ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02638623
Conditions: Osteoarthritis
Keywords: Knee Arthroplasty Hip Arthroplasty
Sponsor: West Virginia University
Start date: 2015-10-01; Completion date: 2016-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are testing the hypothesis that administering 2L of body temperature warmed lactated ringer's intravenously prior to surgery can optimize the postoperative and recovery of patients undergoing total hip and total knee arthroplasty.

Detailed description:
Hip and knee arthroplasty are safe and reliable surgeries for the majority of patients, but a small percentage experience major complications such as myocardial infarction, deep vein thrombosis (DVT), and pulmonary embolism (PE). As these complications are related to local tissue hypoxemia and patient immobility, interventions that can improve the ability of the heart to deliver blood to the tissue and help patients mobilize earlier in their postoperative course may decrease these complications. Based on recent evidence, it has been shown that many patients are dehydrated before surgery, which can make them feel nauseous, tired, and increase their perception of pain making them less likely to mobilize. This predisposes them to DVTs, pulmonary embolism, nausea and vomiting. Peri-operative dehydration can also decrease the ability of the lungs to oxygenate the blood properly and can place additional stress on the heart, which can increase the risk of heart attacks. The specific aim is to determine if patients' peri-operative hemodynamics can be improved with preoperative administration of 2 L of lactated ringers, and consequently reduce postoperative complications and improve recovery in arthroplasty patients.

Arms: arm 1: Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement arm 2: Covered empty bag with no hydration supplement
Interventions: intervention 1: Lactated Ringer intervention 2: Placebo
Intervention descriptions: intervention 1: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty intervention 2: No additional fluids will be administered

Protocol documents:
Clinical trial NCT02644122
Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Keywords: advanced cancer metastatic cancer Squamous Cell Carcinoma of the Head and Neck SCCHN gene mutation PIK3R1, PIK3R5 and PIK3AP1 PIK3CG AKT and mTOR PIK3CA gene PI-3 kinase inhibitor PI-3 kinase pathway genes
Sponsor: Ezra Cohen
Start date: 2016-11-01; Completion date: 2016-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the good and bad effects of an experimental drug called SF1126. This drug is being tested in patients whose cancer has not been controlled by available standard therapies and who have certain genes in their tumor.

SF1126 is a drug that inhibits a cell protein called phosphatidyl inositol 3 kinase (PI3K). PI3K is part of signaling pathway that tells cancer cells to grow, survive, invade and metastasize. PI3K also has an important role in the development of blood vessels that are required to support tumor growth. SF1126 is being developed by SignalRx Pharmaceuticals, Inc. It is considered an experimental drug because it is not approved by the FDA for any disease treatment.

Detailed description:
SignalRx Pharmaceuticals has developed a pan isoform specific PI-3 inhibitor called SF1126 to treat patients with advanced or metastatic cancer. SF1126 is a conjugate that contains two components: SF1101 (the active drug) and SF1174 (an inactive tetrapeptide RGD targeting moiety)

Both components of SF1126 play key roles in the activity of the drug. SF1101 is a selective inhibitor of certain members of the phosphatidyl inositol 3-kinase (PI-3) family and SF1174 binds selectively to receptors known to be present on neovasculature supporting tumors and on some tumor cells themselves. These components result in a drug designed to be both selective in its activity and targeted in its delivery.

This is an open label Phase II study of SF1126 in adult patients with recurrent or refractory advanced SCCHN with PIK3CA mutation. Treatment cycles (28 days) will consist of SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four cycles and then once weekly for subsequent cycles.

Arms: arm 1: SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
Interventions: intervention 1: SF1126
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02649608
Conditions: Parkinson Disease
Sponsor: H. Lundbeck A/S
Start date: 2016-01-01; Completion date: 2016-12-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.

Detailed description:
The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients with Parkinson's disease (men and/or women). Each patient will be treated for 3 or 4 days, with increasing dose each day.

Dosing regimen will be decided at a dosing conferences. Dose levels can be increased, maintained or reduced both between cohorts but also within same cohort. The results are presented by dose level and reflect the actual doses administered.

A follow-up safety visit was scheduled approximately 7 days after the last dose of IMP.

Arms: arm 1: Patients having received a dose of 0.04 mg, independent of which Cohort they belong to. arm 2: Patients having received a dose of 0.08 mg, independent of which Cohort they belong to. arm 3: Patients having received a dose of 0.2 mg, independent of which Cohort they belong to. arm 4: Patients having received a dose of 1.2 mg, independent of which Cohort they belong to. arm 5: Patients having received a dose of 0.6 mg, independent of which Cohort they belong to. arm 6: Patients having received a dose of 0.8 mg, independent of which Cohort they belong to. arm 7: Patients having received a dose of 1.0 mg, independent of which Cohort they belong to. arm 8: Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
Interventions: intervention 1: 0.04 mg Lu AE04621 intervention 2: 0.08 mg Lu AE04621 intervention 3: 0.2 mg Lu AE04621 intervention 4: 0.4 mg Lu AE04621 intervention 5: 0.6 mg Lu AE04621 intervention 6: 0.8 mg Lu AE04621 intervention 7: 1.0 mg Lu AE04621 intervention 8: 1.2 mg Lu AE04621
Intervention descriptions: intervention 1: 0.04 mg dose group intervention 2: 0.08mg dose group intervention 3: 0.2 mg dose group intervention 4: 0.4 mg dose group intervention 5: 0.6 mg dose group intervention 6: 0.8 mg dose group intervention 7: 1.0 mg dose group intervention 8: 1.2 mg dose group

Protocol documents:
Clinical trial NCT02688556
Conditions: Keratoconjunctivitis Sicca
Keywords: KCS dry eye cyclosporine
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2016-02-01; Completion date: 2016-12-01
Enrollment: 745 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Detailed description:

Arms: arm 1: 0.09% cyclosporine nanomicellar ophthalmic solution arm 2: vehicle of OTX-101
Interventions: intervention 1: cyclosporine intervention 2: vehicle of OTX-101
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02734953
Conditions: Pulmonary Arterial Hypertension
Keywords: Inhaled nitric oxide Exercise 6 minute walk test CardioMems
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Start date: 2016-04-01; Completion date: 2016-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pulmonary hypertension is characterized by an increase in the pressures in the blood supply to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary vasculature, PVR will increase with exercise instead of decreasing as it would in normal patients. Based on published evidence, the investigators intend to investigate the effects of inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have separately and previously had an implanted pulmonary artery monitoring device (CardioMems by St Jude Medical, Inc.) placed.

Detailed description:

Arms: arm 1: Determination of non-invasive pulmonary pressures by CardioMems device interrogation pre- and post-administration of inhaled nitric oxide at 0.075 mg/kg IBW/hr
Interventions: intervention 1: Nitric Oxide
Intervention descriptions: intervention 1: Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test

Protocol documents:
Clinical trial NCT02738008
Conditions: Hepatitis B
Sponsor: Arrowhead Pharmaceuticals
Start date: 2016-03-01; Completion date: 2016-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.

Detailed description:
Open-label, multi-center extension study of intravenous ARC-520 in combination with entecavir or tenofovir in patients with chronic HBV infection. Patients who successfully completed the Heparc-2002 (NCT02604199) and Heparc-2003 (NCT02604212) studies and responded to therapy are eligible to participate. Responders are defined as patients who showed a ½ log or greater reduction in their serum Hepatitis B Surface Antigen (HBsAg) levels from baseline to day 71 ± 3 days of the primary Heparc-2002 and Heparc-2003 studies. Patients who have signed a Human Research Ethics Committee approved informed consent and have met all of the protocol eligibility criteria will continue receiving daily oral entecavir or tenofovir and intravenous (IV) injections of ARC-520. Study visits will occur once every 4 weeks for a total of 9 visits for monitoring and ARC-520 administration.

Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate and temperature), weight, adverse events (AEs), 12-lead electrocardiograms (ECGs), concomitant medications, blood sample collection for hematology, coagulation, chemistry, creatine kinase, troponin, hemoglobin A1c, exploratory pharmacodynamic (PD) measures, urinalysis, HBV serology, immunogenicity, and pregnancy testing for females of childbearing potential. Patients will be monitored for HBV virology, AEs, and exploratory PD measures for a total of 24 weeks after the last dose of ARC-520.

Arms: arm 1: Multiple administrations of ARC-520 starting at a dose level of 2 mg/kg, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)
Interventions: intervention 1: ARC-520 Injection intervention 2: entecavir intervention 3: tenofovir intervention 4: antihistamine
Intervention descriptions: intervention 1: IV injection intervention 2: All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily. intervention 3: All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily. intervention 4: All participants will be pretreated with an oral antihistamine. The antihistamine used should in general be an H1\>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.

Protocol documents:
Clinical trial NCT02769247
Conditions: Contraception Pain
Keywords: naproxen lidocaine intrauterine device IUD pain
Sponsor: Walter Reed National Military Medical Center
Start date: 2014-06-01; Completion date: 2016-12-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.

Detailed description:
This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.

The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.

Arms: arm 1: Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion arm 2: Patient will receive naproxen and intrauterine normal saline prior to IUD insertion arm 3: Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion arm 4: Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion
Interventions: intervention 1: Naproxen intervention 2: Lidocaine intervention 3: placebo
Intervention descriptions: intervention 1: Oral naproxen vs placebo intervention 2: Intrauterine lidocaine vs normal saline intervention 3: either normal saline or empty oral capsule

Protocol documents:
Clinical trial NCT02774148
Conditions: Hip Fracture
Sponsor: Spectrum Health Hospitals
Start date: 2016-12-01; Completion date: 2016-12-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine if intravenous acetaminophen decreases pain scores and the amount of morphine equivalence received as compared to oral acetaminophen in patients greater than 65 years old after sustaining a hip fracture.

Detailed description:
Surgeons involved in this research agree to the randomization of patients into one of two groups. After informed consent, patients will be randomly assigned in a 1:1 ratio to the treatment group or the control group.

Group 1: This group will serve as the control group, and will be scheduled to receive one gram (1g) acetaminophen PO every 8 hours.

Group 2: This group will serve as the treatment group, and will be scheduled to receive one gram (1g) acetaminophen IV every 8 hours

The standardized pain control protocol for hip fracture patients will be initiated for all patients. The pain protocol will be initiated at hospital admission, and after three postoperative doses of the group assigned acetaminophen all patients will be switched to one gram scheduled acetaminophen PO in preparation for hospital discharge.

Arms: arm 1: 1,000mg Acetaminophen po every 8 hours until discharge. arm 2: 1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.
Interventions: intervention 1: IV Acetaminophen intervention 2: PO Acetaminophen
Intervention descriptions: intervention 1: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively. intervention 2: The patient will receive 1,000mg po Acetaminophen every 8 hours.

Protocol documents:
Clinical trial NCT02782169
Conditions: Acute Pain
Sponsor: University of Hawaii
Start date: 2015-06-01; Completion date: 2016-12-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Pregabalin 300 mg capsule (over encapsulated to maintain blinding) intervention 2: Matching placebo capsule with excipient to match Pregabalin

Protocol documents:
Clinical trial NCT02783820
Conditions: Malaria
Keywords: malaria, single ascending dose,
Sponsor: Medicines for Malaria Venture
Start date: 2016-05-01; Completion date: 2016-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).

Detailed description:
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).

Primary objectives:

• To evaluate the safety and tolerability of single ascending doses of MMV390048 administered orally to healthy subjects (men and WNCBP) under fasted conditions

Secondary objectives:

• To describe the pharmacokinetics of MMV390048 in healthy subjects (men and WNCBP) after single oral dose administration

Arms: arm 1: MMV390048 40 mg, tablets, single dose arm 2: Placebo to match MMV390048 40 mg, tablets, single dose arm 3: MMV390048 80 mg, tablets, single dose arm 4: Placebo to match MMV390048 80 mg, tablets, single dose arm 5: MMV390048 120 mg, tablets, single dose arm 6: Placebo to match MMV390048 120 mg, tablets, single dose
Interventions: intervention 1: MMV390048 40 mg intervention 2: Placebo to match MMV390048 40 mg intervention 3: MMV390048 80 mg intervention 4: Placebo to match MMV390048 80 mg intervention 5: MMV390048 120 mg intervention 6: Placebo to match MMV390048 120 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT02785159
Conditions: Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2016-02-01; Completion date: 2016-12-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Detailed description:
A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis

Arms: arm 1: Lotion arm 2: Cream arm 3: Lotion arm 4: Cream
Interventions: intervention 1: IDP-118 Lotion intervention 2: Tazorac Cream intervention 3: IDP-118 Vehicle Lotion intervention 4: IDP-118 Vehicle Cream
Intervention descriptions: intervention 1: Lotion intervention 2: Cream intervention 3: Lotion intervention 4: Cream

Protocol documents:
Clinical trial NCT02801370
Conditions: Acute Otitis Externa Swimmer's Ear
Sponsor: Otonomy, Inc.
Start date: 2016-06-01; Completion date: 2016-12-01
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 12 mg ciprofloxacin intervention 2: Sham Control
Intervention descriptions: intervention 1: Single administration of OTO-201 intervention 2: Simulated, single adminstration

Protocol documents:
Clinical trial NCT02840461
Conditions: Moderate to Severe Papulopustular Rosacea
Sponsor: Actavis Inc.
Start date: 2016-06-01; Completion date: 2016-12-01
Enrollment: 630 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of moderate to severe papulopustular rosacea.

Detailed description:

Arms: arm 1: test product, manufactured by Actavis Laboratories UT, Inc. arm 2: reference product, manufactured by Galderma Laboratories, L.P. arm 3: Placebo, manufactured by Actavis Laboratories UT, Inc.
Interventions: intervention 1: Ivermectin Cream, 1% intervention 2: Placebo/Vehicle cream
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02884089
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-08-01; Completion date: 2016-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will look at how a single dose of abemaciclib will impact the body's ability to get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the effect of a single dose of abemaciclib on kidney function by measuring blood and urine markers. Side effects will also be documented.

Each participant will complete four study periods. During each study period, participants will stay in the clinical research unit for nine days and eight nights.

The study will last approximately 10 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

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

Detailed description:

Arms: arm 1: Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods. arm 2: Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods. arm 3: Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods. arm 4: Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.
Interventions: intervention 1: Abemaciclib intervention 2: Metformin intervention 3: Iohexol intervention 4: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered intravenously (IV) intervention 4: Administered orally

Protocol documents: