ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02574858
Conditions: Healthy Adults
Sponsor: University of Michigan
Start date: 2015-11-01; Completion date: 2016-08-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of orally administered QRH-882260, a topically administered Cy5-labeled heptapeptide specific for epithelial growth factor receptor (EGFR).

Detailed description:
This is a Phase IA study of the safety of an orally administered QRH-882260 heptapeptide for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 10 evaluable subjects. The investigators expect to be able to enroll about 1-2 subjects per week, so the study should take about 1-2 months to complete.

Interested, healthy subjects ages 25-100 who respond to recruitment advertising and appear to be eligible based on a screening questionnaire will be scheduled for a study visit at MCRU. At the study visit, the subjects will review and sign the informed consent and eligibility will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a urine sample for urinalysis. A baseline EKG will be recorded. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted QRH-882260 heptapeptide. After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water. Subjects will remain in MCRU for observation for 30 minutes. Vital signs and an EKG will be recorded after 30 minutes. Subjects are required to have repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after QRH-882260 heptapeptide ingestion. The study team will conduct a follow up phone call to verbally assess toxicity after post-ingestion labs (within 7 days).

Arms: arm 1: The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration).
Interventions: intervention 1: QRH-882260
Intervention descriptions: intervention 1: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.

Protocol documents:
Clinical trial NCT02654717
Conditions: Actinic Keratosis
Sponsor: Promius Pharma, LLC
Start date: 2015-11-01; Completion date: 2016-08-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see how well DFD-07 works in treating actinic keratosis on the face and scalp during 8 weeks of treatment. The study will also look at any unwanted effects of the study drug.

Detailed description:

Arms: arm 1: DFD-07 cream applied twice daily arm 2: Placebo cream applied twice daily
Interventions: intervention 1: DFD-07 Cream intervention 2: Placebo Cream
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02694744
Conditions: Hyperkalemia
Keywords: Treatment of Hyperkalemia Hyperkalemia Potassium Chronic Kidney Disease
Sponsor: Relypsa, Inc.
Start date: 2016-02-01; Completion date: 2016-08-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).

Detailed description:
Approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food.

All participants will undergo a screening period (1 day) to determine eligibility for study entry. Eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. There are six planned clinic visits during the Treatment Period and two planned visits after the last dose of patiromer during the Follow-up Period.

The dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.

Arms: arm 1: Patiromer dosing without food arm 2: Patiromer dosing with food
Interventions: intervention 1: patiromer
Intervention descriptions: intervention 1: 8.4 g/day starting dose, administered orally

Protocol documents:
Clinical trial NCT02703324
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2016-03-01; Completion date: 2016-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluated a blood sugar lowering insulin, LY900014, delivered by an insulin pump continuously under the skin. The study was conducted in participants with type 1 diabetes mellitus to investigate how the human body processed LY900014 and its effect on blood sugar levels when it was delivered via an insulin pump. Side effects and tolerability were be documented.

Detailed description:

Arms: arm 1: LY900014 delivered via an insulin pump as a continuous infusion under the skin with intermittent bolus doses during meals for two 3-day periods arm 2: Insulin lispro delivered via an insulin pump as a continuous infusion under the skin with intermittent bolus doses during meals for two 3-day periods
Interventions: intervention 1: LY900014 intervention 2: Insulin Lispro
Intervention descriptions: intervention 1: Administered subcutaneously (SC) intervention 2: Administered SC

Protocol documents:
Clinical trial NCT02703337
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2016-03-01; Completion date: 2016-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.

Detailed description:

Arms: arm 1: Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods arm 2: Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods arm 3: Individualized doses of LY900014 administered by injection under the skin with each meal for 14 days arm 4: Individualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days
Interventions: intervention 1: LY900014 intervention 2: Insulin Lispro
Intervention descriptions: intervention 1: Administered subcutaneously (SC) intervention 2: Administered SC

Protocol documents:
Clinical trial NCT02726971
Conditions: Asherman Syndrome
Keywords: Intrauterine Adhesion Oestrogen Artificial Periodic Therapy
Sponsor: Fu Xing Hospital, Capital Medical University
Start date: 2016-04-01; Completion date: 2016-08-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion.

Detailed description:

Arms: arm 1: Patients in this group will build artificial cycle by Femoston.(oral one red tablet daily for 11 days and oral one yellow tablet in the next 10 days). This process will last for 3 months after the surgery.

P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone. arm 2: Patients in this group will build artificial cycle by Femoston.(oral three red tablets daily for 11 days and oral two yellow tablets in the next 10 days). This process will last for 3 months after the surgery.

P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.
Interventions: intervention 1: Femoston
Intervention descriptions: intervention 1: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

Protocol documents:
Clinical trial NCT02735187
Conditions: Psoriasis Vulgaris
Sponsor: Philips Electronics Nederland BV
Start date: 2016-03-01; Completion date: 2016-08-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients will be screened up to 28 days before start of treatment. During the screening visit, the purpose and procedures of the study will be explained to potential patients and informed consent will be obtained.

At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Eligible patients will be randomized to treatment of the target area with either 30 minutes (group30) or 15 minutes (group15) blue light at 600 milliwatt per square centimeter (mW/cm²). Additionally, two study areas with similar clinical symptomatology will be determined and will be randomized to blue light treated area and Daivonex (Vitamin D) treated area.

After randomization, patients will be trained on a demonstrator device (no actual treatment to ensure investigator is blinded as to which group the patient is randomized to) as well as the Daivonex cream. After patients have been instructed, treatment of the areas will be applied daily (once per day, 5-7 times / week) at home for a treatment period of 12 weeks. During those 12 weeks, patients will return to the study site for safety and effectiveness assessments at week 2, 4, 8 and week 12. A phone call visit will be performed after one week of treatment to check for any adverse events or problems in handling the device or the cream. The visit at week 12 serves as end of treatment visit. The patients will be followed-up for another 4 weeks. Treatment responses will be photo documented.

Detailed description:

Arms: arm 1: Treatment of the target area with 30 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient. arm 2: Treatment of the target area with 15 minutes of blue light at 453nm compared to Vitamin D creme Daivonex on contralateral Plaque of same patient.
Interventions: intervention 1: Blue light treatment intervention 2: Vitamin D
Intervention descriptions: intervention 1: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm. intervention 2: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)

Protocol documents:
Clinical trial NCT02748785
Conditions: Arthritis, Rheumatoid
Sponsor: Seoul National University Hospital
Start date: 2015-09-01; Completion date: 2016-08-01
Enrollment: 277 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate whether a short term discontinuation of methotrexate (MTX) will improve the vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease activity in a randomized clinical trial.

Detailed description:
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects the joints as the main target of the inflammation. Patients with RA require chronic treatment with disease modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX), which constitutes the mainstay of treatment.

Underlying immune dysfunction and the additional immune suppression associated with treatment render patients with RA more susceptible to infection. Thus, vaccination against preventable diseases including influenza, pneumococcal pneumonia and hepatitis B is recommended for all RA patients who are subject to treatment with immunesupprssive drugs, unless there is a contraindication to the use of vaccination. However, low dose of glucocorticoids, conventional DMARDs and biological DMARDs including tumor necrosis factor inhibitors have been reported to substantially decrease vaccine response (4); MTX has been reported to be associated with a decreased response to seasonal influenza vaccination by up to 15%.

To optimize a vaccine response, vaccination should be administrated before the treatment with immunesuppressive medications is initiated. However, most patients with RA are already on stable dose of DMARDs at the time of when vaccinations, especially vaccine against seasonal influenza that needs annual administration, are considered. Alternatively, temporarily discontinuation of DMARDs might restore normal immune response to and so improve the efficacy of vaccination.

Although a short term discontinuation of DMARDs during perioperative period has not been associated with increased disease activity the longer discontinuation of DMARDs might lead to a significant aggravation of RA disease activity. To optimize the vaccine response, a short term discontinuation of DMARDs could be considered if this approach proves to be safe and effective.

Arms: arm 1: Group 1 will continue MTX arm 2: Group 2 will hold MTX 4 weeks before vaccination and resume MTX on the day of vaccination arm 3: Group 3 will hold MTX 2 weeks before vaccination and resume MTX 2 weeks after vaccination arm 4: Group 4 will hold MTX on day of vaccination and resume MTX 4 weeks after vaccination.
Interventions: intervention 1: Methotrexate intervention 2: Seasonal Influenza vaccine
Intervention descriptions: intervention 1: Methotrexate will be continued intervention 2: all subjects will be vaccinated with a seasonal influenza vaccine

Protocol documents:
Clinical trial NCT02749799
Conditions: Plaque Psoriasis
Sponsor: Primus Pharmaceuticals
Start date: 2016-02-01; Completion date: 2016-08-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.

Detailed description:
This multicenter, multi-dose, open-label study was designed to assess clinical response and patient-reported satisfaction after dosing with DFD-01 twice daily for 28 days. The product was approved for the treatment of mild to moderate plaque psoriasis by the FDA on February 5, 2016 before the first patient was enrolled.

Forty five (45) adult males and females, 18 years of age and older with a clinical diagnosis of moderate plaque psoriasis who met inclusion/exclusion criteria were randomized at the Baseline Visit. Each site attempted to enroll 50% of the patients with 3% to 10% body surface area (BSA) involved and 50% of the patients with \> 10% BSA involved.

The initial dose of study product was self-administered by the patient and supervised by clinic staff during the Baseline Visit. Patients continued to apply the study product to all affected areas (avoiding the face, scalp, groin, axillae or other intertriginous areas) twice daily (approximately 12 hours apart) for 28 days. Patients visited the clinic for a total of up to five scheduled visits:

* Screening (Day -60 to 1)\*
* Baseline (Day 1)
* Interim Visit (Day 8 ± 2)
* Interim Visit (Day 14 ± 3)
* End of Study (Day 29 ± 3)

Arms: arm 1: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
Interventions: intervention 1: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Intervention descriptions: intervention 1: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.

Protocol documents:
Clinical trial NCT02756624
Conditions: Healthy Subjects
Sponsor: Nicox Ophthalmics, Inc.
Start date: 2016-04-01; Completion date: 2016-08-01
Enrollment: 516 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

Detailed description:
Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Arms: arm 1: 1 drop in each eye 3 times daily for up to 6 weeks arm 2: 1 drop in each eye 3 times daily for up to 6 weeks
Interventions: intervention 1: AC-170 0.24% intervention 2: AC-170 Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02881840
Conditions: Post-operative Nausea and Vomiting
Sponsor: Acacia Pharma Ltd
Start date: 2016-08-01; Completion date: 2016-08-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: 14C-APD421
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02881996
Conditions: Perforated Appendicitis
Keywords: appendicitis pain perforation
Sponsor: Children's Mercy Hospital Kansas City
Start date: 2014-06-01; Completion date: 2016-08-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate two standard post-operative pain regimens routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia (PCA) to oral pain medications.

Detailed description:
To assess pain control, patient and family perception of pain control, time to return of bowel function defined as passage of first flatus (in days), doses of anti-emetic medications, doses of narcotic pain medications, time to toleration of regular diet (in days), narcotic associated adverse effects (nausea, emesis, respiratory depression, constipation), length of stay, and overall hospital cost in admission.

Post-hospitalization the investigators will assess complications including number and reasons for emergency visits and abscess formation, length of post-hospitalization analgesic use, length of post-hospitalization narcotic use, and time to return to school.

Arms: arm 1: Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. arm 2: Same as above without IV tylenol.
Interventions: intervention 1: IV tylenol intervention 2: No IV tylenol intervention 3: Ketorolac
Intervention descriptions: intervention 1: IV tylenol given scheduled in addition to standard PCA intervention 2: No additional IV Tylenol given intervention 3: both groups receive as part of our standard postop pain protocol after all operations

Protocol documents:
Clinical trial NCT02937506
Conditions: Colon Cancer IBS Polyps
Keywords: propofol colonoscopy patient satisfaction
Sponsor: Mount Carmel Health System
Start date: 2013-11-01; Completion date: 2016-08-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.

Detailed description:
Outpatient colonoscopies are very common, indicated for various reasons, and are more commonly performed in outpatient surgery or endoscopy centers. There is an increase in the use of propofol for sedation because of the short duration of action and quick turn around time. Propofol has been studied extensively for safety and efficacy but patient satisfaction and preference with use has not been well documented in prospective, randomized setting. In the context of the recent changes in healthcare reimbursement where patient satisfaction is becoming an important metric providing data that could improve patient satisfaction is needed.

Patients who presented for a colonoscopy with the Principal Investigator were approached to participate in the study. After obtaining consent the patients were randomized to anesthesia with propofol or control without propofol per random number tables provided by the statistician. The anesthesiologist or nurse anesthetist were asked to remove the paper with the assignment from the envelope to determine which medications to give the patient. Pre-op, intra-op, and post-op data were collected by registered nurses blinded to the anesthetic. The day one follow-up phone call was made by the resident who was blinded to the anesthetic. Data were collected in the pre-op, intra-op, and post-op areas by the researchers who were blinded to the medications used.

Arms: arm 1: Patients in the treatment arm will be given propofol only when having a colonoscopy. arm 2: Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.
Interventions: intervention 1: Propofol intervention 2: Fentanyl Plus Midazolam
Intervention descriptions: intervention 1: The intervention is to use propofol as anesthesia during a colonoscopy. intervention 2: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.

Protocol documents:
Clinical trial NCT01574716
Conditions: Metastatic Soft Tissue Sarcoma
Sponsor: Morphotek
Start date: 2012-08-07; Completion date: 2016-08-02
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MORAb-004 intervention 2: Gemcitabine intervention 3: Docetaxel intervention 4: Gemcitabine intervention 5: Docetaxel intervention 6: Placebo
Intervention descriptions: intervention 1: IV, Days 1 and 8 of every cycle until disease progression intervention 2: IV, Days 1 and 8 of each cycle until disease progression intervention 3: IV, Day 8 of every cycle until disease progression intervention 4: IV, Days 1 and 8 of each cycle until disease progression intervention 5: IV, Day 8 of every cycle until disease progression intervention 6: None

Protocol documents: