ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01892306
Conditions: Bipolar Disorder Anxiety Disorders
Sponsor: Massachusetts General Hospital
Start date: 2013-06-01; Completion date: 2014-12-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders \[Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)\], for the treatment of patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month period and will be assessed monthly to track changes in mood, anxiety and emotion-related symptoms; functional impairment; and relapse rates. Data on the acceptability of the treatment will be gathered concurrently through monthly patient self-reported ratings of treatment satisfaction, and by tracking rates of acceptance for randomization into the study, number of completed sessions, and dropout rates. The study will examine: 1) whether combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and functional impairment are mediated by changes in emotion regulation skills. The broader aim of this study is to address the need for improved treatments for bipolar disorder.

Detailed description:

Arms: arm 1: Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT arm 2: Existing psychiatrist-administered psychopharmacotherapy
Interventions: intervention 1: UP CBT intervention 2: Treatment as usual
Intervention descriptions: intervention 1: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders intervention 2: Existing optimized pharmacotherapy as delivered by treating psychiatrist

Protocol documents:
Clinical trial NCT01894581
Conditions: Obesity Fertility
Sponsor: University of Colorado, Denver
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The United States has the highest prevalence of obesity among all countries surveyed in 2012 by the Organization for Economic Cooperation and Development. Maternal obesity is linked with anovulation, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical complications and congenital anomalies. Changes in reproductive hormones and diminished oocyte quality have also been demonstrated. A gap of knowledge exists as the mechanisms underlying these harmful effects are poorly understood and no specific treatments exist.

This proposal will test the hypothesis that dietary omega-3 fatty acids (FA) will improve the output of hypothalamicpituitary- ovarian axis in obese women. The investigators will perform paired assessments before and after supplementation in 10 obese and 10 normal weight women. To test the pituitary and hypothalamic output, the investigators will examine the luteinizing hormone (LH) and follicle-stimulating hormone (FSH) responsiveness during frequent blood sampling. To test the corpus luteum function, the investigators will examine urinary reproductive hormones (E1c, estrone conjugates, and pregnanediol glucuronide (Pdg)) over an entire menstrual cycle. The investigators ultimate goal is to collect preliminary data for an adequately powered randomized control trial.

Detailed description:

Arms: arm 1: Women with a BMI of greater than or equal to 30 kg/m2 underwent all study interventions, including taking 5 g daily of LOVAZA. Women underwent 8 hours of frequent blood sampling every 10 minutes both at baseline and after LOVAZA supplementation. Each frequent blood sampling included IV administration of GnRH at 6 hours. arm 2: Women with a BMI of between 18-25 kg/m2 underwent all study interventions, including taking 5 g daily of LOVAZA for one cycle. Women underwent 8 hours of frequent blood sampling every 10 minutes both at baseline and after LOVAZA supplementation. Each frequent blood sampling included IV administration of GnRH at 6 hours.
Interventions: intervention 1: LOVAZA intervention 2: GnRH
Intervention descriptions: intervention 1: Subjects will be instructed to take 2 grams twice daily of oral omega-3-acid ethyl esters (Lovaza) starting with day 1 to 3 of their menstrual period. Each capsule contains 60mg of other omega-3 FA. On day 1 of their subsequent menstrual period, subjects will be instructed to discontinue. intervention 2: An intravenous bolus of exogenous GnRH (75 ng/kg dosing based on total body weight) will be administered at 6 hours.

Protocol documents:
Clinical trial NCT01898286
Conditions: Type 1 Diabetes
Keywords: C peptide beta cell function immune modulation of type 1 diabetes immune intervention in type 1 diabetes
Sponsor: Andromeda Biotech Ltd.
Start date: 2013-10-01; Completion date: 2014-12-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.

Detailed description:
Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patients who were initially treated with DiaPep277® and maintained their initial beta-cell function, required continuation of treatment, losing beta-cell function if switched to Placebo. These extension studies were too small for the outcome to be statistically significant, but they suggested that continuation of treatment is needed for long-term maintenance of efficacy.

Therefore, in this extension study, patients who complete the 1001 phase 3 study (NCT01103284) and maintain clinically significant beta-cell function are offered a 2-year continuation of active treatment, since they are likely to benefit from use of the medication. The participation in the extension study will be offered to all eligible subjects who complete the 1001 study, regardless of the treatment arm allocation in the initial study.

By achieving long-term preservation of beta-cell function, patients are expected to maintain good management of the disease, manifesting as better glycemic control and fewer hypoglycemic events.

Arms: arm 1: Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284)
Interventions: intervention 1: DiaPep277®
Intervention descriptions: intervention 1: 1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations

Protocol documents:
Clinical trial NCT01900626
Conditions: Adolescent Idiopathic Scoliosis
Sponsor: University of Wisconsin, Madison
Start date: 2013-07-01; Completion date: 2014-12-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study comparing pain control utlilizing one or two epidural catheters, along with a hydromorphone PCA, for analgesia following surgery for correction of scoliosis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: epidural catheter
Intervention descriptions: intervention 1: epidural catheter with 0.3% ropivacaine

Protocol documents:
Clinical trial NCT01906658
Conditions: Amyotrophic Lateral Sclerosis
Keywords: H.P. Acthar Gel Acthar amyotrophic lateral sclerosis ALS
Sponsor: Mallinckrodt
Start date: 2013-07-01; Completion date: 2014-12-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 8-week randomized, open-label evaluation will examine the acute safety and tolerability of 4 different dosing regimens of Acthar to inform dose selection for future studies of Acthar in patients with Amyotrophic Lateral Sclerosis (ALS). The study will also investigate the mean rate of change in the ALSFRS-R total score as an exploratory endpoint to help design future studies.

This study will enroll up to 40 patients and include an optional 28-week open-label extension period plus a 3-week treatment taper and 1-week follow up period. After completion of Week 8, patients enrolled in a treatment group that is considered safe and tolerable at that time have the option to continue into the open-label extension period. A 3-week treatment taper and a follow-up visit are planned for all patients enrolled in the study, beginning either at Week 8 or at Week 36 if a patient continues into the optional open-label extension period.

Detailed description:

Arms: arm 1: Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly arm 2: Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily arm 3: Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly arm 4: Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily
Interventions: intervention 1: Repository corticotropin injection
Intervention descriptions: intervention 1: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks

Protocol documents:
Clinical trial NCT01916629
Conditions: Psoriasis
Sponsor: Applied Biology, Inc.
Start date: 2013-08-01; Completion date: 2014-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of psoriasis

Detailed description:
NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Psoriasis Area Severity Index (PASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.

Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.

In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.

Arms: arm 1: Active Drug - Photocil for Psoriasis arm 2: Placebo - Sunscreen (SPF 2)
Interventions: intervention 1: Photocil for Psoriasis intervention 2: Placebo - Sunscreen (SPF 2)
Intervention descriptions: intervention 1: Photocil for Psoriasis intervention 2: Placebo - Sunscreen (SPF 2)

Protocol documents:
Clinical trial NCT01923480
Conditions: Parenteral Nutrition (No Primary Condition Studied)
Sponsor: Baxter Healthcare Corporation
Start date: 2013-07-01; Completion date: 2014-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the best rate of infusion of amino acids (15% CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II to IVB head and neck cancer.

Detailed description:

Arms: arm 1: 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. arm 2: 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. arm 3: 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
Interventions: intervention 1: 15% CLINISOL - Sulfite-free (Amino Acid) Injection intervention 2: 15% CLINISOL - Sulfite-free (Amino Acid) Injection intervention 3: 15% CLINISOL - Sulfite-free (Amino Acid) Injection
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01937260
Conditions: Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2013-09-01; Completion date: 2014-12-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects with moderate to severe plaque psoriasis.

Detailed description:
Approximately 30 subjects will be enrolled into two groups. Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single subcutaneous (SC) dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.

Arms: arm 1: open label, all subjects receive brodulamab arm 2: MDZ 2mg oral (Day 1 and Day 9), Brodalumab 210mg SC (Day 2)
Interventions: intervention 1: Brodalumab
Intervention descriptions: intervention 1: Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single SC dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.

Protocol documents:
Clinical trial NCT01940146
Conditions: Seasonal Allergic Rhinitis
Sponsor: Sun Pharma Advanced Research Company Limited
Start date: 2014-10-01; Completion date: 2014-12-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SPARC Placebo intervention 2: SPARC1310 I intervention 3: SPARC1310 II intervention 4: SPARC1310 III
Intervention descriptions: intervention 1: Placebo intervention 2: SPARC1310 I intervention 3: SPARC1310 II intervention 4: SPARC1310 III

Protocol documents:
Clinical trial NCT01962298
Conditions: Diaphragmatic Dysfunction Muscle Weakness Muscle Fatigue
Sponsor: University Hospital, Antwerp
Start date: 2013-10-01; Completion date: 2014-12-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle activity is well known. However, since the availability of sugammadex, to our knowledge, no study has been conducted to evaluate the effect of this novel product on these muscles.

Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking agents and their reversal agents we might see a different activity of the respiratory muscles.

Detailed description:

Arms: arm 1: The patients will receive a single rocuronium dose, and no reversal agent. arm 2: The patients will receive a single rocuronium dose and sugammadex 2mg/kg as a reversal agent arm 3: The patients will receive multiple rocuronium doses and neostigmine 70 mcg/kg as a reversal agent arm 4: The patients will receive multiple rocuronium doses and neostigmine 2mg/kg as a reversal agent arm 5: The participants will receive a continuous rocuronium infusion and sugammadex 4 mg/kg as a reversal agent
Interventions: intervention 1: sugammadex 2mg/kg intervention 2: neostigmine intervention 3: sugammadex 4mg/kg intervention 4: placebo intervention 5: Single rocuronium dose intervention 6: Repeated rocuronium dose intervention 7: Continuous rocuronium infusion
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None

Protocol documents:
Clinical trial NCT01964326
Conditions: Hypercholesterolemia
Keywords: atorvastatin Hypercholesterolemia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2013-10-01; Completion date: 2014-12-01
Enrollment: 1311 participants; Allocation: NA; Intervention model: 

Brief summary:
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Atorvastatin calcium 10 mg
Intervention descriptions: intervention 1: Atorvastatin calcium 10 mg tablet to be administered orally every day

Protocol documents:
Clinical trial NCT01991990
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2014-05-01; Completion date: 2014-12-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV) RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil kinetics data will be collected for all subjects up to Day 10 of the study. Following the last study visit on Day 10, all subjects will attend two further safety follow-up visits on Day 28 and Day 56.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: Single i.v. infusion intervention 2: Single 8 mg/kg i.v. infusion

Protocol documents:
Clinical trial NCT01992172
Conditions: Atopic Dermatitis
Sponsor: Applied Biology, Inc.
Start date: 2013-08-01; Completion date: 2014-12-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of atopic dermatitis.

Detailed description:
NB-UVB phototherapy is a common treatment for patients with atopic dermatitis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Atopic Dermatitis Area Severity Index (ADASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.

Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.

In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.

Arms: arm 1: Active Drug - Photocil for Atopic Dermatitis arm 2: Placebo - Sunscreen (SPF 2)
Interventions: intervention 1: Photocil for Atopic Dermatitis intervention 2: Placebo - Sunscreen (SPF 2)
Intervention descriptions: intervention 1: Photocil for Atopic Dermatitis intervention 2: Placebo - Sunscreen (SPF 2)

Protocol documents:
Clinical trial NCT01992185
Conditions: Vitiligo
Sponsor: Applied Biology, Inc.
Start date: 2013-08-01; Completion date: 2014-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of vitiligo.

Detailed description:
NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Vitiligo Area Severity Index (VASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.

Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.

In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.

Arms: arm 1: Active Drug - Photocil for Vitiligo arm 2: Placebo - Sunscreen (SPF 2)
Interventions: intervention 1: Photocil for Vitiligo intervention 2: Placebo - Sunscreen (SPF 2)
Intervention descriptions: intervention 1: Photocil for Vitiligo intervention 2: Placebo - Sunscreen (SPF 2)

Protocol documents: