ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00678080
Conditions: Pregnancy Complications
Keywords: Type 2 diabetes mellitus Pregnancy Metformin Insulin Pregnant women
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2008-09-01; Completion date: 2011-08-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. We hypothesize that metformin will achieve similar levels of blood sugar control compared to insulin. In doing so, metformin will prevent the increased risk of pregnancy complications associated with T2DM in pregnancy. We propose a pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of T2DM during pregnancy.

Detailed description:
Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. Currently, insulin is the primary medication used to treat pregnant women with T2DM. However, it is administered by injection several times a day and compliance is low in health disparity populations with high rates of obesity and diabetes. Insulin also has the potential to lead to dangerously low blood sugars. Metformin is a medication than can be administered as pills and is not associated with dangerous low blood sugars. In addition, this insulin sensitizer is the medication of choice for women who are obese and have T2DM outside of pregnancy. We hypothesize that metformin will achieve similar levels of blood sugar control compared to insulin. In doing so, metformin will prevent the increased risk of pregnancy complications associated with T2DM in pregnancy. The aims of this study is to determine if in pregnant women with T2DM, metformin achieves similar glycemic control, and similar maternal and neonatal outcomes when compared to insulin. We propose a pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of T2DM during pregnancy.

Arms: arm 1: Metformin therapy as prescribed by their health care provider arm 2: Insulin as prescribed by their health care provider
Interventions: intervention 1: Metformin intervention 2: Insulin (NPH and Regular)
Intervention descriptions: intervention 1: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily intervention 2: Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day

Protocol documents:
Clinical trial NCT00682448
Conditions: Metabolic Complications
Keywords: Olanzapine Zyprexa Weight Gain Antipsychotics Metformin Glucophage Bipolar Disorder Schizophrenia Depression Diabetes Side effects Metabolic complications Prevention Treatment Metabolic side effects of olanzapine
Sponsor: Rush University Medical Center
Start date: 2007-08-01; Completion date: 2011-08-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We hypothesize that metformin co-administered with olanzapine will be well tolerated and associated with significantly less insulin resistance, weight gain and dyslipidemia as compared to olanzapine plus placebo.

Detailed description:
Increased risk of metabolic complications with olanzapine therapy, relative to other antipsychotics, may lead clinicians to avoid its use, despite evidence of greater efficacy. These problems may also pose a therapeutic dilemma for patients who respond well to olanzapine. Metabolic complications negatively impact on morbidity and mortality, impair quality of life and increase illness relapse secondary to medication non-compliance. Thus far, no pharmacologic agent co-administered with olanzapine has proven effective at preventing these untoward effects. The present study proposes to examine the efficacy and safety of metformin to attenuate the metabolic side effects associated with olanzapine.

Arms: arm 1: Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. arm 2: Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months. intervention 2: Drug: Placebo. Subjects will remain on placebo for 6 months.

Protocol documents:
Clinical trial NCT00690235
Conditions: Schizophrenia Schizoaffective Disorder Diabetes Weight Gain
Keywords: Schizophrenia Schizoaffective Olanzapine Zyprexa Clozapine Clozaril Pramlintide Diabetes Weight Gain Obesity Metabolic Syndrome
Sponsor: University of Texas Southwestern Medical Center
Start date: 2007-11-01; Completion date: 2011-08-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain in persons with schizophrenia who are currently taking either drug; measures of the metabolic syndrome will be evaluated as well.

Detailed description:
This study is a sixteen week placebo-controlled, double-blind investigation of the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain. We will recruit approximately 72 volunteers with the plan of having a final N = 25 in each of the 2 treatment groups. (This number is to allow for normal attrition in this patient population. If needed, we will recruit more than 72 volunteers in order to achieve the appropriate number of completed subjects.) Patients will be recruited from the local Dallas public and VA mental health systems as volunteers for this study. This study is anticipated to last 20 weeks (2 weeks lead-in \[approximately 2-3 visits\], 1 week training \[4 visits\], 16 weeks active drug/placebo \[one visit per week for the first 4 weeks, then one visit every 2 weeks for the remainder\], and one week follow-up \[one visit\]. Please see attached chart for more details about each visit.) Volunteers will have to have a history of significant weight gain accompanying olanzapine or clozapine treatment and have a BMI=\>27 and =\<40. Each volunteer will be maintained on their optimal dose of clozapine or olanzapine and be randomized blindly to pramlintide or placebo. Pramlintide will be administered by the patients in a self-injectable form and dosing will begin at 180 mcg bid for 2 weeks and then increase to 360 mcg bid for the remainder of the study. The randomization to pramlintide/placebo will be preceded by a week-long self-administration training program using placebo for pramlintide (with additional information regarding nutrition, exercise, general self-care, and risk factors for diabetes being provided to the patients during this training program).

Arms: arm 1: Patients will be given the Placebo for injection twice daily arm 2: volunteers are given 180mg of pramlintide, twice daily
Interventions: intervention 1: Pramlintide intervention 2: Placebo
Intervention descriptions: intervention 1: 180mg subcutaneous injections, twice daily intervention 2: 180mg subcutaneous injections, twice daily

Protocol documents:
Clinical trial NCT00693485
Conditions: Glaucoma, Open-Angle
Sponsor: Allergan
Start date: 2008-09-01; Completion date: 2011-08-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.

Detailed description:

Arms: arm 1: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. arm 2: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. arm 3: Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Interventions: intervention 1: 400 ug Brimonidine Implant intervention 2: 200 ug Brimonidine Implant intervention 3: Sham (no implant)
Intervention descriptions: intervention 1: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. intervention 2: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. intervention 3: Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Protocol documents:
Clinical trial NCT00706706
Conditions: Carcinoma, Renal Cell
Keywords: sunitinib Phase IV metastatic renal cell carcinoma Chinese
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2011-08-01
Enrollment: 105 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma.

Detailed description:

Arms: arm 1: single agent sunitinib, single arm
Interventions: intervention 1: Sunitinib Malate (SU011248)
Intervention descriptions: intervention 1: Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.

Protocol documents:
Clinical trial NCT00706966
Conditions: Nonmalignant Neoplasm Prostate Cancer
Keywords: adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer benign prostatic hyperplasia
Sponsor: University of California, San Francisco
Start date: 2005-06-01; Completion date: 2011-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer.

PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine whether there is a decrease in the extent of prostate cancer as measured by endorectal MRI and magnetic resonance spectroscopy imaging in patients with symptomatic benign prostatic hypertrophy and low-risk prostate cancer treated with dutasteride for 6 months.

Secondary

* To monitor the effects of dutasteride on serum testosterone, dihydrotestosterone, and free and total prostate-specific antigen (PSA).
* To monitor the effects of dutasteride on symptom and quality-of-life indices.

OUTLINE: Patients receive oral dutasteride once daily for 6 months.

Patients undergo endorectal MRI and magnetic resonance spectroscopy imaging at baseline and at 1, 3, and 6 months.

Patients complete quality-of-life questionnaires using the International Index of Erectile Function Questionnaire, American Urological Association Symptom Index, Functional Alterations due to Changes in Elimination, and Spitzer Quality-of-Life Index at baseline and at 1, 3, and 6 months.

Arms: arm 1: Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months
Interventions: intervention 1: dutasteride
Intervention descriptions: intervention 1: 6 months of dutasteride 3.5 mg daily

Protocol documents:
Clinical trial NCT00723957
Conditions: Advanced/Metastatic Non-Small Cell Lung Cancer
Sponsor: R-Pharm
Start date: 2008-12-01; Completion date: 2011-08-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ixabepilone, 32 mg/m^2 intervention 2: Paclitaxel, 200 mg/m^2 intervention 3: Carboplatin (area under the concentration curve [AUC] 6)
Intervention descriptions: intervention 1: Intravenous (IV) solutions, ixabepilone, 32 mg/m\^2 intervention 2: IV solutions, paclitaxel, 200 mg/m\^2 intervention 3: Carboplatin (AUC 6) day 1, every 21 days, 6 cycles

Protocol documents:
Clinical trial NCT00729924
Conditions: HIV Infections
Keywords: Raltegravir CSF ABCB1 SNP HIV/AIDS
Sponsor: Vanderbilt University
Start date: 2008-08-01; Completion date: 2011-08-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to find out how much of the drug raltegravir (RGV) gets into cerebrospinal fluid (CSF), compared to how much get into the blood and to find out if normal changes in a certain gene in your body affects how much RGV gets into the CSF.

Detailed description:
The multidrug efflux transporter P-glycoprotein (P-gp) is expressed in the blood-brain barrier where it limits entry of substrate drugs into the central nervous system. Raltegravir (MK-0158), a new HIV-1 integrase inhibitor and potentially major addition to the therapeutic armamentarium against HIV, is a substrate for P-gp. Studies are warranted to elucidate the relevance of P-gp transport for raltegravir in the central nervous system.

Arms: arm 1: Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: 400mg orally every 12 hours for 7 days

Protocol documents:
Clinical trial NCT00743093
Conditions: Drug Toxicity Healthy
Keywords: acetaminophen protein adducts drug safety alanine aminotransferase Alanine Amino Transferase
Sponsor: Denver Health and Hospital Authority
Start date: 2008-08-01; Completion date: 2011-08-01
Enrollment: 398 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have completed their part of the study. People that develop abnormal liver function tests will continue taking acetaminophen or placebo, and have their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure these tests return to normal and (2) determine when these tests return to normal while still taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a minor increase, you would be immediately told to stop taking the study drug.

Secondary objective is to determine the proportion of subjects that have detectable acetaminophen-protein adducts after daily dosing.

Detailed description:
Acetaminophen use is common and many consumers take 4g/day for longer than 4 days. The use of 4g/day of acetaminophen for more than 4 days causes an asymptomatic ALT elevation in some people. This elevation most likely resolves while continuing treatment, but it is possible that some individuals may go on to develop clinical liver injury. By carefully following healthy subjects who are taking the maximal daily dose of acetaminophen, we can safely determine if the ALT elevation resolves or progresses to clinical liver injury. If a subject develops clinical liver injury we can intervene before irreversible injury occurs.

Arms: arm 1: acetaminophen, 4 grams/day (1 gram every 4 hours for 4 doses) arm 2: placebo for acetaminophen 4 grams/day (2 caplets every 4 hours for 4 doses)
Interventions: intervention 1: acetaminophen intervention 2: placebo
Intervention descriptions: intervention 1: 500 mg caplets; 2 caplets (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days. intervention 2: placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days

Protocol documents:
Clinical trial NCT00756964
Conditions: Hyperuricemia
Keywords: cardiac surgery hyperuricemia
Sponsor: University of Florida
Start date: 2008-10-01; Completion date: 2011-08-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Acute kidney injury is associated with a rise in serum uric acid during cardiovascular surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury. We hypothesize that hyperuricemia, particularly if chronic and marked, is a risk factor for acute kidney injury. The preoperative lowering of serum uric acid will reduce the incidence of acute kidney injury following cardiovascular surgery.

Detailed description:
The study will be a prospective, double-blind, placebo-controlled, randomized, clinical trial, initiated and implemented conjointly by the Nephrology and Cardiovascular Surgery Departments at Shands Hospital at the University of Florida in Gainesville, FL. We propose to study whether lowering uric acid provides significant renal and cardiovascular protection in subjects undergoing cardiovascular surgery. Up to 30 patients presenting for elective or urgent cardiovascular surgery with uric acid level \> 6.5 mg/dl and estimated glomerular filtration of 30 - 60 ml/min will be included in the study. Patients recruitment will continue until up to 30 patients have completed the study, taking into account expected patient loss due to withdrawal of consent, incomplete study and other reasons.

Patients will be randomized to a control group or rasburicase group. Rasburicase or identical placebo will be administered to each group after randomization. A selected number of patients may undergo additional testing for mechanistic (non-clinical) secondary endpoints.

Arms: arm 1: patients receiving rasburicase to lower serum uric acid arm 2: patients will receive a placebo
Interventions: intervention 1: Rasburicase intervention 2: Placebo
Intervention descriptions: intervention 1: Rasburicase (Dose: 7.5mg in 50ml of normal saline administered over 30 minutes) or identical placebo will be administered as an (dosage form)intravenous infusion preoperatively. intervention 2: Placebo drug (color-coded to appear identical to study drug) administered as an (dosage form) intravenous infusion preoperatively.

Protocol documents:
Clinical trial NCT00781456
Conditions: Migraine
Keywords: Migraine headache menstrual oral contraceptive Menstrually-Related Migraine Headache
Sponsor: Duramed Research
Start date: 2009-01-01; Completion date: 2011-08-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral contraceptive compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.

Detailed description:

Arms: arm 1: Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks. arm 2: Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
Interventions: intervention 1: 91-day Levonorgestrel Oral Contraceptive intervention 2: Placebo
Intervention descriptions: intervention 1: 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE. intervention 2: 1 tablet daily to match experimental arm

Protocol documents:
Clinical trial NCT00791843
Conditions: Congestive Heart Failure
Keywords: CHF
Sponsor: University of Pennsylvania
Start date: 2004-03-01; Completion date: 2011-08-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
PP1- The purpose of this study is to determine whether giving more of the hormone produced by everyone called growth hormone releasing hormone (GHRH) can improve heart function in individuals with congestive heart failure. You must be 50 years old or older, have a diagnosis of congestive heart failure, and have a high likelihood of having lower than normal growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth hormone deficiency because GHRH stimulates Growth Hormone (GH). Its use for treatment of congestive heart failure in adults is investigational.

Growth hormone releasing hormone is a hormone produced in the brain. We will be using synthetic hormone made in the laboratory. It is identical to the hormone in the brain.

Many older people, due to aging have low levels of growth hormone. The aim of this study is to find out whether restoring growth hormone levels to the levels found in younger individuals and then maintaining those levels for 12 weeks will help strengthen heard muscles in older persons with congestive heart failure.

Detailed description:
PP1- The overall purpose of this study is to evaluate the effects of Growth Hormone Releasing Hormone (GHRH) on cardiac structure and function in subjects aged 50 years and older with a diagnosis of congestive heart failure in a single blinded (to the subject) randomized treatment/placebo study design. They will receive 12 weeks of drug or placebo, 6 weeks of washout, and 12 weeks of placebo or drug- whichever they didn't receive in the first 12 weeks. The hypotheses are: 1)normal aging is associated with evidence of declining somatotrophic activity exemplified by IGF-1 levels; 2) GHRH can raise levels of Growth hormone and IGF-1 in elderly individuals in a dose dependent fashion with minimal deleterious side effects; 3) GHRH will produce measurable increments in myocardial performance and structure and demonstrated growth of peripheral musculature; 4) the combination of these benefits will result in better quality of life due to the improvement of overall cardiac function.

Arms: arm 1: Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo
Interventions: intervention 1: Growth hormone releasing hormone/ placebo
Intervention descriptions: intervention 1: 12 weeks of drug at max dose of 2mg/day administered in 4 pulses at 11pm, 1am, 3am, and 5am, followed by 6 weeks of washout period, then 12 weeks of placebo or vise versa- 12 weeks of placebo, 6 weeks washout, 12 weeks of drug.

Protocol documents:
Clinical trial NCT00814333
Conditions: Epistaxis
Keywords: epistaxis
Sponsor: University of Kansas Medical Center
Start date: 2008-12-01; Completion date: 2011-08-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.

Detailed description:

Arms: arm 1: Thrombin-JMI arm 2: Merocel pack
Interventions: intervention 1: Thrombin-JMI intervention 2: Merocel pack
Intervention descriptions: intervention 1: 5,000 IU, to nasal mucosa via syringe spray applicator intervention 2: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps

Protocol documents: