ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02123966
Conditions: Chronic Graft-versus-Host-Disease Oral Mucosal Disease Due to Graft-versus-host Disease
Keywords: Chronic Graft-versus-Host-Disease Oral mucosal disease
Sponsor: Dana-Farber Cancer Institute
Start date: 2014-07-01; Completion date: 2016-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is evaluating the effectiveness of topical sirolimus combined with topical steroid therapy, as a possible treatment for oral cGVHD.

Detailed description:
Topical steroid therapy can be effective in managing oral cGVHD symptoms. However, a certain proportion of participants will not experience an adequate response to topical steroids and continue to have some degree of discomfort. Sirolimus is a non-steroidal immunosuppressive medication that has demonstrated efficacy in the management of cGVHD. Based on this, it is believed that a topical formulation applied inside the mouth may also demonstrate efficacy on a localized basis.

The purpose of this study is to assess the safety and efficacy of topical sirolimus as a swish and spit solution for the treatment of oral cGVHD in participants that have not had an adequate clinical response to topical steroid therapy alone.

Arms: arm 1: A four week supply of topical sirolimus will be dispensed. The treatment instructions will be to rinse and spit (NOT swallow) with one teaspoon (5 mL) of sirolimus solution 0.1mg/mL, combined with one teaspoon (5 mL) of steroid solution (dexamethasone 0.1%, clobetasol 0.05%, or budesonide 0.03%, based on the ongoing topical steroid prescription at the time of study enrollment) four times a day for 5 minutes at a time, and not to eat or drink for 15 minutes afterwards.
Interventions: intervention 1: Sirolimus
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02133664
Conditions: Multiple Sclerosis Cognition
Keywords: multiple sclerosis cognition clinical trial thiotic acid Omega-3 fatty acids
Sponsor: Oregon Health and Science University
Start date: 2014-06-01; Completion date: 2016-05-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim is to collect data to determine the correct effect size on the primary outcome to aid in the design of a larger study: The primary outcome is to determine if lipoic acid and omega-3 fatty acids can improve cognitive function in people with multiple sclerosis that have cognitive dysfunction.

Detailed description:
The study is designed as a randomized, double-blind, placebo-controlled pilot trial. The primary aim of the study is to determine if lipoic acid and omega-3 fatty acids can improve cognitive function over 12-weeks in people with multiple sclerosis that have a baseline score of at least two standard deviations below normative values on any one of four cognitive tests that include, Paced Auditory Serial Addition Task (PASAT), Stroop Color-Word Test, California Verbal Learning Test-II (CVLT-II), and Controlled Oral Word Association Test (COWAT).

The secondary aim is to determine treatment effects on markers of endothelial inflammation, insulin dysregulation, and mitochondrial dysfunction that may be related to cognitive dysfunction by measuring soluble intercellular adhesion molecule-1 (sICAM-1) levels, homeostasis model of insulin resistance (HOMA-IR), and MRI phosphorus imaging in a subset of study participants. The study will also measure safety by adverse event reports and laboratory measures; plasma fatty acid levels; serum lipoic acid levels.

Arms: arm 1: lipoic acid and omega-3 fatty acids arm 2: placebo oil and placebo lipoic acid
Interventions: intervention 1: lipoic acid and omega-3 fatty acids intervention 2: Placebo
Intervention descriptions: intervention 1: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid intervention 2: placebo lipoic acid and placebo oil

Protocol documents:
Clinical trial NCT02164383
Conditions: Smoking Cessation Smoking Nicotine Dependence
Keywords: Smoking Cessation Smoking Nicotine
Sponsor: University of Wisconsin, Madison
Start date: 2014-10-01; Completion date: 2016-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this research is to determine whether smartphone games show promise for helping smokers increase their chances of quitting. The central hypothesis is that smokers who have access to smartphone games during their quit smoking attempt will smoke fewer cigarettes and report less craving than will smokers without such access.

Detailed description:

Arms: arm 1: This arm of the project will address the following question:

How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games. arm 2: This arm of the project will address the following question:

How effective is the following intervention:

Nicotine patch plus behavioral cessation counseling without access to Mobile Games.
Interventions: intervention 1: Nicotine patch intervention 2: Cessation Counseling intervention 3: Mobile Games
Intervention descriptions: intervention 1: 4-week starter kit of nicotine patch intervention 2: 5 brief counseling sessions intervention 3: None

Protocol documents:
Clinical trial NCT02168309
Conditions: Severe Postpartum Hypertension
Sponsor: Cedars-Sinai Medical Center
Start date: 2014-06-01; Completion date: 2016-05-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study's aim is to determine whether oral extended release nifedipine is superior to oral labetolol for the management of postpartum severe hypertension, specifically time to achieve goal blood pressure, and shortening hospital stay. Our hypothesis is that oral extended release nifedipine is superior to oral labetolol for achieving goal blood pressure in the postpartum period.

Detailed description:
Hypertension complicating pregnancy is common and, when uncontrolled, can have devastating consequences. While the true incidence of postpartum hypertension is unknown, blood pressure (BP) is known to initially decrease 48 hours following delivery then peak on postpartum days 3-6, likely 45 from the mobilization of interstitial fluids following parturition.

The American College of Obstetricians and Gynecologists (ACOG) recommends medical treatment of persistent postpartum hypertension, defined as systolic BP (SBP) ≥150 mmHg or diastolic BP (DBP) ≥100 mmHg, on two or more occasions 4-6 hours apart. Prior studies compared intravenous medications to intramuscular and immediate-release oral 50 medications in the treatment of postpartum hypertension. However, oral labetalol and oral extended release nifedipine are the most commonly used medications for post- partum hypertension, and their efficacy has not been directly compared.

Our aim was to determine whether oral labetalol is associated with a shorter time to BP control compared to oral extended release nifedipine for management of persistent 55 postpartum hypertension. Our primary outcome was time to sustained BP control defined as the absence of severe hypertension (SBP ≥160 mmHg or DBP ≥105 mmHg) for at least 12 hours. Secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient-reported side effects.

Arms: arm 1: Labetalol 200mg PO BID starting dose arm 2: Nifedpine XL starting at dose 30mg PO daily
Interventions: intervention 1: Labetalol intervention 2: Nifedipine
Intervention descriptions: intervention 1: Titrate up for blood pressure control intervention 2: Titrate up to achieve blood pressure control

Protocol documents:
Clinical trial NCT02196506
Conditions: Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders
Keywords: OPC-34712 brexpiprazole Major Depressive Disorder Adjunctive Treatment Anxious Distress
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2014-07-01; Completion date: 2016-05-01
Enrollment: 837 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress

Detailed description:
The introduction of atypical antipsychotics has created a renewed interest in adjunctive therapy for MDD, particularly for treatment-resistant MDD. Several atypical antipsychotics have been shown to enhance the response to ADT. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label ADT in depressed subjects with and without anxious distress.

Arms: arm 1: Brexpiprazole + ADT arm 2: Placebo + ADT
Interventions: intervention 1: Placebo + ADT intervention 2: Brexpiprazole +ADT
Intervention descriptions: intervention 1: Placebo + ADT Placebo + FDA Approved Antidepressant (ADT) intervention 2: Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)

Protocol documents:
Clinical trial NCT02212587
Conditions: Cystic Fibrosis Burkholderia Cepacia Infection
Keywords: inhaled antibiotics
Sponsor: Unity Health Toronto
Start date: 2014-09-01; Completion date: 2016-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of cystic fibrosis patient.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TOBI
Intervention descriptions: intervention 1: New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler

Protocol documents:
Clinical trial NCT02217800
Conditions: Acromegaly
Sponsor: Aspireo Pharmaceuticals Limited
Start date: 2013-11-01; Completion date: 2016-05-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to assess the effect of the different continuous s.c. infusion treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.

Detailed description:

Arms: arm 1: Interventions: saline, DG3173 and octreotide. Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
Interventions: intervention 1: saline intervention 2: DG3173 intervention 3: octreotide
Intervention descriptions: intervention 1: Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator. intervention 2: Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator. intervention 3: Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.

Protocol documents:
Clinical trial NCT02230566
Conditions: MPS 7 Sly Syndrome Mucopolysaccharidosis MPS VII
Keywords: MPS 7 Sly Syndrome Mucopolysaccharidosis MPS VII Enzyme Replacement Therapy Mucopolysaccharidosis type 7 rare disease lysosomal storage disease metabolic disorder
Sponsor: Ultragenyx Pharmaceutical Inc
Start date: 2014-12-01; Completion date: 2016-05-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The Phase 3 study will use a novel randomized, intra-subject placebo-controlled, single crossover design, referred to as Blind Start, to evaluate the safety and efficacy of UX003. The Blind Start is a novel design whereby participants will be randomized to 1 of 4 groups, each representing a different treatment sequence, and will cross over to UX003 at different pre-defined time points in a blinded manner. All groups will receive a minimum of 24 weeks treatment with 4 mg/kg UX003 every other week (QOW).

Detailed description:

Arms: arm 1: 4 mg/kg UX003 QOW through Week 46 arm 2: Placebo QOW for the first 8 weeks followed by 4 mg/kg UX003 QOW through Week 46 arm 3: Placebo QOW for the first 16 weeks followed by 4 mg/kg UX003 QOW through Week 46 arm 4: Placebo QOW for the first 24 weeks followed by 4 mg/kg UX003 QOW through Week 46
Interventions: intervention 1: UX003 intervention 2: Placebo
Intervention descriptions: intervention 1: UX003 is a sterile concentrate formulation of rhGUS for intravenous infusion intervention 2: Placebo consisting of the UX003 formulation buffer (without rhGUS)

Protocol documents:
Clinical trial NCT02247960
Conditions: Prostate Cancer Urinary Tract Infection Clostridium Difficile
Sponsor: University of Rochester
Start date: 2014-07-01; Completion date: 2016-05-01
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.

Detailed description:

Arms: arm 1: Antibiotic arm 2: No Antibiotic
Interventions: intervention 1: Ciprofloxacin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02277704
Conditions: PTSD
Keywords: PTSD Military-related PTSD and other related conditions
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2014-10-01; Completion date: 2016-05-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.

Detailed description:

Arms: arm 1: 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. arm 2: 1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. arm 3: 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Interventions: intervention 1: TNX-102 SL intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02305797
Conditions: Generalized Anxiety Disorder (GAD)
Sponsor: Edgemont Pharmaceuticals, LLC
Start date: 2015-01-01; Completion date: 2016-05-01
Enrollment: 495 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.

Detailed description:

Arms: arm 1: EDG004 - Extended release lorazepam capsules arm 2: Placebo
Interventions: intervention 1: Extended-release lorazepam intervention 2: Placebo
Intervention descriptions: intervention 1: Extended-release lorazepam capsules intervention 2: Placebo capsules

Protocol documents:
Clinical trial NCT02320721
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2015-01-01; Completion date: 2016-05-01
Enrollment: 1014 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c).

Secondary Objectives:

To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

* Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning
* Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event
* Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day
* HbA1c change

Detailed description:
The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Arms: arm 1: HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. arm 2: Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Interventions: intervention 1: Insulin Glargine (HOE901 - U300) intervention 2: Insulin Glargine (HOE901 - U100) intervention 3: Background therapy
Intervention descriptions: intervention 1: Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L). intervention 2: Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L). intervention 3: Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.

Protocol documents:
Clinical trial NCT02331680
Conditions: Chronic Renal Failure
Keywords: Undergoing Hemodialysis Undergoing Hemodiafiltration
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2014-12-01; Completion date: 2016-05-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.

Detailed description:

Arms: arm 1: Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 24 week. arm 2: Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 1 week and then OPC-41061 30 mg/day for 23 weeks arm 3: Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. Placebo will be administered for 24 week.
Interventions: intervention 1: OPC-41061 intervention 2: OPC-41061 intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02349048
Conditions: Hepatitis C Virus
Keywords: Hepatitis C virus Hepatitis C virus genotype 1 Chronic Hepatitis C Virus Genotype 1 Infection Liver fibrosis Cirrhosis Simeprevir Daclatasvir Sofosbuvir
Sponsor: Janssen Research & Development, LLC
Start date: 2015-01-01; Completion date: 2016-05-01
Enrollment: 68 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or investigational drug) participants with chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early stages of liver fibrosis or with cirrhosis.

Detailed description:
This is an open-label (participants and researchers are aware about the treatment participants are receiving), and multicenter (when more than 1 hospital or medical school team work on a medical research) study. The study will consist of a Screening Phase (6 weeks); an Open-label Treatment Phase (6 weeks for Arm A and 8 weeks for Arm B); and a Post-treatment Follow-up Phase (until 24 weeks after end of study treatment). Using a staggered approach, all eligible participants will be assigned to 1 of the 2 arms, according to their level of fibrosis. Arm A (consists of chronic HCV genotype 1 infected participants with early stages of liver fibrosis): participants will receive a combination therapy of SMV 150 milligram (mg), DCV 60 mg and SOF 400 mg once daily for 6 weeks. Arm B (consists of chronic HCV genotype 1 infected participants with cirrhosis): participants will receive a combination therapy of SMV 150 mg, DCV 60 mg and SOF 400 mg once daily for 8 weeks. A sub-study will be performed at a selected study site, where only participants who will be eligible to participate in both the main study and the sub-study will be enrolled. Intra-hepatic and plasma HCV ribonucleic acid (RNA) levels; intra-hepatic, peripheral innate and adaptive immune responses during the treatment, will be assessed in the sub-study. Participants' safety will be monitored throughout the study.

Arms: arm 1: Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis, will receive Simeprevir (SMV) 150 milligram (mg), Daclatasvir (DCV) 60 mg and Sofosbuvir (SOF) 400 mg once daily for 6 weeks. arm 2: Chronic HCV genotype 1 infected participants with cirrhosis, will receive SMV 150 mg, DCV 60 mg and SOF 400 mg once daily for 8 weeks.
Interventions: intervention 1: Simeprevir 150 mg intervention 2: Daclatasvir 60 mg intervention 3: Sofosbuvir 400 mg
Intervention descriptions: intervention 1: Simeprevir 150 mg capsule orally once daily. intervention 2: Daclatasvir 60 mg tablet orally once daily. intervention 3: Sofosbuvir 400 mg tablet orally once daily.

Protocol documents: