ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00433004
Conditions: Post Partum
Keywords: Teen Plan B Post Partum Emergency Contraception
Sponsor: University of Pennsylvania
Start date: 2007-02-01; Completion date: 2010-10-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot randomized controlled trial to assess the effects of advanced supply of emergency contraception versus routine care in a teen postpartum population. The goals are to assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.

Detailed description:

Arms: arm 1: No advance supply of emergency contraception arm 2: Advance supply of emergency contraception is given
Interventions: intervention 1: Plan B (Levonorgestrel)
Intervention descriptions: intervention 1: PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.

Protocol documents:
Clinical trial NCT00439647
Conditions: Male Osteoporosis
Keywords: Osteoporosis males vertebral fractures clinical fractures bone mineral density bone biomarkers zoledronic acid
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2010-10-01
Enrollment: 1199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.

Detailed description:

Arms: arm 1: 5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year. arm 2: 100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
Interventions: intervention 1: Zoledronic acid 5 mg iv intervention 2: Placebo
Intervention descriptions: intervention 1: Zoledronic acid 5 mg iv given once a year. intervention 2: Placebo intravenous (i.v.) once a year

Protocol documents:
Clinical trial NCT00446095
Conditions: Lymphoma
Keywords: DLCL Nodular lymphoma Mantle cell lymphoma Syk kinase
Sponsor: Rigel Pharmaceuticals
Start date: 2007-04-01; Completion date: 2010-10-01
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients: B-cell lymphoma, refractory, diffuse, nodular, mantle, other Phase I : Two groups of 6 patients, escalating dose tolerability- 28 days Phase II: Three groups of 16 patients (nodular, diffuse large cell, mantle cell plus others). Oral bid dosing with highest tolerable dose until toxicity, progression, or withdrawal

Detailed description:
This multicenter, open-label study of fostamatinib will take place in two phases.

Phase I Two cohorts, of 6 patients each, will be sequentially assigned to receive 200 mg (Cohort 1) and 250 mg (Cohort 2) PO bid of R788. Patients will be enrolled at 250 mg bid in Cohort 2 only if \< 1/6 patients in Cohort 1 experience dose-limiting toxicity (DLT) during the initial 28-day treatment period. If 2 or more patients in Cohort 1 experience DLT during the initial 28-day treatment period, patients in Cohort 2 will receive 150 mg PO bid.

Patients who do not experience DLT or disease progression may continue treatment at the assigned dose level until disease progression, toxicity or withdrawal. Patients who experience DLT may resume treatment at a lower dose level (dose will be decreased by 50 mg) when the toxicity grade has decreased to ≤ 1. Once all patients in Phase I have completed 28 days of treatment, the optimal dose of fostamatinib, based on safety and anti-tumor activity, will be determined.

Phase II 48 additional patients, 3 groups of 16 patients each, will receive fostamatinib at the optimal biologic dose PO bid until tumor progression, limiting toxicity or withdrawal. Group 1 will consist of patients with diffuse large B-cell lymphoma (DLBCL), Group 2 will consist of patients with follicular lymphoma, and Group 3 will consist of patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas (SLL), and chronic lymphocytic leukemia (CLL).

Arms: arm 1: None
Interventions: intervention 1: fostamatinib
Intervention descriptions: intervention 1: 200 mg PO BID

Protocol documents:
Clinical trial NCT00462735
Conditions: Head and Neck Cancer Cancer of the Pharynx Cancer of the Larynx Nose Neoplasms Paranasal Sinus Neoplasms Cancer of the Oral Cavity
Keywords: Cancer of the Nasal Cavity
Sponsor: Johnny Kao
Start date: 2007-02-01; Completion date: 2010-10-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.

Detailed description:

Arms: arm 1: Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
Interventions: intervention 1: Cetuximab intervention 2: Hydroxyurea intervention 3: Fluorouracil intervention 4: radiotherapy
Intervention descriptions: intervention 1: 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients intervention 2: 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation intervention 3: continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours intervention 4: Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.

Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.

Protocol documents:
Clinical trial NCT00468845
Conditions: Pain, Postoperative
Keywords: pain after hysterectomy amount of opioids used
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-06-01; Completion date: 2010-10-01
Enrollment: 501 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: pregabalin (Lyrica) intervention 2: pregabalin (Lyrica) intervention 3: matched placebo
Intervention descriptions: intervention 1: 150 mg/day double blind (divided doses) intervention 2: 300 mg/day double blind (divided doses) intervention 3: matched placebo

Protocol documents:
Clinical trial NCT00503399
Conditions: Osteoporosis
Keywords: Glucocorticoid Induced
Sponsor: Eli Lilly and Company
Start date: 2007-07-01; Completion date: 2010-10-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to test the hypothesis that teriparatide is superior to the active comparator in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density (BMD) in males with glucocorticoid-induced osteoporosis.

Detailed description:
This study is a multinational, European, multicenter, randomized, open-label, active comparator controlled study with 2 study periods: a screening phase of up to 6 weeks, and an open-label treatment phase of 18 months. Approximately 100 adult men with osteoporosis associated with sustained glucocorticoid therapy will be enrolled into the study. Approximately one-half of the participants (at all investigational sites) will be randomized to teriparatide 20 micrograms/day (ug/day given as a subcutaneous (sc) injection), and the other half randomized to risedronate 35 milligrams (mg) once weekly (QW) oral (po) tablet. All participants will receive approximately 1000 mg/day elemental calcium and 800 to 1200 international units per day (IU/day) of vitamin D.

Arms: arm 1: Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD). arm 2: Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
Interventions: intervention 1: Teriparatide intervention 2: Risedronate
Intervention descriptions: intervention 1: 20 µg/day sc for 18 months intervention 2: 35 mg/week po for 18 months

Protocol documents:
Clinical trial NCT00530088
Conditions: Head and Neck Cancer
Keywords: recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the lip and oral cavity stage 0 laryngeal cancer stage 0 lip and oral cavity cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2001-10-01; Completion date: 2010-10-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat.

PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.

Detailed description:
OBJECTIVES:

* To determine the response of patients with recurrent dysplasia, squamous cell carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated with photodynamic therapy using porfimer sodium.
* To identify the local toxicity of this treatment in these patients.

OUTLINE: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. Patients with incompletely treated or missed sites of disease may receive another dose of laser light on day 5 without additional porfimer sodium. Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the initial treatment.

After completion of study therapy, patients are followed for 1-2 months.

Arms: arm 1: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.
Interventions: intervention 1: porfimer sodium intervention 2: Photdynamic Therapy (PDT)
Intervention descriptions: intervention 1: IV intervention 2: None

Protocol documents:
Clinical trial NCT00531947
Conditions: Major Depressive Disorder
Keywords: Mental Health Adolescents Major Depressive Disorder Depression Adolescent Depression Pediatric Depression
Sponsor: Somerset Pharmaceuticals
Start date: 2007-07-01; Completion date: 2010-10-01
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of your participation in this study is to help answer the following research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major Depressive Disorder (MDD).

Detailed description:
• Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for Major Depressive Disorder (MDD) without psychotic features, single or recurrent

Arms: arm 1: Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg arm 2: Placebo Selegiline Transdermal System 6, 9 or 12
Interventions: intervention 1: Selegiline Transdermal System intervention 2: Placebo
Intervention descriptions: intervention 1: EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study intervention 2: Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study

Protocol documents:
Clinical trial NCT00532948
Conditions: Glioma
Sponsor: Hoffmann-La Roche
Start date: 2007-05-01; Completion date: 2010-10-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: capecitabine [Xeloda]
Intervention descriptions: intervention 1: 500mg/m2 po bid (starting dose)

Protocol documents:
Clinical trial NCT00533546
Conditions: Stroke
Keywords: Acute Ischemic Stroke
Sponsor: University of Rochester
Start date: 2007-09-01; Completion date: 2010-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the safety and learn more about the dose of Activated Protein C (APC) in reducing the damage from stroke.

Detailed description:
An ischemic stroke occurs when there is damage to the brain caused by blockage in the blood vessels supplying the brain. Approximately 500,000 people in the United States experience this type of stroke each year. The only approved treatment for acute stroke is to attempt to dissolve the blood clot using t-PA (tissue plasminogen activator). This treatment must be given within 3 hours of symptom onset and is associated with a risk of brain hemorrhage (bleeding in the brain) of about 6% (6 in 100 patients).

Activated Protein C (APC) is a protein in the blood that is important in dissolving blood clots and reducing inflammation. Studies in animals suggest that APC may also protect brain cells from injury caused by a stroke. We are doing this study to determine if giving APC to individuals who have had a stroke will be safe and will reduce the damage to brain cells caused by the stroke. APC is currently approved by the Food and Drug Administration (FDA) for use in patients with severe, life-threatening infections.

Arms: arm 1: Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one ho.
Interventions: intervention 1: Activated Protein C
Intervention descriptions: intervention 1: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset

Protocol documents:
Clinical trial NCT00538863
Conditions: Cancer Pain
Sponsor: INSYS Therapeutics Inc
Start date: 2007-12-01; Completion date: 2010-10-01
Enrollment: 319 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain.

Detailed description:
This was an open-label multi-center study of the safety of fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication was administered under the tongue as a simple spray and could be self-administered by patients or assisted by their caregivers. In addition to safety, there was a questionnaire to assess satisfaction with the study medication.

Subjects could enter this study by 1 of 2 routes:

* De novo subjects who meet the inclusion criteria and none of the exclusion criteria at the Screening Visit were enrolled into the Open-label Titration Period of the study. Upon successful completion of the titration period, patients entered the Open-label Maintenance Period.
* All patients who successfully completed the Double-blind Randomization Period and the Final Visit of study INS-05-001 (NCT00538850) were eligible to enter the Open-label Maintenance Period of this study.

Arms: arm 1: Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached. arm 2: Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
Interventions: intervention 1: Fentanyl sublingual spray
Intervention descriptions: intervention 1: Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg

Protocol documents:
Clinical trial NCT00549718
Conditions: Schizophrenia
Keywords: Schizophrenia SM-13496 Latuda Lurasidone
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2007-10-01; Completion date: 2010-10-01
Enrollment: 489 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Lurasidone HCl
Intervention descriptions: intervention 1: Once daily

Protocol documents:
Clinical trial NCT00559936
Conditions: Corneal Neovascularization
Sponsor: Massachusetts Eye and Ear Infirmary
Start date: 2007-02-01; Completion date: 2010-10-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization.

Detailed description:
Primary outcomes measures included neovascular area (NA), defined as the area of the corneal vessels themselves; vessel caliber (VC), defined as the mean diameter of the corneal vessels; and invasion area (IA), defined as the fraction of the total cornea into which the vessels extend. The occurrence of ocular and systemic adverse events was closely monitored throughout the course of the study.

Arms: arm 1: Each patient will receive topical Avastin in one eye.
Interventions: intervention 1: Topical Avastin 1%
Intervention descriptions: intervention 1: Avastin (bevacizumab) 1%

Protocol documents:
Clinical trial NCT00564850
Conditions: Precocious Puberty
Sponsor: Ipsen
Start date: 2007-10-01; Completion date: 2010-10-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Intervention descriptions: intervention 1: One intra muscular injection at day 1 and month 3.

Protocol documents:
Clinical trial NCT00566020
Conditions: Bipolar Disorder
Keywords: Open-label extension Tolerability Lamotrigine Safety Bipolar I disorder
Sponsor: GlaxoSmithKline
Start date: 2008-05-01; Completion date: 2010-10-01
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.: SCA104779 (NCT00550407)), i.e. the patients who receive the addition of any additional treatment to intervene in a mood episode in the double-blind phase or the patients completing the double-blind phase.

Detailed description:

Arms: arm 1: study drug
Interventions: intervention 1: BW430C (lamotrigine)
Intervention descriptions: intervention 1: lamotrigine 50mg/day-400mg/day

Protocol documents:
Clinical trial NCT00603291
Conditions: Obesity
Keywords: obesity weight loss lorcaserin APD356 BLOOM-DM hypertension dyslipidemia sleep apnea glucose tolerance cardiovascular disease Arena
Sponsor: Eisai Inc.
Start date: 2007-12-01; Completion date: 2010-10-01
Enrollment: 604 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.

Detailed description:

Arms: arm 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening arm 2: Lorcaserin 10 mg tablet each morning and evening arm 3: Matching placebo tablet each morning and evening
Interventions: intervention 1: Lorcaserin 10 mg once daily (QD) intervention 2: Lorcaserin 10 mg twice a day (BID) intervention 3: Matching Placebo
Intervention descriptions: intervention 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. intervention 2: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. intervention 3: Matching placebo tablet each morning and evening for a duration of 52 weeks.

Protocol documents: