ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02344316
Conditions: Migraine in Adolescents
Sponsor: Amy Gelfand
Start date: 2015-05-01; Completion date: 2016-04-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Migraine in adolescents is common and effective and safe preventive treatments are needed. This is a pilot randomized controlled trial of melatonin versus placebo for migraine prevention in adolescents 12-17 years old.

Detailed description:
This is a pilot randomized controlled trial of melatonin vs. placebo for migraine prevention in adolescents 12-17 years old. The main goal of this pilot study is to estimate variance in the outcome measures to help with planning the future fully powered study. Participants will have an in person enrollment visit, followed by phone follow up visits and headache diary data collection via smart phone or internet.

Arms: arm 1: Group randomized to melatonin 3 mg orally nightly arm 2: Group randomized to placebo orally nightly
Interventions: intervention 1: Melatonin intervention 2: Placebo
Intervention descriptions: intervention 1: Taken at 9 PM or 1 hour before bedtime, whichever is earlier intervention 2: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier

Protocol documents:
Clinical trial NCT02351934
Conditions: Colorectal Disorders
Keywords: colorectal surgery volume status
Sponsor: Mayo Clinic
Start date: 2015-02-01; Completion date: 2016-04-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if giving a medicine called furosemide, which is a diuretic or water pill, after colon surgery will safely shorten the patient's length of hospital stay.

Detailed description:
This study will assess if administration of a loop diuretic, specifically furosemide, to achieve euvolemia can safely reduce length of stay following colorectal surgery.

Arms: arm 1: Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. arm 2: ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale.
Interventions: intervention 1: Furosemide intervention 2: Celecoxib intervention 3: Gabapentin
Intervention descriptions: intervention 1: None intervention 2: Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation. intervention 3: Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.

Protocol documents:
Clinical trial NCT02367014
Conditions: Mitochondrial Myopathy
Keywords: Mitochondrial Myopathy Primary Mitochondrial Disease Bendavia™ elamipretide
Sponsor: Stealth BioTherapeutics Inc.
Start date: 2015-02-01; Completion date: 2016-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1/2, multi-center, randomized, double-blind, multiple ascending dose, placebo-controlled study that enrolled 36 subjects with mitochondrial myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient population.

Detailed description:
This multi-center, randomized, double-blind, placebo-controlled study enrolled 36 subjects into 3 cohorts of 12 subjects each to evaluate treatment with 3 ascending doses of intravenous elamipretide (0.01, 0.10, and 0.25 mg/kg/hr infused for 2 hours). After each cohort, a Safety Monitoring Board (SMB) determined if dose escalation to the next higher dose of elamipretide was warranted. Each cohort went through 3 distinct periods: Screening, Treatment, and Follow-up.

The Screening Period started with informed consent and may have lasted up to 40 days. During this period, screening procedures to determine subject eligibility for the study occurred, including confirmation of disease, which incorporated a committee review of the investigator-submitted diagnosis and genetic results. The Treatment Period began on Day 1 (Visit 2) and lasted for 5 days (until Day 5 \[Visit 6\]). Within each cohort, 9 subjects were randomized to active drug and 3 subjects were randomized to placebo on Day 1 and subjects received treatment once a day for 5 consecutive days. Safety, tolerability, and efficacy measures were performed at pre-specified times. The Follow-up Period began at the time of discharge on Day 5. Subjects returned to the study center for the Follow-up Visit on Day 7 (+1 day).

Arms: arm 1: elamipretide 0.01 mg/kg/hr infused for 2 hours for 5 days arm 2: elamipretide 0.10 mg/kg/hr infused for 2 hours for 5 days arm 3: elamipretide 0.25 mg/kg/hr infused for 2 hours for 5 days arm 4: In each cohort, subjects received either IV elamipretide given once daily for 2 hours for 5 days or matching placebo.
Interventions: intervention 1: elamipretide (low dose) intervention 2: elamipretide (intermediate dose) intervention 3: elamipretide (high dose) intervention 4: Placebo
Intervention descriptions: intervention 1: elamipretide (0.01 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days intervention 2: elamipretide (0.10 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days intervention 3: elamipretide (0.25 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days intervention 4: placebo (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days

Protocol documents:
Clinical trial NCT02379221
Conditions: Anesthesia
Sponsor: David Grant U.S. Air Force Medical Center
Start date: 2014-09-01; Completion date: 2016-04-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to compare two modalities of local anesthetic administration prior to the placement of cosmetic facial injectable fillers. Both short and long term pain perceptions for the facial filler procedure will be compared in patients receiving 4% Topicaine gel on half their face, and 20% benzocaine gel prior to 2% lidocaine 1:100k epinephrine nerve block injections on the other half of their face. The objective is to quantify the subjective pain experienced by these two modalities of local anesthetic during the procedure of Juvederm XC filler injections.

Detailed description:
The purpose of this study is to determine if local anesthesia injections will provide more profound analgesia than topical anesthesia during facial cosmetic filler injections. The study is a single group study design. The attending surgeon or residents will perform the procedure. Each procedure will start with a randomized coin flip to determine which side of the face will be anesthetized with local anesthesia or topical anesthesia. The head side of the coin will coincide with local anesthesia on the patient's right side. The tail of the coin will designate the patient's left side for local anesthetic injections.

To evaluate whether the additional anesthesia of a nerve block brings more pain relief than the initial pain of receiving a nerve block, the pain value will be collected from each nerve block administered. Procedural injection pain data will be collected from the nerve blocked facial half and from the topical anesthetic facial half to provide a comparison of anesthesia during the procedure. The primary outcome will be the collection of "overall" pain data from each side of the face 5-10 minutes after the procedure. Facial anesthesia preference data will also be collected at one week post treatment to determine overall pain perceptions from each method of facial anesthesia.

Arms: arm 1: Half of the face is injected with local anesthesia (lidocaine-epinephrine), the other half is treated with topical anesthesia (topicaine gel) per randomize method.
Interventions: intervention 1: Injectable intervention 2: Topical
Intervention descriptions: intervention 1: 20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection intervention 2: 4% Topicaine gel

Protocol documents:
Clinical trial NCT02388191
Conditions: Contraception
Keywords: Contraception Naproxen Intrauterine devices Pain Control
Sponsor: Planned Parenthood League of Massachusetts
Start date: 2015-04-01; Completion date: 2016-04-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome).
2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes).
3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.

Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.

Detailed description:

Arms: arm 1: 550 mg naproxen sodium arm 2: Placebo
Interventions: intervention 1: Naproxen sodium intervention 2: Placebo tablet
Intervention descriptions: intervention 1: 550 mg, oral, on day 1. Number of Cycles: 1 intervention 2: None

Protocol documents:
Clinical trial NCT02388347
Conditions: Healthy Adults
Sponsor: MedImmune LLC
Start date: 2015-03-01; Completion date: 2016-04-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects and healthy adult female subjects of non-childbearing potential.

Detailed description:
This is a Phase 1a, randomised, blinded (the investigator and subject will be blinded to treatment assignment and sponsor will be unblinded to treatment assignment), placebo-controlled study to evaluate the safety of single-ascending SC doses of MEDI7836 in healthy adult males subjects and healthy adult female subjects of non-childbearing potential. The study will be conducted at a single site in the United Kingdom (UK). Four dosing cohorts of MEDI7836 or placebo are planned for this study for a total of 32 subjects (24 subjects receiving MEDI7836, 8 subjects receiving placebo).

Arms: arm 1: Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1. arm 2: Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1. arm 3: Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1. arm 4: Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1. arm 5: Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
Interventions: intervention 1: Placebo SC intervention 2: MEDI7836 Dose 1 intervention 3: MEDI7836 Dose 2 intervention 4: MEDI7836 Dose 3 intervention 5: MEDI7836 Dose 4
Intervention descriptions: intervention 1: Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1. intervention 2: Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1. intervention 3: Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1. intervention 4: Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1. intervention 5: Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.

Protocol documents:
Clinical trial NCT02406209
Conditions: Non-infectious Anterior Uveitis
Keywords: uveitis acute uveitis anterior uveitis NS2 Aldeyra prednisolone acetate
Sponsor: Aldeyra Therapeutics, Inc.
Start date: 2015-03-01; Completion date: 2016-04-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multi-center, investigator masked, comparator controlled study. The purpose of this study is to determine the efficacy and safety of NS2 in patients with non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.

Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.

Detailed description:

Arms: arm 1: NS2 ophthalmic drops (0.5%) in the affected eye arm 2: NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye arm 3: Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Interventions: intervention 1: NS2 intervention 2: Prednisolone acetate ophthalmic suspension (1%)
Intervention descriptions: intervention 1: NS2 ophthalmic drops (0.5%) intervention 2: None

Protocol documents:
Clinical trial NCT02411643
Conditions: Morphea Localized Scleroderma
Sponsor: Northwestern University
Start date: 2015-03-01; Completion date: 2016-04-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be obtained and used for a control. This is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. This study will look at the differences between affected and unaffected skin. This study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.

Detailed description:

Arms: arm 1: Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects
Interventions: intervention 1: topical calcipotriene 0.005% ointment
Intervention descriptions: intervention 1: Affected area will be treated twice daily for 3 months

Protocol documents:
Clinical trial NCT02431052
Conditions: Acne Vulgaris
Sponsor: Dermira, Inc.
Start date: 2015-04-01; Completion date: 2016-04-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.

Detailed description:

Arms: arm 1: Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks arm 2: Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks arm 3: Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks arm 4: Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks arm 5: Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Interventions: intervention 1: Olumacostat Glasaretil intervention 2: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02439138
Conditions: Waldenstrom's Macroglobulinemia
Keywords: Waldenstrom's Macroglobulinemia
Sponsor: Dana-Farber Cancer Institute
Start date: 2015-10-01; Completion date: 2016-04-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is evaluating a drug called idelalisib (formerly known as GS-1101 or CAL-101) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).

Detailed description:
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, idelalisib, to learn whether idelalisib works in treating a specific cancer. "Investigational" means that idelalisib is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if idelalisib is effective for treating different types of cancer. Idelalisib has already been approved in the US by the FDA to treat patients with relapsed chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma.

Idelalisib is a newly discovered drug that is being developed as an anti-cancer agent. This drug has been used in laboratory experiments and other research studies in B-cell malignancies and information from those other research studies suggests that idelalisib may help to target the tumor cells in B-cell malignancies, including WM. B cells are a type of white blood cell responsible for making antibodies.

In this research study, the investigators are testing the safety and efficacy of idelalisib as a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.

Arms: arm 1: After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.

\-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.
Interventions: intervention 1: GS-1101
Intervention descriptions: intervention 1: Oral twice daily for 6 months followed by once daily until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT02450578
Conditions: Plasmodium Falciparum, Malaria
Keywords: Malaria, Plasmodium falciparum sporozoite challenge, DSM265
Sponsor: Medicines for Malaria Venture
Start date: 2015-10-01; Completion date: 2016-04-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites.

Detailed description:
This study follows the First In Human dose-escalation study of DSM265 (25 - 800 mg of DSM265) and an Induced-Blood Stage Malaria Challenge study (150 mg of DSM265) conducted in healthy adult volunteers in Australia. After identification of efficacious DSM265 plasma concentrations in the Induced-Blood Stage Malaria model, the current study will evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites (Challenge).

Three sequential cohorts of healthy male and women volunteers, of non-childbearing potential or of childbearing potential with predefined accepted methods of contraception, are planned in order to investigate three preventive conditions with regard to administration of DSM265. Preventive administration of the study drug will occur 1 and 7 days before inoculum of Plasmodium falciparum sporozoite Challenge, with a last cohort administered at a time point to be determined from the 2 previous cohorts but which will not exceed 28 days before the challenge. The study will also include a cohort where subjects will be treated with atovaquone-proguanil (Malarone®) using the approved regimen for chemoprophylaxis.

Arms: arm 1: DSM265 400mg / placebo Day -1, sporozoite inoculum Day 0 arm 2: Malarone daily for 9 days from Day -1 to Day 7, sporozoite inoculum Day 0 arm 3: DSM265 400mg / placebo Day -7, sporozoite inoculum Day 0 arm 4: DSM265 400mg / placebo Day -X, sporozoite inoculum Day 0
Interventions: intervention 1: DSM265 400mg intervention 2: Placebo to DSM265 400 mg intervention 3: Plasmodium falciparum sporozoite challenge intervention 4: Malarone
Intervention descriptions: intervention 1: DSM265 400mg, single oral administration in a fed state intervention 2: Placebo to DSM265 400mg, single oral administration in a fed state intervention 3: IV Plasmodium falciparum sporozoites (3200) by direct venous inoculation intervention 4: 250 mg atovaquone, 100 mg proguanil hydrochloride

Protocol documents:
Clinical trial NCT02466399
Conditions: Glaucoma
Sponsor: Peregrine Ophthalmic
Start date: 2015-07-01; Completion date: 2016-04-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, randomized, multi-center, active-controlled parallel-comparison of POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and primary open-angle glaucoma.

Detailed description:

Arms: arm 1: Latanoprost liposome ophthalmic injection arm 2: latanoprost ophthalmic solution 0.005%
Interventions: intervention 1: POLAT-001 intervention 2: Latanoprost ophthalmic solution
Intervention descriptions: intervention 1: Subconjunctival injection intervention 2: Latanoprost ophthalmic solution q.d., evening

Protocol documents:
Clinical trial NCT02473640
Conditions: Healthy Volunteers With Ileostomy
Sponsor: Theriva Biologics, Inc.
Start date: 2015-06-01; Completion date: 2016-04-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a Functioning Ileostomy

Detailed description:
This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects with functioning ileostomies who are between the ages of 18 and 80 years, inclusive, will be enrolled. The entire duration of the study may be up to 63 days (from Screening to the end-of-study \[EOS\] visit).

Arms: arm 1: There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of steady-state esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home.
Interventions: intervention 1: SYN-004 intervention 2: Esomeprazole intervention 3: Ceftriaxone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: