ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01687179
Conditions: Lymphangioleiomyomatosis
Keywords: LAM TSC lymphangioleiomyomatosis
Sponsor: Brigham and Women's Hospital
Start date: 2012-09-01; Completion date: 2015-08-01
Enrollment: 14 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
Specific Aim 1: To investigate whether, in Lymphangioleiomyomatosis (LAM) patients, the combination of sirolimus and hydroxychloroquine is safe and well tolerated

Specific Aim 2: To investigate whether, in LAM patients, 6 months of combination therapy with sirolimus and hydroxychloroquine results in improvement of indicators of disease, and whether the gains are sustained after stopping therapy.

Specific Aim 3: To investigate the potential role of a LAM-specific peripheral blood signature to predict rates of disease progression and determine responsiveness to combination therapy.

This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken orally daily. Up to 18 adult women with LAM will be enrolled.

Detailed description:
This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken orally daily for 6 months. The study is to be conducted at 2 sites. Up to 18 adult women with LAM will be enrolled, and each recruiting site will recruit between 8-12 subjects. The protocol will use the following eligibility criteria.

Arms: arm 1: Subjects will take Sirolimus at an initial dose of 2mg followed by dose adjustment to keep Sirolimus trough levels between 5-15ng/ml consistent with the effective dose in the MILES trial. In addition to Sirolimus subjects will receive Hydroxychloroquine at 200 mg daily for 6 months. Once safety is established at the lower dose ("Sirolimus" and "Hydroxychloroquine" 200 mg), subjects enrolled henceforth will receive Sirolimus and Hydroxychloroquine 400 mg (200 mg twice a day) for 6 months.
Interventions: intervention 1: "Sirolimus" and "Hydroxychloroquine" 200 mg intervention 2: "Sirolimus" and "Hydroxychloroquine" 400 mg
Intervention descriptions: intervention 1: This will be a phase I dose escalation study of the combination of "Sirolimus" (2 mg adjusted to keep trough levels between 5-15 ng/ml) and "Hydroxychloroquine" 200 mg taken orally daily. intervention 2: Once safety is established with the lower dose, (Sirolimus and Hydroxychloroquine 200 mg), subjects will receive Sirolimus 2 mg (adjusted to keep trough levels between 5 to 15 ng/ml) and hydroxychloroquine 200 mg twice a day.

Protocol documents:
Clinical trial NCT01708590
Conditions: Psoriasis
Keywords: psoriasis, brodalumab (AMG 827)
Sponsor: Bausch Health Americas, Inc.
Start date: 2012-08-01; Completion date: 2015-08-01
Enrollment: 661 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

Detailed description:
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.

Arms: arm 1: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. arm 2: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. arm 3: Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
Interventions: intervention 1: 210 mg brodalumab intervention 2: 140 mg brodalumab intervention 3: placebo
Intervention descriptions: intervention 1: 210 mg brodalumab administered subcutaneous (SC) intervention 2: 140 mg brodalumab administered subcutaneous (SC) intervention 3: Placebo administered subcutaneous (SC)

Protocol documents:
Clinical trial NCT01734161
Conditions: Postoperative Nausea and Vomiting
Keywords: cesarean section nausea vomiting dexamethasone postoperative nausea and vomiting antiemetics
Sponsor: Weill Medical College of Cornell University
Start date: 2012-11-01; Completion date: 2015-08-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

Detailed description:
Women having cesarean sections commonly experience post-operative nausea and vomiting (PONV). This can be partly attributed to the long acting morphine (duramorph) given in the anesthetic (either through the epidural or in the spinal anesthetic). Intravenous dexamethasone is a widely used steroid medication with a well-established safety profile which is the standard of care for the prevention of PONV for general anesthesia in both adult and pediatric surgical patients. Many studies have shown that when intravenous dexamethasone is administered before duramorph in the epidural, the incidence of nausea and vomiting following cesarean section is significantly reduced. However, when patients receive intravenous dexamethasone after duramorph in a spinal anesthetic, it does not reduce the incidence of nausea and vomiting. There are not any published studies where dexamethasone was administered before a spinal anesthetic. The investigators believe that if dexamethasone is given intravenously before duramorph in a spinal anesthetic it may reduce the incidence of nausea and vomiting. Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

Arms: arm 1: One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes. arm 2: One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Interventions: intervention 1: Dexamethasone intervention 2: Placebo
Intervention descriptions: intervention 1: 8mg IV dexamethesone given intervention 2: Subjects randomized to placebo receive 50cc normal saline

Protocol documents:
Clinical trial NCT01736865
Conditions: Type 2 Diabetes
Sponsor: Tufts Medical Center
Start date: 2012-12-01; Completion date: 2015-08-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).

Detailed description:

Arms: arm 1: One placebo pill daily for 1 year arm 2: One cholecalciferol pill daily for 1 year
Interventions: intervention 1: Cholecalciferol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01744353
Conditions: Metastatic Pancreatic Cancer
Keywords: newly diagnosed advanced pancreatic cancer pancreatic cancer metastatic pancreatic cancer pancreas
Sponsor: Brown University
Start date: 2012-11-01; Completion date: 2015-08-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.

The experimental part of the study is combining these drugs together in FOLFOX-A.

Detailed description:
More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.

Arms: arm 1: Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion arm 2: Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion arm 3: Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
Interventions: intervention 1: Dose level 1 intervention 2: Dose level 2/MTD intervention 3: Dose level 3
Intervention descriptions: intervention 1: Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion intervention 2: Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion intervention 3: Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Protocol documents:
Clinical trial NCT01766336
Conditions: Alzheimer's Disease
Keywords: Agitation Aggression AD patients
Sponsor: OPKO Health, Inc.
Start date: 2013-01-01; Completion date: 2015-08-01
Enrollment: 296 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.

Detailed description:

Arms: arm 1: Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks. arm 2: Patients who received placebo during Study AG201 will receive ELND005 at the same dosing regimen as the active group in Study AG201 for 36 weeks.
Interventions: intervention 1: Group 1 ELND005 intervention 2: Group 2 ELND005
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01774981
Conditions: Diabetic Nephropathy
Sponsor: Eli Lilly and Company
Start date: 2013-03-01; Completion date: 2015-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria.

Detailed description:

Arms: arm 1: Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. arm 2: Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. arm 3: Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. arm 4: Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. arm 5: Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. arm 6: Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. arm 7: Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. arm 8: Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
Interventions: intervention 1: Placebo intervention 2: LY3016859
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered IV

Protocol documents:
Clinical trial NCT01802073
Conditions: Primary Sclerosing Cholangitis
Keywords: Inflammation of the bile ducts biliary scarring obstruction
Sponsor: Stanford University
Start date: 2012-01-01; Completion date: 2015-08-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.

Detailed description:
The purpose of this study is to evaluate changes in the fecal and salivary/urinary microbiota during vancomycin treatment of children and adults with Primary Sclerosing Cholangitis (PSC), identify features of the host microbiota that are associated with disease activity and/or response to treatment and further delineate the immunological effects of oral vancomycin treatment of PSC. This study will correlate changes in microbiota with the immunological effects of oral vancomycin in children and adults with PSC. The results of this proposal will lead to new and validated targets for diagnosis and treatment of PSC that will have high impact in the short and long term for patients and their families.

Interim results were published in Abarbanel et al, J Clin Immunol 2013 (see References).

Arms: arm 1: 1\) For children who weight \< or = 30 kg, the vancomycin dose will be 50 mg/kg/day given orally 3 times per day for the 1st month and continue with the same dose for subsequent months if the clinical laboratory studies improved and are normal. If the laboratory studies are not normal the dose will be increased to 75 mg/kg/day given orally 3 times per day for the 2nd month and 100mg/kg/day given orally 3 times per day the 3rd month. If the laboratory studies do not improve by the end of the 3rd month since starting the vancomycin, the vancomycin will be stopped and the child will not continue the study. 2) For adults and children who weigh \>30 kg, the vancomycin dose will be 500 mg given orally 3 times per day for the 1st month and continue with this dose if the clinical laboratory studies improve and are normal. If the laboratory studies are not normal the dose will be increased to 750 mg 3 times per day for the 2nd month and 1000 mg 3 times per day the 3rd month.
Interventions: intervention 1: Oral Vancomycin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01825122
Conditions: Smoking Cessation
Sponsor: Invion, Inc.
Start date: 2014-03-01; Completion date: 2015-08-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test the hypothesis that treatment with the inverse agonist nadolol will improve smoking cessation in patients with chronic cough associated with long-term smoking, with or without airflow obstruction, including those with established chronic obstructive pulmonary disease (COPD) (chronic bronchitis dominant) or non-obstructive chronic bronchitis (NCB), compared to placebo and standard of care, while undergoing a validated smoking cessation program.

Detailed description:

Arms: arm 1: placebo arm 2: Active
Interventions: intervention 1: Nadolol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01838694
Conditions: Lupus Erythematosus, Systemic
Sponsor: Invion, Inc.
Start date: 2013-07-01; Completion date: 2015-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4 weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.

Detailed description:

Arms: arm 1: Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes. arm 2: Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.
Interventions: intervention 1: Ala-Cpn10 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01859949
Conditions: Short Stature Born Small for Gestational Age (SGA)
Keywords: Genotropin(somatropin) SGA Short Stature Long-term Safety
Sponsor: Pfizer
Start date: 2002-10-01; Completion date: 2015-08-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Genotropin (somatropin)
Intervention descriptions: intervention 1: Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients

Protocol documents:
Clinical trial NCT01882868
Conditions: Colorectal Cancer Metastatic
Sponsor: Sanofi
Start date: 2013-07-01; Completion date: 2015-08-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by objective response rate (ORR).

Secondary Objective:

To assess the following:

* safety profile;
* progression free survival (PFS);
* overall survival (OS);
* pharmacokinetics (PK);
* immunogenicity.

Detailed description:
Screening was up to 24 days. Treatment period was continued until DP, unacceptable toxicity, or participant's refusal. Follow up period was continued until death, participant's refusal, or end of study, whichever came first.

This trial was conducted in Japan, where the International Nonproprietary Name (INN) designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".

Arms: arm 1: Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m\^2 (2 hours) and irinotecan 180 mg/m\^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m\^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m\^2.
Interventions: intervention 1: Aflibercept intervention 2: Levofolinate intervention 3: Irinotecan intervention 4: 5-FU
Intervention descriptions: intervention 1: Pharmaceutical form: Concentrated solution (100 mg/4 mL \[25 mg/mL\], 200 mg/8 mL \[25 mg/mL\]) for infusion; Route of administration: Intravenous intervention 2: Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous intervention 3: Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous intervention 4: Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous

Protocol documents:
Clinical trial NCT01912404
Conditions: Alcoholic Hepatitis
Keywords: alcoholic hepatitis
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2013-07-01; Completion date: 2015-08-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.

Detailed description:
The study will also see if overall patient survival is affected at 6 months, and if the study drug improves liver function.

Arms: arm 1: IDN-6556 capsules, 25 mg BID arm 2: Placebo capsules BID
Interventions: intervention 1: IDN-6556 intervention 2: Placebo
Intervention descriptions: intervention 1: 25 mg BID for 28 days intervention 2: Placebo controlled

Protocol documents:
Clinical trial NCT01931878
Conditions: Restless Leg Syndrome
Keywords: Restless Legs Syndrome Leg pain Sleep Dysesthesias incobotulinumtoxin
Sponsor: Yale University
Start date: 2012-09-01; Completion date: 2015-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to compare the safety and effectiveness of local injections of botulinum toxin A (Xeomin®) to an inactive test substance (placebo) in a medical condition called Restless Leg Syndrome. This study has a double blind cross over design. Cross over means that you will have two sets of injections. The first set of injections can be either Xeomin or placebo. The order of injection will be reversed at the three month point following the first injection. Double blind means neither the investigators nor you know which one of the two (Xeomin or placebo) you received.

Detailed description:
Please contact the PI for details about the clinical study.

Arms: arm 1: The subject may be randomly assigned to receive Placebo, saline arm 2: The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)
Interventions: intervention 1: incobotulinumtoxinA intervention 2: Placebo
Intervention descriptions: intervention 1: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections. intervention 2: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections.

Protocol documents: