ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00890929
Conditions: Acute Myeloid Leukemia (AML) Adult Acute Myeloblastic Leukemia
Keywords: Acute myeloid leukemia Acute myeloblastic leukemia AML
Sponsor: Stanford University
Start date: 2009-04-01; Completion date: 2012-06-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study has a phase 1 and a phase 2 component.

In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide when after azacitidine.

In phase 2, the objective is to determine the efficacy of the combination treatment.

Detailed description:
The treatment regimen in this study is 7 day courses of azacitidine 75 mg/m2 followed by a 21-day courses of lenalidomide. For the primary objective, each 28-day cycle was repeated for a total of up to 6 cycles. Study completion was defined as 18 cycles of treatment, disease progression, or death.

In phase 1, the objective was to determine the maximum tolerated dose (MTD) of lenalidomide 5 mg, 10 mg, 25 mg or 50 mg, when administered after azacitidine.

In phase 2, the objective was to assess the efficacy of MTD lenalidomide administered after azacitidine, in up to six 28-day cycles.

Arms: arm 1: Dose escalation then dose expansion
Interventions: intervention 1: Lenalidomide intervention 2: Azacitidine
Intervention descriptions: intervention 1: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle intervention 2: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Protocol documents:
Clinical trial NCT00893984
Conditions: Coronary Artery Disease
Keywords: Intolerance Beta blocker
Sponsor: Minneapolis Heart Institute Foundation
Start date: 2009-05-01; Completion date: 2012-06-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use.

The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.

Detailed description:
Patients who have been prescribed standard beta blockers but were unable to tolerate them due to side effects will be studied. They will take a new beta blocker, Nebivolol (Bystolic) for 30 days, if tolerated. Side effects will be tracked and compared to previous.

Arms: arm 1: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Interventions: intervention 1: Nebivolol
Intervention descriptions: intervention 1: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.

Protocol documents:
Clinical trial NCT00903344
Conditions: Osteoporosis
Sponsor: Leigh Eck, MD
Start date: 2009-12-01; Completion date: 2012-06-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactation occurs rapidly. Although bone density increases after weaning, there is controversy on whether or not it is completely restored. Epidemiological studies find no significant negative impact of lactation on bone mass or fractures, and in fact there is evidence that lactation has a positive effect on bone mass. We think that interventions that attenuate this physiologic loss of bone that is associated with lactation and accelerate restoration of bone mass after weaning may result in improved long term bone mass and diminished fracture risk.

Detailed description:
Adequate vitamin D stores are necessary for skeletal health. Vitamin D deficiency is pronounced in women of child bearing age as well as pregnant women in the United States. This study will provide important information about whether vitamin D supplementation may positively impact the normal physiologic loss of bone mass that is observed during lactation.

Recruitment will begin while subjects are pregnant in order to expedite entry into the study in the immediate post-partum period. If subjects are deemed eligible during pregnancy, contact information to include name, address, expected delivery date and two contact phone numbers will be obtained. Subjects will be contacted two weeks prior to expected delivery date and then again at expected delivery date. Subjects will be followed for a total of 18 months.

Arms: arm 1: 4000IU Vitamin D3 in tablet taken daily with multivitamin arm 2: Multivitamin with 400IU vitamin D tablet
Interventions: intervention 1: Vitamin D3 intervention 2: Multivitamin
Intervention descriptions: intervention 1: 4000IU vitamin D3 tablet taken daily intervention 2: Multivitamin containing 400IU vitamin D in tablet taken daily

Protocol documents:
Clinical trial NCT00911053
Conditions: Insomnia Blindness Daytime Sleepiness
Keywords: melatonin sleep blindness blind individuals
Sponsor: Oregon Health and Science University
Start date: 1997-06-01; Completion date: 2012-06-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1). The second study phase identifies the optimum dose and timing of melatonin for regulating each individual's 24-hour sleep/waking cycle (including sub-study 2). The third study phase introduces a new independent variable, light (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study.

Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm. Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how individuals' endogenous melatonin production responds to bright outdoor light and Sub-study 4 tests a previous finding that artificial bright light exposed daily behind the knee can regulate the body clock. Sub-study 5 is an optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.

Detailed description:

Arms: arm 1: None arm 2: Subjects will be administered melatonin. arm 3: None arm 4: None arm 5: Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
Interventions: intervention 1: Melatonin intervention 2: Regular Sleep Schedule intervention 3: Light
Intervention descriptions: intervention 1: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg. intervention 2: Subjects will maintain a regular sleep schedule of their choosing. intervention 3: Subjects will be exposed to light.

Protocol documents:
Clinical trial NCT00915928
Conditions: Hematoma, Subdural, Chronic
Sponsor: Odense University Hospital
Start date: 2009-07-01; Completion date: 2012-06-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.

Detailed description:
Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this

Arms: arm 1: patients randomized to this arm will be treated with ACE inhibitors after surgery arm 2: patients randomized to this arm will be treated with placebo after surgery
Interventions: intervention 1: Perindopril intervention 2: Placebo
Intervention descriptions: intervention 1: 2,5 mg daily for 3 months intervention 2: Placebo dayli for 3 months

Protocol documents:
Clinical trial NCT00922779
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2002-06-01; Completion date: 2012-06-01
Enrollment: 6661 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin
Intervention descriptions: intervention 1: 180micrograms sc weekly for 12-48 weeks intervention 2: 800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

Protocol documents:
Clinical trial NCT00937924
Conditions: Endoscopic Ultrasound (EUS) Endoscopic Retrograde Cholangiopancreatography (ERCP)
Keywords: EUS ERCP Sedation Level Adverse Symptoms Recovery time
Sponsor: University of California, Irvine
Start date: 2008-02-01; Completion date: 2012-06-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.

Detailed description:
Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.

Arms: arm 1: Control. Normal Saline Injections. arm 2: Diphenhydramine injections given as adjunct sedative. arm 3: Promethazine given as an adjunct sedative.
Interventions: intervention 1: Meperidine, Midazolam intervention 2: Diphenhydramine intervention 3: Promethazine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00939900
Conditions: Avascular Necrosis of Femoral Head
Keywords: avascular necrosis of femoral head bisphosphonate collapse
Sponsor: Seoul National University Bundang Hospital
Start date: 2009-07-01; Completion date: 2012-06-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effect of zoledronic acid over 2 years in preventing early collapse and progression of joint dome depression (≥ 2 mm by X-ray) of the femoral head in patients with large (\> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.

Detailed description:
Until now, the best treatment option in early (precollapse) large osteonecrosis femoral head is vascularizing fibular graft. However, it requires high microsurgical technique. Also it needs very long operation time (3-6hours), and morbidity associated with surgery is not low. In early stage osteonecrosis, osteoclasts are activated and resorb the necrotic portion of bone and osteoblasts are followed to lay down new bone. This process can weaken the bone function to support loading and can lead to collapse of bone. Bisphophonate can inhibit this osteoclastic bone resorption and enhance osteoblastic new bone formation. Recently, everyday oral intake of alendronate with vitamin D and calcium had a high success rate to prevent the collapse and decrease of hip joint pain in a short-term follow-up. However, the compliance or adherence to everyday oral intake is questionable. Moreover, the exact comparison based on MRI according to various classifications is not available currently. There is no report about the effect of zoledronic acid to prevent early collapse and progression of joint dome depression (≥2 mm by X-ray) of the early stage large nontraumatic osteonecrosis of the femoral head or its effect on MRI signal change after infusion of zoledronic acid in noncollapsed cases (estimated about 30% of cases) The investigators need a controlled randomized multicenter interventional study about the efficacy of bisphophonates in the treatment of ONFH.

Arms: arm 1: aclasta group arm 2: control group
Interventions: intervention 1: zoledronic acid (aclasta)
Intervention descriptions: intervention 1: Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period

Protocol documents:
Clinical trial NCT00945958
Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: Glaucoma Ocular hypertension
Sponsor: Sun Pharma Advanced Research Company Limited
Start date: 2010-11-01; Completion date: 2012-06-01
Enrollment: 161 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.

Detailed description:
This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.

Arms: arm 1: None
Interventions: intervention 1: SPARC0913
Intervention descriptions: intervention 1: One drop of SPARC0913 in affected eye once daily for 24 weeks

Protocol documents:
Clinical trial NCT00947284
Conditions: Healthy
Sponsor: University of California, San Francisco
Start date: 2010-01-01; Completion date: 2012-06-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. A second reason for this study is to find out if study medications work more effectively in women or in men. Subjects will come to the University of California at San Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a 2-hour screening to assess the subject for study eligibility. During the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.

Detailed description:

Arms: arm 1: Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm. arm 2: Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm
Interventions: intervention 1: nalbuphine plus naloxone intervention 2: nalbuphine plus saline intervention 3: naloxone plus saline
Intervention descriptions: intervention 1: single dose administered intravenously intervention 2: single dose administered intravenously intervention 3: single dose administered intravenously

Protocol documents:
Clinical trial NCT00970489
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation fish oil
Sponsor: Brigham and Women's Hospital
Start date: 2010-08-01; Completion date: 2012-06-01
Enrollment: 1516 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery (CS).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Omega -3 fatty acids intervention 2: Placebo
Intervention descriptions: intervention 1: 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first. intervention 2: Olive Oil capsules

Protocol documents:
Clinical trial NCT00977548
Conditions: Myelodysplastic Syndrome
Keywords: MDS blood diseases bone marrow hematopoietic leukemia
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2009-09-01; Completion date: 2012-06-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out what effects, good and/or bad, erlotinib has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib use in this study is considered investigational as the FDA has not approved it for the treatment of myelodysplastic syndrome.

Detailed description:
Screening Period: Informed consent, physical examination, medical history report, blood tests, pregnancy test (if applicable), list of current medications, description of symptoms, chest x-ray, ECG, bone marrow aspirate/biopsy within 4 weeks of study start.

Weeks 2,6,10 and 14: Blood tests.

Weeks 4 and 12: Blood tests, physical exam, patients will answer question about how they are feeling and if there are any changes to medication they have taken.

Weeks 8 and 16: Blood tests, physical exam, patients will answer question about how they are feeling and if there are any changes to medication they have taken, bone marrow aspirate/biopsy (if physician has determined the patient has had a clinical response or partial response to treatment.

After week 16 (if responding to treatment): Have a bone marrow aspirate/biopsy (will be repeated at time of relapse, i.e., more than 50% increase in the percentage of myeloblasts \[leukemia cells\] or drop in blood counts after they improved or requiring regular blood transfusions after not requiring them for at least 8 weeks, or after 1 year in study).

After the patient has stopped taking erlotinib: Periodic follow-up on patients' status.

Arms: arm 1: Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Participants took erlotinib at least 1 hour before, or 2 hours after they ate a meal or snack. Participants were advised to take erlotinib at around the same time every day.

Protocol documents:
Clinical trial NCT00980343
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2010-02-01; Completion date: 2012-06-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well GDC-0449 works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. GDC-0449 may be effective in treating patients with glioblastoma multiforme.

Detailed description:
PRIMARY OBJECTIVES:

I. 6-month progression-free survival (PFS-6) measured from start of treatment following surgery.

SECONDARY OBJECTIVES:

I. Toxicity. (Clinical) II. Overall survival. (Clinical) III. Tumor response. Partial Response (PR) + Complete Response (CR): MacDonald criteria). (Clinical)

Correlative Studies

* Determination of in vivo drug effect in recurrent Glioblastoma Multiform (GBM). (Correlative studies)
* Determination of in vitro drug effect on CD133+ glioma-derived neurospheres. (Correlative studies)
* Determination of Sonic Hedgehog pathway activation in primary vs. recurrent GBM. (Correlative studies)

TERTIARY OBJECTIVES:

I. Correlate clinical outcome (6 mo PFS) with biologic correlates (1-3) above.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral Hedgehog antagonist GDC-0449 once daily for 7 days before surgery.

Arm II: Patients do not receive treatment before surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Fresh and paraffin-embedded tissue samples are collected for correlative laboratory studies.

After completion of study treatment, patients are followed up every 2 months.

Arms: arm 1: Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis arm 2: Patients do not receive treatment before therapeutic conventional surgery.

Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis
Interventions: intervention 1: vismodegib intervention 2: therapeutic conventional surgery intervention 3: laboratory biomarker analysis intervention 4: pharmacological study
Intervention descriptions: intervention 1: Given orally intervention 2: undergo surgery intervention 3: correlative studies intervention 4: correlative studies

Protocol documents:
Clinical trial NCT00993967
Conditions: Freidreich's Ataxia
Keywords: FRDA idebenone FRDA disease
Sponsor: Santhera Pharmaceuticals
Start date: 2007-06-01; Completion date: 2012-06-01
Enrollment: 200 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with Friedreich's Ataxia.

Detailed description:

Arms: arm 1: 1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or \>45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.
Interventions: intervention 1: idebenone
Intervention descriptions: intervention 1: Idebenone 1350 mg/d, patients \< or equal 45 kg Idebenone 2250 mg/d, patients \> 45 kg

Protocol documents: