ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01739790
Conditions: COPD Chronic Bronchitis
Keywords: COPD Chronic Bronchitis N-acetylcysteine
Sponsor: University of Minnesota
Start date: 2013-01-01; Completion date: 2015-12-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is widely prescribed for patients with chronic obstructive lung disease (COPD), particularly for those who have accompanying symptoms of chronic cough and sputum production. Compared to placebo, high-dose NAC will improve Saint George Respiratory Questionnaire scores in patients with COPD and chronic bronchitis.

Detailed description:
A total of 130 subjects with COPD and chronic bronchitis will be randomized (in a double-blind fashion) to receive either high-dose NAC (1800 mg) or matching placebo twice daily for eight weeks. Respiratory health status, assessed by changes in St. George's Respiratory Questionnaire, will be used to determine the effects of NAC on lung function. It is anticipated that the subjects on high dose NAC will have improved scores.

Arms: arm 1: Identical placebo pills twice daily for 8 weeks Placebo pills manufactured to mimic appearance of intervention drug n-acetylcysteine and prescribed with identical frequency and duration. arm 2: 1800 mg twice daily for 8 weeks
Interventions: intervention 1: N-Acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: 1800 mg twice daily for 8 weeks intervention 2: Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.

Protocol documents:
Clinical trial NCT01740206
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Nationwide Children's Hospital
Start date: 2012-11-01; Completion date: 2015-12-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be randomized to one of two groups: stimulant medication administered on the day of surgery or stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology will be at the discretion of the attending anesthesiologist, but the endpoint will be a bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia. Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and the incidence of hypotension, bradycardia, or administration of medications will be compared between the two groups.

Detailed description:

Arms: arm 1: Patients who took their amphetamine and/or methylphenidate the morning of surgery. arm 2: Patients who did not take their stimulant medication the morning of surgery.
Interventions: intervention 1: Amphetamine and/or methylphenidate intervention 2: Hold stimulant medication
Intervention descriptions: intervention 1: Patients who took their stimulant medication the day of surgery. intervention 2: Patients who held their stimulant medication the day of surgery.

Protocol documents:
Clinical trial NCT01774851
Conditions: HER-2 Gene Amplification Esophagus Cancer Gastroesophageal Junction Cancer Stomach Cancer
Keywords: HER-2 Gene Amplification Esophagus Cancer Gastroesophageal Junction Cancer Stomach Cancer Her2 Positive Her2+ Esophageal Cancer Metastatic
Sponsor: Merrimack Pharmaceuticals
Start date: 2013-01-01; Completion date: 2015-12-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone

Detailed description:
This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.

Arms: arm 1: MM-111 + Paclitaxel + Trastuzumab arm 2: Paclitaxel + Trastuzumab
Interventions: intervention 1: MM-111 intervention 2: Paclitaxel intervention 3: Trastuzumab
Intervention descriptions: intervention 1: MM-111 (IV) intervention 2: Paclitaxel (IV) intervention 3: Trastuzumab (IV)

Protocol documents:
Clinical trial NCT01783821
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Keywords: Acute respiratory distress syndrome (ARDS)
Sponsor: Mayo Clinic
Start date: 2013-07-01; Completion date: 2015-12-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD), but the use of these two drugs is experimental for ARDS.

Detailed description:
Subjects were randomized to either placebo or combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 calendar days for a total of 10 doses or until hospital discharge or death. Local hospital pharmacies prepared identical appearing solutions and drug was delivered by respiratory therapists blinded to randomization by using standard jet nebulizers that produce aerosol particle size within the respirable range (\<5.5 microns). The first dose was administered within 4 hours after randomization.

Arms: arm 1: Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours. arm 2: Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
Interventions: intervention 1: Budesonide intervention 2: Placebo intervention 3: Formoterol
Intervention descriptions: intervention 1: Subjects will receive the standard aerosolized dose of budesonide (0.5 mg). intervention 2: Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same. intervention 3: Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .

Protocol documents:
Clinical trial NCT01792518
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2013-02-01; Completion date: 2015-12-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.

Detailed description:

Arms: arm 1: linagliptin 5 mg once daily arm 2: matching placebo for linagliptin dose once daily
Interventions: intervention 1: Placebo intervention 2: Linagliptin 5mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01797822
Conditions: Keratoconjunctivitis Sicca Dry Eye Syndrome
Sponsor: Baylor College of Medicine
Start date: 2013-02-01; Completion date: 2015-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the counter artificial tears and the prescription eye drop, dexamethasone, change or effect the eyes response to a low humidity environment.

It is known that irritation from dry eye can be improved by over the counter artificial tears because they wet and lubricate the eyes. The prescription eye drop, dexamethasone, can also improve eye irritation by decreasing the inflammation that develops in dry eye. Thus, the investigators hypothesize that the use of these conventional dry eye treatments will improve the eyes' response to a low humidity environment.

Detailed description:
This study evaluated the effects of the corticosteroid dexamethasone on suppressing development of eye irritation, cornea epithelial disease and increased production of inflammatory mediators in subjects who were subjected to an experimental low humidity drafty environment.

Arms: arm 1: Artificial tears four times a day both eyes for two weeks, then Dexamethasone 0.01% four times a day both eyes for two weeks
Interventions: intervention 1: Dexamethasone intervention 2: Artificial tear
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01798485
Conditions: Non-Small-Cell Lung Adenocarcinoma Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Metastatic
Sponsor: Synta Pharmaceuticals Corp.
Start date: 2013-04-01; Completion date: 2015-12-01
Enrollment: 696 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

Detailed description:
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival (OS) has been observed.

Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility.

The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.

Arms: arm 1: Ganetespib (150 mg/m\^2) and docetaxel (75 mg/m\^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle. arm 2: Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Interventions: intervention 1: Docetaxel intervention 2: Ganetespib
Intervention descriptions: intervention 1: Docetaxel, 75 mg/m\^2, was administered according to prevailing practice and Investigator decision, generally until disease progression, intolerability, or patient's withdrawal of consent. intervention 2: Ganetespib, 150 mg/m\^2, was administered with docetaxel. After docetaxel treatment ceased, participants whose disease has not progressed continued to receive ganetespib alone until disease progression, unacceptable toxicity, or patient's withdrawal of consent.

Protocol documents:
Clinical trial NCT01805440
Conditions: Bipolar Disorder Bipolar Depression Manic Depression
Keywords: Adolescent Bipolar Disorder Bipolar Depression Manic Depression Neuroimaging Magnetic Resonance Spectroscopy Uridine Pyrimidines
Sponsor: University of Utah
Start date: 2013-08-01; Completion date: 2015-12-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for depressed adolescents with bipolar disorder (i.e. "bipolar depression"). Participants initially randomized to placebo who complete the 6-week protocol will be offered 6 months of open-label uridine treatment and follow-up. Participants initially randomized to uridine will be offered the open-label treatment as well.

Detailed description:
This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for depressed adolescents with bipolar disorder (i.e. "bipolar depression").

In addition to treatment with the investigational drug versus placebo, the study includes a translational neuroimaging component: magnetic resonance spectroscopy (1H-MRS) brain scans are performed at baseline, and then repeated following 6 weeks of treatment with uridine or placebo. The scans do not use radiation, and are performed on a 3 Tesla MRI system that is approved for clinical use. The scans allow researchers to measure the concentrations of several chemicals in the brain that are believed to be involved in bipolar disorder and depression.

The primary hypothesis is that uridine treatment will be associated with a significant decrease in GLX (i.e. glutamate + glutamine) levels, compared to placebo, in a part of the brain known as the anterior cingulate cortex.

The secondary hypothesis is that decreased depressive symptoms measured with the Children Depression Rating Scale-Revised (CDRS-R) and Montgomery-Asberg Depression Rating Scale (MADRS) will be correlated with reductions in GLX.

All participants who complete the initial 6-week protocol, including two brain scans, will be offered 6 months of open-label treatment with uridine.

Arms: arm 1: Subjects randomized to this study arm will receive uridine 500 mg twice daily by mouth for 6 weeks. arm 2: Subjects randomized to this arm of the study will receive placebo 500 mg twice daily by mouth for 6 weeks. arm 3: Subjects are not randomized, and do not receive any treatment intervention.
Interventions: intervention 1: Uridine intervention 2: Placebo
Intervention descriptions: intervention 1: Uridine is the active treatment in this clinical trial. intervention 2: Pill placebo is the inactive treatment comparator in this clinical trial.

Protocol documents:
Clinical trial NCT01809639
Conditions: Concussion
Keywords: Concussion
Sponsor: Wake Forest University Health Sciences
Start date: 2013-06-01; Completion date: 2015-12-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Concussions are a common injury among athletes in the United States. The annual incidence of sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8 million, and the likelihood of an athlete in a contact sport experiencing a concussion is as high as 20 percent per season. Even mild traumatic brain injury, including concussion, can cause long-term cognitive problems that affect a person's ability to perform daily activities and to return to school or work. Far more concerning is the mounting body of evidence that concussions are not just transient injuries - but have cumulative effects. It has been well established in animal models that progesterone has neuroprotective benefits. Animal studies using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema, reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral outcomes. To date, there have been no studies to assess whether or not progesterone will be effective for the treatment of concussions. This double-blind placebo controlled trial will assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize that athletes treated with progesterone will have faster resolution of their concussive symptoms. The investigators believe this study may be the first clinical trial to show an effective treatment for concussion.

Detailed description:

Arms: arm 1: 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five arm 2: None
Interventions: intervention 1: Progesterone intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Standard placebo

Protocol documents:
Clinical trial NCT01814241
Conditions: Food Hypersensitivity
Keywords: Peanut allergy
Sponsor: University of North Carolina, Chapel Hill
Start date: 2013-04-01; Completion date: 2015-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to attempt to understand how desensitization works in peanut allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify the early changes in the desensitization process the immune cells undergo to become desensitized to the peanut protein.

Detailed description:
Peanut allergic children will undergo an oral food challenge (OFC) to 1 gm peanut protein in order to accomplish two objectives: (1)to confirm the diagnosis of peanut allergy, and (2) to measure the amount of peanut protein it takes to cause an allergic reaction. Each subject will then undergo a modified rush phase in which the subject receives 6 doses of peanut protein in one day. The build-up phase begins afterward in which the subject's dose of peanut protein is increased every 2 weeks for 36 weeks. After the final build-up dose, the subject consumes that dose for 2 weeks after which he or she returns to the food allergy center for the second food challenge. If the subject successfully consumes this food challenge without symptoms, the daily dosing of peanut protein will be stopped and the subject will then undergo a third food challenge. If the subject successfully consumes the peanut protein during that challenge, he or she will return for a fourth food challenge to peanut.

Arms: arm 1: Open label orally ingested peanut flour with maintenance dose of 1450mg
Interventions: intervention 1: Open label peanut OIT
Intervention descriptions: intervention 1: Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg.

Protocol documents:
Clinical trial NCT01817530
Conditions: Heavy Uterine Bleeding Uterine Fibroids
Keywords: Uterine Fibroids Leiomyomata Elagolix Menorrhagia Elagolix sodium Heavy Uterine Bleeding ABT-620
Sponsor: AbbVie
Start date: 2013-04-08; Completion date: 2015-12-01
Enrollment: 571 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.

Detailed description:

Arms: arm 1: Placebo for elagolix and placebo for E2/NETA twice daily (BID) arm 2: Elagolix 300 mg BID alone arm 3: Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD) arm 4: Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD arm 5: Placebo for elagolix and E2/NETA QD arm 6: Elagolix 600 mg QD alone arm 7: Elagolix 600 mg QD plus LD E2/NETA QD arm 8: Elagolix 600 mg QD plus SD E2/NETA QD
Interventions: intervention 1: Elagolix placebo intervention 2: Elagolix intervention 3: 0.5 mg estradiol / 0.1 mg norethindrone acetate intervention 4: 1 mg estradiol / 0.5 mg norethindrone acetate intervention 5: E2/NETA placebo
Intervention descriptions: intervention 1: oral coated tablet intervention 2: oral coated tablet intervention 3: oral hard capsule intervention 4: oral hard capsule intervention 5: oral hard capsule

Protocol documents:
Clinical trial NCT01880099
Conditions: Nicotine Dependence
Keywords: addiction smoking tobacco cigarettes
Sponsor: Yale University
Start date: 2013-12-01; Completion date: 2015-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.

Detailed description:
We propose a double-blind, placebo-controlled, outpatient study with a between-groups design. Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to the target doses over a 2-week period (Table 2). During Week 3, following overnight abstinence from smoking, participants will present for a laboratory Test Session in which they will have the option of cigarette self-administration. After this Test Session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. Smokers will establish a quit date at the beginning of this Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will administer EMA assessments. The study medication will be tapered after the end of Week 4 of the Treatment Phase. Participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.

Arms: arm 1: Placebo (sugar Pill) will be given daily for 7 weeks. arm 2: Galantamine extended release (8mg) will be given daily for 7 weeks. arm 3: Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.
Interventions: intervention 1: placebo intervention 2: Galantamine 8mg intervention 3: Galantamine 16mg
Intervention descriptions: intervention 1: placebo compared to 8mg of Galantamine intervention 2: 8mg of galantamine compared to placebo intervention 3: 16mg of galantamine compared to placebo

Protocol documents:
Clinical trial NCT01911429
Conditions: Schizophrenia
Keywords: schizophrenia Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2013-08-01; Completion date: 2015-12-01
Enrollment: 327 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and Safety study of Lurasidone in pediatric patients.

Detailed description:
To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision \[DSM-IV-TR\] criteria) as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.

Arms: arm 1: Lurasidone 40 mg once daily arm 2: Lurasidone 80 mg once daily Arm received the Lurasidone 40mg dose first, from Days 1-3, and then received the Lurasidone 80 mg dose from day 4 to Week 6 arm 3: Placebo 40 or 80 mg once daily
Interventions: intervention 1: Lurasidone 40 mg intervention 2: Lurasidone 80 mg intervention 3: Placebo 40 or 80 mg
Intervention descriptions: intervention 1: Lurasidone 40 mg once daily intervention 2: Lurasidone 80 mg once daily intervention 3: Placebo 40 or 80 mg once daily

Protocol documents: