ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00729560
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Sponsor: Virginia Commonwealth University
Start date: 2008-07-01; Completion date: 2012-02-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Polycystic Ovary Syndrome (PCOS) is the major cause of infertility in the United States. Many women with PCOS demonstrate insulin resistance and a compensatory hyperinsulinemia.This is due to both an intrinsic form of insulin resistance unique to PCOS and, in many cases, acquired insulin resistance due to obesity. The importance of this observation lies in the fact that hyperinsulinemia appears to play an important pathogenetic role in the hyperandrogenism and anovulation of both obese and lean women with PCOS.

Detailed description:
Hyperinsulinemia stimulates ovarian production of androgens, especially testosterone, in PCOS. Therefore, it is theoretically possible that testosterone increases urinary clearance of D-chiro-inositol (uCl(DCI) in PCOS, and that this serves as the explanation for the correlation between uClDCI and insulin sensitivity. While we regard this possibility as unlikely, it is important that it be tested. To accomplish this, we will assess obese (Body Mass Index (BMI) \>30 kg/m2) women with and without PCOS at baseline, and again after 4 weeks of androgen action blockade with the drug flutamide. Flutamide is an antiandrogen that works by blocking the binding of androgens to the androgen receptor.

We will determine if this pharmacologic blockade i) decreases the renal clearance of DCI, ii) increases the circulating concentration of DCi, and iii) enhances the insulin-stimulated release of the D-chiro-inositol-containing inositolphosphoglycan (DCI-IPG) mediator during an OGTT.

Arms: arm 1: Flutamide arm 2: control to arm 1
Interventions: intervention 1: Flutamide intervention 2: Placebo
Intervention descriptions: intervention 1: 250 mg twice daily for 4 weeks intervention 2: Placebo twice daily for 4 weeks

Protocol documents:
Clinical trial NCT00737360
Conditions: Head and Neck Cancer
Sponsor: Taiho Pharmaceutical Co., Ltd.
Start date: 2008-08-01; Completion date: 2012-02-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TAS-106
Intervention descriptions: intervention 1: 6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Protocol documents:
Clinical trial NCT00784459
Conditions: Atopic Asthma
Keywords: Asthma Allergy
Sponsor: Washington University School of Medicine
Start date: 2008-10-01; Completion date: 2012-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine if treatment with abatacept is effective in decreasing allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick test. Following baseline evaluation, fiberoptic bronchoscopy with segmental allergen challenge (SAC) will be performed. The subjects will be randomized to either placebo or abatacept. After 12 weeks of study drug, the subjects will undergo repeat SAC. The primary endpoint will be to determine if treatment with abatacept results in a 50% or greater decrease in the percentage of eosinophils recovered in the bronchoalveolar lavage (BAL) fluid following SAC as compared to placebo control. Secondary endpoints include measures of airway obstruction and hyperreactivity, airway inflammation and symptoms as well as determination of the safety of abatacept administration in this subject population.

Detailed description:
please see summary

Arms: arm 1: Administration of Abatacept intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses. arm 2: Administration of placebo (normal saline) intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses.
Interventions: intervention 1: abatacept intervention 2: Placebo
Intervention descriptions: intervention 1: Treatment with abatacept, 10 mg/kg IV, for 5 doses. intervention 2: Treatment with Placebo, IV

Protocol documents:
Clinical trial NCT00799396
Conditions: Platelet Aggregation Inhibitors Coronary Heart Disease
Sponsor: University of Maryland, Baltimore
Start date: 2006-07-01; Completion date: 2012-02-01
Enrollment: 682 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or clopidogrel. However, studies have shown that not all people respond to these medications. The variance in treatment response may be linked to genetics. This study will examine the effects of aspirin and clopidogrel in a population whose genes are well known in order to determine the role that genes play in treatment responses.

Detailed description:
CHD is the leading cause of death in the United States. Anti-platelet agents lessen platelet aggregation and are used commonly to prevent recurrent CHD events. Two of the most common anti-platelet agents are aspirin and clopidogrel. However, up to 25% to 30% of people do not respond to these medications. Evidence indicates that treatment response may be related to genetics. The purpose of this study is to determine specific gene variants that predict response to aspirin and clopidogrel therapy.

This study is part of a larger group of studies called the Pharmacogenomics Research Network (PGRN). Participants will include the Old Order Amish of Lancaster, Pennsylvania. They are well suited for genetic studies because they are a homogenous, closed, founder population. Participants will receive 300 mg of clopidogrel on the first day, then 75 mg of clopidogrel per day for the next 6 days. On the last day of clopidogrel treatment, participants will take a single dose of 324 mg aspirin. Participants will undergo platelet function tests before and after clopidogrel alone, and then again after taking clopidogrel plus aspirin. Using the gene variation profiles across the genome, researchers will analyze which genes correspond to treatment response.

Arms: arm 1: Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
Interventions: intervention 1: Clopidogrel intervention 2: Aspirin
Intervention descriptions: intervention 1: 300 mg on first day, then 75 mg per day for the next 6 days intervention 2: Single dose of 324 mg on the last day of clopidogrel treatment

Protocol documents:
Clinical trial NCT00828191
Conditions: In Vitro Fertilization
Keywords: Luteal support in IVF
Sponsor: IBSA Institut Biochimique SA
Start date: 2008-12-01; Completion date: 2012-02-01
Enrollment: 800 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Progesterone intervention 2: Progesterone
Intervention descriptions: intervention 1: 25 mg, once a day, SC intervention 2: 100 mg, twice a day, vaginally

Protocol documents:
Clinical trial NCT00840996
Conditions: Spine Surgery
Keywords: Spine Surgery Intraocular pressure Lidocaine Epidural Anesthetic
Sponsor: The Cleveland Clinic
Start date: 2008-05-01; Completion date: 2012-02-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is determine if epidural anesthesia administered after surgery or lidocaine administered during surgery will decrease inflammation after spinal surgery and decrease the need for post operative pain medication compared to intravenous patient controlled analgesia. Participants undergoing spine surgery will be randomized into one of two groups;

\- A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion.

B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia.

Detailed description:
According to a survey of 1570 U.S neurosurgeons, in the United States about 527.000 spine surgeries were done in 1999. This represents close to 65% of the procedures performed by neurosurgeons. Furthermore, the number of hospitalizations related with spine surgery has significantly increased since 1970.

IV PCA is considered the standard of care for postoperative pain control after surgery. Intravenous opioids have significant side effects such as respiratory depression, postoperative nausea and vomiting and sedation. Furthermore, they cause delayed return of bowel function and ileus.

There is the possibility of surgically inserting a catheter into the epidural space at the end of surgery. In general epidural analgesia provides excellent pain relief after surgery and decreases opioid consumption significantly und thus opioid related postoperative complications. Furthermore epidural anesthesia affects the surgical stress response and might decrease inflammatory responses after surgery, thereby improving postoperative recovery and mobilization of the patients.

Intravenous local anesthetics have potent anti-inflammatory properties. They also decrease postoperative opioid consumption. Clinical studies have shown that perioperative local anesthetic administration significantly reduces the incidence of thrombosis and postoperative pain, shortens postoperative ileus and decreases duration of hospitalization.

Arms: arm 1: Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia. arm 2: Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia.
Interventions: intervention 1: Lidocaine intervention 2: placebo
Intervention descriptions: intervention 1: perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours intervention 2: perioperative placebo IV saline infusion of 2 mg/kg/h with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours

Protocol documents:
Clinical trial NCT00844415
Conditions: Venous Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2009-06-01; Completion date: 2012-02-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.

Detailed description:

Arms: arm 1: open label; patient to receive dabigatran etexilate BID for three days
Interventions: intervention 1: dabigatran etexilate
Intervention descriptions: intervention 1: 2.14 mg/kg BID to a max 150 mg BID

Protocol documents:
Clinical trial NCT00847613
Conditions: Arthritis, Rheumatoid
Keywords: double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays
Sponsor: Pfizer
Start date: 2009-03-01; Completion date: 2012-02-01
Enrollment: 800 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: Placebo intervention 6: CP-690,550 intervention 7: Placebo intervention 8: CP-690,550
Intervention descriptions: intervention 1: Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. intervention 2: Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period. intervention 3: Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. intervention 4: Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period. intervention 5: Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. intervention 6: Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period. intervention 7: Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. intervention 8: Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

Protocol documents:
Clinical trial NCT00859495
Conditions: Pleural Mesothelioma
Sponsor: Columbia University
Start date: 2008-02-01; Completion date: 2012-02-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to determine the feasibility (as determined by lack of serious adverse events) and tolerability (as determined by patient's ability to complete the study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.

Detailed description:
Current surgical and/or chemotherapeutic approaches for malignant pleural mesothelioma are unsatisfactory and have not been shown to significantly prolong survival, and often lead to worsened pulmonary function and quality of life. We will investigate whether a prospective trial of trimodal (surgery, pleural chemotherapy, and pleural radiation) therapy can improve the overall 1 year survival in patients with malignant pleural mesothelioma. The proposed treatment will include exploratory thoracoscopy, placement of Mediport catheters into the pleural space, intraoperative chemotherapy, repeated intraperitoneal chemotherapy, and intrapleural instillation of radioactive P32 to radiate the pleural surfaces. In addition, because this study is randomized, half the patients will receive an additional three intravenous systemic chemotherapy treatments of cisplatin and pemetrexed (Alimta) in tandem with their intrapleural chemotherapy (weeks 3, 6, and 9 only).

The potential significance of this research is that such treatment may render it less necessary to surgically remove the affected lungs in whole or in part, in order to achieve significant disease cytoreduction. We hope to alter the currently accepted paradigm that major lung surgery is an inescapable component of such treatment, and advance the concept that a combination of judicious preparative surgery, systemic chemotherapy, and locoregional drug treatment of the pleural surfaces may offer the best hope for prolongation of survival with intact lung function.

Arms: arm 1: Intrapleural chemotherapy plus systemic chemotherapy:

Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.
Interventions: intervention 1: Doxorubicin intervention 2: Cisplatin intervention 3: Pemetrexed intervention 4: Radiotherapy
Intervention descriptions: intervention 1: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species. intervention 2: Platinum-based antineoplastic intervention 3: Folate Analog Metabolic Inhibitor intervention 4: Standard procedure given 3 weeks after last dose of chemotherapy

Protocol documents:
Clinical trial NCT00865709
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal Cancer Metastasis Stage IV Liver Metastasis
Sponsor: Bayer
Start date: 2009-03-01; Completion date: 2012-02-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.

Detailed description:

Arms: arm 1: Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD) arm 2: Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin) intervention 2: Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Intervention descriptions: intervention 1: Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD) intervention 2: Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease

Protocol documents:
Clinical trial NCT00868699
Conditions: Bipolar Depression
Keywords: Bipolar I, Depression
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2009-04-01; Completion date: 2012-02-01
Enrollment: 505 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: lurasidone intervention 2: lurasidone intervention 3: Placebo
Intervention descriptions: intervention 1: lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day intervention 2: lurasidone 20 mg/day for Days 1-7 intervention 3: Placebo Comparator

Protocol documents:
Clinical trial NCT00880269
Conditions: Refractory Leukemia Acute Myelogenous Leukemia
Keywords: Acute myeloid leukemia AML relapsed acute myeloid leukemia refractory AML refractory de novo AML refractory secondary AML secondary AML AML following myelodysplastic syndrome (MDS) AML following antecedent hematological disorder (AHD) AML resistant to therapy
Sponsor: Novartis Pharmaceuticals
Start date: 2009-08-01; Completion date: 2012-02-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.

Detailed description:

Arms: arm 1: patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week. arm 2: patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
Interventions: intervention 1: Panobinostat/LBH589
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00902746
Conditions: Dysmenorrhea
Sponsor: Nobelpharma
Start date: 2009-05-01; Completion date: 2012-02-01
Enrollment: 149 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.

Detailed description:

Arms: arm 1: Norethisterone, Ethinyl Estradiol
Interventions: intervention 1: NPC-01
Intervention descriptions: intervention 1: This study consist of the following steps.

Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.

Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):

After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point.

Protocol documents: