ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02459197
Conditions: Peripheral Neuropathies Osteoarthritis
Keywords: Pain
Sponsor: Tools4Patient
Start date: 2015-06-01; Completion date: 2016-10-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Heat Pain Stimuli A intervention 2: Heat Pain Stimuli B intervention 3: Positive Video intervention 4: Neutral Video intervention 5: Administration of T4P1001 capsules intervention 6: Administration of Placebo capsules
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: This treatment is given as add-on therapy to patient's regular analgesic treatment intervention 6: This treatment is given as add-on therapy to patient's regular analgesic treatment

Protocol documents:
Clinical trial NCT02463409
Conditions: Pseudohypoparathyroidism Type 1a Albright Hereditary Osteodystrophy
Sponsor: Vanderbilt University Medical Center
Start date: 2015-06-01; Completion date: 2016-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test an investigational drug, theophylline, in children with pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt Clinical Research Center.

Detailed description:
Study measures will be done at baseline and during a 24h infusion of IV theophylline. Theophylline levels will be drawn to ensure therapeutic dosing and to monitor for toxicity. Measures include laboratory values, response to PTH infusion and resting energy expenditure.

Arms: arm 1: Patients will receive a 24 hour continuous infusion of intravenous theophylline.
Interventions: intervention 1: Theophylline
Intervention descriptions: intervention 1: 24 hour infusion of IV theophylline

Protocol documents:
Clinical trial NCT02476994
Conditions: Essential Fatty Acid Deficiency (EFAD)
Keywords: Essential Fatty Acids (EFA) Parenteral Nutrition Clinolipid/Clinoleic Parenteral Nutrition Associated Cholestasis (PNAC) Parenteral Nutrition Associated Liver Disease (PNALD) Intestinal Failure Associated Liver Disease (IFALD) Phytosterols Intralipid Infants/Preterm Infants FADS1 and FADS2 Short Bowel Syndrome Cancer Nutrition Olive Oil Emulsion Soybean Oil Emulsion
Sponsor: Baxter Healthcare Corporation
Start date: 2015-05-01; Completion date: 2016-10-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.

Detailed description:

Arms: arm 1: Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. arm 2: Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.
Interventions: intervention 1: Clinolipid intervention 2: Intralipid
Intervention descriptions: intervention 1: None intervention 2: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Protocol documents:
Clinical trial NCT02480166
Conditions: PT-NANBH
Keywords: hepatitis C, genotype 6
Sponsor: Stanford University
Start date: 2015-06-01; Completion date: 2016-10-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to describe the efficacy of:

1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
2. 12-week treatment of SOF/LED for all other HCV-6 populations

Detailed description:
The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.

Arms: arm 1: Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily. arm 2: Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
Interventions: intervention 1: 8 weeks SOF/LED intervention 2: 12 weeks SOF/LED
Intervention descriptions: intervention 1: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. intervention 2: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.

Protocol documents:
Clinical trial NCT02481934
Conditions: Multiple Myeloma
Keywords: Recurrent multiple myeloma NK cells cell therapy NKAE Relapsed multiple myeloma
Sponsor: Joaquín Martínez López, MD, PhD
Start date: 2013-03-01; Completion date: 2016-10-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine wether activated and expanded autologous Natural Killer cells (NKAEs) are effective in the treatment of patients with multiple myeloma on second or later relapse. NKAEs are used in combination with anti-myeloma drugs such as lenalidomide or bortezomib.

Detailed description:
It is expected to enroll 10 to 15 patients within 18 months. Patients have to achieve stable disease after induction therapy. Peripheral blood from patients will be collected every cycle (n=4) to produce NKAEs under Good Manufacturing Practice (GMP) conditions peripheral blood mononuclear cell (PBMCs) will be co-cultured with a genetically modified cell line (K562-mb15-41BBL) and 100 IU/ml interleukin-2.

Treatment consists of 4 cycles of anti-myeloma consolidation treatment with two infusions of NKAEs every day 1 and 8 of each cycle. Usually, chosen treatment regime will be bortezomib (Velcade) or lenalidomide (Revlimid). These treatments are used to be combined with corticosteroid medications which needs to be suspended before NKAEs infusions. A washout period of 2 weeks is required.

NKAEs dose of cells will be constant, 7.5x106/kg. There will be an interim analysis intra-cohort one week after the first batch of two infusions. If at the analysis no grade IV adverse effect is observed we will proceed to the second cycle and the inclusion of other patients.

Arms: arm 1: Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).
Interventions: intervention 1: NKAE cells infusion intervention 2: Lenalidomide intervention 3: Bortezomib
Intervention descriptions: intervention 1: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle. intervention 2: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles. intervention 3: Bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.

Protocol documents:
Clinical trial NCT02504827
Conditions: Cystic Fibrosis
Keywords: pharmacokinetics ceftazidime/avibactam
Sponsor: University of Southern California
Start date: 2015-09-01; Completion date: 2016-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.

Detailed description:
Cystic fibrosis is a genetic disorder characterized by a chronic cycle of airway infection, obstruction, and inflammation leading to progressive loss of lung function and eventual respiratory failure. The principal pathogen is Pseudomonas aeruginosa which is present in the airways of 70% of adult patients with CF. Of particular concern is the increasing resistance observed to existing agents.

While ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. Ceftazidime/avibactam offers a potential advancement in the management of infections involving P. aeruginosa in CF due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.

Arms: arm 1: Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
Interventions: intervention 1: Ceftazidime/avibactam
Intervention descriptions: intervention 1: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses

Protocol documents:
Clinical trial NCT02549755
Conditions: Hepatocellular Carcinoma
Sponsor: Justin Sims
Start date: 2015-09-01; Completion date: 2016-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
It is thought that PET of the abdomen with 11C Acetate will provide new information regarding whether or not patient's have benefited from radiotherapy. To test this theory, the project will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of treatment success.

Detailed description:

Arms: arm 1: All patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points.
Interventions: intervention 1: 11C-Acetate
Intervention descriptions: intervention 1: The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).

There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient

Protocol documents:
Clinical trial NCT02576249
Conditions: Osteoarthritis
Keywords: osteoarthritis injection steroid anesthetic
Sponsor: Mayo Clinic
Start date: 2015-10-01; Completion date: 2016-10-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Corticosteroid injections are commonly used for the symptomatic treatment of knee osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid and local anesthetic, with the rationale of providing longer duration pain relief with the corticosteroid and immediate, though short duration relief with the anesthetic. However, multiple in vitro and animal studies have shown that local anesthetic may be harmful to chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many clinicians believe incorporating the anesthetic is important because it can provide immediate pain relief and facilitate patient confidence in the treatment program. However, there is no published data to validate this reasoning. Therefore, the anesthetic has unknown clinical benefit and may have adverse effects on articular cartilage. In light of this, the investigators question the routine use of anesthetics in joint injections. The purpose of this study is to compare the effects of knee joint injections using: 1) corticosteroid with local anesthetic versus 2) corticosteroid with normal saline.

Detailed description:

Arms: arm 1: 0.2% ropivacaine and methylprednisolone knee joint injection arm 2: 0.9% normal saline and methylprednisolone knee joint injection
Interventions: intervention 1: Ropivacaine intervention 2: Normal saline intervention 3: Methylprednisolone
Intervention descriptions: intervention 1: 4cc 0.5% ropivacaine intervention 2: 4cc of sterile normal saline (0.9%) intervention 3: 1cc 40mg methylprednisolone

Protocol documents:
Clinical trial NCT02577718
Conditions: Catheter-Associated Infections Catheter-Related Infections
Sponsor: Novel Anti-Infective Technologies, LLC
Start date: 2015-11-01; Completion date: 2016-10-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a non- antibiotic chelator based lock solution that contains nitroglycerin in combination with sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated bloodstream infection (CLABSI).

* The primary objective of this study is to evaluate the safety and estimate the rate of adverse events associated with the NiCE lock solution.
* The second primary objective is to estimate the rate of CLABSI in patients receiving the NiCE lock solution.

Detailed description:

Arms: arm 1: Antimicrobial Nitroglycerin-Citrate-Ethanol catheter lock solution was administered for 2 hours then flushed
Interventions: intervention 1: Nitroglycerin-citrate-ethanol (NiCE)
Intervention descriptions: intervention 1: Lock solution instilled in catheter lumens for 2 hours then flushed. Administration for up to 30 days, daily as in-patient or once weekly as out-patient

Protocol documents:
Clinical trial NCT02612285
Conditions: Cancer
Sponsor: Esanex Inc.
Start date: 2016-03-01; Completion date: 2016-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of the molecular chaperone heat shock protein 90 (Hsp90). Initial in vitro evidence supports that SNX-5422 may be active against TP53 null tumors irrespective of tumor type .

Detailed description:
The tumor suppressor gene TP53 codes for a central regulator of the DNA-damage-response pathway, and its activation leads to cell-cycle arrest and DNA repair, apoptosis, or senescence through both transcription-dependent and transcriptional-independent activities. Somatic TP53 gene alterations are frequent in most human cancers.

SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of the molecular chaperone heat shock protein 90 (Hsp90). Inhibitors of the chaperone protein Hsp90 are of current interest because of the central role that Hsp90 plays in the maturation and maintenance of numerous proteins that are critical for tumor cell viability and growth.

SNX-2112 retains activity in cell lines with loss of the TP53 gene from one of the alleles. SNX-2112 displays good activity in cell lines with TP53 null/TP53 wild type (e.g., MEC-1 \[chronic lymphocytic leukemia\]) and TP53 null/TP53 mutation (e.g., EBC-1, NCI-H520 \[all NSCLC - squamous cell carcinoma\]). Even in the most extreme case in which TP53 is lost from both alleles, i.e., the cancer cell is totally devoid of the TP53 gene (e.g., H1299, KATO III, HL-60, SK-MES-1), SNX-2112 retains activity

It appears that SNX-2112 could be active against both hematological and solid tumors with a TP53 null status.

Arms: arm 1: Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422.
Interventions: intervention 1: SNX-5422
Intervention descriptions: intervention 1: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle

Protocol documents:
Clinical trial NCT02651220
Conditions: Acne
Sponsor: Actavis Inc.
Start date: 2015-11-01; Completion date: 2016-10-01
Enrollment: 1001 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide) gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris

Detailed description:
Up to 1000 patients 12 to 40 years of age inclusive will be enrolled to have 870 patients in the modified intent-to-treat (mITT) population and 579 patients in the per-protocol (PP) population. The primary inclusion criteria are the presence of ≥ 20 inflammatory lesions (papules and pustules) and ≥ 25 non-inflammatory lesions (opened and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts) on the face and an Investigator's Global Assessment (IGA) score of 3 or 4.

Eligible patients will be randomized in a 1:1:1 ratio to one of the three treatments (Test, Reference or Placebo) on Visit 1. Patients will be instructed to apply the first treatment on the evening of enrollment into the study and then continue to apply once daily for the next 83 days (for a total 84 days). Patients will attend the following scheduled clinic visits:

* Visit 1 - Screening/Baseline: Day 1
* Visit 2 - Interim Visit: Day 28 ± 4
* Visit 3 - Interim Visit: Day 56 ± 4
* Visit 4 - End of Study: Day 85 ± 4 Efficacy evaluations will be based on dermatological assessments in the clinic. The primary statistical analyses of interest are (1) the percent change from baseline to Week 12 in the number of inflamed (papules/pustules) lesions and non-inflamed (open and closed comedones) lesions. In addition, patients will also be evaluated by the Investigator to determine "Clinical Success" or "Clinical Failure" at Week 12

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Epiduo® Forte Gel intervention 2: Adapalene and Benzoyl Peroxide Gel intervention 3: placebo gel
Intervention descriptions: intervention 1: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w intervention 2: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w intervention 3: vehicle used as placebo

Protocol documents:
Clinical trial NCT02667236
Conditions: Seborrheic Keratosis
Keywords: seborrheic keratosis
Sponsor: Aclaris Therapeutics, Inc.
Start date: 2016-01-01; Completion date: 2016-10-01
Enrollment: 450 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle Solution.

Detailed description:
This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. The Target Lesions will be treated, by an investigational staff member other than the evaluating investigator, a maximum of two times.

Arms: arm 1: A-101 Solution 40% administered once arm 2: Vehicle Solution administered once
Interventions: intervention 1: A-101 Solution intervention 2: Vehicle Solution
Intervention descriptions: intervention 1: Active Drug intervention 2: Placebo

Protocol documents:
Clinical trial NCT02667275
Conditions: Seborrheic Keratosis
Keywords: seborrheic keratosis
Sponsor: Aclaris Therapeutics, Inc.
Start date: 2016-01-01; Completion date: 2016-10-01
Enrollment: 487 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, vehicle-controlled, parallel group study.

Detailed description:
This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.

Arms: arm 1: A-101 Solution 40% administered once arm 2: Vehicle Solution administered once
Interventions: intervention 1: A-101 Solution intervention 2: Vehicle Solution
Intervention descriptions: intervention 1: None intervention 2: Placebo

Protocol documents:
Clinical trial NCT02667288
Conditions: Seborrheic Keratosis
Sponsor: Aclaris Therapeutics, Inc.
Start date: 2016-01-01; Completion date: 2016-10-01
Enrollment: 147 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label safety study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.

Detailed description:
This is an open-label safety study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. The Target Lesions will be treated a maximum of 4 times.

Arms: arm 1: A-101 Solution 40% administered once
Interventions: intervention 1: A-101 Solution
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02672423
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-02-01; Completion date: 2016-10-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected.

This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part.

This study is for research purposes only and is not intended to treat any medical condition.

Detailed description:

Arms: arm 1: Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods. arm 2: R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods. arm 3: T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
Interventions: intervention 1: Abemaciclib Capsules (Reference Formulation) intervention 2: Abemaciclib Tablet (Test Formulation)
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT02804399
Conditions: Healthy
Keywords: rifampin pharmacokinetics PF-06463922 drug interaction
Sponsor: Pfizer
Start date: 2016-07-01; Completion date: 2016-10-01
Enrollment: 12 participants; Allocation: ; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.

Detailed description:
This will be a Phase 1, open-label, 2-period, 2-treatment, fixed-sequence, cross-over study in approximately 12 healthy subjects employing administration of a single oral dose of PF-06463922 in the fasted state alone, and with multiple dosing of rifampin 600 mg once a day to estimate the effect of multiple dose rifampin on the single dose PK of PF-06463922.

Arms: arm 1: subjects will receive a 100 mg single oral dose of PF-06463922 followed by a 100 mg single dose of PF-06463922 combined with 600 mg QD dose of rifampin with at least 10 days of washout period between two PF-06463922 doses.
Interventions: intervention 1: PF-06463922 intervention 2: rifampin
Intervention descriptions: intervention 1: 100 mg oral dose on day 1 in period 1 and on day 8 in period 2 intervention 2: 600 mg QD from day 1 to day 12 in period 2.

Protocol documents: