ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00336895
Conditions: Immunosuppression
Keywords: Liver transplantation mycophenolate mofetil gastrointestinal adverse effects
Sponsor: University of Pittsburgh
Start date: 2006-11-01; Completion date: 2008-11-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to determine the tolerability and safety of Myfortic in liver transplant patients. Patients receiving CellCept who have GI side effects will have CellCept discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it is enteric-coated). Our hypothesis is that Myfortic has less GI side effects and will, therefore, be tolerated better than CellCept and also that Myfortic will have a comparable effectiveness to CellCept.

Detailed description:
This is a prospective, single center, open-label, safety and tolerability study on the use of Myfortic after liver transplantation. Adult liver transplant patients who are experiencing GI symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia) attributable to CellCept are eligible to enter the study. CellCept will be discontinued and replaced with Myfortic. The duration of the study will be 3 months, and during this time, we will assess the incidence and severity of GI adverse events, the incidence and severity of bone marrow suppression (leukopenia), and the incidence of cytomegalovirus (CMV) infection or disease in patients receiving Myfortic.

Arms: arm 1: All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.
Interventions: intervention 1: Myfortic
Intervention descriptions: intervention 1: Myfortic 360mg or 720 mg BID for 90 days.

Protocol documents:
Clinical trial NCT00349336
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-08-01; Completion date: 2008-11-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: XELOX intervention 3: bevacizumab [Avastin] intervention 4: FOLFOX-4
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle intervention 2: As prescribed intervention 3: 5mg/kg iv on day 1 of each 2 week cycle intervention 4: As prescribed

Protocol documents:
Clinical trial NCT00355082
Conditions: Epilepsy, Partial
Keywords: epilepsy lamotrigine Lamictal monotherapy
Sponsor: GlaxoSmithKline
Start date: 2006-05-01; Completion date: 2008-11-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.

Detailed description:
The study consists of a Treatment phase, where efficacy is determined and a Continuation phase for extended safety information. The Continuation phase is open to all Treatment phase participants and those who did not qualify for treatment because of an insufficient number of seizures during the Baseline phase.

Arms: arm 1: 300 mg/day treatment arm 2: 250 mg/day treatment
Interventions: intervention 1: lamotrigine, 300 mg/day intervention 2: lamotrigine, 250 mg/day
Intervention descriptions: intervention 1: 300 mg/day intervention 2: 250 mg/day

Protocol documents:
Clinical trial NCT00358917
Conditions: Human Immunodeficiency Virus Infections
Sponsor: Abbott
Start date: 2006-08-01; Completion date: 2008-11-01
Enrollment: 599 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) intervention 2: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Intervention descriptions: intervention 1: LPV/r 800/200 mg once-daily (QD) tablet intervention 2: LPV/r 400/100 mg twice-daily (BID) tablet

Protocol documents:
Clinical trial NCT00374543
Conditions: Generalized Anxiety Disorder Bipolar Disorder
Keywords: Bipolar Disorder Generalized Anxiety Disorder Double-blind Placebo-controlled Ziprasidone
Sponsor: Massachusetts General Hospital
Start date: 2006-02-01; Completion date: 2008-11-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience.

Detailed description:
This study would be the first prospective, placebo-controlled study to our knowledge of any pharmacotherapy strategy for the treatment of comorbid generalized anxiety (or any comorbid anxiety) in patients with bipolar disorder. Our hypotheses are:

1. Ziprasidone flexibly dosed from 40 to 160 mg/day will reduce anxiety symptoms significantly more than placebo in patients with bipolar disorder who have a full or subsyndromal diagnosis of generalized anxiety disorder (GAD).
2. Ziprasidone will be well tolerated in patients with generalized anxiety based on the incidence of treatment emergent adverse effects during 8 weeks of therapy, and based on a lack of worsening of bipolar depression, mania or hypomania compared to placebo.
3. Treatment with ziprasidone will have a significantly greater positive impact on measures of quality of life and resilience than placebo.

Arms: arm 1: Ziprasidone will be dosed on a twice daily (BID) basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day, for 8 weeks. This time period reflects the rapid onset of effect seen in studies of atypical antipsychotics, but allows time for a potentially longer response for some anxiety symptoms. arm 2: Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
Interventions: intervention 1: Ziprasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks. intervention 2: Placebo administered daily for 8 weeks

Protocol documents:
Clinical trial NCT00384111
Conditions: Follicular Lymphoma Lymphoma, Follicular
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2006-10-01; Completion date: 2008-11-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP. The two patient groups will be compared to determine if Zevalin given after R-CVP therapy provides greater benefits than receiving no additional anti-cancer therapy after R-CVP.

Detailed description:

Arms: arm 1: Participants will receive standard R-CVP followed by Zevalin Therapeutic Regimen (Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin). arm 2: Participants will receive standard R-CVP.
Interventions: intervention 1: Zevalin Therapeutic Regimen intervention 2: R-CVP
Intervention descriptions: intervention 1: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin intervention 2: Standard R-CVP

Protocol documents:
Clinical trial NCT00396591
Conditions: Ovarian Neoplasms
Keywords: Ovarian cancer malignant ascites angiogenesis angiogenesis inhibition VEGF-Trap fusion recombinant protein
Sponsor: Sanofi
Start date: 2006-10-01; Completion date: 2008-11-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites.

The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.

Detailed description:
The study consisted of:

* A 30-day screening phase prior to Day 1
* Day 1 registration and pre-treatment paracentesis
* Aflibercept administration within 1-day of registration
* Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration
* A 60-day post-treatment follow-up phase

During the study, participants were treated with Aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation:

* Participant (or legal representative) chose to withdraw from treatment
* The investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being
* Participant had intercurrent illness that prevented further administration of investigational product (IP)
* Participant had more than 2 IP dose reductions
* Participant had unacceptable adverse events (AEs)
* Participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina
* Participant required surgical intervention for intestinal obstruction or gastrointestinal perforation

Arms: arm 1: Participants with advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) treated with Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
Interventions: intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Intervention descriptions: intervention 1: 4.0 mg/kg administered intravenously (IV) once every 2 weeks

Protocol documents:
Clinical trial NCT00400634
Conditions: Idiopathic Parkinson's Disease
Sponsor: Sangamo Therapeutics
Start date: 2006-11-01; Completion date: 2008-11-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 \[AAV2\]-neurturin \[NTN\]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of the brain. The design of this study involves approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).

Detailed description:

Arms: arm 1: Intracerebral administration of CERE-120 arm 2: Sham Neurosurgery
Interventions: intervention 1: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) intervention 2: Sham Surgery
Intervention descriptions: intervention 1: CERE-120 5.4 x 10\^11 vg intervention 2: Bilateral partial thickness burr holes placed, no intraparenchymal injections

Protocol documents:
Clinical trial NCT00420017
Conditions: Atrial Fibrillation Esophagectomy
Keywords: Amiodarone Atrial fibrillation Surgical procedures, thoracic
Sponsor: Indiana University
Start date: 2005-09-01; Completion date: 2008-11-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:

Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy surgery; Determine the influence of the prevention of AF following esophagectomy surgery on post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical hospital stay; and Determine the safety of amiodarone for the prevention of AF following esophagectomy surgery.

Detailed description:
Thousands of patients undergo major esophagectomy surgery in the United States each year, during which all or a portion of the esophagus is removed. A major complication of these surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following esophagectomy can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following esophagectomy is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following esophagectomy is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important.

Amiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following esophagectomy has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in this population. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.

Arms: arm 1: Intravenous amiodarone arm 2: Control
Interventions: intervention 1: Amiodarone intervention 2: Control
Intervention descriptions: intervention 1: Intravenous amiodarone continuous infusion x 4 days intervention 2: No amiodarone

Protocol documents:
Clinical trial NCT00424008
Conditions: Asthma
Keywords: Glucocorticosteroids Dry Powder Inhaler Bronchodilator Metered-Dose Inhaler
Sponsor: Organon and Co
Start date: 2007-04-01; Completion date: 2008-11-01
Enrollment: 722 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.

Detailed description:

Arms: arm 1: Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily. arm 2: Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID
Interventions: intervention 1: Mometasone furoate/formoterol (MF/F) MDI intervention 2: Fluticasone propionate/salmeterol (F/SC) DPI
Intervention descriptions: intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks. intervention 2: Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.

Protocol documents:
Clinical trial NCT00424177
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: idiopathic thrombocytopenic purpura ITP thrombocytopenia platelets
Sponsor: GlaxoSmithKline
Start date: 2007-03-01; Completion date: 2008-11-01
Enrollment: 66 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the pharmacodynamics and durability of eltrombopag response as measured by the peripheral platelet counts.

For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: eltrombopag
Intervention descriptions: intervention 1: experimental

Protocol documents:
Clinical trial NCT00431132
Conditions: Menopause Postmenopausal Vaginal Atrophy
Sponsor: Novo Nordisk A/S
Start date: 2007-01-01; Completion date: 2008-11-01
Enrollment: 336 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

Detailed description:

Arms: arm 1: One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
Interventions: intervention 1: estradiol, 10 mcg
Intervention descriptions: intervention 1: Tablets, administered intravaginally twice weekly

Protocol documents:
Clinical trial NCT00434278
Conditions: Cystic Fibrosis
Keywords: Lung disease CF Pulmozyme
Sponsor: Genentech, Inc.
Start date: 2007-03-01; Completion date: 2008-11-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dornase alfa intervention 2: placebo
Intervention descriptions: intervention 1: 2.5 mg inhalation dose twice daily for 14±2 days intervention 2: 2.5 mg inhalation dose twice daily for 14±2 days

Protocol documents:
Clinical trial NCT00444106
Conditions: Malaria Falciparum
Keywords: Malaria hearing co-artemether auditory Plasmodium falciparum marsh fever Plasmodium infections remittent fever paludism artemether artemisinins benflumetol lumefantrine
Sponsor: Novartis
Start date: 2007-05-01; Completion date: 2008-11-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the potential effects of artemether- lumefantrine on the auditory function

Detailed description:

Arms: arm 1: Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight. arm 2: Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight. arm 3: Artesunate-mefloquine tablets containing 50 mg artesunate (Plasmotrim) and 250 mg mefloquine (Mephaquin). Artesunate 4 mg/kg/day (for 3 days) and mefloquine 25 mg/kg/day (days 2 and 3) total dose was given once daily dependent upon body weight.
Interventions: intervention 1: Artesunate-mefloquine intervention 2: Atovaquone-proguanil intervention 3: Artemether-lumefantrine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00446199
Conditions: Vasomotor Symptoms Hot Flashes
Keywords: Vasomotor symptom relief Postmenopausal women Severe to Moderate Vasomotor symptoms
Sponsor: Bayer
Start date: 2007-03-01; Completion date: 2008-11-01
Enrollment: 735 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Detailed description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Arms: arm 1: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). arm 2: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). arm 3: One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle). arm 4: Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Interventions: intervention 1: 0.5mg DRSP / 0.5mg E2 (BAY86-4891) intervention 2: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) intervention 3: Estradiol (E2 0.3mg) intervention 4: Placebo
Intervention descriptions: intervention 1: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). intervention 2: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). intervention 3: One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle). intervention 4: Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Protocol documents:
Clinical trial NCT00448227
Conditions: Herpes Simplex
Keywords: Infants, Herpes simplex infection
Sponsor: Novartis
Start date: 2007-10-01; Completion date: 2008-11-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Detailed description:

Arms: arm 1: Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
Interventions: intervention 1: famciclovir
Intervention descriptions: intervention 1: Administered orally as a single individualized dose between 25-200 mg based on body weight.

Protocol documents: