ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01944969
Conditions: Major Depressive Disorder
Sponsor: H. Lundbeck A/S
Start date: 2013-10-01; Completion date: 2014-05-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)

Detailed description:
This extension safety study was terminated early because one of the lead-in studies (14571A) in elderly was terminated and because the Sponsor considered that sufficient long-term safety data has already been collected in the development programme in the population aged 18-65 yrs.

Arms: arm 1: Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: 1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)

Protocol documents:
Clinical trial NCT00083382
Conditions: Multiple Myeloma
Keywords: Myeloma Thalidomide Pamidronate Aredia Bisphosphonate Anti-Angiogenesis Smoldering/Indolent Myeloma Zometa
Sponsor: University of Arkansas
Start date: 1998-12-01; Completion date: 2014-05-01
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects.

Detailed description:
Recently laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called "anti-angiogenesis" It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.

Arms: arm 1: 200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
Interventions: intervention 1: Pamidronate intervention 2: Thalidomide intervention 3: Zometa
Intervention descriptions: intervention 1: Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy. intervention 2: All Patients will receive thalidomide 200 mg as an oral, once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met.

Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose) intervention 3: Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.

Protocol documents:
Clinical trial NCT00129545
Conditions: Atrial Fibrillation Stroke
Keywords: Atrial Fibrillation AF A Fib Stroke Coumadin Warfarin Blood thinning medication transient ischemic attack (TIA) WATCHMAN Left atrial appendage LAA isolation LAA occlusion
Sponsor: Boston Scientific Corporation
Start date: 2005-02-01; Completion date: 2014-05-01
Enrollment: 800 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

Detailed description:
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Arms: arm 1: Implant of WATCHMAN Left Atrial Appendage Closure Technology arm 2: Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin arm 3: Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
Interventions: intervention 1: WATCHMAN Left Atrial Appendage Closure Technology intervention 2: Warfarin
Intervention descriptions: intervention 1: Implant of WATCHMAN Left Atrial Appendage Closure Technology intervention 2: Subjects receive warfarin

Protocol documents:
Clinical trial NCT00182767
Conditions: Fallopian Tube Cancer Female Reproductive Cancer Recurrent Breast Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Breast Cancer Stage IV Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-01-01; Completion date: 2014-05-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is studying the side effects and best dose of ixabepilone when given together with pegylated liposomal doxorubicin hydrochloride and to see how well they work in treating women with advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer. Drugs used in chemotherapy, such as ixabepilone and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose and recommended phase II dose of ixabepilone when combined with pegylated doxorubicin hydrochloride (HCl) liposome (pegylated liposomal doxorubicin hydrochloride) in women with previously treated advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer.

II. To determine the safety profile of this regimen in these patients. III. To determine the clinical efficacy of this regimen in patients with platinum- and taxane-resistant advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.

OUTLINE: This is a phase I, multicenter, open-label, dose-escalation study of ixabepilone followed by a phase II study.

Patients receive ixabepilone intravenously (IV) over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. Courses repeat every 21-28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 2 years.

Arms: arm 1: Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
Interventions: intervention 1: ixabepilone intervention 2: pegylated liposomal doxorubicin hydrochloride
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00195013
Conditions: Peripheral Neuropathy Breast Cancer
Sponsor: Weill Medical College of Cornell University
Start date: 2003-12-01; Completion date: 2014-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.

Detailed description:
1. Determine whether oral glutamine supplementation can reduce the symptoms and signs of peripheral neuropathy.
2. Determine whether alterations in the symptoms and signs of peripheral neuropathy are correlated with an alteration of circulating nerve growth factor or insulin-like growth factor levels.
3. Assess whether oral glutamine affects circulating nerve growth factor or insulin-like growth factor levels.
4. Assess whether glutamine interferes with paclitaxel pharmacokinetics

Arms: arm 1: 10 grams three times a day (orally) for four days and then stop arm 2: 10 grams three times a day (orally) for four days and then stop
Interventions: intervention 1: glutamine intervention 2: Placebo
Intervention descriptions: intervention 1: 10 grams three times a day (orally) for four days and then stop intervention 2: 10 grams three times a day (orally) for four days and then stop

Protocol documents:
Clinical trial NCT00250718
Conditions: Non-Hodgkin's Lymphoma Cancer
Keywords: Non Hodgkin's Lymphoma Phase II Lymphoid malignancies
Sponsor: New Mexico Cancer Research Alliance
Start date: 2004-10-01; Completion date: 2014-05-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
1.1 To determine the efficacy of a combination treatment of VP-16, chlorambucil, dexamethasone, and vincristine in patients with relapsed/refractory hematological malignancies.

1.2 To determine the toxicity profile of the above regimen in this patient population.

1.3 Evaluate the effect of low dose administration of chemotherapy on angiogenesis, and correlate this with tumor responses.

Detailed description:
The purpose of the study is to see how effective the combination of chemotherapy drugs VP-16, chlorambucil, dexamethasone, and vincristine is for patients who have blood cancers that have returned or not responded to prior treatment. Some patients may also receive a medication called rituximab if their doctor thinks it is appropriate. This drug combination will be given to study participants in a low dose continuous basis. The study will also collect information about the side effects of the above drug combination on patients with these types of cancers. Previous studies on patients with non-Hodgkin's lymphoma indicate that some patients treated with this drug combination achieved a high response. The aim of this study is to test this drug combination in a controlled setting.

Arms: arm 1: Treatment with combination therapy as follows:

VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily

At least 2 courses, but no more than 8 courses total, will be administered to each patient
Interventions: intervention 1: Vincristine intervention 2: VP-16 intervention 3: Rituximab intervention 4: Dexamethasone intervention 5: Levofloxacin
Intervention descriptions: intervention 1: Vincristine should be administered intravenously through a freely-running IV. intervention 2: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. intervention 3: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.

Patients will only receive rituximab if their tumors are CD20 positive CLL or NHL.

Rituximab will only be administered to patients if they have previously had less than 8 doses. If a patient is treated with rituxan they should have at least 4 doses intervention 4: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion. intervention 5: Levofloxacin will be administered at 500 mg PO qd.

Protocol documents:
Clinical trial NCT00315588
Conditions: Diabetes Mellitus, Type 1
Keywords: Islet Transplantation
Sponsor: Rodolfo Alejandro
Start date: 2000-12-01; Completion date: 2014-05-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.

Detailed description:
1. To reverse hyperglycemia and insulin dependency by islet cell transplantation, in patients with Type 1 Diabetes Mellitus who have a stable kidney allograft;
2. To eliminate the incidence of hypoglycemic coma and unawareness by islet cell transplantation;
3. To assess long-term function of successful islet cell transplants;
4. To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells.
5. To assess the effect of exenatide to improve islet graft function and survival in subjects that demonstrate partial graft loss and have returned to using exogenous insulin.
6. To assess the ability of exenatide to improve islet survival at time of islet transplantation

Arms: arm 1: Islet Transplantation in subjects with a previous kidney transplant.
Interventions: intervention 1: Islet Transplantation
Intervention descriptions: intervention 1: Islet Transplantation in subjects with a previous kidney transplant.

Protocol documents:
Clinical trial NCT00324740
Conditions: Recurrent Renal Cell Cancer Stage III Renal Cell Cancer Stage IV Renal Cell Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-03-01; Completion date: 2014-05-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of isotretinoin when given together with vorinostat and to see how well they work in treating patients with advanced kidney cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may cause kidney cancer cells to look more like normal cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose and phase II dose of isotretinoin when given in combination with vorinostat (SAHA) in patients with advanced renal cell carcinoma. (Phase I) II. Define dose-limiting and other toxicities in patients treated with this regimen. (Phase I) III. Determine the objective response rate of patients treated with this regimen. (Phase II)

SECONDARY OBJECTIVES:

I. Conduct a pharmacokinetic analysis of this regimen in these patients. (Phase I) II. Conduct gene profiling analysis of pre-study, paraffin-embedded tissues from patients treated with this regimen. (Phase I) III. Conduct correlative studies to identify the effect of SAHA and isotretinoin on RAR-B, LRAT, and STAT1-3 expression. (Phase I)

OUTLINE: This is a multicenter, phase I, dose-escalation study of isotretinoin, followed by a multicenter, phase II, prospective, non-randomized study.

Phase I: Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of isotretinoin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Phase II: Patients receive SAHA as in phase I and isotretinoin as in phase I at the MTD determined in phase I. Tissue and blood samples are obtained for biomarker/laboratory studies in weeks 1 and 4.

Gene profile analysis is conducted on tumor tissue. After completion of study treatment, patients are followed for 12 weeks.

Arms: arm 1: Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: vorinostat intervention 2: isotretinoin
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT00358956
Conditions: Thyroid Cancer
Keywords: medullary thyroid cancer MTC hereditary medullary thyroid cancer thyroid cancer
Sponsor: Genzyme, a Sanofi Company
Start date: 2006-08-01; Completion date: 2014-05-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This will be a Phase II, open label study to establish the effect of once-daily oral doses of ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid cancer in whom no standard therapeutic option is available.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ZD6474 (vandetanib)
Intervention descriptions: intervention 1: 100 mg once daily oral tablet

Protocol documents:
Clinical trial NCT00375505
Conditions: Breast Cancer
Keywords: Breast Cancer Premenopausal Bone mineral density Cancer therapy induced bone loss zoledronic acid
Sponsor: Novartis Pharmaceuticals
Start date: 2005-10-01; Completion date: 2014-05-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment

Detailed description:

Arms: arm 1: Zoledronic acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). arm 2: Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
Interventions: intervention 1: Zoledronic acid intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo

Protocol documents:
Clinical trial NCT00375518
Conditions: Thoracic Surgery
Keywords: Thoracic Surgery Cardiopulmonary complications Atorvastatin
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2006-07-01; Completion date: 2014-05-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will compare atorvastatin (Lipitor) with a placebo (inactive pill) to see if this drug reduces heart rhythm abnormalities (arrhythmias) or lung inflammation after thoracic surgery. Preliminary results suggest that cholesterol lowering drugs (statins) may reduce problems after surgery such as arrhythmias or lung inflammation which may be serious. This study will be randomized and double blind, meaning that patients are placed in groups purely by chance, like flipping a coin. Neither the patient or doctor will know which group the patient is in.

Detailed description:
Hypothesis: Statins attenuate perioperative inflammatory and oxidative mechanisms that contribute to the initiation and severity of cardiopulmonary complications after thoracic surgery.

Aim 1. To determine whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative response to surgery and significantly reduces the composite risk of cardiovascular morbidity (atrial fibrillation (AF), acute coronary syndrome, myocardial infarction (MI), cerebrovascular accident (CVA), pulmonary embolism) and mortality within 30 days after thoracic surgery.

Aim 2. To explore whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative (CRP, IL-6, TNF, and MPO) response to surgery and significantly reduces the overall risk of pulmonary complications (atelectasis, pneumonia, pneumonitis, acute respiratory failure) after thoracic surgery.

Aim 3. To explore the association of single nucleotide polymorphism (SNP) changes in genes linked to atrial fibrillation and inflammatory markers and development of pulmonary morbidity after thoracic surgery.

Aim 4. To explore whether an imbalance between metalloproteinase (MMP)-1 and its inhibitor (TIMP) is associated with postoperative atrial fibrillation risk and/or development of pulmonary morbidity after thoracic surgery.

Arms: arm 1: Atorvastatin arm 2: placebo
Interventions: intervention 1: Atorvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days. intervention 2: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.

Protocol documents:
Clinical trial NCT00405704
Conditions: Vesicoureteral Reflux Urinary Tract Infections
Keywords: Vesicoureteral Reflux Urinary Tract Infections Renal Scarring Antibiotic Resistance Controlled Clinical Trial Trimethoprim-Sulfamethoxazole Children
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2007-05-01; Completion date: 2014-05-01
Enrollment: 607 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.

Detailed description:
This multicenter, randomized, double-blind, placebo-controlled trial was designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR). Eligibility criteria are described elsewhere. Patients were randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study was designed to recruit 600 children (approximately 300 in each treatment group). The protocol encouraged prompt evaluation of children with UTI symptoms and early therapy of culture-proven UTIs. It was expected that approximately 10% of children will have to discontinue study medication due to allergic reactions. Assuming a 20% placebo event rate and 10% non-compliance rate, the study has 83% power to detect an absolute 10% event rate in the antimicrobial prophylaxis group. If the placebo event rate is instead 25%, power is 97% to detect an absolute 10% event rate in the treated group, even if non-compliance is as high as 15%. The primary analysis is intention-to-treat with missing outcome data analyzed as UTI.

In addition to collecting follow-up data on urinary tract infections, renal scarring and antimicrobial resistance, quality of life, compliance, safety parameters, utilization of health resources, and change in VUR were assessed periodically throughout the study.

Arms: arm 1: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily. arm 2: Cherry-flavored liquid suspension matched to active comparator.
Interventions: intervention 1: Trimethoprim-Sulfamethoxazole intervention 2: Placebo
Intervention descriptions: intervention 1: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily. intervention 2: Cherry flavored liquid suspension matched to active comparator.

Protocol documents: