ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01238575
Conditions: Pervasive Development Disorders
Keywords: Pervasive Developmental Disorders PDD PDD-NOS Autistic Disorder Autism Asperger's Disorder Hyperactivity Attention Deficit Hyperactivity Disorder ADHD Medication Drug Guanfacine Intuniv Placebo Methylphenidate
Sponsor: Yale University
Start date: 2011-12-01; Completion date: 2014-03-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).

Detailed description:
Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise Specified. Children with PDD show delays in speech and language and reduced social interaction. Some children with PDD have also have problems with overactivity, impulsiveness and distractability. These behaviors are seen in children with Attention Deficit Hyperactivity Disorder (ADHD). Extended release guanfacine (Intuniv) is FDA-approved for the treatment of children with ADHD. The purpose of this study is to evaluate whether Intuniv is an effective treatment for ADHD symptoms in children with PDD.

This study has four parts: an 8-week double-blind trial, an 8-week blinded extension phase (for positive responders only), an 8-week open-label trial, and a 4-week add-on study. Following confirmation of eligibility, participants will be randomly assigned to receive either guanfacine or placebo in the 8-week double-blind trial. Children who show improvement after 8 weeks of treatment will continue on their assigned treatment for an additional 8 weeks (blinded extension phase). Children who show partial improvement with guanfacine will be offered 4 weeks of treatment with guanfacine plus methylphenidate (add-on study). Children who show no improvement on placebo will be offered 8 weeks of treatment with guanfacine (open-label trial). Children who show no improvement on guanfacine will exit the study.

Side effects and treatment response will be assessed at regularly scheduled visits.

The study protocol was formally revised with the Yale University IRB in May 2013 to address an early close to enrollment due to a reduction in funding. The original anticipated enrollment numbers of 112 subjects was reduced to 60 subjects. The study statistician was consulted prior to enrollment closure to address any issues related to statistical power and the adjustments made to the final statiscal analysis plan.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: extended-release guanfacine
Intervention descriptions: intervention 1: Administered for 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 NCT01253291
Conditions: Rheumatoid Arthritis
Sponsor: Eli Lilly and Company
Start date: 2010-05-01; Completion date: 2014-03-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.

Detailed description:

Arms: arm 1: Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study. arm 2: Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed.
Interventions: intervention 1: LY2127399
Intervention descriptions: intervention 1: Administered subcutaneously every 4 weeks for 48 weeks

Protocol documents:
Clinical trial NCT01258153
Conditions: Infantile Colic
Keywords: Infantile Colic tachykinin antagonist Nepadutant
Sponsor: Menarini Group
Start date: 2010-11-01; Completion date: 2014-03-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.

Detailed description:
Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day.

Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory.

In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit.

This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo.

The experimental clinical phase encompasses the following periods:

* Screening period (no study medication) to be done 7 to 4 days prior to randomisation
* Treatment period, lasting seven days with once daily administration
* Post treatment period, lasting seven days A safety follow-up visit will be performed approximately 1 month after the first administered dose.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Nepadutant oral solution intervention 2: Nepadutant oral solution intervention 3: Placebo matching Nepadutant oral solution
Intervention descriptions: intervention 1: Oral administration once daily for 7 days intervention 2: Oral administration once daily for 7 days intervention 3: Oral administration once daily for 7 days

Protocol documents:
Clinical trial NCT01269918
Conditions: Adult Intracranial Tumor Adult Solid Tumor
Keywords: Craniotomy, pain relief Adult solid neoplasm
Sponsor: The Cleveland Clinic
Start date: 2011-07-01; Completion date: 2014-03-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized blinded clinical trial. Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team will know the result of randomization at induction. Data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.

Detailed description:
Anesthesia for craniotomy presents a unique challenge to the anesthesiologist. Anesthesia for neurosurgical procedures should provide optimal surgical conditions while maintaining appropriate cerebral oxygen supply and stable systemic hemodynamics. (1) It is important to prevent patient response to noxious stimuli during the procedure like pinning, drilling of the bone, opening and manipulation of the dura etc., avoid coughing and bucking during surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia. At the same time it is desirable to have the patient fully awake toward the end of the surgery in order to facilitate neurologic evaluation. Management of the above presents a challenge during induction, maintenance and extubation and also during multiple critical stages of surgery Fear of the side effects of analgesic drugs frequently leads to the under-treatment of post-craniotomy pain. (2) Nevertheless, this pain continues to be commonly observed, is frequently severe, and, if unrelieved, may cause distress for the neurosurgical patient and serious complications for the operative brain. (2) There is a need for larger trials to delineate safety and efficacy of analgesic therapies with a focus on short- and long-term outcomes.

Arms: arm 1: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS arm 2: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Interventions: intervention 1: Remifentanil intervention 2: Dexmedetomidine
Intervention descriptions: intervention 1: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS intervention 2: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Protocol documents:
Clinical trial NCT01287039
Conditions: Eosinophilic Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2011-04-01; Completion date: 2014-03-01
Enrollment: 489 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.

Detailed description:
Demonstrate the efficacy of reslizumab, at a dose of 3 mg/kg administered iv every 4 weeks over 12 months, as assessed by the reduction in frequency of clinical asthma exacerbations (CAEs) during 12 months.

An exacerbation event will be considered a CAE if the patient meets either or both of the criteria listed below and this is corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:

* use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days
* asthma-related emergency treatment The above criteria must be corroborated with at least 1 other measurement to indicate worsening in the clinical signs and symptoms of asthma.

Arms: arm 1: Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses. arm 2: Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
Interventions: intervention 1: Reslizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses. intervention 2: Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.

Protocol documents:
Clinical trial NCT01289041
Conditions: Advanced Endometrial Cancer
Keywords: Advanced endometrial cancer PI3K pathway second-line treatment
Sponsor: Novartis Pharmaceuticals
Start date: 2011-02-01; Completion date: 2014-03-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: BKM120
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01337050
Conditions: Neoplasms
Keywords: Hepatocellular Carcinoma Advanced/Metastatic solid tumors
Sponsor: Pfizer
Start date: 2011-07-01; Completion date: 2014-03-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose escalation and designed to define the Maximum Tolerated Dose \[MTD\] and the Recommended Phase 2 Dose \[RP2D\].

Detailed description:

Arms: arm 1: PF-03446962
Interventions: intervention 1: PF-03446962
Intervention descriptions: intervention 1: PF 03446962 given by a 1 hour IV infusion. Each patient will initially receive the first dose on Cycle 1 Day 1 with a 28 day observation period. Cycle 2 will start on Day 29. The dosing interval will be 14 days for Cycle 2 and subsequent cycles.

Protocol documents:
Clinical trial NCT01339689
Conditions: PTSD
Keywords: PTSD Posttraumatic Stress Disorder pharmacotherapy ganaxolone
Sponsor: Marinus Pharmaceuticals
Start date: 2011-04-01; Completion date: 2014-03-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population.

Detailed description:

Arms: arm 1: active arm 2: non-active
Interventions: intervention 1: Ganaxolone intervention 2: Placebo
Intervention descriptions: intervention 1: 200-600 mg bid, capsules, up to 12 weeks intervention 2: capsules, bid, up to 12 weeks

Protocol documents:
Clinical trial NCT01343888
Conditions: Hepatitis C
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2014-03-01
Enrollment: 656 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

Detailed description:

Arms: arm 1: PegIFN/RBV for 48 weeks arm 2: BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks arm 3: Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Interventions: intervention 1: PegIFN/RBV intervention 2: BI 201335 intervention 3: BI 201335 intervention 4: Placebo
Intervention descriptions: intervention 1: PegIFN/RBV for 48 weeks intervention 2: BI 201335 once daily high dose intervention 3: BI 201335 once daily low dose intervention 4: None

Protocol documents:
Clinical trial NCT01347112
Conditions: Smoking Tobacco Dependence Alcohol Dependence
Keywords: smoking tobacco dependence alcohol dependence
Sponsor: Mayo Clinic
Start date: 2011-06-01; Completion date: 2014-03-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alcohol dependence is a significant and prevalent public health problem affecting approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk for both morbidity and mortality related to alcohol consumption and tobacco dependence. Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently drinking alcoholic smokers.

Varenicline is the most effective medication currently available for treating tobacco dependence. While some randomized trials have included recovering alcoholics, active alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the first such clinical trial in currently drinking alcoholic smokers. In addition to helping smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in rats. The goal of this proposal is to explore the potential efficacy of varenicline for treating tobacco dependence and reducing drinking among alcohol dependent smokers.

The investigators hypothesize that 12 weeks of treatment with varenicline, a partial nicotinic acetylcholine receptor agonist will be more effective than placebo in treating tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic smokers. The investigators will also explore whether varenicline has an effect on drinking behavior among currently drinking alcoholics. The investigators propose the following specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited at the Mayo Clinic in Rochester, Minnesota.

Detailed description:
Seventy smokers who are currently alcohol dependent will be enrolled to this study. If found to be study eligible they will be randomized to either active varenicline or placebo for 12 weeks. During these two weeks, they will be seen either weekly or biweekly. At the end of treatment, they will be followed up for an addition 12 weeks. Their last study visit will be 6 months after randomization.

Arms: arm 1: varenicline 1.0 mg twice daily for 12 weeks arm 2: Varenicline look alike sugar pill twice daily for 12 weeks
Interventions: intervention 1: Varenicline intervention 2: placebo
Intervention descriptions: intervention 1: varenicline 1.0 mg dose, twice daily for 12 weeks intervention 2: sugar pill twice daily for 12 weeks

Protocol documents:
Clinical trial NCT01350102
Conditions: Diabetes, Type 1 Diabetes, Type 2 Foot Ulcer, Diabetic
Keywords: Adult
Sponsor: Susan Hassenbein
Start date: 2012-02-01; Completion date: 2014-03-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will be done to evaluate impact on time to wound closure.

Detailed description:
This is a prospective randomized controlled study evaluating the relationship of hemoglobin A1c in diabetic wound healing. Length of time for wound closure will be compared using four treatment options.

Arms: arm 1: Bacitracin wound care dressing alone arm 2: Bacitracin wound care dressing with Vitamin C supplementation arm 3: AmeriGel® wound care dressing alone arm 4: AmeriGel® wound care dressing with Vitamin C supplementation
Interventions: intervention 1: Bacitracin intervention 2: AmeriGel® intervention 3: Vitamin C
Intervention descriptions: intervention 1: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. intervention 2: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. intervention 3: Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve

Protocol documents:
Clinical trial NCT01379534
Conditions: Solid Tumors and Advanced Endometrial Cancer Endometrial Cancer Second-line Treatment VEGF
Keywords: Solid tumors, advanced endometrial cancer, Endometrial Cancer, Second-line treatment, VEGF, Neoplasms, Endometrial Neoplasms, Uterine Neoplasms, Female Genital Neoplasms, Cancer, Carcinoma, Uterine Diseases, Female Genital Diseases, Tumors, Oral Administration, Capsules, Tablets, CHIR258, CHIR-258, CHIR 258, TKI258, TKI-258, TKI 258
Sponsor: Novartis Pharmaceuticals
Start date: 2011-11-01; Completion date: 2014-03-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.

Detailed description:

Arms: arm 1: 1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Interventions: intervention 1: TKI258
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01392495
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension imatinib 6MWD
Sponsor: Novartis Pharmaceuticals
Start date: 2011-06-01; Completion date: 2014-03-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.

Detailed description:

Arms: arm 1: Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
Interventions: intervention 1: Imatinib
Intervention descriptions: intervention 1: 200 mg or 400 mg qd

Protocol documents:
Clinical trial NCT01406574
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2011-07-01; Completion date: 2014-03-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is:

Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy

Detailed description:

Arms: arm 1: Phase1 step arm 2: Phase2 step
Interventions: intervention 1: OPB-31121 intervention 2: OPB-31121 phase2
Intervention descriptions: intervention 1: Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month) intervention 2: Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)

Protocol documents: