ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00515879
Conditions: Social Anxiety Disorder
Keywords: Generalized subtype
Sponsor: Boston University Charles River Campus
Start date: 2007-12-01; Completion date: 2011-12-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior therapy in treating people with social anxiety disorder.

Detailed description:
Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD.

Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 9-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with social situations. During 5 of the CBT sessions, participants will receive a pill containing either DCS or sugar (placebo). Assessment visits will include interviews, self-report questionnaires, and laboratory tests. These visits will occur at Weeks 1, 7, and 12 during treatment and at Months 3, 6, and 9 post-treatment.

Arms: arm 1: Participants will receive cognitive behavioral therapy plus D-cycloserine arm 2: Participants will receive cognitive behavioral therapy plus pill placebo
Interventions: intervention 1: D-cycloserine intervention 2: Cognitive behavioral therapy (CBT) intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg intervention 2: CBT sessions aim to help participants become more comfortable with social situations. intervention 3: Same dosage as active pill

Protocol documents:
Clinical trial NCT00527735
Conditions: Lung Cancer Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung
Keywords: Non Small Cell Lung Cancer (NSCLC) Small Cell Lung Cancer (SCLC)
Sponsor: Bristol-Myers Squibb
Start date: 2008-02-01; Completion date: 2011-12-01
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ipilimumab intervention 2: Placebo intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose. intervention 2: Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose. intervention 3: 175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label. intervention 4: Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

Protocol documents:
Clinical trial NCT00537771
Conditions: Breast Cancer
Keywords: Early Breast cancer adjuvant therapy hormone receptor hormonal therapy anastrozole tamoxifen
Sponsor: AstraZeneca
Start date: 2007-09-01; Completion date: 2011-12-01
Enrollment: 384 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.

The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.

Detailed description:

Arms: arm 1: Anastrozole (ARIMIDEX) arm 2: Tamoxifen
Interventions: intervention 1: Anastrozole intervention 2: Tamoxifen
Intervention descriptions: intervention 1: 1 mg once daily oral dose intervention 2: 20 mg once daily oral dose

Protocol documents:
Clinical trial NCT00555620
Conditions: Stomach Neoplasms
Sponsor: Pfizer
Start date: 2008-05-01; Completion date: 2011-12-01
Enrollment: 76 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: capecitabine intervention 2: oxaliplatin intervention 3: sunitinib malate intervention 4: capecitabine intervention 5: cisplatin intervention 6: sunitinib malate
Intervention descriptions: intervention 1: Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period. intervention 2: Oxaliplatin is given 110mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. intervention 3: sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period. intervention 4: Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period. intervention 5: Cisplatin is given 80mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. intervention 6: sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

Protocol documents:
Clinical trial NCT00558103
Conditions: Neoplasms, Breast
Keywords: GW572016 Breast Cancer RECIST Inflammatory Breast Cancer Pazopanib ErbB2 Cutaneous Disease Tykerb Inflammatory Skin Her2 Lapatinib GW786034
Sponsor: GlaxoSmithKline
Start date: 2007-12-01; Completion date: 2011-12-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

Detailed description:

Arms: arm 1: Lapatinib arm 2: Pazopanib monotherapy (open label) arm 3: Lapatinib+ pazopanib
Interventions: intervention 1: lapatinib intervention 2: Pazopanib
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration

Protocol documents:
Clinical trial NCT00575965
Conditions: Waldenstrom's Macroglobulinemia
Keywords: simvastatin
Sponsor: Dana-Farber Cancer Institute
Start date: 2007-11-01; Completion date: 2011-12-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study seeks to find new ways to treat people with Waldenstrom's Macroglobulinemia (WM). The study is for participants with slow growing WM who otherwise might not need therapy for at least 3-6 months. Simvastatin is a drug approved by the FDA for lowering cholesterol. In test tube studies the study drug appears to have direct anti-cancer effect against WM tumor cells and mast cells.

Detailed description:
OBJECTIVES:

To define objective response, time to progression and safety of Simvastatin in Waldenström's Macroglobulinemia.

STATISTICAL DESIGN:

For this phase II study, a single-stage design is used to evaluate the efficacy of Simvastatin. With a target enrollment of 30 participants, the 95% exact confidence bounds surrounding the response estimate will be no wider than +/- 19%.

Arms: arm 1: Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression.
Interventions: intervention 1: Simvastatin
Intervention descriptions: intervention 1: Oral tablets taken daily

Protocol documents:
Clinical trial NCT00577122
Conditions: Estrogen Receptor-negative Breast Cancer Progesterone Receptor-negative Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
Keywords: Medroxyprogesterone progesterone acetate (MPA) Cyclophosphamide plus Methotrexate
Sponsor: Indiana University
Start date: 2007-07-01; Completion date: 2011-12-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the impact of MPA alone and in combination with low dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the clinical benefit rate (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\] \>= 6 months) of medroxyprogesterone acetate (MPA) monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of MPA and MPA + ldoCM in this patient population. II. To explore the relationship between MPA trough level and clinical benefit. III. To explore genetic determinants of MPA bioavailability and trough concentration.

IV. To explore potential surrogates of biologic activity including Nm-23 expression in primary tumor, change in Nm-23 expression in skin, change in plasma thrombospondin (TSP)-1, change in plasma plasminogen activator inhibitor (PAI)-1 antigen and activity.

OUTLINE: Patients are assigned to 1 of 2 treatment arms.

COHORT I: Patients receive MPA orally (PO) once daily (QD).

COHORT II: Patients receive MPA as in Cohort I, cyclophosphamide PO QD, and methotrexate PO twice daily (BID) on days 1 and 2 of every week.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose. arm 2: Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.

Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.
Interventions: intervention 1: Medroxyprogesterone progesterone acetate (MPA) intervention 2: Medroxyprogesterone with Cyclophosphamide + Methotrexate
Intervention descriptions: intervention 1: 1000 mg po daily intervention 2: Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week

Protocol documents:
Clinical trial NCT00578136
Conditions: Umbilical Hernia
Keywords: Rectus Sheath Local infiltration Pain Control
Sponsor: Children's Hospital of Philadelphia
Start date: 2006-11-01; Completion date: 2011-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Umbilical hernia repair is a common painful outpatient procedure performed in children. Often analgesia for this procedure is provided by using local infiltration of the surgical site by the surgeons and perioperative opioids and NSAIDS both IV and orally. The use of opioids can cause adverse side effects which include, but are not limited to nausea, vomiting, itching, and respiratory depression, etc. The rectus sheath block can be performed in these patients to decrease their post operative pain.

Detailed description:
Umbilical hernia repair, a common Day Surgery procedure in children, is associated with considerable postoperative discomfort. The patient has to meet certain discharge criteria such as tolerating liquids, adequate level of analgesia, etc., prior to being discharged from the day surgery unit.

Currently, both rectus sheath block and local infiltration of the surgical site are used for providing post-operative analgesia for umbilical hernia repair surgery. The local infiltration can only be done at the end of the surgical procedure as it could alter the planes of the surgical field if performed preoperatively. We believe that the analgesia provided prior to the surgical incision will decrease the amount of intraoperative and postoperative opioids used and the subsequent side effects of these medications (5,6). The rectus sheath block, a regional anesthetic technique, offers possible improved pain management following umbilical hernia repair in a recent observational study (1-3,7). We will perform a double-blinded, randomized study to compare the efficacy of rectus sheath block and surgical infiltration in providing postoperative analgesia.

Arms: arm 1: 1\) One group will receive the rectus sheath block prior to Umbilical hernia repair. arm 2: 2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
Interventions: intervention 1: Bupivacaine
Intervention descriptions: intervention 1: Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area.

Protocol documents:
Clinical trial NCT00579098
Conditions: Atrial Fibrillation Arrhythmia Inflammation Endothelial Dysfunction
Keywords: Atrial Fibrillation Arrhythmia Pulmonary Vein Isolation Left atrial catheter ablation Inflammation Endothelial dysfunction
Sponsor: Mayo Clinic
Start date: 2007-12-01; Completion date: 2011-12-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial ablation procedure. We further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP) values in the blood.

Detailed description:
Although pharmacologic therapy is the traditional mainstay of therapy for AF, curative therapy has recently become possible.

There is growing evidence that inflammation may be involved in the pathogenesis of AF. CRP, a sensitive marker of systemic inflammation, is increased in patients with AF compared with patients in sinus rhythm. Elevated CRP levels are associated with increased likelihood of new onset AF and with recurrence of AF after successful cardioversion. Clinical and basic laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins may also have anti-inflammatory properties and protective effect against AF.

125 eligible patients with AF, undergoing left atrial ablation, will be randomly assigned in a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3 months after their ablation procedure.

Patients will have baseline lipids, CRP, endothelial function tests and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.

Arms: arm 1: Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days arm 2: Placebo (dummy) tablet taken once daily by mouth for 90 days
Interventions: intervention 1: Atorvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 80 mg tablet taken by mouth daily for 90 days intervention 2: Placebo tablet taken by mouth once daily for 90 days

Protocol documents:
Clinical trial NCT00580229
Conditions: Rheumatoid Arthritis
Keywords: Rituxan Rituximab
Sponsor: University of South Florida
Start date: 2007-12-01; Completion date: 2011-12-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will be an open-label prospective analysis of oral prednisone (compared to IV methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis. The study will be useful as pilot data to establish that there are no different trends between the two treatment strategies at decreasing the frequency and severity of acute infusion reactions. It would also establish proof of principle that pre-treatment with oral prednisone is equally as efficacious as IV methylprednisolone.

The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in RA.

By showing that there are no differences in the frequency or severity of acute infusion reactions after rituximab when using pre-treatment with oral prednisone compared to I.V. methylprednisolone, we will establish proof of principle that oral prednisone is a viable alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a practical advantage for both the patient and the treating physician. The patient could self-administer this treatment at home thereby decreasing the time they would need to spend at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of methylprednisolone.

Detailed description:
This study will be an open-label prospective analysis of oral prednisone (compared to IV methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis. The study will be useful as pilot data to establish that there are no different trends between the two treatment strategies at decreasing the frequency and severity of acute infusion reactions. It would also establish proof of principle that pre-treatment with oral prednisone is equally as efficacious as IV methylprednisolone.

The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in RA.

By showing that there are no differences in the frequency or severity of acute infusion reactions after rituximab when using pre-treatment with oral prednisone compared to I.V. methylprednisolone, we will establish proof of principle that oral prednisone is a viable alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a practical advantage for both the patient and the treating physician. The patient could self-administer this treatment at home thereby decreasing the time they would need to spend at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of methylprednisolone..

Arms: arm 1: Prednisone 40mg by mouth 30-60 minutes prior to rituximab.
Interventions: intervention 1: prednisone
Intervention descriptions: intervention 1: prednisone 40mg by mouth 30-60 minutes prior to rituximab

Protocol documents:
Clinical trial NCT00582205
Conditions: Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Uterine Cancer
Keywords: Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Uterine Cancer Intraperitoneal Chemotherapy IP Chemotherapy Gynecologic Cancer Women's Cancer Cisplatin Paclitaxel Recurrent Platinum Sensitive Ovarian Cancer
Sponsor: University of Oklahoma
Start date: 2006-01-01; Completion date: 2011-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.

Detailed description:
Giving chemotherapy directly into the abdomen is called intraperitoneal (IP) chemotherapy. Because ovarian, fallopian, primary peritoneal and uterine cancer spread in the abdominal cavity, giving chemotherapy drugs by infusion into the abdominal cavity may result in a greater dose of the drugs reaching the tumor cells. Intraperitoneal treatments will be administered through an implantable peritoneal catheter. These catheters are to be inserted into the peritoneal cavity, tunneled through the subcutaneous tissue, and connected to an implantable port, which is placed in the subcutaneous tissue of the anterior, inferior thorax.

Arms: arm 1: There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy
Interventions: intervention 1: Paclitaxel, Cisplatin IP
Intervention descriptions: intervention 1: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

Protocol documents:
Clinical trial NCT00585078
Conditions: Pancreatic Cancer
Keywords: capecitabine oxaliplatin
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2004-05-01; Completion date: 2011-12-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

Detailed description:
OBJECTIVES:

Primary

* To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
* To determine safety
* To determine overall survival
* To determine time to progression

Arms: arm 1: Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: