ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01390246
Conditions: Pregnancy Related Tobacco Use Disorder
Keywords: Pregnancy Tobacco use disorder Smoking cessation Bupropion SR Zyban
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2011-07-01; Completion date: 2016-12-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

Detailed description:
This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy. A total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. Compassionate care/continuance of therapy will be available to pregnant subjects. Women who relapse to smoking postpartum will be offered an additional course of medication treatment. All subjects regardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month postpartum period. Subject participation will begin between 13-30 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13) months in length.

Arms: arm 1: Bupropion SR and smoking cessation counseling Subjects received Bupropion SR 150 mg tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose Bupropion SR 150 mg tablet orally BID for a total medication treatment of 12 full weeks.

Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse. arm 2: Placebo and smoking cessation counseling Subjects received matching Bupropion SR placebo tablet orally twice daily (BID) for 12 weeks. Subjects were instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which was approximately 1 week prior to their quit date. Thereafter, they were continued to dose matching Bupropion SR placebo tablet orally BID for a total medication treatment of 12 full weeks of therapy.

Smoking cessation counseling included 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the trained study nurse.
Interventions: intervention 1: Bupropion SR intervention 2: Smoking Cessation Counseling intervention 3: Placebo
Intervention descriptions: intervention 1: Bupropion SR 150 mg tablet intervention 2: 35-min counseling by trained research nurse intervention 3: Matching Bupropion SR placebo tablet

Protocol documents:
Clinical trial NCT01404208
Conditions: Obsessive-Compulsive Disorder
Sponsor: Massachusetts General Hospital
Start date: 2011-07-01; Completion date: 2016-12-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if D-Cycloserine (DCS), taken at the same time as a child gets cognitive behavioral therapy (CBT) can help children with pediatric obsessive-compulsive disorder.

Cognitive Behavior Therapy is a talking therapy that will teach children new skills to better cope with his/her OCD. CBT usually uses "exposure-based therapy". This means that the person with OCD slowly learns to deal with things they usually avoid. This is done by moving from less stressful situations to more challenging ones.

The investigators hope to enroll about 75 children ages 7-17 years old with OCD in this study at Massachusetts General Hospital (MGH). The National Institute of Mental Health (NIMH) is paying for this study to be done.

If your child qualifies for the study, the investigators will assign him or her by chance (like a coin toss) to either the DCS group or the placebo group. You and the study doctor cannot choose your child's study group. Your child will have an equal chance (1 in 2) of being assigned to the DCS group.

Your child will be asked to take one or two capsules of the study drug (either DCS or placebo, depending which study group they were assigned to) one hour before CBT visits 4-10. The study coordinator will give your child the study drug at the location of the CBT sessions. This is to make sure that your child takes the study drug one hour before his/her scheduled therapy session. We will ask you to record any bad side effect from the study drug that your child may have before each CBT session.

It will take your child about 34 weeks to complete the study. During this time, the investigators will ask you and your child to make a minimum of 17 trips to the study center. There may be up to 23 trips when including CBT Booster sessions.

This study uses a placebo. The placebo looks exactly like the DCS, but it contains no DCS. The investigators use placebos in research studies to learn if the the results are caused by the study drug or are due to other reasons. This is a double-blind study. A double-blind study is a study where both the doctor and the study participant do not know whether the study participant is being given DCS or placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: D-Cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session. intervention 2: Sugar pill

Protocol documents:
Clinical trial NCT01449279
Conditions: Melanoma
Sponsor: Stanford University
Start date: 2011-10-01; Completion date: 2016-12-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the safety of local palliative radiation therapy used in combination with anti-CTLA-4 immunotherapy.

Detailed description:
This is a single institution, open-label, pilot study of palliative radiation therapy (RT) combined with ipilimumab in patients with stage IV melanoma. The primary objective of this study is to assess the safety of combining ipilimumab with palliative RT in patients with Stage IV melanoma. Secondary objectives are a) to assess the induction of anti-melanoma immune responses using laboratory correlative studies of T cell responses to melanoma antigens, and b) to compare tumor response rates and duration of response at unirradiated sites with responses in patients with Stage IV disease treated with ipilimumab alone on expanded access study CA184045. In this study, ipilimumab will be administered as recently approved by the FDA (3 mg/kg iv every 3 weeks for a total of 4 treatments). Palliative RT will start within 2 days of the first ipilimumab dose. Patients will be seen at least every 12 weeks for follow-up following completion of ipilimumab therapy until progression of disease by imaging criteria or increased symptomatology that requires another therapy. A total of 20 patients with previously treated unresectable metastatic melanoma requiring palliative radiation therapy will be treated on this pilot study over approximately 18 months. All subjects who receive study drug will be monitored for safety. Relevant tumor imaging studies will be obtained at baseline, 2-4 weeks following the 4th/last dose of ipilimumab, and then every 12 weeks until disease progression. This study will provide the safety data (and possibly early efficacy signals) needed to proceed with a randomized Phase II study for proof of principle. If compelling data is obtained supporting this IT + RT vaccine strategy, this approach will be extended to other solid tumor types.

Arms: arm 1: Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1 to 2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2 to 4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.
Interventions: intervention 1: Ipilimumab intervention 2: Radiation Therapy
Intervention descriptions: intervention 1: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. intervention 2: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist.

Protocol documents:
Clinical trial NCT01515046
Conditions: Pancreatic Neoplasms Pancreatic Cancer
Keywords: Vitamins Complementary medicine Pancreatic cancer Ascorbate Ascorbic Acid Antioxidants Gemcitabine Pharmacologic actions
Sponsor: Joseph J. Cullen
Start date: 2012-09-01; Completion date: 2016-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study. It is designed to provide information about if high-dose ascorbate (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that vitamin C is well tolerated and increases cancer treatment effectiveness, lengthening survival time for patients with advanced pancreatic cancer.

Detailed description:
Adenocarcinoma of the pancreas is the fourth leading cause of cancer death in the United States and is increasing in incidence; the prognosis remains dismal. We propose to investigate an entirely new approach, using pharmacological ascorbate, combined with Gemcitabine, to treat this cancer. Intravenous ascorbate (i.e., ascorbic acid, vitamin C), but not oral ascorbate, produces high plasma concentrations, which are in the range that can be cytotoxic to tumor cells. Though ascorbate has been utilized in cancer therapy, few studies have investigated intravenous deliver of ascorbate. Preliminary studies from our group have demonstrated that ascorbate induces oxidative stress and cytotoxicity in pancreatic cancer cells; this cytotoxicity appears to be greater in tumor vs. normal cells. We hypothesize that production of H2O2 mediates the increased susceptibility of pancreatic cancer cells to ascorbate-induced metabolic oxidative stress. Gemcitabine is the standard chemotherapy drug used to treat pancreatic cancer.

Arms: arm 1: Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.

Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.
Interventions: intervention 1: Gemcitabine with escalating ascorbic acid
Intervention descriptions: intervention 1: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)

Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)

Protocol documents:
Clinical trial NCT01531439
Conditions: Pain, Postoperative Postoperative Nausea and Vomiting Scoliosis
Keywords: Narcotic Antagonists Naloxone infusion Postoperative pruritis Patient controlled analgesia Pediatric Children
Sponsor: Children's Mercy Hospital Kansas City
Start date: 2011-11-01; Completion date: 2016-12-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.

Detailed description:
Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.

Arms: arm 1: None arm 2: Naloxone infusion 2.5 mcg/kg/hr
Interventions: intervention 1: Naloxone intervention 2: Naloxone
Intervention descriptions: intervention 1: Naloxone infusion 0.5 mcg/kg/hr intervention 2: Naloxone infusion 2.5 mcg/kg/hr

Protocol documents:
Clinical trial NCT01537029
Conditions: Breast Cancer Obesity
Keywords: Breast cancer Pharmacokinetics Obesity Doxorubicin Cyclophosphamide Weight
Sponsor: Texas Tech University Health Sciences Center
Start date: 2012-02-01; Completion date: 2016-12-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases.

Detailed description:
This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This study is designed to measure drug concentrations in the blood of 18 female breast cancer patients who require doxorubicin (30 minute infusion) and cylcophosphamide (30 minute infusion) as part of standard medical care. Up to a total of 40 adult female participants will be consented for the study at the cancer center. Eighteen of these participants are needed to complete the study. The others will likely be screen failures. The participants will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just prior to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h after the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The intravenous catheter will be removed when the participant is discharged from the cancer center on day 1. The participant will be asked to return to the cancer center at 12-24 and 24-72 hours to have the final 2 blood draws conducted.

The participants must be treated with Doxurubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis study.

Arms: arm 1: None
Interventions: intervention 1: Doxorubicin intervention 2: Cyclophosphamide
Intervention descriptions: intervention 1: Dosed by the patient's treating physician according to local standard of care. intervention 2: dosage form: IV, Dosage, frequency, and duration: According to local standard of care

Protocol documents:
Clinical trial NCT01547000
Conditions: Tourette Disorder Tourette Syndrome
Keywords: Tourette Syndrome Tourette Disorder Tics Motor tics Vocal tics Intuniv Guanfacine Medication Drug Placebo Child Children Adolescent
Sponsor: Yale University
Start date: 2012-04-01; Completion date: 2016-12-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).

Detailed description:
Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings.

This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: extended-release guanfacine (Intuniv)
Intervention descriptions: intervention 1: Administered up to 8 weeks. intervention 2: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Protocol documents:
Clinical trial NCT01648270
Conditions: Healthy
Keywords: buprenorphine CYP3A
Sponsor: Washington University School of Medicine
Start date: 2012-04-01; Completion date: 2016-12-01
Enrollment: 25 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
The determine the effect of cyclosporine on buprenorphine disposition

Detailed description:
Subjects studied on four occasions:

1. Intravenous buprenorphine
2. Sublingual buprenorphine
3. Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until
4. Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days

Arms: arm 1: Subjects will be studied on four occasions. Sessions and drugs are:

1. Intravenous buprenorphine
2. Sublingual buprenorphine
3. Cyclosporine plus intravenous buprenorphine
4. Cyclosporine plus sublingual buprenorphine
Interventions: intervention 1: buprenorphine
Intervention descriptions: intervention 1: Session 1 Intravenous buprenorphine: 0.2 mg over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3 Intravenous buprenorphine 0.2 mg over 1 hr beginning 1 hr after starting cyclosporine Session 4 Sublingual buprenorphine: 2 mg after cyclosporine.

Protocol documents:
Clinical trial NCT01669343
Conditions: Breast Neoplasms
Keywords: Aromatase Inhibitors
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Start date: 2012-10-01; Completion date: 2016-12-01
Enrollment: 121 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine how key patient factors, including body size affect how well letrozole suppresses circulating estrogen levels.

This study has two components: (1) Part A - an observational phase to evaluate the impact of vitamin D and obesity on estrogen suppression in post-menopausal women already receiving letrozole treatment, and (2) Part B - an interventional phase for women with body mass index (BMI) \> 25 kg/m2 to assess the effect of double AI dose on estrogen levels.

If BMI or other patient factors reduce the effectiveness of letrozole, modifications to treatment recommendations and studies to test higher dosing of letrozole may be needed to maximize the benefit of this treatment and minimize the risk of the breast cancer coming back.

Detailed description:
The available evidence suggests that circulating estradiol levels play a critical role in determining effectiveness of aromatase inhibitor therapy, and that maximal suppression of aromatase activity and estrogen production is essential for optimal disease control. Host factors such as high 25-Hydroxy Vitamin D (25-OH D) levels and obesity, which might increase residual estrogen levels, could adversely impact outcome and lead to an increased risk of recurrence or death. The primary objective of Part A (which includes women regardless of BMI) is to directly evaluate the relationship between (i) 25-OH D levels and serum estrogen levels and (ii) BMI and serum estrogen levels in a cohort of postmenopausal women on standard dose letrozole therapy (2.5 mg/day). Part B (which includes only women with BMI \> 25 kg/m2) will determine whether an increased dose of letrozole (5 mg/day), which had no dose limiting side effects in a Phase I study improves suppression of estrogen in overweight/obese women.

Arms: arm 1: Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants
Interventions: intervention 1: Letrozole
Intervention descriptions: intervention 1: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.

Protocol documents:
Clinical trial NCT01691781
Conditions: Hyperparathyroidism
Keywords: Hyperparathyroidism Renin-angiotensin-aldosterone system ACE inhibitors
Sponsor: Brigham and Women's Hospital
Start date: 2012-10-01; Completion date: 2016-12-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.

Detailed description:
The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism.

Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with increased PTH. The principal investigator, and other investigators, have previously shown that inhibiting the RAAS may lower PTH. The current study will focus on:

1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?
2. Pathophysiology: Does an ACEi reduce PTH in individuals with primary hyperparathyroidism?

The results of this study may have important implications for cardiovascular and skeletal health, as both the RAAS and PTH have been implicated as mediators of these conditions.

Arms: arm 1: Lisinopril - open-label, 2.5-40mg daily
Interventions: intervention 1: Lisinopril
Intervention descriptions: intervention 1: Each subject will receive one week of lisinopril and return for repeat for blood measurements.

Protocol documents: