-01; Completion date: 2008-08-01
Enrollment: 755 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks. arm 2: A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
Interventions: intervention 1: Paclitaxel (Taxane) intervention 2: Docetaxel (Taxane) intervention 3: Carboplatin intervention 4: Cetuximab
Intervention descriptions: intervention 1: IV, 225 mg/m\^2 intervention 2: IV, 75 mg/m\^2 intervention 3: AUC=6, q 3 weeks (6 cycles maximum) intervention 4: Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2

Protocol documents:
Clinical trial NCT00233402
Conditions: Bladder Cancer
Keywords: Bladder Cancer Hexvix Fluorescence Cystoscopy
Sponsor: Photocure
Start date: 2005-01-01; Completion date: 2008-08-01
Enrollment: 789 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.

Detailed description:
In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors (Ta) in the bladder are relatively easy to visualize by cystoscopic examination under white light. However, dysplasia, carcinoma in situ (CIS) or small exophytic tumors are easily overlooked. These lesions are predictive of recurrence and progression of disease, and the identification of these lesions is a crucial factor for the prognosis of the patient. The present situation with 50-75% recurrence rate show the inadequacy of white light cystoscopy for detection and resection of the lesions.

A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB, a more optimal pharmacological treatment when needed, may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient.

The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Hexvix intervention 2: Standard white light cystoscopy
Intervention descriptions: intervention 1: Single Instillation, Transurethral Resection of the Bladder intervention 2: None

Protocol documents:
Clinical trial NCT00420420
Conditions: Alzheimer's Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-11-01; Completion date: 2008-08-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the efficacy and safety of an investigational medication for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication or placebo for 28 days. Tests of memory, concentration will be included. Safety will be monitored using routine clinical and laboratory tests.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MK0249 intervention 2: Comparator: Placebo (unspecified)
Intervention descriptions: intervention 1: MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period. intervention 2: MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period

Protocol documents: