ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02239094
Conditions: Bipolar Depression
Keywords: Bipolar Disorder depression Bipolar depression
Sponsor: New York State Psychiatric Institute
Start date: 2015-01-01; Completion date: 2016-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.

Detailed description:
The study proposes to enroll 20 participants with a bipolar disorder who are currently in an episode of major depression.Magnetic resonance imaging (MRI), recordings of brain electrical activity (EEG), and psychological testing to explore possible predictors of lurasidone treatment response will be conducted. Blood samples will be collected for a future study of blood protein predictors of response. After testing, participants will receive an open-label 8-week trial of lurasidone (Latuda™) at approved dosage levels. Participants who attain remission of their major depressive episode will be eligible for a six-month continuation phase to explore predictors of sustained response to continuation treatment. Data analyses will use statistical testing to explore potential biological predictors of lurasidone response. This will provide a framework for clarifying which patients are best suited to this treatment and begin to develop a model for precision treatment of this difficult-to-treat disorder.

Arms: arm 1: All study participants will receive open-label Latuda.
Interventions: intervention 1: Lurasidone (Latuda)
Intervention descriptions: intervention 1: Antipsychotic medication approved for use with Bipolar disorder

Protocol documents:
Clinical trial NCT02239679
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Sponsor: DUSA Pharmaceuticals, Inc.
Start date: 2014-09-01; Completion date: 2016-09-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.

Detailed description:

Arms: arm 1: Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments arm 2: Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. arm 3: Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
Interventions: intervention 1: Aminolevulinic Acid intervention 2: Topical Solution Vehicle intervention 3: BLU-U intervention 4: Cryotherapy
Intervention descriptions: intervention 1: 20% ALA applied to face for one hour prior to 10 J/cm2 blue light intervention 2: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light intervention 3: 10 J/cm2 blue light delivered at 10 mW/cm2 intervention 4: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

Protocol documents:
Clinical trial NCT02241720
Conditions: Upper GI Cancer
Sponsor: University of Utah
Start date: 2014-05-01; Completion date: 2016-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: regorafenib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02242201
Conditions: Total Hip Arthroplasty
Sponsor: Mayo Clinic
Start date: 2014-09-01; Completion date: 2016-09-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Total hip arthroplasty is a one of the most commonly performed surgical procedures with increasing numbers anticipated over the next several decades. The purpose of this study was to find a better way to make patients comfortable after their hip surgery. Three different ways of providing pain relief were compared, a peripheral nerve block in the lower back outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine (Exparel®).

Detailed description:
Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal clinical pathway for pain management has yet to be established. Multimodal pain management incorporating the use of regional anesthesia for THA has led to decreased hospital length of stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and cost-effective. This investigation compared multimodal total joint arthroplasty pathways with continuous lumbar plexus blockade versus two different periarticular injection mixtures to potentially determine an ideal perioperative analgesia pathway for THA.

Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI) with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac, and epinephrine. The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study.

Arms: arm 1: Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. arm 2: Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. arm 3: Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.
Interventions: intervention 1: PNB Bupivacaine intervention 2: PAI Ropivacaine intervention 3: PAI liposomal bupivacaine intervention 4: Epinephrine intervention 5: Ketorolac
Intervention descriptions: intervention 1: Infusion intervention 2: Injection intervention 3: Injection intervention 4: Injection, weight-based dosage of 100 mcg - 300 mcg intervention 5: Injection, 30 mg

Protocol documents:
Clinical trial NCT02308124
Conditions: Orthostatic; Hypotension, Neurogenic
Sponsor: Seoul National University Hospital
Start date: 2014-11-01; Completion date: 2016-09-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.

Detailed description:
In patients with neurogenic orthostatic hypotension, the appropriate treatment was identified by comparing the treatment effects and side effects for each treatment drug. In addition, by confirming the effect of orthostatic hypotension on lowering the quality of life, it is expected that the improvement of the quality of life will help.

Arms: arm 1: Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. arm 2: Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. arm 3: Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
Interventions: intervention 1: Midodrine intervention 2: Pyridostigmine Bromide intervention 3: Midodrine + pyridostigmine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02317744
Conditions: Binge Eating Disorder
Sponsor: Yale University
Start date: 2014-12-01; Completion date: 2016-09-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.

Detailed description:

Arms: arm 1: 50 mg naltrexone and 300 mg bupropion per day for 3 months arm 2: Daily placebo medication for 3 months
Interventions: intervention 1: Naltrexone and bupropion combination intervention 2: Pill Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02327013
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: H. Lundbeck A/S
Start date: 2014-12-01; Completion date: 2016-09-01
Enrollment: 227 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult patients with ADHD in a 12 weeks study.

Detailed description:
The study employed the Sequential Parallel Comparison Design (SPCD), a clinical study design which intend to increase signal detection by using two stages of treatment:

* Stage 1 - first 6 weeks of the 12-weeks treatment period (Visit 2/Baseline 1 to Visit 5/Week 6)
* Stage 2 - last 6 weeks of the 12-weeks treatment period (Visit 5/Baseline 2 to Visit 8/Week 12)

In Stage 1, patients were randomized to placebo or vortioxetine 10 or 20mg. Patients on vortioxetine 10 or 20mg/day during Stage 1 remained on the same treatment in Stage 2. Responders to placebo in Stage 1 remained on Placebo in Stage 2. Patients who were placebo non-responders during Stage 1, defined as patients with a \<30% reduction in AISRS total score from Baseline 1, were re-randomized to placebo or vortioxetine 10 or 20mg/day in Stage 2.

Arms: arm 1: In Stage 1, patients will receive vortioxetine 10mg/day for 6 weeks.

In Stage 2, patients who received vortioxetine 10mg/day in Stage 1 will continue on the same treatment for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks. arm 2: In Stage 1, patients will receive vortioxetine 20mg/day for 6 weeks.

In Stage 2, patients who received vortioxetine 20mg/day in Stage 1 will continue on the same treatment for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks. arm 3: In Stage 1, the patients will receive placebo for 6 weeks.

In Stage 2, placebo responders will continue on placebo for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks.
Interventions: intervention 1: vortioxetine 10 mg tablet intervention 2: vortioxetine 20 mg tablet intervention 3: Placebo tablet
Intervention descriptions: intervention 1: Oral tablets, once daily intervention 2: Oral tablets, once daily intervention 3: Oral tablets, once daily

Protocol documents:
Clinical trial NCT02342314
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-01-01; Completion date: 2016-09-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.

Detailed description:

Arms: arm 1: Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1 arm 2: Single SC injection of ascending doses of LY3185643 on Day 1 arm 3: Single SC injection of normal saline on Day 1 arm 4: Single SC injection on Day 1 arm 5: Single SC injection of normal saline on Day 1
Interventions: intervention 1: LY3143753 (Part A) intervention 2: LY3185643 (Part B) intervention 3: Placebo (Part A and Part B) intervention 4: rGlucagon (Part B)
Intervention descriptions: intervention 1: Administered via SC injection intervention 2: Administered via SC injection intervention 3: Administered via SC injection intervention 4: Administered via SC injection

Protocol documents:
Clinical trial NCT02383940
Conditions: Type 1 Diabetes Mellitus
Sponsor: Lexicon Pharmaceuticals
Start date: 2015-04-01; Completion date: 2016-09-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.

Detailed description:

Arms: arm 1: Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks. arm 2: Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
Interventions: intervention 1: Sotagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Sotagliflozin 400 mg, once daily before the first meal of the day intervention 2: Placebo, once daily before the first meal of the day

Protocol documents:
Clinical trial NCT02422303
Conditions: Depression Major Depressive Disorder
Keywords: Depression Gynecoligical surgery Ketamine
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2015-12-01; Completion date: 2016-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ketamine has been shown to have an antidepressant effect when given intravenously in doses of 2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known in this instance to decrease postoperative pain. No one has studied whether or not ketamine when given in doses used during general anesthesia (0.5mg/kg intravenous) has an antidepressant effect on surgical patients who suffer from depression. The study is designed to determine whether or not a small dose of ketamine when given at the induction of anesthesia could have an antidepressant effect on surgical patients with depression.

Detailed description:
Non-pregnant females between the ages of 18-65 who are being admitted for gynecological surgery will be given a bedside Goldberg depression screen as part of their routine preanesthetic assessment. If the patient scores five or above on the Goldberg depression screening, they will be asked if they would like to enroll in the study. Exclusion criteria include uncontrolled hypertension, pregnancy, or allergy to ketamine.

Once the patient is consented they will be randomized to one of two groups. Every patient will receive an antianxiety medication Midazolam and a narcotic fentanyl prior to going to the operating room. Group A will receive ketamine 0.5mg/kg intravenous as part of their induction for general anesthesia. Group B will not receive ketamine as part of their anesthetic. All other induction drugs will be at the discretion of the anesthesiologist performing the anesthetic.

The patients will be seen by a separate anesthesia provider (who is blinded to the group the patient is in) and the results of the depression screening will be added to the patient's data sheet.

The patients will be followed again one week after their surgery either in their hospital room (if still hospitalized) or by phone. They will again be given the Goldberg Depression screen and the data will again be added to their data sheet.

Several times during the study and at its conclusion the data will be matched with the patients group in order to assess for adverse events such as suicidal ideations, nausea and vomiting. If adverse events are noted, the study design will be altered to take into account the adverse events.

Arms: arm 1: This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia. arm 2: This group will not receive ketamine at induction of general anesthesia.
Interventions: intervention 1: ketamine
Intervention descriptions: intervention 1: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.

Protocol documents:
Clinical trial NCT02423122
Conditions: Alzheimer's Disease Mild Cognitive Impairment
Sponsor: EIP Pharma Inc
Start date: 2015-04-01; Completion date: 2016-09-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and day 45.

Detailed description:

Arms: arm 1: Active Group 1: VX-745 40 mg twice daily arm 2: Active Group 2: VX-745 125 mg twice daily
Interventions: intervention 1: VX-745
Intervention descriptions: intervention 1: Orally-Active Selective P45 MAP Kinase inhibitor

Protocol documents:
Clinical trial NCT02436096
Conditions: Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases
Keywords: Pain Sleep
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2015-04-01; Completion date: 2016-09-01
Enrollment: 519 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

Detailed description:

Arms: arm 1: 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks arm 2: 1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks
Interventions: intervention 1: TNX-102 SL Tablet, 2.8mg intervention 2: Placebo SL Tablet
Intervention descriptions: intervention 1: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. intervention 2: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.

Protocol documents:
Clinical trial NCT02450383
Conditions: Tooth Loss Peri-implant Mucosa Defect
Sponsor: University of Iowa
Start date: 2015-01-01; Completion date: 2016-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults.

AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of the American Association of Tissue Banks (AATB).

Twenty adult subjects will be recruited who are in need of dental implant placement with simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the subjects will be randomized to the ADM group and half will be randomized to the sCTG group. The surgical intervention will be performed according to the protocol and subjects will return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of healing, gum thickness, subject perception of pain, and esthetic photographs.

Detailed description:
Although little is known about the influence of peri-implant mucosa thickness (PMT) on long-term biologic outcomes, soft tissue thickness is a critical component to esthetic dental implant restorations. While the subepithelial connective tissue graft (sCTG) has been recognized as the gold standard for gingival augmentation, several studies have reported acellular dermal matrix (ADM) may produce similar outcomes. Healthy patients with a thin biotype were selected on the basis of an eligibility criteria and randomized to the control (sCTG) or test (ADM) group. Measurements were completed by a masked examiner at baseline and at implant uncovering. Patient reported outcomes were recorded, as well. A power analysis suggested 20 subjects be recruited. The gain in PMT at 1mm, 3mm and 5mm from the expected CEJ and recipient site wound dehiscence were measured and recorded in both groups at different time points by a calibrated, masked examiner. Patient-related outcome measures (PROMs), such as pain and level of satisfaction with final outcome, were also recorded for all study participants.

Arms: arm 1: Autologous subepithelial connective tissue graft arm 2: Acellular Dermal Matrix
Interventions: intervention 1: Acellular Dermal Matrix intervention 2: Autologous subepithelial connective tissue graft
Intervention descriptions: intervention 1: Placement of acellular dermal matrix (Alloderm®) on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach intervention 2: Placement of autologous subepithelial connective tissue graft on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach

Protocol documents:
Clinical trial NCT02459080
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Sponsor: Mylan Inc.
Start date: 2015-09-01; Completion date: 2016-09-01
Enrollment: 619 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.

Detailed description:

Arms: arm 1: 88 mcg arm 2: 175 mcg arm 3: Placebo
Interventions: intervention 1: TD-4208 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: