ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02463357
Conditions: Mountain Sickness
Keywords: Exercise, Aerobic Cognitive Function
Sponsor: University of Colorado, Denver
Start date: 2015-08-01; Completion date: 2016-09-01
Enrollment: 148 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS. Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance and endurance exercise capacity are impaired. Therefore, the goal of this research is to identify effective pharmacological agents that will help reduce the symptoms of AMS and improve physical and cognitive performance at high altitude.

The investigators will study the efficacy of the dietary supplement, quercetin, the drugs nifedipine (extended release) and methazolamide taken together, the drug metformin, and the drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at high altitudes.

Detailed description:

Arms: arm 1: Quercetin: 500mg pill, twice daily for 5 days arm 2: Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days arm 3: Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days) arm 4: Sugar pill manufactured to look like all other investigational products arm 5: Nitrite: 20mg pill, three times daily for 5 days
Interventions: intervention 1: Quercetin intervention 2: Nifedipine extended release intervention 3: Methazolamide intervention 4: Metformin intervention 5: Placebo intervention 6: Nitrite
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT02499887
Conditions: Asthma COPD
Sponsor: State University of New York at Buffalo
Start date: 2016-01-01; Completion date: 2016-09-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.

Detailed description:

Arms: arm 1: Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)

Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications. arm 2: Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days

Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.
Interventions: intervention 1: beclamethasone dipropionate intervention 2: albuterol intervention 3: Prednisone
Intervention descriptions: intervention 1: Inhaler intervention 2: Inhaler intervention 3: Oral corticosteroid

Protocol documents:
Clinical trial NCT02512510
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: 611 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:
Clinical trial NCT02514473
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2015-07-01; Completion date: 2016-09-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

Detailed description:

Arms: arm 1: Fixed-dose combination with lumacaftor (LUM) 200 mg every 12 hours (q12h)/ ivacaftor (IVA) 250 mg q12h arm 2: Matching placebo q12h
Interventions: intervention 1: VX-809 intervention 2: Placebo intervention 3: VX-770
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02520726
Conditions: Post-traumatic Stress Disorder
Keywords: Posttraumatic stress disorder PTSD Sertraline Burns
Sponsor: University of Utah
Start date: 2013-09-01; Completion date: 2016-09-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled study to determine whether administration of sertraline to patients who exhibit acute stress disorder secondary to severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).

Detailed description:

Arms: arm 1: Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age \>65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration arm 2: Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.
Interventions: intervention 1: Sertraline intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: \< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop. intervention 2: Matched encapsulated placebo from 1-4 capsules daily

Protocol documents:
Clinical trial NCT02526524
Conditions: Type 2 Diabetes Mellitus
Sponsor: Elcelyx Therapeutics, Inc.
Start date: 2015-09-01; Completion date: 2016-09-01
Enrollment: 571 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning \[qAM\]) compared to placebo. A single-blind reference treatment of 2000 mg metformin immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID) will also be included.

Detailed description:

Arms: arm 1: 600 mg metformin delayed-release once daily in the morning arm 2: 900 mg metformin delayed-release once daily in the morning arm 3: 1200 mg metformin delayed-release once daily in the morning arm 4: 1500 mg metformin delayed-release once daily in the morning arm 5: placebo match for 600 and 1200 mg Met DR qAM treatment groups arm 6: placebo match for 900 and 1500 mg Met DR qAM treatment groups arm 7: 1000 mg metformin immediate-release twice daily
Interventions: intervention 1: Met DR intervention 2: Met IR intervention 3: Placebo
Intervention descriptions: intervention 1: metformin delayed-release tablets intervention 2: metformin immediate-release tablets intervention 3: None

Protocol documents:
Clinical trial NCT02561338
Conditions: Diabetes Mellitus, Type 2
Keywords: GKA,T2DM,HMS5552
Sponsor: Hua Medicine Limited
Start date: 2015-09-01; Completion date: 2016-09-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.

Detailed description:
Glucokinase (GK, also called hexokinase IV or D) can phosphosphorylate glucose to glucose-6-phosphate (G-6-P) in pancreatic β-cells and liver cells, which represents the first step of glucose metabolism. GK also acts as a glucose sensor and exerts a key role in maintaining glucose homeostasis. HMS5552 is a 4th-generation GK agonist or activator (GKA), which was originally licensed from Roche and subsequently developed by Hua Medicine. HMS5552 has been shown to activate GK in pancreatic beta cells, liver and intestinal epithelial cells. It regulates systemic blood glucose through a variety of mechanisms including directly enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and by indirectly promoting GLP-1 release (enteroendocrine L-cells).

Arms: arm 1: 75mgQD oral administration arm 2: 100mgQD oral administration arm 3: 50mgBID oral administration arm 4: 75mgBID oral administration arm 5: Placebo, BID/QD oral administration
Interventions: intervention 1: HMS5552 intervention 2: HMS5552 intervention 3: HMS5552 intervention 4: HMS5552 intervention 5: Placebo
Intervention descriptions: intervention 1: 75mgQD intervention 2: 100mgQD intervention 3: 50mgBID intervention 4: 75mgBID intervention 5: QD/BID

Protocol documents:
Clinical trial NCT02564016
Conditions: Pregnancy
Sponsor: Medical University of South Carolina
Start date: 2014-10-01; Completion date: 2016-09-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.

Detailed description:
The aim of this research is to determine the effect of postpartum epidural saline infusion on the reactivation of labor epidural catheters which are used as the anesthetic technique for PPTL following vaginal delivery. It is proposed that continuous epidural saline infusion will decrease the incidence of catheter obstruction by preventing clot, fibrosis, or tissue plugging and therefore improve reactivation rates. To our knowledge, this is a novel method for attempting to improve epidural reactivation rate and if successful, it would challenge the current practice of only capping epidurals following delivery and later attempting reactivation prior to PPTL. This may, possibly, become a new technique used to improve the rate of epidural reactivation for PPTL.

If study results show improved labor epidural reactivation rates, benefits would include decreased patient morbidity and greater patient comfort and satisfaction by avoiding the risks of additional neuraxial procedures as well as general anesthesia. These risks include difficult or failed intubation, aspiration, hypotension, headache, postoperative nausea and vomiting, and sore throat. Improving epidural reactivation rate could also result in greater OR efficiency and decreased costs for the patient and hospital.

The investigators also hope to elucidate factors associated with catheter migration or dislodgement and subsequent failure of epidural reactivation. Additionally, we hope to determine what effect obesity and length of time prior epidural reactivation have on epidural reactivation rates.

Arms: arm 1: Group 1 (control) will have the epidural catheter capped and left in place. arm 2: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Interventions: intervention 1: Normal Saline Infusion intervention 2: Capped Epidural
Intervention descriptions: intervention 1: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour intervention 2: epidural will be capped with no saline infusion.

Protocol documents:
Clinical trial NCT02564354
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis CF ΔF508 CFTR QR-010 antisense oligonucleotide RNA therapy F508del NPD nasal potential difference
Sponsor: ProQR Therapeutics
Start date: 2015-09-01; Completion date: 2016-09-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Exploratory proof of concept study to determine whether intranasal administration of QR-010 in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation, can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).

Detailed description:
This is an open-label, multi-center, exploratory study to estimate the effect of intranasal administration of QR-010 on the nasal mucosa in the restoration of CFTR function, as measured by nasal potential difference (NPD), in the nasal epithelium of adult subjects with CF who are homozygous or compound heterozygous for the ΔF508 CFTR mutation.

Arms: arm 1: QR-010 administered intranasally as an atomized liquid 10 mg (5 mg per nostril), 3 times weekly for 4 weeks. arm 2: QR-010 administered intranasally as an atomized liquid 10 mg (5 mg per nostril), 3 times weekly for 4 weeks.
Interventions: intervention 1: QR-010
Intervention descriptions: intervention 1: Single-stranded RNA antisense oligonucleotide in isoosmolar solution

Protocol documents:
Clinical trial NCT02584257
Conditions: Mild Persistent Asthma
Sponsor: Lupin, Inc.
Start date: 2016-04-01; Completion date: 2016-09-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Detailed description:
A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, 5-Treatment, Randomized, Crossover Study to Demonstrate the Pharmacodynamic Bioequivalence of Test and Reference Metered Dose Inhalers containing Albuterol Sulfate using Bronchoprovocation in Adult Patients with Stable Mild Asthma

Arms: arm 1: Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols arm 2: 90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols arm 3: 180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols arm 4: 90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols arm 5: 180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols
Interventions: intervention 1: methacholine chloride intervention 2: placebo ProAir HFA intervention 3: ProAir HFA intervention 4: Lupin albuterol HFA MDI intervention 5: placebo Lupin albuterol HFA MDI
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02590003
Conditions: Carcinoma, Non-small Cell Lung
Sponsor: Yale University
Start date: 2015-11-01; Completion date: 2016-09-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will enroll elderly patients with advanced non-small cell lung cancer who are at high risk of developing chemotherapy toxicity (side effects). Patients will receive treatment with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity will be compared in the two treatment groups to determine the best treatment strategy for this group of patients.

Detailed description:
The primary objective of this trial is to compare the treatment failure-free survival rate in high-risk elderly patients, identified by geriatric assessment, treated with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel in advanced non-small cell lung cancer. Treatment failure-free survival is the most appropriate primary outcome as it captures excessive toxicity due to chemotherapy in addition to death and disease progression.

The secondary objectives are to evaluate grade 3-5 toxicities, overall response rate, progression free survival, symptom assessment, and overall survival between the two randomization arms.

Arms: arm 1: * Carboplatin AUC 5 30 minute infusion IV on day 1
* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle arm 2: -Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
Interventions: intervention 1: Carboplatin intervention 2: Nab-paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02616250
Conditions: Rosacea
Sponsor: Galderma R&D
Start date: 2015-12-01; Completion date: 2016-09-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.

Detailed description:

Arms: arm 1: Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.

Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks. arm 2: Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.
Interventions: intervention 1: Brimonidine 0.33% gel (Br) intervention 2: CD07805/47 (Br) placebo gel intervention 3: Ivermectin 1% cream (IVM) intervention 4: CD5024 (IVM) placebo cream
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02617667
Conditions: Dry Eye Syndromes
Sponsor: Novaliq GmbH
Start date: 2016-01-01; Completion date: 2016-09-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).

Detailed description:
This phase 2 study explored the safety, efficacy and tolerability of two CyclASol concentrations as one drop twice daily versus vehicle (placebo). In addition to the masked vehicle control arm, an open-label comparator arm consisting of Restasis was included.

The study explored a range of signs and symptoms of DED to gain an understanding of the possible treatment effects in comparison to vehicle and estimation of effect sizes. In line with current treatment guidelines, the proposed phase 2 population consisted of patients suffering from moderate to severe DED.

The primary treatment comparisons in this study were between the two CyclASol concentrations versus vehicle for the sign variable total corneal fluorescein staining and the symptom variable dryness severity visual analogue scale at day 113. All other comparisons between treatments groups were considered secondary analyses.

Arms: arm 1: Cyclosporine A solution (dose-level 1) in vehicle arm 2: Cyclosporine A solution (dose-level 2) in vehicle arm 3: Vehicle only arm 4: Cyclosporine A 0.05% ophthalmic emulsion
Interventions: intervention 1: Cyclosporine A intervention 2: Placebo
Intervention descriptions: intervention 1: topical ocular, eye drops intervention 2: topical ocular, eye drops

Protocol documents:
Clinical trial NCT02626026
Conditions: Rheumatoid Arthritis
Sponsor: Gilead Sciences
Start date: 2016-01-26; Completion date: 2016-09-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will consist of two parts: Part A will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of tirabrutinib in healthy participants. Part B will evaluate the safety, tolerability, and the effect of tirabrutinib on disease-specific clinical markers and outcomes in participants with rheumatoid arthritis (RA).

Detailed description:

Arms: arm 1: Tirabrutinib 20 mg capsules orally once daily (QD) in the morning for 1 week. arm 2: Placebo to match tirabrutinib capsules orally QD in the morning for 1 week. arm 3: Tirabrutinib 10 mg capsules orally twice daily (BID) (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered. arm 4: Placebo to match tirabrutinib capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered. arm 5: Tirabrutinib 20 mg capsules orally QD for 4 weeks. arm 6: Placebo to match tirabrutinib capsules orally QD for 4 weeks.
Interventions: intervention 1: Tirabrutinib intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules administered orally. intervention 2: Capsules administered orally.

Protocol documents: