ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00810199
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-03-01; Completion date: 2013-01-01
Enrollment: 556 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

Detailed description:

Arms: arm 1: Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drugs (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred. arm 2: Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: methotrexate intervention 3: placebo
Intervention descriptions: intervention 1: tocilizumab 8 mg IV every 4 weeks. intervention 2: Approximately 15-17 mg methotrexate capsule orally once a week. intervention 3: Placebo matching methotrexate capsule taken orally once a week.

Protocol documents:
Clinical trial NCT00815919
Conditions: Chronic Graft Versus Host Disease
Keywords: cGVHD Velcade bortezomib
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-12-01; Completion date: 2013-01-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the effectiveness of bortezomib (Velcade) plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this drug combination in this patient population. Chronic GVHD is a medical condition that may occur after allogeneic stem cell transplantation. The donor's immune system may recognize the participants body (the host) as foreign and attempt to "reject" it. Bortezomib has been used in other research studies, and information from those studies suggests that this drug may help to control the abnormal immune responses that underlie cGVHD.

Detailed description:
* Each treatment cycle lasts five weeks, during which time participants will come to the clinic to receive bortezomib intravenously once a week for the first 4 weeks. Prednisone will be taken orally on a daily basis and dose reduction may be initiated after 1 cycle of therapy.
* During all treatment cycles, participants will have the following: physical exam and blood work. At the end of cycle 3 (week 15) the participants cGVHD will be evaluated. These assessments may include an eye examination, a skin examination, a pulmonary function test and/or, a flexion assessment test.
* Participants will receive 3 cycles of bortezomib.

Arms: arm 1: None
Interventions: intervention 1: bortezomib intervention 2: Prednisone
Intervention descriptions: intervention 1: Given intravenously at a dose of 1.3 mg/m\^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles intervention 2: Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.

Protocol documents:
Clinical trial NCT00817479
Conditions: Ovarian Cancer
Keywords: Subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer
Sponsor: University of Chicago
Start date: 2003-01-01; Completion date: 2013-01-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objective is to compare changes in expression of glucocorticoid-induced genes that may be involved in cell survival signaling in the tumors of ovarian cancer patients before and after an intraoperative dose of 20mg dexamethasone.

Detailed description:
This trial will examine the upregulation of dexamethasone-inducible genes in the tumors of ovarian cancer patients undergoing surgical debulking. A core biopsy of tumor will be taken at the first opportune time during surgery. Dexamethasone 20 mg IV will then be administered, and a second biopsy taken 30 minutes later. Samples at two and four hours later will also be obtained if surgery is still in progress and biopsiable tumor remains. Tissue will be snap-frozen. Subsequently tumor will be microdissected out from stroma, and tumor RNA will be extracted for gene expression profiling. Sixteen patients with epithelial ovarian cancer receiving dexamethasone will be studied, and an additional eight patients with epithelial ovarian cancer will receive a small saline (placebo) injection and serve as controls. Enrollment is limited to those patients with a serum albumin of at least 3.0 g/dL to minimize any theoretical adverse effect of a single dose of dexamethasone on wound healing.

Arms: arm 1: 20 mg of dexamethasone arm 2: Saline
Interventions: intervention 1: Dexamethasone intervention 2: Placebo
Intervention descriptions: intervention 1: 20 MG OF DEXAMETHASONE OR PLACEBO intervention 2: Placebo saline

Protocol documents:
Clinical trial NCT00846027
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-01-01; Completion date: 2013-01-01
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m\^2 iv, and gemcitabine 200 mg/m\^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.

Detailed description:

Arms: arm 1: Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
Interventions: intervention 1: Bevacizumab intervention 2: Paclitaxel intervention 3: Gemcitabine
Intervention descriptions: intervention 1: Bevacizumab was supplied as a sterile liquid in glass vials. intervention 2: Paclitaxel was supplied as a sterile liquid in glass vials. intervention 3: Gemcitabine was supplied as a sterile liquid in glass vials.

Protocol documents:
Clinical trial NCT00849056
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
Sponsor: GlaxoSmithKline
Start date: 2009-01-01; Completion date: 2013-01-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.

Detailed description:

Arms: arm 1: Placebo albiglutide weekly injection + pioglitazone (with or without metformin) arm 2: albiglutide weekly injection + pioglitazone (with or without meformin)
Interventions: intervention 1: albiglutide intervention 2: placebo
Intervention descriptions: intervention 1: albiglutide weekly subcutaneous injection intervention 2: placebo weekly subcutaneous injection

Protocol documents:
Clinical trial NCT00906698
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-06-01; Completion date: 2013-01-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine

Detailed description:

Arms: arm 1: Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine i.v. arm 2: Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine per os.
Interventions: intervention 1: BIBW 2992 low (20mg) dosage intervention 2: BIBW 2992 medium (40mg) dosage intervention 3: BIBW 2992 high (50mg) dosage intervention 4: Vinorelbine per os 60 mg/m² intervention 5: Vinorelbine per os 80 mg/m² intervention 6: Vinorelbine i.v. 25 mg/m²
Intervention descriptions: intervention 1: Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine. intervention 2: Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine. intervention 3: Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine. intervention 4: Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15 intervention 5: Patients will receive 80 mg/m² Vinorelbine per os at J22 intervention 6: Patients will receive 25 mg/m² of Vinorelbine i.v.

Protocol documents:
Clinical trial NCT00915278
Conditions: Advanced Non-Hematologic Malignancies
Keywords: Neoplasms monoclonal antibody PF-04605412 advanced metastatic solid tumors
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2013-01-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-04605412
Intervention descriptions: intervention 1: PF-04605412 will be administered as 2 hr IV infusion every 4 or 2 weeks. Start dose is 7.5 mg. Multiple doses are foreseen. Treatment will continue until intolerable toxicity, progression of disease or patient's refusal

Protocol documents:
Clinical trial NCT00917865
Conditions: Prostate Cancers
Sponsor: David M. Schuster, MD
Start date: 2008-04-01; Completion date: 2013-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer.

The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy.

The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.

This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.

Detailed description:

Arms: arm 1: Dynamic FACBC PET of primary prostate carcinoma.
Interventions: intervention 1: anti [18F]FACBC
Intervention descriptions: intervention 1: Anti\[18F\]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate.

Protocol documents:
Clinical trial NCT00932152
Conditions: Non-small Cell Lung Cancer Postmenopausal Women
Keywords: advanced non-small cell lung cancer postmenopausal bevacizumab fulvestrant anastrozole
Sponsor: University of Pittsburgh
Start date: 2010-09-01; Completion date: 2013-01-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study will test whether dual anti-estrogen therapy (anastrozole and fulvestrant) slows the time to when the cancer progresses.

Detailed description:
Women invited to participate in this study must be post-menopausal and be 18 years of age or older. The study is being performed on a total of 100 individuals. Of this group, 75 will be in the Treatment Groups using Fulvestrant/Anastrozole with our without bevacizumab and 25 will be in the "Best Supportive Care" groups receiving no treatment or just bevacizumab at the University of Pittsburgh Medical Center.

Arms: arm 1: Best supportive care only: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support PRN arm 2: Best supportive care and Bevacizumab 15mg/kg every 21 days arm 3: Fulvestrant and anastrozole only arm 4: Fulvestrant, anastrozole and Bevacizumab
Interventions: intervention 1: fulvestrant (Faslodex) intervention 2: anastrozole (Arimidex) intervention 3: Bevacizumab (Avastin) intervention 4: Best supportive care
Intervention descriptions: intervention 1: Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 15 of cycle 1. intervention 2: Anastrozole (Arimidex) 1 mg orally QD intervention 3: Bevacizumab (Avastin) 15 mg/kg IV, every 21 days intervention 4: Subjects will not receive any chemotherapy for NSCLC nor will they received anti-cancer surgery, immunotherapy, radiotherapy or hormonal therapy. Among the therapies they may take are therapies considered acceptable include, but are not limited to, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral

Protocol documents:
Clinical trial NCT00940992
Conditions: Rosacea
Sponsor: Sol-Gel Technologies, Ltd.
Start date: 2012-01-01; Completion date: 2013-01-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

Detailed description:

Arms: arm 1: DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks arm 2: Placebo Gel applied topically once a day for 12 weeks arm 3: DER 45 EV Gel, 5% applied topically once a day for 12 weeks
Interventions: intervention 1: DER 45 EV intervention 2: Vehicle
Intervention descriptions: intervention 1: Topical application to face for 12 weeks intervention 2: Topical application to face for 12 weeks

Protocol documents:
Clinical trial NCT00958282
Conditions: Cocaine Dependence
Keywords: cocaine treatment lisdexamfetamine dependence addiction crack
Sponsor: University of Minnesota
Start date: 2009-07-01; Completion date: 2013-01-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.

Detailed description:
This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.

Arms: arm 1: lisdexamfetamine 70mg/day plus Behavior Therapy arm 2: Placebo Comparator once per day
Interventions: intervention 1: lisdexamfetamine/Behavior Therapy intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00958880
Conditions: Social Anxiety Disorder
Sponsor: Southern Methodist University
Start date: 2009-03-01; Completion date: 2013-01-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the utility of Yohimbine hydrochloride for facilitating fear extinction in a sample of patients with social phobia who will be treated with CBT.

Detailed description:
The primary aim is to determine the relative efficacy of exposure-based CBT for social phobia when conducted with adjunctive acute (prior to four of five sessions) administration of either Yohimbine hydrochloride (10.8 mg) or placebo during core exposure sessions. Based on the available evidence, the investigators hypothesize that acute treatment with Yohimbine hydrochloride prior to exposure-based CBT would facilitate the extinction of fear that occurs with this treatment and would enhance treatment outcome.

Arms: arm 1: Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy arm 2: Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
Interventions: intervention 1: Group Cognitive Behavioral Therapy intervention 2: Yohimbine Hydrochloride intervention 3: Sugar Pill
Intervention descriptions: intervention 1: 5 weeks of group CBT for Social Anxiety. The aim of CBT is to help participants become more comfortable with social situations

One arm will receive placebo augmented Group Cognitive Behavioral Therapy and the other will receive yohimbine hydrochloride augmented cognitive behavioral therapy. intervention 2: Participants in the Yohimbine augmented arm will receive 4 doses of Yohimbine Hydrochloride before 4 of the 5 group cognitive behavioral therapy sessions. intervention 3: Participants in the placebo (sugar pill) augmented arm will receive 4 doses of a sugar pill before 4 of the 5 group cognitive behavioral therapy sessions.

Protocol documents:
Clinical trial NCT00962429
Conditions: CIDP Chronic Inflammatory Demyelinating Polyneuropathy
Keywords: neuropathy, lipoic acid
Sponsor: Oregon Health and Science University
Start date: 2009-02-01; Completion date: 2013-01-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

Detailed description:
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a progressive disease leading to paralysis. CIDP is an immune-mediated disorder resulting from a synergistic interaction of T cell-mediated and B cell-mediated immune responses directed against peripheral nerve antigens. These immune mediated responses in turn increase the production of reactive oxygen intermediate and cause oxidative damage of the peripheral nerve system. Although corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) reduce impairment caused by CIDP at least temporarily and can be used as a first-line treatments, they are not ideal for long-term treatment because of serious side effects and cost. Alpha lipoic acid (LA) is an antioxidant that also possesses anti-immune activity. It is effective in treating diabetic neuropathy. It is also promising in treating patients with multiple sclerosis.

Arms: arm 1: alpha lipoic acid arm 2: sugar pill
Interventions: intervention 1: lipoic acid
Intervention descriptions: intervention 1: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.

Protocol documents:
Clinical trial NCT00962741
Conditions: Arthritis, Juvenile Idiopathic
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2013-01-01
Enrollment: 127 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.

Detailed description:

Arms: arm 1: Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Protocol documents: