ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01274429
Conditions: Peanut Allergy
Keywords: Peanut allergy Immunotherapy OIT
Sponsor: University of North Carolina, Chapel Hill
Start date: 2010-12-01; Completion date: 2015-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to produce a new treatment that would benefit adult subjects by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This project is designed to study the innovative idea that oral immunotherapy (OIT), the ingestion of small increasing amounts of food allergen, will desensitize subjects with peanut hypersensitivity by regulating their mucosal and systemic immune reactivity and cause long-term tolerance.

Detailed description:
The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This is a research study to test stimulation of the immune system to improve peanut allergy. The approach the investigators will use for peanut allergy is called desensitization. A person becomes desensitized to a food by taking small, increasing amounts of the food to help the body become used to the food so that it no longer causes a severe allergic reaction.

The study also looks at the safety and immune system effects of the investigational study product, peanut protein. The word "investigational" means the study product is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

This project is designed to study if peanut oral immunotherapy (POIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance.

Arms: arm 1: Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Interventions: intervention 1: Peanut flour
Intervention descriptions: intervention 1: Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose.

Protocol documents:
Clinical trial NCT01317199
Conditions: Prostate Cancer
Keywords: Rising psa
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2011-07-01; Completion date: 2015-11-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to test an investigational product called Muscadine Plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (PSA) level.

Detailed description:
In phase I the investigators are evaluating the safety of the product and checking blood levels of the active components. In phase II the investigators are evaluating the effect of MPX on PSA doubling time

Arms: arm 1: Muscadine Plus Grape Skin Extract (MPX): Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle. arm 2: Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle). arm 3: Randomly-assigned participants receive low-dose (500mg) MPX arm 4: Randomly-assigned participants receive high-dose (4000mg) MPX
Interventions: intervention 1: Muscadine Plus Grape Skin Extract intervention 2: Low-dose MPX intervention 3: High-dose MPX intervention 4: Placebo oral capsule
Intervention descriptions: intervention 1: Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle intervention 2: Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle). intervention 3: Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle). intervention 4: Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).

Protocol documents:
Clinical trial NCT01393743
Conditions: Seizure Disorder Generalized Tonic Clonic
Keywords: Central Nervous System
Sponsor: Eisai Inc.
Start date: 2011-09-01; Completion date: 2015-11-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic drugs (AED).

Detailed description:
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive-therapy study with an open-label Extension Phase. The Core Study consists of 2 phases: Prerandomization and Randomization. The Prerandomization Phase consisted of 2 periods: Screening (up to 4 weeks) and Baseline (4 or 8 weeks, depending on the accuracy of diary-documented seizures during Screening), during which participants will be assessed for eligibility to participate in the study. The Randomization Phase consisted of 3 periods: Titration (4 weeks), Maintenance (13 weeks), and Follow-up (4 weeks; only for those participants not entering into the Extension Phase). At the start of the Randomization Phase, eligible participants will be randomized to the perampanel or placebo treatment groups in a 1:1 ratio. The extension phase consists of 142 weeks.

Arms: arm 1: Participants received 6 tablets (initially 1 tablet of 2-mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2-mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/placebo. arm 2: Participants received 6 tablets of perampanel matched placebo, once a day.
Interventions: intervention 1: Perampanel intervention 2: Placebo comparator
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01418001
Conditions: Sarcoma Leiomyosarcoma Malignant Peripheral Nerve Sheath Tumor Malignant Fibrous Histiocytoma/Undifferentiated Pleomorphic Sarcoma
Keywords: GEMCITABINE GW786034 (PAZOPANIB) TAXOTERE (DOCETAXEL) 11-104
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2011-08-01; Completion date: 2015-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see the effects, good and/or bad, of the drug combination of gemcitabine, docetaxel and pazopanib on sarcoma. This is a phase Ib-phase II clinical trial. The goal of a phase Ib part of the clinical trial is to confirm a dose of the drugs that is safe. The investigators determine this by closely checking for side effects that the patient may experience.

Detailed description:

Arms: arm 1: This will be a multicenter single arm phase IB/II trial to evaluate the clinical safety and efficacy of gemcitabine/docetaxel and pazopanib in the neoadjuvant treatment of soft tissue sarcoma.
Interventions: intervention 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination
Intervention descriptions: intervention 1: Patients who meet the eligibility criteria above will be treated with the combination therapy of Gemcitabine, Docetaxel, and Pazopanib for two cycles and subsequently re-evaluated for treatment effect. If no progression of the tumor is seen, patients will continue with two more cycles of treatment (total four cycles). Those patients who have progression of disease will proceed directly to surgical resection.

Following completion of neoadjuvant treatment, all patients will have definitive surgical resection. Following recovery from surgery, patients will proceed with adjuvant radiation therapy. Patients will then be followed for 2 years or until January 1st 2015, whichever comes first .

Protocol documents:
Clinical trial NCT01425307
Conditions: Sickle Cell Anemia
Keywords: Phase III Sickle cell anemia Abnormally high Transcranial Doppler velocities. Reduce risk of primary stroke Pediatric patients Chelation therapy
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2011-08-01; Completion date: 2015-11-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently receive chronic transfusions to reduce the risk of primary stroke. For the alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must have a mean TCD velocity similar to that observed with transfusion prophylaxis.

Detailed description:
Despite the clear results of the STOP and the follow-up STOP II trials, the use of chronic erythrocyte transfusions for primary stroke prevention in children with Sickle Cell Anemia (SCA) remains controversial for many practicing hematologists, as well as for patients and families. Transfusions have proven clinical efficacy in preventing first stroke in children with SCA and abnormal TCD velocities, but their indefinite use may still be difficult to justifY.

The risk of transfusion acquired iron overload is now recognized as a serious consequence of chronic erythrocyte transfusions in children with SCA. After one to two years of monthly transfusions, virtually every patient will have excess hepatic iron deposition that warrants intervention with chelation therapy. The effectiveness of iron chelation has not yet been realized, despite the availability of the oral chelator deferasirox (Exjade®), due to its lack of palatability and increasing recognition of serious drug-related toxicities including renal and hepatic dysfunction. Simply put, indefinite erythrocyte transfusions cannot be viewed as adequate and acceptable long-term therapy for primary stroke prevention in SCA. There is an urgent need to develop an equivalent effective alternative therapy for the prevention of primary stroke in children with SCA, specifically one that better manages iron overload and improves quality of life.

Arms: arm 1: Standard Therapy of monthly transfusions arm 2: Hydroxyurea will be provided as capsules or liquid
Interventions: intervention 1: Hydroxyurea
Intervention descriptions: intervention 1: Capsules (300 mg, 400 mg, or 500 mg) taken once daily liquid formulation (100 mg/mL)

Protocol documents:
Clinical trial NCT01429064
Conditions: Prostate Cancer
Sponsor: Orion Corporation, Orion Pharma
Start date: 2011-06-01; Completion date: 2015-11-01
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ODM-201
Intervention descriptions: intervention 1: ODM-201 administered orally daily

Protocol documents:
Clinical trial NCT01431976
Conditions: Epilepsy
Sponsor: GlaxoSmithKline
Start date: 2011-09-01; Completion date: 2015-11-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, uncontrolled, open-label study to evaluate the efficacy and safety of lamotrigine monotherapy on newly diagnosed typical absence seizure in children and adolescents in Japan and South Korea.

The study period is composed the baseline, fixed escalation phase, escalation phase, maintenance phase, taper phase, and post study examination. During the fixed escalation phase, the investigational product is administered at 0.3 mg/kg/day for 2 weeks (Week 1 to 2), followed by 0.6 mg/kg/day for 2 weeks (Week 3 to 4). Subjects thereafter visit the clinic once every 1 to 2 weeks during the escalation phase to increase the dose by 0.6 mg/kg/day up to a maximum of 10.2 mg/kg/day or 400 mg/day (whichever was less) until patients are confirmed to be seizure-free by HV tests for clinical signs. After seizure free is confirmed by HV-clinical signs, the dose is increased by one level and HV-EEG (electroencephalography) test (first test) is assessed at the next visit. If seizure free is observed by HV-EEG, the same dose is administered. Thereafter, HV-EEG (second test) is assessed at the next visit and if seizure free is confirmed again, the subjects enter the 12-week maintenance phase. During the maintenance phase, patients visit the clinic once every 4 weeks. The dose can be adjusted as necessary within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day (whichever was less) taking into account the status of seizures and the safety. The investigational product is administered once daily (in the evening). However, if the number of tablets is large, twice-daily administration (in the morning and evening) is also allowed. After the completion of maintenance phase, subjects who have responded to lamotrigine without tolerability issues are eligible to enter the extension phase of the study if clinically indicated.

Detailed description:

Arms: arm 1: No comparison
Interventions: intervention 1: Lamictal
Intervention descriptions: intervention 1: No comparison

Protocol documents:
Clinical trial NCT01439347
Conditions: Acute Lymphoblastic Leukemia (ALL)
Keywords: Marqibo HALLMARQ leukemia front-line ALL acute lymphoblastic leukemia
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2012-03-01; Completion date: 2015-11-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase 3 study in the treatment of subjects \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).

Detailed description:
A phase 3, multicenter, randomized study to evaluate the substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for standard Vincristine Sulfate Injection (VSI) in the induction, intensification, and maintenance phases of combination chemotherapy in the treatment of subjects \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).

Arms: arm 1: VSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes. arm 2: Marqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
Interventions: intervention 1: Vincristine Sulfate Liposomes Injection (VSLI) intervention 2: Vincristine Sulfate Injection (VSI)
Intervention descriptions: intervention 1: 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes. intervention 2: 1.4 mg/m\^2 with a 2 mg dose cap as an IV infusion over 10 minutes.

Protocol documents:
Clinical trial NCT01524627
Conditions: Nicotine Dependence
Keywords: Smokers fMRI varenicline
Sponsor: University of Pennsylvania
Start date: 2011-12-01; Completion date: 2015-11-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Varenicline is the best smoking cessation agent to date; however it is only effective in a subgroup of smokers and is associated with undesirable side effects in other subgroups. To understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion functional magnetic resonance imaging and a functional candidate gene association approach using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic varenicline administration in smokers. Brain and behavioral responses to smoking cues will be will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats. For the purposes of the clinical trial portion of the study, the change from cigarettes per day at Baseline to the last day of treatment will be reported.

Detailed description:

Arms: arm 1: Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective for Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks. arm 2: Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks. intervention 2: Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective for Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.

Protocol documents:
Clinical trial NCT01635101
Conditions: Acute Pain
Keywords: Moderate to severe acute pain following surgery or trauma
Sponsor: Mallinckrodt
Start date: 2012-06-01; Completion date: 2015-11-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age \< 2 years) compared to placebo plus standard of care rescue opioids as well as characterize the concentration-effect relationship (PK/PD) of the intravenous acetaminophen as compared to the control group.

Detailed description:

Arms: arm 1: Participants receive a low dose of acetaminophen intravenously (IV) for 24 hours arm 2: Participants receive a low dose of acetaminophen (IV) for 24 hours arm 3: Participants receive matching placebo (IV) for 24 hours
Interventions: intervention 1: IV Acetaminophen intervention 2: IV Control
Intervention descriptions: intervention 1: IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours intervention 2: IV Control q6h; 4 doses, in 24 hours

Protocol documents:
Clinical trial NCT01653912
Conditions: Recurrent Platinum-resistant Ovarian Cancer
Keywords: cancer ovarian platinum-resistant
Sponsor: Accenture
Start date: 2012-11-01; Completion date: 2015-11-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
* Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer.
* Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.

Detailed description:
PKB116611 is an open-label Phase I/II study of the investigational drug GSK2110183 given in combination with carboplatin and paclitaxel to subjects with recurrent ovarian cancer. Phase I is a dose escalation evaluation of daily oral doses of GSK2110183 administered in combination with every 3 week carboplatin and paclitaxel to any subject with recurrent ovarian cancer. Phase II is a single arm evaluation of the clinical efficacy of the combination identified in Phase I to subjects with platinum-resistant ovarian cancer.

Arms: arm 1: Subjects will be treated with a maximum of six doses of carboplatin + paclitaxel in combination with continuous daily GSK2110183 followed by single agent GSK2110183 at the single-agent MTD of 125 mg or above oral daily.
Interventions: intervention 1: GSK2110183 in combination with carboplatin and paclitaxel
Intervention descriptions: intervention 1: Phase I is a dose escalation evaluation of increasing doses of GSK2110183 administered on a continuous daily schedule in combination with carboplatin AUC 5 and paclitaxel 175mg/m2 given every three weeks for a maximum 6 cycles. The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. Treatment with the three drug regimen will continue for a maximum of 6 x 21 day cycles followed by continuous GSK2110183 at the single agent MTD. Subjects may continue on study drug until progression, death or unacceptable toxicity.

Protocol documents:
Clinical trial NCT01667926
Conditions: Major Depressive Disorder
Sponsor: Massachusetts General Hospital
Start date: 2013-01-01; Completion date: 2015-11-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. The investigators therefore plan to investigate the feasibility and efficacy of repeated intravenous administration of ketamine in severely depressed, treatment resistant patients. The results of the study could lead to development of new strategies for treating depression.

Detailed description:

Arms: arm 1: Subject will receive 6 infusions of ketamine over three weeks. arm 2: Subjects will receive 6 infusions of normal saline over 3 weeks.
Interventions: intervention 1: Ketamine intervention 2: Placebo
Intervention descriptions: intervention 1: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen. intervention 2: None

Protocol documents:
Clinical trial NCT01727024
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Breezhaler Respimat Indacaterol Tiotropium
Sponsor: Novartis Pharmaceuticals
Start date: 2013-04-01; Completion date: 2015-11-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD

Detailed description:

Arms: arm 1: In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days. arm 2: In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
Interventions: intervention 1: Tiotropium intervention 2: Indacaterol
Intervention descriptions: intervention 1: Tiotropium via Respimat® device once a day intervention 2: Indacaterol via Breezhaler® device once a day

Protocol documents: