ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01639560
Conditions: Smoking
Keywords: smoking tobacco dependence nicotine dependence
Sponsor: Mayo Clinic
Start date: 2013-01-01; Completion date: 2016-06-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if varenicline is effective in treating tobacco dependence in adults who smoke 5-10 cigarettes per day.

Detailed description:
Nearly 50% of U.S. cigarette smokers smoke ≤ 10 cigarettes per day (CPD) and are considered "light smokers." Most light smokers will either maintain a chronic light smoking habit or increase their level of smoking during their lifetime. Importantly, light smokers are at risk for adverse health consequences and increased all-cause mortality. While multiple factors such as reinforcement behavior, diminished autonomy, economic constraints and tobacco control policies influence light smoking, nicotine dependence appears particularly important in 5 to 10 CPD smokers. Despite the high prevalence of light smoking and its increased healthcare burden, few studies have evaluated the efficacy of pharmacotherapy for this group of smokers. Varenicline, which targets symptoms of nicotine dependence, has been shown to increase smoking abstinence rates in moderate to heavy smokers (≥ 10 cigarettes per day). However, varenicline has not been evaluated in subjects who smoke \< 10 CPD. In the current proposal we will investigate the efficacy of varenicline for smoking cessation in 5 to 10 CPD light smokers who wish to quit. This study will be conducted as a double-blind, placebo-controlled, randomized clinical trial at the Mayo Clinic, enrolling 224 eligible participants who smoke 5 to 10 CPD. Participants will receive behavior therapy and either varenicline or placebo for 12 weeks with follow up through 26 weeks. We will determine if varenicline increases smoking abstinence in light smokers at end-of-treatment and 26 weeks as compared to placebo.

Arms: arm 1: 1 mg of varenicline twice per day for 12 weeks. arm 2: 1 placebo tablet twice a day for 12 weeks
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling intervention 2: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling

Protocol documents:
Clinical trial NCT01676714
Conditions: Non-Small Cell Lung Cancer Colorectal Cancer
Keywords: Dovitinib Fibroblast Growth Factor Receptor Biomarkers Anti-Vascular Endothelial Growth Factor Therapy
Sponsor: University of California, Davis
Start date: 2013-02-01; Completion date: 2016-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if dovitinib is an effective treatment for patients with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on anti-vascular endothelial growth factor (VEGF) treatment.

Detailed description:
The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory initial observations of the relationship between FGF signaling alterations and the clinical activity of dovitinib. This trial is expected to provide key biologic information that will inform the clinical development of dovitinib and provide initial evaluation of the analytic characteristics of these potential predictive biomarkers of its efficacy.

Arms: arm 1: 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
Interventions: intervention 1: Dovitinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01703169
Conditions: Severe Aplastic Anemia Very Severe Aplastic Anemia Moderate Aplastic Anemia
Keywords: severe aplastic anemia very severe aplastic anemia moderate aplastic anemia bleeding
Sponsor: University of Utah
Start date: 2012-11-01; Completion date: 2016-06-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators hypothesis is that eltrombopag given to patients with moderate to very severe aplastic anemia will result in an increase in platelet counts. The investigators hypothesize that in patients with moderate to very severe aplastic anemia, treatment with eltrombopag will lead to fewer platelet transfusions, red blood cell transfusions, and fewer bleeding events. The investigators hypothesize that in patients with moderate to very severe aplastic anemia, eltrombopag will have an acceptable toxicity rate \<3%, at doses that result in increased platelet counts. Finally the investigators hypothesize that plasma eltrombopag levels in peripheral blood will correlate with improved platelet counts.

Detailed description:

Arms: arm 1: Single arm study. Dose Escalation.
Interventions: intervention 1: Eltrombopag
Intervention descriptions: intervention 1: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count

Protocol documents:
Clinical trial NCT01706965
Conditions: Schizophrenia Schizoaffective Disorder
Sponsor: New York State Psychiatric Institute
Start date: 2012-10-01; Completion date: 2016-06-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Rater blinded trial of six weeks of Kuvan vs. multivitamin in 60 outpatients with schizophrenia or schizoaffective disorder. The aims are to evaluate an anticipated clinical response to Kuvan treatment including negative symptom and cognitive deficits, evaluate safety of Kuvan treatment for schizophrenic patients and evaluate the relationship of changes in plasma Kuvan levels and efficacy outcomes.

Detailed description:
Tetrahydrobiopterin (BH4) is a vital central nervous system (CNS) cofactor that maintains availability of amine neurotransmitters such as dopamine (DA) and serotonin (5HT), and stimulates and modulates the glutamatergic system. Dysregulation of these neurotransmitter systems has been implicated in the pathogenesis of schizophrenia (SZ). A central role of BH4 in schizophrenia is further supported by a study finding a relative deficit of 32% for SZ patients as compared to controls. The observed BH4 deficit is comparable to that reported for genetic BH4 deficiency disorders, supporting its characterization as having physiological significance. This highly significant finding, along with: a) the known roles of BH4 in neurotransmitter maintenance, b) dysregulation of CNS neurotransmitter synthesis observed in human BH4 deficiencies, c) evidence that plasma biopterin levels are correlated with CNS biopterin levels, and d) evidence that urinary biopterin excretion is not increased in SZ, all support our hypothesis that dysregulation of BH4 biosynthesis is involved in the pathophysiology of SZ. Moreover, additional data suggesting that mood stabilizer drugs can moderately increase levels of biopterin in patients with psychiatric disorders, and the reported efficacy of BH4 in pilot studies of neuropsychiatric disorders, suggest that alleviation of the schizophrenia BH4 deficit via treatment with synthetic BH4 supplement (Sapropterin dihydrochloride or Kuvan), may give rise to an improvement of the symptoms of schizophrenia, including positive and negative symptoms as well as neurocognitive deficits. Sapropterin dihydrochlorides, teh active pharmaceutical ingredient in Kuvan Tablets,is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4)

Arms: arm 1: Kuvan once-daily dosing initiated with 10mg/kg for the first week followed by 20mg/kg for the remaining weeks of the study arm 2: Daily multivitamin tablet
Interventions: intervention 1: Kuvan intervention 2: Multivitamin
Intervention descriptions: intervention 1: 20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight intervention 2: Multi-vitamin will be used as an active control in this study. Will be dosed daily

Protocol documents:
Clinical trial NCT01718444
Conditions: Polycystic Ovary Syndrome Infertility
Keywords: PCOS Polycystic ovary syndrome Infertility Anovulation Clomiphene citrate Clomid Progestin Provera Progesterone Endometrial shedding
Sponsor: University of Illinois at Chicago
Start date: 2015-03-01; Completion date: 2016-06-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some preliminary data suggest that skipping PIES could result in a higher live birth rate. The investigators are performing the first randomized controlled trial to find out if skipping the use of progestin during fertility treatment of anovulatory PCOS women is associated with improved pregnancy and live birth rates compared to the traditional approach of using progestin prior to use of clomiphene citrate.

Detailed description:
This is a prospective randomized trial of clomiphene citrate (CC) preceded by progestin-induced endometrial shedding (PIES) vs CC without PIES in the treatment of infertility in patients with PCOS, for up to 5 treatment cycles.

Participants will be randomized to receive either progestin followed by CC starting on day 3 of the induced menses, or CC without induced menses. Study participants will be monitored at regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal parameters. The maximum dose of CC will not exceed 750 mg/cycle. Treatment will not exceed 5 ovulatory cycles. Participants who are resistant to 150 mg of CC will exit the study.

170 anovulatory PCOS women actively seeking pregnancy, aged 18 through 40 years will be enrolled and randomized in a 1:1 treatment ratio into the two study arms. Anovulation will be the only infertility factor in all patients.

Arms: arm 1: Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.

* CC 50 mg oral for 5 days ("Days 3-7")
* If no ovulation, CC 100 mg for 5 days ("Days 12-16")
* If no ovulation, CC 150 mg for 5 days ("Day 21-25")
* Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles arm 2: Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)

* Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)
* CC 50 mg oral for 5 days (Day 3-7)
* If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses
* If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days
* Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles
Interventions: intervention 1: Progestin intervention 2: Clomiphene Citrate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01798394
Conditions: Tobacco Use Cessation Tobacco Use Disorder
Keywords: pregnant smoker cigarette tobacco
Sponsor: University of Minnesota
Start date: 2014-06-01; Completion date: 2016-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.

Detailed description:
Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery, women will be randomly assigned to receive 4 weeks of active or placebo exogenous progesterone starting on the 4th day postpartum. Participants will be in contact with study staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking status and protocol compliance, measure serum progesterone levels and receive behavioral counseling.

Arms: arm 1: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. arm 2: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Interventions: intervention 1: Progesterone intervention 2: Placebo
Intervention descriptions: intervention 1: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. intervention 2: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Protocol documents:
Clinical trial NCT01803646
Conditions: Tinnitus
Sponsor: Auris Medical, Inc.
Start date: 2014-02-01; Completion date: 2016-06-01
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months.

Detailed description:
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratymanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months from onset).

Arms: arm 1: AM-101 arm 2: Placebo
Interventions: intervention 1: AM-101 intervention 2: Placebo
Intervention descriptions: intervention 1: AM-101 gel for intratympanic injection intervention 2: Placebo gel for intratympanic injection

Protocol documents:
Clinical trial NCT01803711
Conditions: Major Depression Cancer Diabetes Cardiovascular Diseases
Keywords: Omega 3 fatty acid Fish oil Depression cancer diabetes high blood pressure cardiovascular
Sponsor: UConn Health
Start date: 2013-02-01; Completion date: 2016-06-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients with select medical conditions (cancer, cardiovascular diseases and diabetes).

Detailed description:

Arms: arm 1: Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period arm 2: Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period
Interventions: intervention 1: Desvenlafaxine intervention 2: Omega 3 Fatty acids intervention 3: Placebo (for Omega 3 fatty acid supplement)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01833455
Conditions: Ventricular Premature Complexes Blood Pressure
Sponsor: University of Wisconsin, Madison
Start date: 2013-02-01; Completion date: 2016-06-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.

Detailed description:

Arms: arm 1: This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. arm 2: This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
Interventions: intervention 1: PVC Suppression using Flecainide intervention 2: No PVC Suppression using Placebo
Intervention descriptions: intervention 1: Flecainide will be administered to result in a reduction in PVC burden. intervention 2: Placebo (sugar pills) will be given to result in no alteration in PVC burden.

Protocol documents:
Clinical trial NCT01841021
Conditions: Peripheral T-Cell Lymphoma
Keywords: Peripheral T-Cell Lymphoma (PTCL) Relapsed Refractory CD30 Receptor Large B-Cell Lymphoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2014-04-01; Completion date: 2016-06-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied. It is not known if brentuximab vedotin is better or worse than other treatment patients might be given.

Detailed description:

Arms: arm 1: Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
Interventions: intervention 1: Brentuximab vedotin
Intervention descriptions: intervention 1: Brentuximab vedotin will be given by intravenous infusion (into a vein) on Day 1 of every 21 day cycle.

Protocol documents:
Clinical trial NCT01873729
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Naltrexone Adults
Sponsor: Massachusetts General Hospital
Start date: 2013-11-01; Completion date: 2016-06-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain.

We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD.

Detailed description:

Arms: arm 1: Naltrexone
Interventions: intervention 1: Naltrexone
Intervention descriptions: intervention 1: Adults with ADHD

Protocol documents:
Clinical trial NCT01874535
Conditions: Erosive Esophagitis
Sponsor: Chang Gung Memorial Hospital
Start date: 2010-06-01; Completion date: 2016-06-01
Enrollment: 408 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis

Detailed description:
Patients:

Patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.

Outcome parameters:

The main outcome measures

1. Rate of complete symptom relief (CSR) at the end of initial treatment phase
2. rate of symptom relapse within 12 weeks after stopping initial therapy

Arms: arm 1: Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group arm 2: Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group
Interventions: intervention 1: Esomeprazole 40 mg
Intervention descriptions: intervention 1: Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis

Protocol documents:
Clinical trial NCT01895452
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Alkermes, Inc.
Start date: 2013-07-01; Completion date: 2016-06-01
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ALKS 9072, Low Dose intervention 2: ALKS 9072, High Dose
Intervention descriptions: intervention 1: Intramuscular injection, given monthly intervention 2: Intramuscular injection, given monthly

Protocol documents: