ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00700180
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-09-01; Completion date: 2012-09-01
Enrollment: 303 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: bevacizumab [Avastin] intervention 3: Carboplatin-based chemotherapy
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle intervention 2: 15mg/kg iv on day 1 of each 3 week cycle intervention 3: As prescribed

Protocol documents:
Clinical trial NCT00731211
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma Metastatic Pazopanib Previously-treated
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-09-01; Completion date: 2012-09-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, non-randomized, open-label, single-arm study in patients with metastatic renal cell carcinoma who have received one prior targeted therapy with either sunitinib or bevacizumab. The planned enrollment for this study is 60 patients.

Detailed description:
All eligible patients will receive 800 mg of pazopanib orally each day continuously. Patients will be re-evaluated for treatment response after 8 weeks of daily oral pazopanib therapy. Response to therapy will be assigned using RECIST criteria (Section 6.0) Patients who have objective response or stable disease will continue treatment with evaluations every 8 weeks, until the time of tumor progression or intolerable treatment-related side effects.

Arms: arm 1: 800 mg of pazopanib orally each day continuously
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: 800 mg of pazopanib orally each day continuously

Protocol documents:
Clinical trial NCT00734344
Conditions: Acute HIV Infection
Sponsor: University of Alabama at Birmingham
Start date: 2008-09-01; Completion date: 2012-09-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-site, investigator-initiated, open-label, randomized/controlled clinical trial to compare the viral load response in plasma (and, in a subset of subjects, in gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than a commitment to life-long HAART, as has been the experimental approach in a variety of clinical protocols in the United States and Europe. Subjects will complete a 12 week course of therapy, and those who meet treatment-response and safety criteria will then undergo a similarly intensive period of virology and immunology monitoring to compare the timing and dynamics of any observed virologic rebound following the treatment intervention.

Detailed description:

Arms: arm 1: Raltegravir plus Truvada arm 2: Efavirenz plus Truvada
Interventions: intervention 1: Raltegravir intervention 2: Efavirenz intervention 3: Emtricitibine intervention 4: Tenofovir disoproxil once daily intervention 5: Tenofovir disoproxil twice daily
Intervention descriptions: intervention 1: Raltegravir 400 mg. BID intervention 2: 600 mg once daily intervention 3: 200mg once daily intervention 4: 300mg once daily intervention 5: 300mg twice daily

Protocol documents:
Clinical trial NCT00741338
Conditions: Mucopolysaccharidosis I
Keywords: MPS I, Mucopolysaccharidosis, Hurler syndrome
Sponsor: Genzyme, a Sanofi Company
Start date: 2008-09-01; Completion date: 2012-09-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.

Detailed description:

Arms: arm 1: Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39. arm 2: TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
Interventions: intervention 1: Laronidase intervention 2: Cyclosporine A (CsA) intervention 3: Azathioprine (Aza)
Intervention descriptions: intervention 1: 0.058 mg/kg - 0.58 mg/kg IV infusion weekly. intervention 2: Orally three times daily. intervention 3: Orally either every day for Cohort 1 or every other day for Cohort 2.

Protocol documents:
Clinical trial NCT00743509
Conditions: Osteosarcoma
Keywords: sarcoma Cyclophosphamide Sirolimus Progressive or recurrent, advanced (unresectable or metastatic) high-grade osteosarcoma, Ewing's or soft tissue sarcoma previously treated with chemotherapy.
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2008-08-01; Completion date: 2012-09-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase II study will assess the effectiveness of the combination of oral cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who cannot be cured by surgery, radiation or conventional chemotherapy.

Detailed description:
The purpose of this Phase II study you are being asked to participate in will assess the effectiveness of the combination of oral cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who cannot be cured by surgery, radiation or conventional chemotherapy. Malignant connective tissue tumors of soft tissue and bone (sarcomas) are highly aggressive cancers. There are few available chemotherapy treatments that are active in treating sarcomas. Sarcomas that have metastasized (spread throughout the body) are usually fatal. There is a great need to identify new active drugs to treat metastatic or relapsed sarcomas. Low dose oral daily cyclophosphamide is an established chemotherapy regimen for treatment of malignant and autoimmune disease and is generally well tolerated. Sirolimus is approved for prevention of kidney rejection after transplantation. Temsirolimus, a form of sirolimus, is approved for the treatment of kidney cancer. Sirolimus combined with cyclophosphamide in animal models of sarcoma resulted in significant anti-tumor activity. Tumor and blood samples will be studied to look for known protein targets of the medication to help learn why certain subjects have a favorable response to the treatment.

Arms: arm 1: Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.
Interventions: intervention 1: Cyclophosphamide and Sirolimus
Intervention descriptions: intervention 1: The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.

Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously

Protocol documents:
Clinical trial NCT00763867
Conditions: Heart Failure
Keywords: Heart Failure, Diastolic Decompensated Heart Failure Sildenafil Exercise Capacity
Sponsor: Duke University
Start date: 2008-09-01; Completion date: 2012-09-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Diastolic heart failure (DHF), which affects older individuals and women at a disproportionate rate, is a condition that can lead to shortness of breath and fluid build-up in the lungs. This study will evaluate the effectiveness of the medication sildenafil at improving exercise ability and health outcomes in people with DHF.

Detailed description:
DHF is a condition in which one of the chambers of the heart, the left ventricle, loses its ability to relax completely because the muscle has become too stiff. When this occurs, the heart is unable to properly fill with blood, which can lead to decreased blood circulation. People with DHF may experience shortness of breath and pulmonary congestion, which is an abnormal build-up of fluid in the lungs. Current treatment for DHF includes guidelines/recommendations to lower blood pressure, stop smoking, and lose weight, but there are no medications available to specifically treat DHF. Sildenafil, commonly known as Revatio or Viagra, is a medication that increases the supply of blood to the lungs and reduces the workload of the heart. Preliminary studies have shown that sildenafil may be beneficial at improving heart and lung function in people with DHF, but more research is needed to confirm these findings. The purpose of this study is to determine if sildenafil can improve exercise ability and health outcomes in people with DHF.

This 24-week study will enroll people with DHF. Participants will be randomly assigned to receive either sildenafil or placebo three times a day for 24 weeks. Participants will attend study visits at baseline and Weeks 1, 4, 12, 13, and 24. At most study visits, the following procedures will occur: physical exam, medical history review, questionnaires, blood collection, 6-minute walk test to measure endurance, and an exercise test. At baseline and Week 24, participants will also undergo an electrocardiogram, which will measure the electrical activity of the heart, and a cardiac magnetic resonance imaging (MRI) procedure and an echocardiogram, which will both obtain pictures of the heart. At Weeks 3, 8, 16, and 20, study researchers will call participants to collect health information.

Arms: arm 1: Placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks arm 2: Sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Interventions: intervention 1: Placebo intervention 2: Sildenafil
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00769860
Conditions: Inclusion Body Myositis
Keywords: myositis IBM inclusion body myositis
Sponsor: Richard Barohn, MD
Start date: 2008-09-01; Completion date: 2012-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Inclusion body myositis (IBM) is the most common progressive and debilitating muscle disease beginning in persons over 50 years of age. This study will assess the safety and tolerability of Arimoclomol in IBM as compared to placebo over 4 months of treatment.

Detailed description:
IBM is a chronic disorder in which muscles become inflamed (swollen) and cause muscle weakening. The cause is unknown. There is new evidence to suggest that the pathology in IBM results from cellular changes induced by a variety of stressful events and diseases. In response to these stressful events the body's normal response is to increase the levels of Heat Shock Proteins (HSP) to help counteract and stop these cellular changes. In people with IBM this increase does not appear sufficient enough to reverse these toxic cellular changes. Arimoclomol causes the body to make more of this HSP protein. By increasing HSP levels in IBM patients we hope to reverse the toxic cellular changes that might be responsible for the pathology of IBM.

Arms: arm 1: Arimoclomol arm 2: None
Interventions: intervention 1: Arimoclomol intervention 2: Placebo
Intervention descriptions: intervention 1: Arimoclomol 100 mg TID for 4 months intervention 2: Placebo for 4 months

Protocol documents:
Clinical trial NCT00799643
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus (T2D) Inflammation Obesity Metabolic Syndrome Salicylates
Sponsor: Joslin Diabetes Center
Start date: 2008-11-01; Completion date: 2012-09-01
Enrollment: 638 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Growing evidence over recent years supports a potential role for low grade chronic inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we will determine whether salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2 diabetes. The study will determine whether salicylates represent a new pharmacological option for diabetes management. The study is conducted in two stages. Enrollment in the first stage is complete. The primary objective of the first stage was to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk.

Detailed description:

Arms: arm 1: Salsalate, 3.5 g/d orally, divided dosing arm 2: Salsalate Placebo, orally, divided dosing
Interventions: intervention 1: Salsalate intervention 2: Salsalate Placebo
Intervention descriptions: intervention 1: Salsalate 3.5 g/d orally, divided dosing intervention 2: None

Protocol documents:
Clinical trial NCT00808509
Conditions: Arthritis, Rheumatoid
Keywords: adalimumab,Remission,drug discontinuation
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2009-01-01; Completion date: 2012-09-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab therapy in patients with rheumatoid arthritis who are in stable remission after treatment with adalimumab in combination with methotrexate.

Detailed description:
Treatments with adalimumab and other tumor necrosis factor (TNF) blockers, once started as therapy for rheumatoid arthritis (RA), are usually continued indefinitely. Information concerning the possibility of discontinuing anti-TNF therapy in RA patients who are in remission is limited. This is a pilot study in one country to study the effect of adalimumab discontinuation. The objective is to assess the proportion of patients with established RA in stable remission (Disease Activity Score \[DAS\]28 \<2.6) after treatment with adalimumab in combination with methotrexate, in whom it is possible to discontinue adalimumab and to compare the remission rates among patients on sustained therapy with adalimumab + methotrexate with remission rates among patients who discontinued adalimumab.

Rheumatoid arthritis patients in stable remission (DAS28 \< 2.6) treated with adalimumab + methotrexate were randomized in a 1:1 ratio to continue with adalimumab treatment or discontinue adalimumab treatment for the following 52 weeks. Subsequently an observational extension was conducted to observe patients treated at the discretion of the investigator. The observational extension period lasted until Weeks 105 - 156 (average Week 125) and consisted of one follow-up visit. Participants randomized to discontinue adalimumab therapy will be reinstituted to adalimumab if DAS28-score increases by \>1.2 units from baseline and/or is scored ≥2.6 at any visit during the study and will be followed for an additional 12 weeks.

Arms: arm 1: Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator. arm 2: Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
Interventions: intervention 1: adalimumab intervention 2: methotrexate
Intervention descriptions: intervention 1: 40 mg every other week via subcutaneous injection intervention 2: At least 10 mg/week administered orally or subcutaneously

Protocol documents:
Clinical trial NCT00833547
Conditions: Schizophrenia
Keywords: sleep schizophrenia procedural learning motor skill
Sponsor: Massachusetts General Hospital
Start date: 2006-09-01; Completion date: 2012-09-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography and sleep-dependent motor skill learning.

Detailed description:

Arms: arm 1: 3mg of eszopiclone on two consecutive nights arm 2: placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
Interventions: intervention 1: eszopiclone intervention 2: placebo
Intervention descriptions: intervention 1: 3 mg of eszopiclone at bedtime on two consecutive nights intervention 2: Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights

Protocol documents:
Clinical trial NCT00848783
Conditions: Gastric Cancer Gastric Adenocarcinoma Esophageal Cancer
Keywords: gastric cancer gastroesophageal junction stomach cancer intraperitoneal infusion capecitabine irinotecan cisplatin floxuridine
Sponsor: NYU Langone Health
Start date: 2008-05-01; Completion date: 2012-09-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the patients with advanced stomach or gastro-esophageal junction cancers in the treatment consisting of pre- and post-surgery chemotherapies.

Detailed description:
A previous Phase-II trial conducted by the same principle investigator(s), utilizing preoperative chemotherapy and intraperitoneal consolidation, was conducted in patients with locally advanced, potentially resectable gastric cancer or cancer of the gastro-esophageal junction (GEJ), both staged as T3N0, T4N0, any TN1 or TN2 disease. The data suggest that for patients with locally advanced gastric or GEJ cancer, systemic induction therapy, curative surgery with high Ro resection rates, and IP adjuvant therapy, has acceptable toxicity and encouraging survival outcome. The Medical Research Council Adjuvant Gastric Infusional Chemotherapy (MAGIC) trial has also shown that perioperative chemotherapy - chemotherapy given both before and after surgery - can provide a significant survival benefit.

The investigators hypothesize that adjuvant intraperitoneal salvage of cancer micrometastatic residues after surgery contributes to disease-free survival. The goal of this trial is to determine whether IP Floxuridine, added to adjuvant postoperative chemotherapy, prolongs patient's survival. This will be tested during the randomized open-label trial.

Arms: arm 1: 1. Induction treatment:

   Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.
2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
3. Randomization
4. Surgery.
5. Postoperative IP treatment:

   Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once
6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral arm 2: Same as Arm A except no postoperative IP treatment.
Interventions: intervention 1: Irinotecan intervention 2: Cisplatin intervention 3: Surgery intervention 4: Floxuridine intervention 5: Capecitabine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00885638
Conditions: Healthy Type 2 Diabetes
Keywords: GLP-1 Insulin secretion Macronutrients
Sponsor: Lund University
Start date: 2009-08-01; Completion date: 2012-09-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

Detailed description:
Meal ingestion releases gut hormones which stimulate insulin secretion. A most important gut hormone is the incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 is rapidly degraded and inactivated after its release by the enzyme dipeptidyl peptidase-4 (DPP-4). Inhibition of DPP-4 therefore increases the concentration of active GLP-1 after meal ingestion, which augments insulin secretion. How this process is regulated after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

Arms: arm 1: A placebo tablet is given before ingestion of macronutrients arm 2: Sitagliptin is given before ingestion of macronutrients
Interventions: intervention 1: Sitagliptin intervention 2: placebo
Intervention descriptions: intervention 1: 100 mg sitagliptin before ingestion of macronutrient intervention 2: A placebo tablet is given before ingestion of macronutrients

Protocol documents: