ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00421954
Conditions: Schizophreniform Disorder Schizoaffective Disorder Psychosis Depressive Disorder, Major Bipolar Disorder
Keywords: psychosis NOS MDD w/ psychotic features bipolar disorder w. psychotic features
Sponsor: New York State Psychiatric Institute
Start date: 2006-05-01; Completion date: 2009-05-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients, aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for 7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI) Schizophrenia Research Unit (SRU) inpatient facility.

Detailed description:
This study is an open-label assessment of the feasibility of treating adolescents with psychotic disorders (schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified \[NOS\], major depressive disorder with psychotic features, and bipolar disorder with psychotic features) in an inpatient and day hospital setting with ziprasidone (Geodon). Ziprasidone is a second-generation antipsychotic (SGA) that is FDA-approved for the treatment of schizophrenia and for the treatment of the manic phase of bipolar disorder in adults. It is also used clinically in the treatment of psychotic disorders in children, adolescents and adults. This protocol will help to elucidate the feasibility of studying the treatment of psychotic disorders with ziprasidone in adolescents 13-17 years and help facilitate the further study of the treatment of psychosis with novel agents that have a favorable side effect and weight gain profile.

The duration of the study can be up to 7 weeks. Depending on the level of symptom severity patients will be managed on either the Schizophrenia Research Unit (SRU) (GAS\<35, CGI-S\>5), or the Children's Day Unit (CDU) of the NYSPI. The seven weeks would encompass a 3 day period at the beginning of the study including time for screening and reviewing lab results. Over a period of one to two weeks patients will be titrated up to 120 mg/day (80 mg for patients under 45kg), and, if necessary, cross tapered off of another SGA that had not been working successfully. Subjects who do not respond to the medication after 1 week at the target dose will be discontinued from the study.

Arms: arm 1: None
Interventions: intervention 1: Ziprasidone
Intervention descriptions: intervention 1: subjects will use ziprasidone

Protocol documents:
Clinical trial NCT00423267
Conditions: Coccidioidomycosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-05-01; Completion date: 2009-05-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and participants in Period A may have been eligible to roll over to an open-label, non-comparitive Period B. During Period B, participants received posaconazole for a treatment duration not to exceed 12 months.

Detailed description:

Arms: arm 1: Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. arm 2: Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A.
Interventions: intervention 1: Posaconazole intervention 2: Fluconazole
Intervention descriptions: intervention 1: Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months intervention 2: Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months

Protocol documents:
Clinical trial NCT00424463
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic lateral sclerosis (ALS)
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2007-01-01; Completion date: 2009-05-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MCI-186 intervention 2: Placebo of MCI-186
Intervention descriptions: intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times. intervention 2: Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.

Protocol documents:
Clinical trial NCT00425308
Conditions: Renal Transplantation
Keywords: Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy
Sponsor: Novartis Pharmaceuticals
Start date: 2006-10-01; Completion date: 2009-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

Detailed description:

Arms: arm 1: Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids arm 2: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
Interventions: intervention 1: Everolimus + Cyclosporine intervention 2: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) intervention 3: Steroids
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00425854
Conditions: Breast Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2006-11-01; Completion date: 2009-05-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.

Detailed description:

Arms: arm 1: high dose once daily
Interventions: intervention 1: BIBW 2992
Intervention descriptions: intervention 1: high dose once daily

Protocol documents:
Clinical trial NCT00452699
Conditions: Asthma
Keywords: fluticasone propionate long-term study Salmeterol FLOVENT 250 Asthma ADVAIR 250
Sponsor: GlaxoSmithKline
Start date: 2007-05-01; Completion date: 2009-05-01
Enrollment: 621 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Detailed description:

Arms: arm 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID arm 2: Fluticasone propionate 250 mcg BID
Interventions: intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID
Intervention descriptions: intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID

Protocol documents:
Clinical trial NCT00467350
Conditions: Constipation
Keywords: constipation treatment fecal impaction pediatric
Sponsor: Children's Mercy Hospital Kansas City
Start date: 2006-12-01; Completion date: 2009-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.

Detailed description:
Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments.

Comparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation.

Arms: arm 1: Rectal enema containing mixture of milk and molasses arm 2: Medication to be taken orally once each day for three consecutive days
Interventions: intervention 1: PEG 3350 intervention 2: milk and molasses enema
Intervention descriptions: intervention 1: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance intervention 2: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance

Protocol documents:
Clinical trial NCT00477230
Conditions: Atrial Fibrillation
Keywords: AF PAF paroxysmal atrial fibrillation ablation failed drugs
Sponsor: CardioFocus
Start date: 2007-03-01; Completion date: 2009-05-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:

* A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter
* Standard drug therapy (antiarrhythmic drugs)

To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you.

Eligibility Criteria

Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:

* 18 to 80 years of age
* Frequent episodes of AF
* Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)
* Other criteria

Detailed description:

Arms: arm 1: Single ablation procedure with Endoscopic Ablation System arm 2: Medication
Interventions: intervention 1: Endoscopic Ablation System intervention 2: Standard Anti-arrhythmic Drug (AAD) Therapy
Intervention descriptions: intervention 1: Single ablation procedure with Endoscopic Ablation System intervention 2: Medication as prescribed by physician.

Protocol documents:
Clinical trial NCT00482703
Conditions: Myeloid Leukemia, Chronic
Keywords: Imatinib resistant or intolerant chronic phase CML
Sponsor: Bristol-Myers Squibb
Start date: 2007-05-01; Completion date: 2009-05-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dasatinib intervention 2: dasatinib
Intervention descriptions: intervention 1: tablets, Oral, 100 mg, once daily intervention 2: tablets, Oral, 50 mg, twice daily

Protocol documents:
Clinical trial NCT00499590
Conditions: Macular Degeneration
Keywords: AMD Macular Degeneration bevasiranib COBALT study age related macular degeneration wet AMD wet age related macular degeneration
Sponsor: OPKO Health, Inc.
Start date: 2007-08-01; Completion date: 2009-05-01
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.

Detailed description:

Arms: arm 1: Lucentis® (0.5mg) every 4 weeks. arm 2: Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. arm 3: Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.
Interventions: intervention 1: bevasiranib intervention 2: ranibizumab
Intervention descriptions: intervention 1: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks intervention 2: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Protocol documents:
Clinical trial NCT00504426
Conditions: Pain Due to Osteoporosis
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2007-07-01; Completion date: 2009-05-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: OPC-249
Intervention descriptions: intervention 1: 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)

Protocol documents:
Clinical trial NCT00519532
Conditions: Parkinson's Disease
Keywords: Neupro® Rotigotine Parkinson's Disease
Sponsor: UCB Pharma
Start date: 2007-07-01; Completion date: 2009-05-01
Enrollment: 84 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.

Detailed description:

Arms: arm 1: Rotigotine Transdermal Patch
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine transdermal patches:

10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)

Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h

Protocol documents:
Clinical trial NCT00520910
Conditions: Aging Skin Abnormalities
Keywords: Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos Skin Aging and Damage
Sponsor: University of Miami
Start date: 2007-08-01; Completion date: 2009-05-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light.

Detailed description:

Arms: arm 1: Subject is given a 7.5 mg/kg dose of Polypodium leucotomos. arm 2: Subject is not given any treatment.
Interventions: intervention 1: Polypodium leucotomos
Intervention descriptions: intervention 1: Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.

Protocol documents:
Clinical trial NCT00521339
Conditions: Psoriasis-Type Psoriasis Plaque-Type Psoriasis
Keywords: Apremilast, Psoriasis, PASI-75, sPGA
Sponsor: Amgen
Start date: 2007-08-01; Completion date: 2009-05-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will test the safety and tolerability of Apremilast twice a day in participants with recalcitrant plaque type psoriasis.

Detailed description:
This is a phase 2, multicenter, open-label, study to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and efficacy of Apremilast in participants with recalcitrant plaque-type psoriasis.

Approximately 31 participants were enrolled and received 20 mg apremilast orally BID and, in participants who are non-responders after 84 days of apremilast, 30 mg Apremilast over the course of the two study treatment phases. The study consisted of four phases: Screening Phase - up to 35 days, Treatment Phase of 84 days, Extension Phase of 84 days and a Observational Follow-up Phase of 28 days.

During the Treatment Phase, participants received two 20 mg Apremilast capsules each day. Following the Treatment Phase, participants had the option to continue on treatment during the Extension Phase. During the Extension Phase, participants either continued to take two 20 mg or dose escalated to two 30 mg of Apremilast each day. Participants who were considered responders (achieved a Psoriasis Area and Severity Index (PASI-75) at the beginning of the Extension Phase continued on 20 mg twice per day (BID) while the remaining participants received 30 mg capsules BID. The Extension Phase was introduced after some participants had already completed the study; therefore, there were several participants who never had the opportunity to continue into the Extension Phase. All participants were asked to participate in a 4-week post-treatment observational follow-up phase either upon completion of the study or upon discontinuation of study drug for those participants who terminated the study early.

Arms: arm 1: Apremilast 20 mg or 30 mg orally twice per day
Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: 20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID.

Protocol documents:
Clinical trial NCT00527488
Conditions: BPH
Keywords: Benign Prostate Hyperplasia BPH PK/PD GnRH antagonist
Sponsor: Ferring Pharmaceuticals
Start date: 2007-10-01; Completion date: 2009-05-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix.

Detailed description:
The present study aims at exploring the potential of the currently available formulation of degarelix to treat BPH with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing regimens (32 and 64 mg administered either as a single administration or as two administrations separated by 14 days) will be evaluated for 42 days.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix intervention 4: Degarelix
Intervention descriptions: intervention 1: Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. intervention 2: One dose of 32 mg administered as a single administration will be evaluated for 42 days. intervention 3: Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. intervention 4: One dose of 64 mg administered as a single administration will be evaluated for 42 days.

Protocol documents:
Clinical trial NCT00531453
Conditions: Multiple Myeloma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2007-10-01; Completion date: 2009-05-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE, dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed symptomatic multiple myeloma who have received no prior treatment and are candidates to receive high-dose therapy and autologous bone marrow/stem cell transplantation.

Detailed description:

Arms: arm 1: bortezomib, dexamethasone, and thalidomide arm 2: bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Interventions: intervention 1: bortezomib, dexamethasone, and thalidomide intervention 2: bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Intervention descriptions: intervention 1: VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21)

Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.

Thalidomide will be given by mouth (p.o.)every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime). intervention 2: VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy(HDT)and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21).

Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.

Thalidomide will be given by mouth (p.o.) every day, starting on Day 1 of Cycle 1 (e.g., the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).

Cyclophosphamide will be given as an intravenous (i.v.) dose of 400 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for a total of 4 cycles.

Protocol documents: