ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00247728
Conditions: Carcinoma, Hepatocellular
Keywords: PI-88 post resection hepatoma adjuvant therapy hepatectomy hepatoma
Sponsor: Cellxpert Biotechnology Corp.
Start date: 2004-06-01; Completion date: 2008-06-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy.

Detailed description:
Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is rarely cured and recurs frequently after regional therapy or transplantation. Hepatic resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of patients at the time of surgery, and probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a curative resection have been tried, including various regimens of adjuvant and neoadjuvant therapy.

In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC patients after curative hepatic resection. The efficacy endpoints, including tumour non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated. Several risk factors associated with tumour recurrence are also being analysed.

Arms: arm 1: Untreated control arm arm 2: PI-88 160 mg/day SC injection arm 3: PI-88 250 mg/day SC injection
Interventions: intervention 1: PI-88
Intervention descriptions: intervention 1: Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks

Protocol documents:
Clinical trial NCT00249288
Conditions: Schizophrenia
Keywords: Schizophrenia Negative Symptoms Folate
Sponsor: Massachusetts General Hospital
Start date: 2003-12-01; Completion date: 2008-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.

Detailed description:
This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are:

* To examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between patients at baseline, including dietary intake and cigarette smoking.
* To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. We will also control for dietary intake cigarettes smoking, gender, and age.
* To examine the efficacy of folate supplementation for reducing negative symptoms

Arms: arm 1: Participants will receive a 2 mg/ day dose of folate, for 12 weeks arm 2: Participants will receive a 2 mg/ day dose of placebo, for 12 weeks
Interventions: intervention 1: Folate intervention 2: Placebo
Intervention descriptions: intervention 1: Folic acid taken as 2, 1mg capsule daily for 12 weeks intervention 2: Placebo taken as 2, 1mg capsule daily for 12 weeks

Protocol documents:
Clinical trial NCT00251641
Conditions: Psoriasis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-09-01; Completion date: 2008-06-01
Enrollment: 868 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may also be enrolled).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: infliximab intervention 2: methotrexate
Intervention descriptions: intervention 1: The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22. intervention 2: Methotrexate will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.

Protocol documents:
Clinical trial NCT00255034
Conditions: Hepatitis C, Chronic
Keywords: chronic hepatitis C pegylated interferon alfa-2b ribavirin Australia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-02-01; Completion date: 2008-06-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an Australian, open-label, multicenter, randomized, double-blind clinical trial designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at least F1A2). The primary endpoint will be a sustained virological response defined by undetectable HCV RNA in serum at 24 weeks after completion of therapy.

Detailed description:

Arms: arm 1: Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks arm 2: Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
Interventions: intervention 1: Peginterferon alfa-2b intervention 2: Peginterferon alfa-2b intervention 3: Ribavirin intervention 4: Ribavirin
Intervention descriptions: intervention 1: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks intervention 2: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 3: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks intervention 4: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks

Protocol documents:
Clinical trial NCT00264238
Conditions: Obsessive-Compulsive Disorder
Sponsor: Stanford University
Start date: 2006-01-01; Completion date: 2008-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).

Detailed description:
The purpose of this study is to determine whether memantine (Namenda), in doses up to 20 mg/day, will be effective in treating the OCD of adult patients who have not responded to their OCD medication. Memantine is not FDA approved for OCD, but is approved for the treatment of Alzheimer's Disease. Memantine appears to work by regulating the activity of glutamate, one of the brain's specialized messenger chemicals, which may play a role in OCD. All patients in the study will receive memantine; no one will receive placebo.

Arms: arm 1: All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder

Protocol documents:
Clinical trial NCT00284050
Conditions: Diabetic Macular Edema
Keywords: DME Diabetic macular edema ranibizumab Diabetic macular edema with center involvement
Sponsor: Novartis
Start date: 2005-10-01; Completion date: 2008-06-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.

Detailed description:

Arms: arm 1: Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections. arm 2: Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections. arm 3: Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
Interventions: intervention 1: Ranibizumab 0.3 mg intervention 2: Ranibizumab 0.5 mg intervention 3: Sham injection
Intervention descriptions: intervention 1: 6 mg/ml ranibizumab solution for intravitreal injection intervention 2: 10 mg/ml ranibizumab solution for intravitreal injection intervention 3: Non-treatment control for sham intravitreal injection.

Protocol documents:
Clinical trial NCT00284934
Conditions: Kidney Diseases
Keywords: Dose optimization immune suppressive regimen enteric-coated mycophenolate sodium EC-MPS renal transplantation kidney transplant maintenance patients Renal transplantation in maintenance
Sponsor: Novartis
Start date: 2005-12-01; Completion date: 2008-06-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.

Detailed description:

Arms: arm 1: Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) adjusted to maintain the trough blood level (C0) contained between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day. arm 2: Patients received 1440 mg/day (720 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) tapered to reach a trough blood level target contained between 2 and 4.5 ng/mL within 15 days after randomization at the most. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
Interventions: intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Tacrolimus intervention 3: Corticosteroids
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: At a dose of at least 5 mg/day.

Protocol documents:
Clinical trial NCT00285207
Conditions: Cervical Intraepithelial Neoplasia Uterine Cervical Dysplasia
Keywords: Cervical Intraepithelial Neoplasia (CIN) High-grade Cervical Intraepithelial Neoplasia High-grade Squamous Intraepithelial Lesions (HSIL) Human Papilloma Virus (HPV) High-Grade Cervical Intraepithelial Lesions (CIN 2/3)
Sponsor: Tigris Pharmaceuticals
Start date: 2006-01-01; Completion date: 2008-06-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

Detailed description:
This is a randomized, double-blind, placebo-controlled study. It will randomize patients in a 1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 5 consecutive days of a 28-day cycle for 2 cycles. Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and immunologic testing.

Arms: arm 1: Placebo administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles. arm 2: 0.25% A007 administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.
Interventions: intervention 1: placebo intervention 2: A007
Intervention descriptions: intervention 1: 5 days of 28 day cycle for 2 cycles intervention 2: 5 days of 28 day cycle

Protocol documents:
Clinical trial NCT00293020
Conditions: Pain Cancer
Keywords: Breakthrough Pain in Cancer Patients
Sponsor: BioDelivery Sciences International
Start date: 2006-02-01; Completion date: 2008-06-01
Enrollment: 244 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.

BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive) fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the disc are water soluble, so the entire dosage form dissolves within 30 minutes of application.

Detailed description:

Arms: arm 1: BEMA Fentanyl
Interventions: intervention 1: BEMA Fentanyl
Intervention descriptions: intervention 1: buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily

Protocol documents:
Clinical trial NCT00298896
Conditions: Carcinoma, Small Cell Small Cell Lung Cancer
Keywords: Lung Squamous Cell Small Cell Carcinoma Cancer Small Cell Lung Cancer
Sponsor: Sunesis Pharmaceuticals
Start date: 2006-02-01; Completion date: 2008-06-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the objective tumor response rate to SNS-595 in patients with small cell lung cancer (SCLC).

Detailed description:
Other objectives of this study are to assess the safety, survival rate, best response, time to disease progression, duration of tumor response, and to explore several potential biomarkers to see how these levels change after administration of SNS-595.

Arms: arm 1: SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
Interventions: intervention 1: SNS-595
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00314249
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Sponsor: Forest Laboratories
Start date: 2006-04-01; Completion date: 2008-06-01
Enrollment: 1025 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Detailed description:

Arms: arm 1: Placebo, oral administration, twice daily for 12 weeks arm 2: Milnacipran 100mg/day (50mg BID \[twice a day\])
Interventions: intervention 1: Placebo intervention 2: Milnacipran 100mg
Intervention descriptions: intervention 1: Placebo, oral administration, twice daily for 12 weeks intervention 2: Milnacipran 100mg per day (50mg BID \[twice a day\])

Protocol documents:
Clinical trial NCT00337571
Conditions: Behavioral Symptoms Autistic Disorder
Keywords: Serious behavioral problems in children and adolescents with AD
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2006-06-01; Completion date: 2008-06-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Detailed description:

Arms: arm 1: 5 mg arm 2: 10 mg arm 3: 15 mg arm 4: None
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, once daily, 8 weeks intervention 2: Tablets, Oral, once daily, 8 weeks

Protocol documents:
Clinical trial NCT00345540
Conditions: Ovarian Cancer
Keywords: Platinum Resistant Tumors of Ovarian Origin
Sponsor: Cellectar Biosciences, Inc.
Start date: 2006-07-01; Completion date: 2008-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin.

Detailed description:
The purpose of this research study is to learn if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer. Platinum containing drugs such as carboplatin are the standard treatment for ovarian cancer, and are effective for many women. However, in many women the cancer eventually stops responding to the chemotherapy (becomes resistant).

The active part of NOV-002 is a substance made by the body that is involved in many chemical reactions in cells. NOV-002 does not directly kill cancer cells, but previous research has shown that it may make cancer cells more likely to be killed by chemotherapy drugs. Specifically, it may help platinum chemotherapy kill cancer that has become resistant to platinum chemotherapy. Previous trials have also shown that patients receiving NOV-002 in addition to carboplatin may have tolerated chemotherapy better than those who received chemotherapy alone. NOV-002 has been used in other research studies on various types of cancer. It is approved for use in Russia. It is not approved by the US Food and Drug Administration (FDA) for use outside of research studies.

In this research study, the investigators are looking to see if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer in women whose cancer has stopped responding to carboplatin chemotherapy alone.

Arms: arm 1: NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
Interventions: intervention 1: NOV-002 intervention 2: Carboplatin
Intervention descriptions: intervention 1: 60 mg / mL / day / 20-23 Days intervention 2: AUC 5 following IV bolus administration of NOV-002

Protocol documents:
Clinical trial NCT00350844
Conditions: Sickle Cell Disease Pulmonary Hypertension
Keywords: Sickle Cell Disease Pulmonary Hypertension
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Start date: 2006-07-01; Completion date: 2008-06-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to test the hypothesis that hydroxyurea is effective for the specific treatment of secondary pulmonary hypertension found on screening in children and young adults with sickle cell disease.

Detailed description:
Increasing evidence suggests that pulmonary hypertension, defined by an elevated tricuspid regurgitant jet velocity (TRJV) on echocardiogram, is a major cause of morbidity and mortality in adults with sickle cell disease (SCD). However, both the prevalence and optimal treatment of pulmonary hypertension in children and young adults with SCD are unknown.

We hypothesize that short term therapy with hydroxyurea will decrease TRJV in children and young adults with pulmonary hypertension found on screening. Patients eligible for treatment will have had evidence of pulmonary hypertension on at least 2 screening echocardiograms. Baseline laboratory tests will be obtained and other causes of secondary pulmonary hypertension will be excluded prior to initiation of treatment. Patients will be treated with hydroxyurea according to a standard dose escalation schedule for a total of 12 months. A clinic visit will be required every 2 months and standard screening for toxicity will be performed monthly. There will be an interim analysis of the primary outcome at 6 months following therapy.

Arms: arm 1: None
Interventions: intervention 1: Hydroxyurea
Intervention descriptions: intervention 1: 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.

Protocol documents: