ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00211757
Conditions: Autism
Keywords: autism aggression irritability divalproex sodium
Sponsor: Montefiore Medical Center
Start date: 2002-09-01; Completion date: 2008-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms.

Detailed description:
This study compares divalproex sodium and placebo in the treatment of autistic disorder. Twenty six child or adolescent outpatients, with age ranges from 5-17, will be randomized into a 12-week double-blind, placebo-controlled parallel treatment study. During the 12 weeks, patients will be monitored by the treating psychiatrist and assessed by an independent evaluator (IE). The IE will perform study assessments while remaining blind to medication regimens (including possible tapering) as well as any side effects. Study assessments will be administered at designated time points

Arms: arm 1: Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium. arm 2: Subjects will receive the study drug, divalproex sodium.
Interventions: intervention 1: Divalproex sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Study drug. intervention 2: Placebo comparator.

Protocol documents:
Clinical trial NCT00226590
Conditions: Lung Cancer
Keywords: non-small cell lung cancer carcinoma unresectable Stage IIIA Stage IIIB thoracic radiation
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2003-04-01; Completion date: 2008-07-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single institution Phase II study for patients with unresectable Stage IIIA and IIIB non-small cell lung cancer. The treatment started with 2 cycles of gemcitabine and carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation included using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy. Response rate was determined following the chemotherapy with gemcitabine and carboplatin and evaluated again after the chemoradiation. Treatment toxicities were also assessed.

Detailed description:
In this trial we adopted the approach of using both induction and concurrent chemotherapy together with Thoracic Radiation Therapy (TRT) planned conformally to a tumor dose of 74 Gy. Substitution of gemcitabine for paclitaxel in the induction chemotherapy allowed us to evaluate the impact of RRM1 expression on the activity of this agent. The expression of Ribonucleotide Reductase, M1 Subunit (RRM1) was evaluated prior to initiation of therapy, following induction chemotherapy but prior to concurrent chemoradiation, and following completion of all therapy by CT-guided core needle biopsies. This is a single institution phase II clinical trial, of induction treatment with gemcitabine and carboplatin followed by concurrent chemoradiation using paclitaxel and carboplatin and daily thoracic radiation to a total dose of 74 Gy for patients with unresectable Stage IIIA and IIIB NSCLC. The specific clinical objectives of this study are as follows: To determine the response rate (both CT scan and PET scan assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin; To determine the response rate (both CT scan and PET scan assessment) to concurrent thoracic radiation and weekly paclitaxel and carboplatin; To evaluate the patterns of local and distant failure for patients treated with induction chemotherapy followed by concurrent chemoradiation according to this regimen; To estimate the median, 1 year, and overall survival; To assess acute and long term toxicities of treatment.

Arms: arm 1: In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
Interventions: intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Radiation
Intervention descriptions: intervention 1: Induction Chemotherapy. intervention 2: Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy. intervention 3: Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy. intervention 4: Radiation Therapy will begin on day 57 if there has been adequate hematologic recovery from Induction Chemotherapy.

Protocol documents:
Clinical trial NCT00243152
Conditions: Facial Neuropathy
Keywords: pain neuropathic face trigeminal
Sponsor: Pain and Analgesia Imaging and Neuroscience Group
Start date: 2005-10-01; Completion date: 2008-07-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI).

Detailed description:
Currently there are no pharmacological agents that can control neuropathic pain akin to the efficacy of antibiotics for bacterial infection. All current neuropathic pain drugs have approximately the same efficacy of less than 30% in controlled trials, and many of these drugs do not have known mechanisms of action. fMRI studies may provide insight into how brain circuitry is altered by chronic pain, and how these drugs act on altered circuitry. The trigeminal system in particular offers unique advantages for studying such alterations, including a large central representation and high degree of somatotopy. The administration of lamotrigine to neuropathic pain patients in conjunction with fMRI will allow us to compare subjective ratings of pain with objective measures of neural activity during increased conditions of allodynia/hyperalgesia.

Arms: arm 1: The drug lamotrigine will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for placebo will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit. arm 2: The placebo will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, the drug lamotrigine (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for drug will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.
Interventions: intervention 1: Lamotrigine intervention 2: Placebo (for Lamotrigine)
Intervention descriptions: intervention 1: : 25mg and 50mg tablets intervention 2: Sugar pill manufactured to mimic Lamotrigine tablets

Protocol documents:
Clinical trial NCT00260533
Conditions: Generalized Social Phobia
Sponsor: University of California, San Diego
Start date: 2005-11-01; Completion date: 2008-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and tolerability of atomoxetine (Strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder characterized by a fear of interpersonal interactions).

Detailed description:
Controlled studies show that approximately 50% of patients with generalized social anxiety disorder(GSAD)will respond to treatment with available pharmacotherapeutic agents such as SSRI's. This still leaves 50% that respond partially or not at all. Those who do respond, often experience adverse events (e.g., sexual dysfunction), which leads them to discontinue treatment. Thus, there is a strong rational for identifying alternatives to SSRI's that are effective with fewer side effects (or with a different side-effect profile, that features less sexual dysfunction)for the treatment of GSAD. Available data demonstrate that sustained-release venlafaxine, a dual reuptake inhibitor, is also effective for GSAD.(Stein et al., 2005). It is unclear from these studies whether serotonin reuptake is integral to efficacy for social anxiety disorder, or whether norepinephrine reuptake will convey similar efficacy. Atomoxetine (Strattera)an inhibitor of the presynaptic norepinephrine transporter, is an ideal candidate to address both these issues.

Arms: arm 1: Atomoxetine arm 2: Placebo
Interventions: intervention 1: atomoxetine intervention 2: placebo
Intervention descriptions: intervention 1: Flexible dose, up to 50 mg per day intervention 2: placebo (matching to atomoxetine)

Protocol documents:
Clinical trial NCT00262522
Conditions: Human Immunodeficiency Virus Infections
Keywords: Human Immunodeficiency Virus Infections
Sponsor: Abbott
Start date: 2005-11-01; Completion date: 2008-07-01
Enrollment: 664 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) intervention 2: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) intervention 3: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) intervention 4: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Intervention descriptions: intervention 1: LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD intervention 2: LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD intervention 3: LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD intervention 4: LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD

Protocol documents:
Clinical trial NCT00277394
Conditions: Deep Vein Thrombosis
Keywords: Acute, symptomatic and objectively confirmed DVT
Sponsor: LEO Pharma
Start date: 2005-12-01; Completion date: 2008-07-01
Enrollment: 541 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).

The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.

Detailed description:

Arms: arm 1: innohep® 175 anti-Xa IU/kg once daily arm 2: Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
Interventions: intervention 1: innohep® intervention 2: Heparin
Intervention descriptions: intervention 1: 175 anti-Xa IU/kg administered subcutaneously (SC) once daily intervention 2: Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.

Protocol documents:
Clinical trial NCT00300742
Conditions: Alcohol Dependence Binge Eating
Keywords: drinking eating obesity alcohol binge eating
Sponsor: University of Virginia
Start date: 2006-03-01; Completion date: 2008-07-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the feasibility of using topiramate to reduce binge eating and drinking episodes in alcohol dependent individuals with comorbid binge eating disorder.

Detailed description:
Research has shown an alarming coincidence of binge eaters also reporting serious alcohol abuse. Evidence has shown this population to have higher rates of psychiatric comorbidity, higher caloric intakes during meals, higher rates of tobacco use, more frequent binge episodes, and an earlier age of onset for binge eating and alcohol abuse. It is believed that topiramate may reduce binge eating and has been found helpful in reducing the cravings associated with alcohol consumption.

This study is to test the feasibility of administering topiramate to individuals with alcohol dependence and binge eating disorder. This will involve determining the adequacy of the amount of assessment and scheduled visits.

Arms: arm 1: Drug: Topiramate Other Name for Topiramate: Topamax
Interventions: intervention 1: Topiramate
Intervention descriptions: intervention 1: Topiramate up to 300 mg per day.

Protocol documents:
Clinical trial NCT00302211
Conditions: Pulmonary Hypertension
Keywords: PAH Pulmonary Arterial Hypertension
Sponsor: Actelion
Start date: 2006-02-01; Completion date: 2008-07-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.

Detailed description:

Arms: arm 1: inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period arm 2: Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period arm 3: Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period arm 4: Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period arm 5: Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
Interventions: intervention 1: Inhaled Iloprost (5 μg) intervention 2: Inhaled Placebo intervention 3: Sildenafil intervention 4: Bosentan
Intervention descriptions: intervention 1: iloprost inhalation solution (Ventavis) (5 μg) intervention 2: inhaled placebo intervention 3: oral sildenafil (dosage between 60 and 300 mg/day) intervention 4: oral bosentan (dosage between 62.5 and 125 mg BID)

Protocol documents:
Clinical trial NCT00317044
Conditions: Asthma GERD
Keywords: Moderate to severe Asthma Gastroesophageal Reflux Disease esomeprazole GERD
Sponsor: AstraZeneca
Start date: 2006-04-01; Completion date: 2008-07-01
Enrollment: 961 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Esomeprazole intervention 2: Esomeprazole intervention 3: Placebo
Intervention descriptions: intervention 1: Esomeprazole 40 mg twice daily intervention 2: Esomeprazole 40 mg once daily intervention 3: Placebo twice daily

Protocol documents:
Clinical trial NCT00331799
Conditions: Major Depressive Disorder
Keywords: Depression Pharmacotherapy Duloxetine
Sponsor: Duke University
Start date: 2007-04-01; Completion date: 2008-07-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to explore benefits of duloxetine in enhancing psychological resilience and to understand the relevance of inhibiting of both serotonin (5HT) and norepinephrine (NE)to therapeutic responses.

Detailed description:
This is an investigator-initiated, single-site study consisting of 8 weeks of open-label, fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with Major Depressive Disorder (MDD).

Arms: arm 1: Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.

Protocol documents:
Clinical trial NCT00364689
Conditions: Hepatic Encephalopathy
Keywords: Encephalopathy, Hepatic Portosystemic Encephalopathy Encephalopathy, Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy, Portosystemic Hepatic Coma Hepatic Stupor Hepatocerebral Encephalopathy Portal-Systemic Encephalopathy
Sponsor: University of Miami
Start date: 2006-08-01; Completion date: 2008-07-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Rifaximin intervention 2: Lactulose intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00370331
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: ITP idiopathic platelets purpura thrombocytopenia Idiopathic Thrombocytopenic Purpura thrombocytopenic
Sponsor: GlaxoSmithKline
Start date: 2006-11-01; Completion date: 2008-07-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP. Subjects will be randomized 2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects will receive study medication for 6 months, during which the dose of study medication may be adjusted based upon individual platelet counts. In addition, subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care. After discontinuation of study medication, subjects will complete follow-up visits at weeks 1, 2, 4 and months 3 and 6.

Detailed description:
A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).

Arms: arm 1: Subjects will initiate treatment with 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down. arm 2: Subjects will initiate treatment with 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down.
Interventions: intervention 1: eltrombopag intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down. intervention 2: Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down

Protocol documents:
Clinical trial NCT00377819
Conditions: Postmenopausal Osteoporosis
Keywords: RANKL RANK denosumab AMG 162 osteoporosis bone turnover bone mineral density clinical trial postmenopausal osteoporosis alendronate total hip bone mineral density
Sponsor: Amgen
Start date: 2006-09-01; Completion date: 2008-07-01
Enrollment: 504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: alendronate intervention 2: Denosumab (AMG 162)
Intervention descriptions: intervention 1: 70 mg oral QW intervention 2: 60 mg SC q 6 mos

Protocol documents:
Clinical trial NCT00379639
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer advanced solid tumors
Sponsor: Celgene
Start date: 2006-07-01; Completion date: 2008-07-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted.

Detailed description:

Arms: arm 1: Participants were to receive 7, 10 or 12 mg/m\^2 of romidepsin intravenously on either Days 1, 8 and 15 (Schedule A) or Days 1 and 15 (Schedule B) of each 28-day cycle, followed by 800 or 1000 mg/m\^2 of gemcitabine. Subsequent doses of both drugs were based on treatment-related toxicities. The planned duration of study therapy was 6 cycles or until disease progression occurred. Patients who responded could continue beyond 6 cycles until disease progression or until a withdrawal criterion was met.
Interventions: intervention 1: Romidepsin intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 7, 10 or 12 mg/m\^2 via intravenous infusion over 4 hours on either Days 1, 8 and 15 or Days 1 and 15 of each 28-day cycle. intervention 2: 800 or 1000 mg/m\^2 via intravenous infusion over 30 minutes on either Days 1,8 and 15 or Days 1 and 15 of each 28 day cycle.

Protocol documents: