ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01479127
Conditions: Advanced Parkinson's Disease
Keywords: Levodopa-carbidopa intestinal gel Advanced Parkinson's disease Severe motor fluctuations Dyskinesia
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-10-01; Completion date: 2012-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced Parkinson's disease (PD) patients with severe motor complications. The complications of medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be investigated.

Detailed description:

Arms: arm 1: Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.

The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms.
Interventions: intervention 1: ABT-SLV187 intervention 2: Oral Levodopa/Carbidopa intervention 3: Infusion Pump: CADD-Legacy® 1400 Pump intervention 4: NJ-Tube: Silicon ED Tube intervention 5: Adaptor: Hakko Adaptor
Intervention descriptions: intervention 1: None intervention 2: Tablet; contains 100 mg levodopa and 10 mg carbidopa intervention 3: General infusion pump, manufactured by Smiths Medical (US) intervention 4: Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan) intervention 5: Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)

Protocol documents:
Clinical trial NCT00157209
Conditions: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2000-08-01; Completion date: 2012-07-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective open label, controlled, randomized study to test the safety and efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of subjects with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC). To be eligible, subjects entering the trial will have to demonstrate either stable disease or a clinical response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy) and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Following a 3 week washout period, subjects will be stratified by disease status (either Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV), and randomized to either best supportive care (BSC) plus tecemotide (L-BLP25) treatment or BSC alone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tecemotide (L-BLP25) intervention 2: Single low dose cyclophosphamide intervention 3: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: After receiving single low dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from the study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of the investigator, and in case of unavailability of study vaccine. intervention 2: A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment. intervention 3: The BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease.

Protocol documents:
Clinical trial NCT00391118
Conditions: Ovarian Cancer Fallopian Tube Neoplasms Peritoneal Neoplasm
Sponsor: Eli Lilly and Company
Start date: 2006-11-01; Completion date: 2012-07-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Participants with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many participants the tumor will shrink, or even disappear, after treatment with these drugs. But, unfortunately, the tumor will grow again in many participants. This trial will try to address the question: Can we delay the time till the tumor grows again by adding a 3rd drug to the standard therapy? To answer this question, participants will, by chance, either get the experimental drug enzastaurin or a "dummy pill" (placebo) during the chemotherapy and for up to 3 years after chemotherapy. Participants and physicians will not know if a participant gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment will be uncovered, and the number of participants with tumor growth at a specific time point will be compared between the two treatments.

Detailed description:

Arms: arm 1: Enzastaurin: 1125 milligram (mg) loading dose then 500 mg oral tablet, daily for six 21-day cycles or up to 3 years

Carboplatin: Area under the concentration time curve (AUC) 5 intravenous (IV), every (q) 21 days for six 21-day cycles

Paclitaxel:175 milligrams/square meter (mg/m²) IV, q21 days for six 21-day cycles arm 2: Carboplatin: AUC5 IV, q21 days for six 21-day cycles

Paclitaxel: 175 mg/m², IV, q21 days for six 21-day cycles

Placebo: oral tablet
Interventions: intervention 1: enzastaurin intervention 2: carboplatin intervention 3: paclitaxel intervention 4: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00410202
Conditions: Hepatitis B, Chronic
Sponsor: Bristol-Myers Squibb
Start date: 2008-03-01; Completion date: 2012-07-01
Enrollment: 629 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine

Detailed description:

Arms: arm 1: With the option of adding tenofovir at week 48. (This does not apply to Korea) arm 2: None arm 3: None
Interventions: intervention 1: Entecavir intervention 2: Tenofovir intervention 3: Adefovir intervention 4: Lamivudine
Intervention descriptions: intervention 1: Tablets, Oral, 1mg, once daily, 100 weeks intervention 2: Tablets, Oral, 300 mg, once daily intervention 3: Tablets, Oral, 10mg, once daily, 100 weeks intervention 4: Tablets, Oral, 100mg, once daily, 100 weeks

Protocol documents:
Clinical trial NCT00467363
Conditions: Birth Spontaneous Abortion
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date: 2007-06-01; Completion date: 2012-07-01
Enrollment: 1228 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.

Detailed description:
Despite the fundamental nature of reproduction, for many it is a process fraught with frustration, inefficiency and imperfections, the effects of which can be severe. Infertility affects 10-15% of couples attempting to conceive. Among all women who conceive, the incidence of spontaneous abortion (SA) has been estimated to be between 15 and 31%, and in many cases the cause is unknown. Additionally, of the four million births yearly in the United States, between 8 and 15% will be born prematurely and experience increased morbidity and mortality as a result. An intervention with even a small absolute effect on any of these outcomes has great implications at the population level due to the large potential attributable benefit.

One such potential intervention is low-dose acetylsalicylic-acid (aspirin). Aspirin has been a primary target of interest because of its anti-inflammatory, vasodilatory and platelet aggregation inhibition properties. To evaluate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortion, we are conducting a multi-site randomized controlled trial study with two sites and one data coordinating center. Women aged 18-40 currently trying to become pregnant and who have had a single spontaneous abortion in the past year will be eligible for the study. The recruitment goal is 1600 women. Participating women will be randomly assigned to one of two treatment groups. Those randomized to treatment will receive daily low-dose aspirin. Those randomized to placebo will receive daily placebo. Both groups will receive folic acid daily in accordance with recommendations from the U.S. Public Health Service for prevention of birth defects. The duration of treatment regimens (LDA and folic acid or placebo and folic acid) will be 6 menstrual cycles, with those who become pregnant continuing until the end of pregnancy. Monthly urine and blood samples will be collected and questionnaires administered.

Arms: arm 1: 81mg of low-dose aspirin plus 400micrograms of folic acid. arm 2: 400micrograms of folic acid.
Interventions: intervention 1: acetylsalicylic-acid (aspirin) intervention 2: Folic acid
Intervention descriptions: intervention 1: 81mg of low-dose aspirin plus 400micrograms of folic acid. intervention 2: 400micrograms of folic acid.

Protocol documents:
Clinical trial NCT00468546
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2003-05-01; Completion date: 2012-07-01
Enrollment: 520 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.

Detailed description:

Arms: arm 1: Participants will be administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg per os (p.o.) or parenterally once a week up to 24 weeks and will be followed up to Week 104. arm 2: Participants will be administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and will be followed up to Week 104.
Interventions: intervention 1: MabThera/Rituxan intervention 2: Methotrexate intervention 3: Placebo
Intervention descriptions: intervention 1: 1 intervention 2: 2 intervention 3: 3

Protocol documents:
Clinical trial NCT00594906
Conditions: Pelvic Fracture
Keywords: Fracture Healing Teriparatide Forteo Pelvic Fractures
Sponsor: University of Rochester
Start date: 2008-01-01; Completion date: 2012-07-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.

Detailed description:
Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing.

This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.

Arms: arm 1: 30 participants will receive teriparatide (Forteo) injection pens. arm 2: 30 participants will receive placebo injection pens.
Interventions: intervention 1: Teriparatide intervention 2: Placebo
Intervention descriptions: intervention 1: Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks) intervention 2: Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Protocol documents:
Clinical trial NCT00652626
Conditions: MDS AML Solid Tumors Multiple Myeloma Non-Hodgkin's Lymphoma Hodgkin's Disease
Keywords: MDS AML Solid Tumors Azacitidine PK Pharmacokinetics Renal Impairment Multiple Myeloma Non-Hodgkin's Lymphoma Hodgkin's Disease
Sponsor: Celgene
Start date: 2008-11-01; Completion date: 2012-07-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate three things. The first being whether azacitidine is absorbed in the body at the same rate or proportion for different concentrations. The second is to determine the effect renal impairment has or does not have on the absorption of azacitidine. The third is to determine if azacitidine is safe and well tolerated in patients with renal function impairment.

Detailed description:

Arms: arm 1: Participants with normal renal function received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m\^2 daily on Days 1-7 of each 28-day cycle. arm 2: Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m\^2 daily on Days 1-7 of each 28-day cycle. arm 3: Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m\^2 daily on Days 1-7 of each 28-day cycle. arm 4: Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m\^2 daily on Days 1-7 of each 28-day cycle. arm 5: Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5. Participants could continue treatment in the extension phase, which allowed up to 6 cycles of treatment with 75 mg/m\^2 daily on Days 1-7 of each 28-day cycle.
Interventions: intervention 1: azacitidine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00670046
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2008-05-01; Completion date: 2012-07-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Valproic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether valproic acid is more effective than observation in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well valproic acid works in treating patients with progressive, non-metastatic prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* Assess whether treatment with valproic acid (a type I histone deacetylase inhibitor) can alter the kinetics of prostate-specific antigen (PSA) progression in patients with non-metastatic prostate cancer and biochemical progression.

Secondary

* Determine the duration of PSA response.
* Assess the percentage of patients who achieve a complete response.
* Assess the percentage of patients who achieve a partial response.
* Assess the quality of life of these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.

* Arm I (observation): Patients undergo observation according to standard of care.
* Arm II (valproic acid): Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.

Arms: arm 1: Patients undergo observation according to the standard of care. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year. arm 2: Patients receive oral valproic acid twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, 6 months, and 1 year.
Interventions: intervention 1: valproic acid intervention 2: standard of care follow-up
Intervention descriptions: intervention 1: given orally intervention 2: participant follow the standard of care for patient with metastatic prostate cancer

Protocol documents:
Clinical trial NCT00680225
Conditions: Choroidal Melanoma
Keywords: Choroidal melanoma Lucentis TTT-ICG
Sponsor: New England Retina Associates
Start date: 2007-09-01; Completion date: 2012-07-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To report preliminary results on safety and tolerability of intravitreal injection of Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.

Detailed description:

Arms: arm 1: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Interventions: intervention 1: Ranibizumab injection and TTT - ICG based
Intervention descriptions: intervention 1: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.

Protocol documents:
Clinical trial NCT00680953
Conditions: Osteoporosis
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2008-05-01; Completion date: 2012-07-01
Enrollment: 1262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

Detailed description:

Arms: arm 1: Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). arm 2: Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). arm 3: Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
Interventions: intervention 1: Denosumab intervention 2: Placebo intervention 3: Alendronate sodium hydrate
Intervention descriptions: intervention 1: Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months). intervention 2: Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months). intervention 3: Oral tablet once a week for 24 months

Protocol documents:
Clinical trial NCT00694564
Conditions: Abdominal Pain
Keywords: abdominal pain children
Sponsor: Huang, Jeannie, M.D.
Start date: 2007-06-01; Completion date: 2012-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent abdominal pain in children. This will be an open-labeled study and all participants will receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of depression and pain with minimal side effects as compared to other antidepressant therapy, we hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal pain.

Detailed description:

Arms: arm 1: This an open-labeled study. All participants will be part of the treatment group and receive SAM-e. S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Interventions: intervention 1: S-adenosyl methionine
Intervention descriptions: intervention 1: S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.

Protocol documents: