ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01054976
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease Galantamine Dementia
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2006-10-01; Completion date: 2009-02-01
Enrollment: 99 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine whether the administration of galantamine is effective for improvement of attention and more effective for patients with serious disturbance of attention by administering galantamine to patients with Alzheimer's dementia and performing an attention test on baseline, week 4 and 12.

Detailed description:
This is an open label (all people know the identity of the intervention), multi-center, prospective study investigating the effect of galantamine on the attention of Alzheimer's dementia patients. The objectives of this study include the evaluation of the relationship between change in attention after 4 weeks of galantamine administration and to investigate the effect of study drug after 12 weeks administration (the difference in the improvement of attention after the administration of galantamine). The secondary objective of this study is to clarify the causal relationship between improvement of attention and activities of daily living (ADL). The design of this study is prospective, open-label, multi-center study. Study populations are probable Alzheimer's dementia patients diagnosed by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association), DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria. The efficacy of study drug will be assessed by evaluating cognitive function, attention and behavioral symptoms before and after the treatment using the following assessment tools: ADAS-K-cog11 (Alzheimer's Disease Assessment Scale - cognitive subscale), computerized attention test and activities of daily living. Safety evaluations include adverse event monitoring and clinical lab tests. The patient is administered oral galantamine 8 mg/day for the first 4 weeks and then 16 mg/day. The dose of galantamine is increased up to 24 mg if tolerated.

Arms: arm 1: None
Interventions: intervention 1: Galantamine
Intervention descriptions: intervention 1: Orally administered Galantamine 8 mg/day for the first 4 weeks. Thereafter the dose will be increased to 16 mg/day. If tolerated, the dose of galantamine can be increased up to 24 mg/day.

Protocol documents:
Clinical trial NCT01060124
Conditions: Pain; Cancer
Keywords: Pain; Cancer TTS-Fentanyl D-trans Durogesic D-trans
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2007-04-01; Completion date: 2009-02-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.

Detailed description:
This is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will primarily be evaluated by participant's satisfaction with pain treatment. Participant's safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Fentanyl D-trans
Intervention descriptions: intervention 1: Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.

Protocol documents:
Clinical trial NCT01276457
Conditions: Transplantation Infection
Keywords: immunosuppression kidney transplantation everolimus safety
Sponsor: Novartis Pharmaceuticals
Start date: 2006-05-01; Completion date: 2009-02-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.

Detailed description:

Arms: arm 1: Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study. arm 2: Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
Interventions: intervention 1: Everolimus 0.25 and 0.75 mg tablets intervention 2: Cyclosporine very low dose (150-300 ng/mL) microemulsion intervention 3: Cyclosporine low dose (350-500 ng/mL) microemulsion
Intervention descriptions: intervention 1: The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range. intervention 2: The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose. intervention 3: The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.

Protocol documents:
Clinical trial NCT01361633
Conditions: Treatment Placebo
Keywords: d-cycloserine geriatric neuropsychology cognition cognitive-enhancer aging neuropsychological functioning
Sponsor: Hartford Hospital
Start date: 2008-01-01; Completion date: 2009-02-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to determine whether a study medication (d-cycloserine) improves the ability of older adults to perform on tests of neuropsychological functioning. Tests of neuropsychological functioning assess attention, memory, and executive functioning skills (for example, problem-solving, planning and organizing skills). It was hypothesized that participants who received study medication would perform better on neuropsychological tests than would participants who received the sugar pill.

Detailed description:
Accumulating data support the augmenting effects of d-cycloserine (DCS) when combined with exposure-based treatment for anxiety disorders. Additional research is needed to determine whether DCS facilitates other forms of cognitive processing (e.g., attention, memory, executive functioning) that are involved in cognitive behavioral therapies which do not rely on extinction as a mechanism of action. This question is particularly important among older adults who have experienced normal age-related declines in cognitive functioning, which may interfere with their ability to benefit from cognitive-behavioral therapies. The aim of the current study was to determine the cognitive enhancing effects of DCS on neuropsychological test performance among healthy older adults. It was hypothesized that participants who received d-cycloserine would demonstrate superior performance on neuropsychological tests than would participants who received placebo.

Arms: arm 1: 250 mg d-cycloserine arm 2: None
Interventions: intervention 1: d-cycloserine intervention 2: Sugar Pill
Intervention descriptions: intervention 1: single oral administration of 250 mg d-cycloserine intervention 2: Single oral administration 250 mg Sugar Pill

Protocol documents:
Clinical trial NCT01653158
Conditions: Advanced Non-Hematologic Malignancies
Keywords: non-hematologic cancer advanced solid tumors prostrate cancer
Sponsor: Pfizer
Start date: 2005-03-01; Completion date: 2009-02-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: CP-751,871 intervention 2: Docetaxel
Intervention descriptions: intervention 1: CP-751,871 was given intravenously \[IV\] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.

Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year). intervention 2: Docetaxel up to 75 mg/m\^2 was administered intravenously \[IV\] on Day 1 of each 3-week dosing cycle.

Protocol documents:
Clinical trial NCT01855074
Conditions: Schizophrenia Schizophreniform Disorder Schizoaffective Disorder
Keywords: Schizophrenia Schizophreniform Disorder Schizoaffective Disorder Risperidone Risperdal consta
Sponsor: Janssen-Cilag Ltd.
Start date: 2007-11-01; Completion date: 2009-02-01
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of long acting injectable microspheres of risperidone in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders (disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations).

Detailed description:
This is an open-label (all people know the identity of the intervention), longitudinal (participants are followed over time with continuous or repeated monitoring of risk factors or health-outcomes), non-randomized (a clinical trial in which the participants are not assigned by chance to different treatment groups), single-center study to evaluate the efficacy and safety of long acting microspheres of risperidone in adult participants with schizophrenia, schizophreniform or schizoaffective disorders. The duration of this study will be 12 months and duration of treatment will be 6 months. The study will include 4 visits: Baseline, and 3 follow-up visits including Week 4, 12 and 26. All eligible participants will be treated with risperidone 25 milligram (mg) intramuscular injection (injection of a substance into a muscle) for every two weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics (agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect) will be initiated with higher doses of risperidone. Doses will be adjusted according to the response of the treatment. Efficacy and safety of the participants will be primarily evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' quality of life and safety will be monitored throughout the study.

Arms: arm 1: Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion.
Interventions: intervention 1: Risperidone
Intervention descriptions: intervention 1: Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion.

Protocol documents:
Clinical trial NCT02091414
Conditions: Heart Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2006-08-01; Completion date: 2009-02-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: Participants received mycophenolate mofetil (MMF) 1.0 grams (g), orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of cyclosporine A (CsA) 4 to 6 milligrams per kilogram (mg/kg) within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
Interventions: intervention 1: mycophenolate mofetil (MMF) intervention 2: cyclosporine A (CsA) intervention 3: corticosteroids
Intervention descriptions: intervention 1: 1.0 g PO BID intervention 2: Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL intervention 3: As per the practice of each participating center

Protocol documents:
Clinical trial NCT03644095
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser Inc.
Start date: 2009-01-16; Completion date: 2009-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Determine bioequivalence, safety and tolerability of guaifenesin extended-release 600 mg (Mucinex® SE) compared to an immediate-release syrup reference product in normal healthy subjects.

Detailed description:

Arms: arm 1: Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet taken with 240 mL of water after an overnight fast arm 2: Vicks Cough Syrup for Chesty Coughs 200 mg every 4 hours taken with 240 mL of water after an overnight fast
Interventions: intervention 1: Mucinex® SE intervention 2: Vicks Cough Syrup for Chesty Coughs
Intervention descriptions: intervention 1: Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet intervention 2: Vicks Cough Syrup for Chesty Coughs 15 mL (200 mg guaifenesin q4h) immediate release (IR) syrup

Protocol documents:
Clinical trial NCT00381238
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease Rosiglitazone
Sponsor: GlaxoSmithKline
Start date: 2006-06-20; Completion date: 2009-02-03
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease.

Detailed description:

Arms: arm 1: Extended Release Tablets
Interventions: intervention 1: rosiglitazone
Intervention descriptions: intervention 1: Extended Release Tablets

Protocol documents:
Clinical trial NCT00628095
Conditions: Arthritis, Rheumatoid
Keywords: rheumatoid arthritis DMARD methotrexate
Sponsor: Pfizer
Start date: 2008-04-07; Completion date: 2009-02-04
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CE-224,535 intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mg po BID intervention 2: no active ingredient

Protocol documents:
Clinical trial NCT00202930
Conditions: Neuroblastoma Opsoclonus-myoclonus
Keywords: neuroblastoma Opsoclonus-myoclonus rituximab
Sponsor: Jean M. Tersak, M.D.
Start date: 2005-07-01; Completion date: 2009-02-05
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the feasibility of giving four weekly doses of Rituximab (anti-CD20 antibody) in the treatment of children with refractory neuroblastoma associated opsoclonus-myoclonus. Patients must have continued symptoms of opsoclonus, myoclonus and or ataxia despite surgical resection and a minimum of one month of steroid therapy. Evaluations include clinical symptoms of opsoclonus-myoclonus and ataxia as well as detailed evaluation of learning and development.

Detailed description:
Opsoclonus-myoclonus ataxia syndrome (OMS) is a rare immune mediated paraneoplastic syndrome that occurs in approximately 2 to 3% of children with neuroblastoma. Children with neuroblastoma associated opsoclonus-myoclonus tend to have a favorable prognosis from the standpoint of the cure of their cancer. Unfortunately,approximately two-thirds of this subgroup of patients are left with long term sequellae of the syndrome, including residual symptoms of opsoclonus, myoclonus, ataxia, learning difficulties and disturbance of sleep and mood.

Multiple lines of evidence indicate an immune mechanism to this rare disorder. This includes occurence of OMS in the post-infectious state, aggressive lymphocytic infiltration of the tumor in children with OMS, and documented responses to therapries that act through suppression of the immune system.

The current study utilizes four weekly doses of anti-CD 20 antibody (rituximab) to treat children with refractory OMS. Refractory disease is defined as continued symptoms of OMS despite surgical resection of the tumor and a minimum of one month of steroid therapy.

All patients have baseline OMS evaluation and detailed neurocognitive testing with all studies being repeated at the completion of the four weekly infusions. OMS testing is repeated at Month 3. OMS testing and detailed neurocognitive testing is conducted at 6 months intervals until 2 years from the initial infusion.

The goal of the study is to utilize this novel therapy to improve long term neurologic and neurodevelopmental outcome in children with refratory neuroblastoma associated opsoclonus-myoclonus.

Arms: arm 1: Single Arm
Interventions: intervention 1: anti-CD20 (Rituximab)
Intervention descriptions: intervention 1: 4 weekly doses of IV rituxan at 375 mg/m2 on days 1, 8, 15 and 22

Protocol documents:
Clinical trial NCT00696657
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-06-03; Completion date: 2009-02-05
Enrollment: 415 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None arm 11: None arm 12: None arm 13: None arm 14: None
Interventions: intervention 1: semaglutide intervention 2: semaglutide intervention 3: semaglutide intervention 4: semaglutide intervention 5: semaglutide intervention 6: semaglutide intervention 7: placebo intervention 8: placebo intervention 9: placebo intervention 10: placebo intervention 11: placebo intervention 12: liraglutide intervention 13: liraglutide
Intervention descriptions: intervention 1: 0.1 mg, once weekly, s.c. injection intervention 2: 0.2 mg, once weekly, s.c. injection intervention 3: 0.4 mg, once weekly, s.c. injection intervention 4: 0.8 mg, once weekly, s.c. injection intervention 5: 0.8 mg with titration, once weekly, s.c. injection intervention 6: 1.6 mg with titration, once weekly, s.c. injection intervention 7: 0.1 mg, once weekly, s.c. injection intervention 8: 0.2 mg, once weekly, s.c. injection intervention 9: 0.4 mg, once weekly, s.c. injection intervention 10: 0.8 mg with titration, once weekly, s.c. injection intervention 11: 1.6 mg, once weekly, s.c. injection intervention 12: 1.2 mg with titration, once daily, s.c. injection intervention 13: 1.8 mg with titration, once daily, s.c. injection

Protocol documents: