ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01216293
Conditions: Homeostasis Bone and Bones
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2010-11-01; Completion date: 2015-02-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.

Detailed description:
Research on drugs that affect bone homeostasis have shown changes in levels of bone formation and resorption biomarkers. This study will evaluate the effect of dexlansoprazole on bone homeostasis by assessing changes in biochemical markers of bone formation and bone resorption. This study will also assess changes in bone mineral density by dual-energy x-ray absorptiometry scan and other markers of bone homeostasis.

The study will consist of a 12-week screening period, a 26-week treatment period with a total of 5 visits during the treatment period and a follow-up visit at Week 52 for bone mineral density assessment.

Arms: arm 1: Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26. arm 2: Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. arm 3: Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26.
Interventions: intervention 1: Dexlansoprazole intervention 2: Esomeprazole intervention 3: Placebo
Intervention descriptions: intervention 1: Dexlansoprazole 60 mg capsules intervention 2: Esomeprazole 40 mg capsules intervention 3: Placebo-matching capsules

Protocol documents:
Clinical trial NCT01233050
Conditions: Colorectal Surgery
Keywords: undergoing elective colon and /or rectal surgical procedures involving an abdominal incision
Sponsor: University of Pennsylvania
Start date: 2010-12-01; Completion date: 2015-02-01
Enrollment: 802 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex \[0.7% available Iodine\] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.

Detailed description:

Arms: arm 1: Preoperative Skin Antisepsis Preparation arm 2: Preoperative Skin Antisepsis Preparation
Interventions: intervention 1: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol intervention 2: Iodine Povacrylex/74% Isopropyl Alcohol
Intervention descriptions: intervention 1: Preoperative skin antisepsis preparation intervention 2: preoperative skin antisepsis preparation

Protocol documents:
Clinical trial NCT01248104
Conditions: Cardiopulmonary Bypass
Keywords: Cardiac Surgery Antifibrinolytic agents Blood transfusion epsilon aminocaproic acid tranexamic acid
Sponsor: Loma Linda University
Start date: 2010-03-01; Completion date: 2015-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.

Detailed description:
Background: This study compares the efficacy of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in reducing blood loss in patients undergoing cardiac surgery. Methods: This was a double-blinded randomized trial. Patients (n=100) undergoing cardi- ac surgery were randomized to receive either TXA (10 mg/kg bolus followed by an infu- sion of 1mg/kg/hr) or EACA (150mg/kg bolus followed by an infusion of 20 mg/kg/hr). The primary outcome measure was a difference in transfusion amounts.

Arms: arm 1: The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The TXA group re- ceived a bolus of 10 mg / kg over 15 minutes fol- lowed by an infusion of 1 mg/kg/hr. arm 2: The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The EACA group received a bolus of 100 mg / kg given over 15 minutes shortly after induction of anesthesia followed by an infusion of 10 mg/kg/hr.
Interventions: intervention 1: Tranexamic Acid intervention 2: Aminocaproic Acid
Intervention descriptions: intervention 1: Infusion during cardiac surgery intervention 2: Infusion during cardiac surgery

Protocol documents:
Clinical trial NCT01287897
Conditions: Crohn's Disease
Keywords: Crohn's Disease safety efficacy pharmacokinetics pharmacodynamics Crohn's Disease Activity Index (CDAI)
Sponsor: Pfizer
Start date: 2011-02-01; Completion date: 2015-02-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: PF-04236921 SC injection intervention 2: PF-04236921 SC injection intervention 3: PF-04236921 SC injection
Intervention descriptions: intervention 1: Placebo delivered SC, 2 doses separated by 4 weeks intervention 2: Drug dose level 1 delivered SC, 2 doses separated by 4 weeks intervention 3: Drug dose level 2 delivered SC, 2 doses separated by 4 weeks

Protocol documents:
Clinical trial NCT01291017
Conditions: Non-small Cell Lung Cancer
Keywords: Advanced stage
Sponsor: University of Florida
Start date: 2011-02-01; Completion date: 2015-02-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy and the toxicities of the study drug PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype retinoblastoma protein (RB) and inactivated cyclin dependent kinase (CDK) N2A in the tumor.

Detailed description:
The oral drug PD0332991 is a highly selective reversible inhibitor of cyclin-dependent kinases 4 \& 6 that is being studied for use in the treatment of advanced non-small cell lung cancer.

Arms: arm 1: PD0332991 125 mg PO days 1 - 21
Interventions: intervention 1: PD0332991
Intervention descriptions: intervention 1: PD0332991 125 mg PO days 1 - 21

Protocol documents:
Clinical trial NCT01299961
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Subcutaneous Abatacept Ultrasound
Sponsor: University of California, Los Angeles
Start date: 2011-03-01; Completion date: 2015-02-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing pain and swelling) associated with significant health problems. It is a difficult disease to manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints that can cause joint damage, deformity, and progressive disability and impairment. It is estimated that 1% of the world's population suffers from this disease.

The purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.

Detailed description:

Arms: arm 1: All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Interventions: intervention 1: abatacept
Intervention descriptions: intervention 1: 125 mg once a week up to 12 months.

Protocol documents:
Clinical trial NCT01327573
Conditions: Kidney; Complications, Allograft
Keywords: chronic kidney allograft injury complement protein eculizumab Kidney transplantation
Sponsor: Sanjay Kulkarni
Start date: 2011-03-01; Completion date: 2015-02-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the effectiveness of eculizumab in recipients of kidney transplantation with donor-specific antibodies (DSA) and worsening kidney function and to assess if eculizumab improves endothelial cell injury in the kidney.

The investigators hypothesize that complement inhibition with eculizumab will reduce allograft injury, resulting from less complement-mediated injury of endothelial cells and less endothelial cell activation.

Detailed description:
This study will address the clinical challenge that currently exists in the management of kidney transplant recipients who have developed de novo DSA, have deteriorating graft function, yet have no established treatment alternative.

This is a randomized, open-label, pilot intervention trial. Post transplant patients with deteriorating renal function (defined as 20% reduction in GFR) will be screened for the development of DSA and biopsied for the presence of C4d deposition. All patients with DSA and those meeting inclusion/exclusion criteria will undergo protocol renal biopsy and will be assessed for C4d deposition. Participants will be randomized to treatment with eculizumab plus standard of care (SOC) or SOC only. Randomization will be stratified by C4d status (C4d+/C4d-) with 10 subjects (7 eculizumab, 3 SOC only) in each stratum.

Eculizumab is an antibody that has been developed to inhibit the complement protein C5. Eculizumab will be delivered via IV according to the following schedule:

* Eculizumab Induction 600mg IV every 7 days for 4 doses
* Eculizumab 900mg IV 7 days later
* Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks

Arms: arm 1: eculizumab will be given in addition to standard immunosuppression regimen (oral tacrolimus or equivalent, MMF \[mycophenolate mofetil

\], prednisone) arm 2: patients in this arm will receive standard immunosuppression regimen (oral tacrolimus or equivalent, MMF, prednisone only, no additional therapy
Interventions: intervention 1: eculizumab
Intervention descriptions: intervention 1: * Eculizumab Induction 600mg IV every 7 days for 4 doses
* Eculizumab 900mg IV 7 days later
* Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks

Protocol documents:
Clinical trial NCT01359982
Conditions: Malignant Solid Tumor Lymphomas
Keywords: Advanced Solid Tumors Lymphomas Safety Blood flow Nitric oxide Cancer Dynamic contrast enhanced MRI (DCE-MRI) Contrast Enhanced Ultrasound (CEUS)
Sponsor: EpicentRx, Inc.
Start date: 2011-09-01; Completion date: 2015-02-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.

Detailed description:
The DINAMIC (DINitroazetidines As Medications In Cancer) trial represents a provascular approach to temporarily change tumor blood flow and oxygenation. Blood supply to most tumors is poor, causing parts of tumors to have a low oxygen content which promotes aggressiveness and metastasis. The DINAMIC trial uses specific imaging techniques (including ultrasound), biopsy, and breath analysis to provide an early assessment of therapeutic activity.

Arms: arm 1: None
Interventions: intervention 1: RRx-001 intervention 2: RRx-001 intervention 3: RRx-001 intervention 4: RRx-001 intervention 5: RRx-001 intervention 6: RRx-001
Intervention descriptions: intervention 1: Dose level 1 (10 mg/m2) intervention 2: Dose Level 2 (16.7 mg/m2) intervention 3: Dose Level 3 (24.6 mg/m2) intervention 4: Dose Level 4 (33 mg/m2) intervention 5: Dose Level 5 (55.0 mg/m2) intervention 6: Dose Level 6 (83 mg/m2)

Protocol documents:
Clinical trial NCT01360996
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Sponsor: Woman's
Start date: 2011-08-01; Completion date: 2015-02-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS effectively reduces circulating androgens. Although OCs are the most common and one of the oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of PCOS women with different body mass index (BMI) are limited. This study is being done to compare the hormone and metabolic changes after treatment with low-dose oral birth control regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with different body weights.

Detailed description:
Clinically, polycystic ovary syndrome (PCOS) is a heterogeneous disorder of functional androgen excess and the features of PCOS can run through a spectrum of severity. The optimal modality for long-term treatment of PCOS should positively influence androgen synthesis, sex hormone binding globulin (SHBG) production, insulin sensitivity, the lipid profile, and clinical symptoms including hirsutism and irregular menstrual cycles. Combined oral contraceptives have been a key component of the chronic treatment of women with PCOS; improving androgen excess and regulating menstrual cycles. The effect of OCs on ovarian folliculogenesis significantly decreases androgen production. This mechanism was confirmed in both healthy women and women with PCOS. In obese patients with PCOS, it is likely that the suppression of androgen production is not as significant. It is thus possible to hypothesize that the effects of OCs in PCOS could be dependent on body weight and what is needed is a head-to-head comparison. The aim of this study is to compare the effect of 6 months of a low-dose oral contraceptive regimen of 24/4 DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg on androgen profiles, cardiometabolic measures, B-vitamin status, and menstrual cycle regulation in three groups, normal (BMI 18-24.9 kg/ m2) overweight (BMI 25-29.9 kg/ m2) and obese (BMI 30-35 kg/ m2) women with PCOS.

Arms: arm 1: Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive

Normal weight -BMI 18-24.9 kg/ m2 arm 2: Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive

BMI 25-29.9 kg/ m2 arm 3: Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive

BMI 30-34.9 kg/ m2
Interventions: intervention 1: 3 mg DRSP/20 μg EE
Intervention descriptions: intervention 1: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only

Protocol documents:
Clinical trial NCT01363011
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 Treatment Naive Treatment Experienced
Sponsor: Gilead Sciences
Start date: 2011-05-01; Completion date: 2015-02-01
Enrollment: 106 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.

Detailed description:

Arms: arm 1: Participants who have not received prior antiretroviral (ARV) treatment and who are virologically unsuppressed at baseline will initiate treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) single-tablet regimen (STR) for up to 96 weeks.

Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country. arm 2: Participants who have received prior ARV treatment and who are virologically suppressed at baseline will continue their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to cobicistat (COBI), and continuing their existing protease inhibitor (PI; either atazanavir (ATV) or darunavir (DRV)) plus 2 nucleoside reverse transcriptase inhibitor (NRTI) regimen for up to 96 weeks.

Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.
Interventions: intervention 1: E/C/F/TDF intervention 2: COBI intervention 3: ATV intervention 4: DRV intervention 5: NRTI
Intervention descriptions: intervention 1: E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily intervention 2: COBI 150 mg tablet administered with food orally once daily intervention 3: ATV 300 mg tablet administered orally once daily intervention 4: DRV 800 mg tablet administered orally once daily intervention 5: Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information.

Protocol documents:
Clinical trial NCT01374451
Conditions: Islet Cell Tumor
Keywords: Pancreatic Neuroendocrine tumors PNET Pasireotide Everolimus Advanced progressive pancreatic neuroendocrine tumor
Sponsor: Novartis Pharmaceuticals
Start date: 2011-06-01; Completion date: 2015-02-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET.

A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.

Detailed description:

Arms: arm 1: everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im arm 2: everolimus 10 mg once daily po alone
Interventions: intervention 1: Everolimus intervention 2: Pasireotide LAR
Intervention descriptions: intervention 1: Everolimus was supplied as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets intervention 2: Pasireotide LAR intra-muscular depot injections were supplied as a powder in vials containing 20 mg and 40 mg with ampoules containing 2 mL of vehicle (for reconstitution).

Protocol documents:
Clinical trial NCT01387269
Conditions: Cachexia Non-Small Cell Lung Cancer
Sponsor: Helsinn Therapeutics (U.S.), Inc
Start date: 2011-07-01; Completion date: 2015-02-01
Enrollment: 484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Detailed description:
This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.

Arms: arm 1: Anamorelin HCL 100 mg will be administered daily arm 2: Placebo tablets identical in appearance to active tablets; oral administration once daily
Interventions: intervention 1: Anamorelin HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Anamorelin HCl will be orally administered daily at least one hour before meal intervention 2: Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal

Protocol documents:
Clinical trial NCT01387282
Conditions: Cachexia Non-Small Cell Lung Cancer
Sponsor: Helsinn Therapeutics (U.S.), Inc
Start date: 2011-07-01; Completion date: 2015-02-01
Enrollment: 495 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Detailed description:
This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function.

Arms: arm 1: Investigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day. arm 2: Placebo tablets identical in appearance to active tablets; oral administration once daily
Interventions: intervention 1: Anamorelin HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal intervention 2: Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.

Protocol documents: