ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00777179
Conditions: NSCLC
Keywords: Vandetanib, NSCLC, Maintenance, Phase II
Sponsor: Genzyme, a Sanofi Company
Start date: 2008-10-01; Completion date: 2011-12-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vandetanib intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, oral, daily intervention 2: Placebo

Protocol documents:
Clinical trial NCT00788892
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia elderly Newly Diagnosed
Sponsor: Jazz Pharmaceuticals
Start date: 2008-10-01; Completion date: 2011-12-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens.

The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.

Detailed description:
This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or standard induction treatment with cytarabine and daunorubicin("7 and 3" regimen).

Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.

Arms: arm 1: First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 arm 2: First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Interventions: intervention 1: CPX-351 intervention 2: Cytarabine intervention 3: Daunorubicin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00789737
Conditions: Type 2 Diabetes Mellitus
Sponsor: Daiichi Sankyo
Start date: 2009-01-01; Completion date: 2011-12-01
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.

Detailed description:

Arms: arm 1: Welchol 625mg tablets arm 2: placebo
Interventions: intervention 1: Welchol intervention 2: Placebo
Intervention descriptions: intervention 1: Welchol 625mg tablets intervention 2: placebo

Protocol documents:
Clinical trial NCT00798889
Conditions: Solid Tumors
Keywords: Solid tumors
Sponsor: Pfizer
Start date: 2004-03-01; Completion date: 2011-12-01
Enrollment: 314 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol

Protocol documents:
Clinical trial NCT00809276
Conditions: Lymphoma Multiple Myeloma Leukemia Myelodysplastic Syndrome
Keywords: Acute lymphocytic leukemia (ALL) Acute myeloid leukemia (AML) Acute Leukemia Refractory or Relapsed AML Myelodysplastic syndrome (MDS) Chronic myeloid leukemia (CML) Chronic myelomonocytic leukemia Hodgkin's Lymphoma Non-Hodgkin's lymphoma Philadelphia-negative myeloproliferative disorder Hematologic Malignancies Transplantation Busulfan Fludarabine Cytoxan Bone Marrow Allogeneic Related donor unrelated donor
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2009-05-01; Completion date: 2011-12-01
Enrollment: 92 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

Detailed description:
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)

However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Interventions: intervention 1: Busulfan, Fludarabine, Cytoxan
Intervention descriptions: intervention 1: Busulfan once a day for 4 days

Fludarabine once a day for 4 days

Bone marrow transplant

Cytoxan two doses

Protocol documents:
Clinical trial NCT00817219
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2009-07-01; Completion date: 2011-12-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.

Detailed description:
TACLONEX ointment has marketing approval in many countries for the treatment of psoriasis vulgaris in adults. No studies have been conducted in patients less than 18 years of age. However, about 25% of affected individuals are diagnosed between 10 and 19 years of age, hence psoriasis is also prevalent in the adolescent age group (12-17 years).

All patients will receive TACLONEX. To evaluate the safety of TACLONEX ointment, all adverse events will be recorded. In addition, any systemic absorption of the active components, betamethasone dipropionate and calcipotriene, will be evaluated by assessing adrenal function (using CORTROSYN™ test) and calcium metabolism (by measuring serum calcium and the urinary calcium:creatinine ratio), respectively.

Arms: arm 1: None
Interventions: intervention 1: Calcipotriene plus betamethasone dipropionate ointment
Intervention descriptions: intervention 1: Once daily application for 4 weeks

Protocol documents:
Clinical trial NCT00824746
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Gefitinib Recurrence Carcinoma, Non-Small-Cell Lung
Sponsor: Chonnam National University Hospital
Start date: 2009-01-01; Completion date: 2011-12-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous gefitinib failure.

Primary endpoint

* to assess Disease Control Rate (Remission + Stable disease)

Secondary endpoints

* to assess the progression free survival

Detailed description:

Arms: arm 1: Gefitinib retreatment
Interventions: intervention 1: Gefitinib retreatment
Intervention descriptions: intervention 1: phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous EGFR-TKI failure.

Protocol documents:
Clinical trial NCT00835731
Conditions: Cervical Ripening
Keywords: induced abortion misoprostol cervical ripening second trimester abortion Dilapan-S
Sponsor: Planned Parenthood League of Massachusetts
Start date: 2009-01-01; Completion date: 2011-12-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.

Detailed description:

Arms: arm 1: 400mcg buccal misoprostol arm 2: Dilapan-S, control: vitamin B-12 administered sublingually
Interventions: intervention 1: misoprostol intervention 2: Dilapan-S, vitamin B-12
Intervention descriptions: intervention 1: 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E intervention 2: One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E

Protocol documents:
Clinical trial NCT00837369
Conditions: Coronary Artery Disease Myocardial Perfusion Abnormalities
Keywords: Stress echocardiography SPECT Myocardial perfusion imaging
Sponsor: University of Nebraska
Start date: 2009-04-07; Completion date: 2011-12-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography.

Detailed description:
To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the adenosine receptor (A2A) agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis\> 50% in diameter by quantitive angiography will be analyzed

Arms: arm 1: RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement.
Interventions: intervention 1: Regadenoson
Intervention descriptions: intervention 1: 400ug IV bolus injection, single dosage

Protocol documents:
Clinical trial NCT00838695
Conditions: Vascular Reaction to Medications
Keywords: Hand vein sensitivity phenylephrine nitroglycerin
Sponsor: Vanderbilt University
Start date: 2009-01-01; Completion date: 2011-12-01
Enrollment: 106 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this project is to determine the genetic factors contributing to interindividual differences in response to physiological and pharmacological vasoconstrictors and vasodilators.

Detailed description:
The dorsal hand vein model is a relatively non-invasive and robust experimental model to examine the local in vivo effect of vasoactive drugs without elucidating systemic counterregulatory reflexes. Infusion of incremental low doses of phenylephrine into a dorsal hand vein results in increasing local venoconstriction, without systemic effects. Similarly, infusion of incremental low doses of nitroglycerin into a preconstricted dorsal hand vein results in increasing local venodilation, without systemic effects. Systemic vascular responses can be measured by the cold pressor test (CPT),that leads to increase in blood pressure and heart rate , or mental stress that is also known to stimulate cardiovascular responses. Individuals vary in their local and systemic vascular responses but the genetic determinants of these are not clear.

Arms: arm 1: Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing arm 2: Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing
Interventions: intervention 1: Phenylephrine
Intervention descriptions: intervention 1: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)

Protocol documents:
Clinical trial NCT00842257
Conditions: Colorectal Cancer
Keywords: panitumumab cetuximab KRAS wild-type
Sponsor: Massachusetts General Hospital
Start date: 2009-05-01; Completion date: 2011-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to learn whether panitumumab helps treat colorectal cancer in participants who have not responded to treatment with cetuximab. Panitumumab is a human monoclonal antibody. Antibodies are proteins that recognize a foreign substance in the body and then attach themselves to it making it exposed to destruction. Panitumumab attaches itself to a protein on cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells to grow, and blocking EGFR helps prevent cancer cells from growing.

Detailed description:
* Panitumumab will be given to the participants through a central line. A central line is a long, thin tube (catheter) that is inserted through the skin into a large vein in the chest. This is placed by a radiologist or surgeon.
* Panitumumab will be given in 4-week cycles. Panitumumab infusions will be given on days 1 and 15 of each cycle (every 2 weeks).
* The following procedures will be performed on days 1 and 15 of each cycle, before each infusion: physical exam; questions about any symptoms or side effects; performance status; routine blood tests and CT or MRI (every 2 cycles).
* Participants can continue to receive panitumumab until their disease gets worse or they experience unacceptable side effects.

Arms: arm 1: Panitumumab administered by a central line infusion on days 1 and 15 of each 4 week cycle.
Interventions: intervention 1: panitumumab
Intervention descriptions: intervention 1: Panitumumab is administered intravenously (IV) by an infusion pump through a peripheral line or indwelling catheter using a 0.2 or 0.22-micron in-line filter infusion set-up over 1 hour 15 minutes. The starting panitumumab dose is 6 mg/kg administered every 14 days for as long as patients are on study without evidence of disease progression or demonstrating intolerance to treatment. The total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose will be calculated based on the subject's actual body weight at each visit. Panitumumab will be diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution (normal saline solution, supplied by the site). The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.

Protocol documents:
Clinical trial NCT00845858
Conditions: Gastroparesis Diabetic Gastroparesis Diabetes Diabetes Mellitus Delayed Gastric Emptying
Keywords: Gastroparesis Diabetic Gastroparesis Diabetes Diabetes Mellitus Delayed Gastric Emptying
Sponsor: Evoke Pharma
Start date: 2009-04-01; Completion date: 2011-12-01
Enrollment: 287 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: metoclopramide intervention 2: Placebo
Intervention descriptions: intervention 1: 30 minutes before meals and at bedtime for 4 weeks intervention 2: 30 minutes before meals and at bedtime

Protocol documents:
Clinical trial NCT00855166
Conditions: Type 2 Diabetes Mellitus
Keywords: Dapagliflozin Metformin Type 2 diabetes body weight
Sponsor: AstraZeneca
Start date: 2009-02-01; Completion date: 2011-12-01
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Detailed description:

Arms: arm 1: Dapagliflozin 10 mg plus Metformin arm 2: Placebo plus Metformin
Interventions: intervention 1: Dapagliflozin intervention 2: Metformin intervention 3: Sitagliptin intervention 4: Placebo
Intervention descriptions: intervention 1: Tablet oral 10 mg total daily dose once daily 102 weeks intervention 2: Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks intervention 3: Tablet oral 100 mg total daily dose once daily rescue medication intervention 4: Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

Protocol documents:
Clinical trial NCT00857506
Conditions: Alzheimer's Disease Mild Cognitive Impairment
Keywords: Cognitive outcome 18F-AV-45 PET scan Amyloid PET scan Florbetapir F 18 amyloid PET scan Normal cognition Change in cognitive status in relation to brain amyloid on PET
Sponsor: Avid Radiopharmaceuticals
Start date: 2009-01-01; Completion date: 2011-12-01
Enrollment: 152 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease.

Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative.

The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET.

Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.

Detailed description:
Study AV-45-A11 is designed to determine if brain amyloid aggregation imaged on 18F-AV-45 PET scans is predictive of progression of cognitive impairment during the subsequent 36 months. Approximately 180 subjects enrolled in a prior clinical study (AV-45-A05\[NCT00702143\]) will be offered an opportunity to be studied under this protocol. The initial visit will occur as soon as possible following the AV-45-A05(NCT00702143) imaging day. Subjects who qualify for the study and their caregiver/partners will be contacted approximately 6,12,18,24 and 36 months after PET imaging in study AV-45-A05(NCT00702143), and will undergo a standardized functional and psychometric evaluation.

NOTE: This study is a clinical follow-up of subjects previously enrolled in trial 18F-AV-45-A05(NCT00702143). No new patients are being enrolled in this trial.

Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: 370 Mega Becquerel (10 mCi)

Protocol documents:
Clinical trial NCT00874432
Conditions: Cardiovascular Disease Chronic Kidney Disease
Keywords: cardiovascular disease angiotensin converting enzyme inhibitors chronic kidney disease cardiovascular disease in elderly patients with CKD
Sponsor: University of Wisconsin, Madison
Start date: 2009-01-01; Completion date: 2011-12-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.

Detailed description:
This study will be the first to examine whether aortic stiffness is increased in elderly patients with CKD compared to their age-matched healthy controls and further examine whether ACE-I may delay the progression of aortic stiffness in elderly CKD patients. If ACE-I therapy appears beneficial in preventing or delaying arterial stiffening in elderly patients with CKD, this work has important implications for improving the overall health of this population.

Arms: arm 1: ace inhibitor arm 2: None arm 3: ace-inhibitor arm 4: Placebo
Interventions: intervention 1: angiotensin converting enzyme inhibitor intervention 2: lisinopril
Intervention descriptions: intervention 1: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day intervention 2: 1 x 40 mg per day

Protocol documents:
Clinical trial NCT00881504
Conditions: Biliary Tract Cancer
Keywords: Biliary Oxaliplatin Bevacizumab
Sponsor: Georgetown University
Start date: 2009-06-01; Completion date: 2011-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for patients with biliary tract cancer that has spread and who are not candidates for surgical resection.

The purpose of this research is to determine if bevacizumab can be safely administered with Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on biliary cancer.

In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent, bevacizumab will be tested.

Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their disease gets worse or they are unable to tolerate treatment.

Detailed description:
This is a single-center, open labeled, single-arm study in patients with previously untreated unresectable biliary tract cancer. This trial will follow a Simon's two-stage optimal design. For the first stage, 9 patients will be accrued. If none of the 9 patients have controlled disease with mFOLFOX6 in combination with bevacizumab, the combination will be rejected and the trial stopped. However, if at least 1 patient of the 9 (11%) respond to treatment in the first stage, then an additional 15 patients will be entered into the second stage, for a total of 24 patients in the phase II study. If 3 (13%) or more patients respond to therapy, then the combination will be considered for further investigation.

Arms: arm 1: Intervention = "bevacizumab" in combination with chemotherapy

Treatment of biliary system carcinoma using "Bevacizumab" in combination with "modified FOLFOX6".
Interventions: intervention 1: "Bevacizumab" in combination with "modified FOLFOX6".
Intervention descriptions: intervention 1: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks

Protocol documents: