ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02393950
Conditions: Healthy Volunteer Study
Sponsor: Orion Corporation, Orion Pharma
Start date: 2015-03-01; Completion date: 2016-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.

Detailed description:
Eight planned dose levels of ODM-106 will be compared with placebo.There will be 2 panels of subjects with 4 dose levels in each panel. Subjects will be randomised to receive 3 dose levels of active treatment (single doses) and 1 dose of placebo. The dose levels will be escalated from the smallest dose upwards within the study and within the study subject. A third panel of 8 subjects may be included to investigate further dose levels of ODM-106, investigate the effect of taking ODM-106 with food or to compare two different formulations of ODM-106. For an individual subject, the study will consist of a screening period (maximum 4 weeks), 4 study treatment periods with a wash-out period between each study treatment administration and a post-treatment period of about 2 weeks.

The study duration for an individual will be approximately 12-16 weeks. Blood samples will be collected for the assessment of the concentration of ODM-106 and its metabolite.Plasma samples and cumulative urinary samples will be collected for metabolite screening. Safety will be assessed by a 12-lead electrocardiogram (ECG), continuous ECG monitoring, Holter ECG, supine and orthostatic blood pressure and heart rate, body temperature, physical examination, electroencephalogram (EEG), laboratory safety assessments and adverse events. Sedation and psychomotor tests and a quantitative EEG will also be performed.

Arms: arm 1: Oral capsules dosage 2-800mg once daily for one day arm 2: Oral capsules given once daily for one day
Interventions: intervention 1: ODM-106 intervention 2: Placebo
Intervention descriptions: intervention 1: Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo. intervention 2: Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.

Protocol documents:
Clinical trial NCT02404493
Conditions: Eczema
Keywords: Atopic Dermatitis
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Start date: 2015-03-01; Completion date: 2016-03-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.

Detailed description:
50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group.

Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas.

Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.

Arms: arm 1: Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin. arm 2: Not Yet Marketed. Apply in a thin layer to the affected skin areas at least once at night or more if needed (anytime), and massage gently into the skin.
Interventions: intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: 1% Colloidal Oatmeal Balm
Intervention descriptions: intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: Experimental Product 1% Colloidal Oatmeal Balm

Protocol documents:
Clinical trial NCT02409459
Conditions: Iron Deficiency Fibromyalgia
Sponsor: American Regent, Inc.
Start date: 2015-03-01; Completion date: 2016-03-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days.

Detailed description:
This is a blinded, randomized, placebo-controlled study. All subjects who meet the inclusion requirements and no exclusion criteria will be entered into an up to 14 day screening phase. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days. Subjects will visit the clinic on days 0 and 5 for treatment, and then on days 14, 28, and 42. The subject's participation in the study will be for approximately 42 days from day 0.

Arms: arm 1: 15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute arm 2: 15 cc of Normal Saline IV push at 2 ml/minute
Interventions: intervention 1: Injectafer intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Normal saline solution

Protocol documents:
Clinical trial NCT02428478
Conditions: Sleep Apnea, Obstructive
Sponsor: Brigham and Women's Hospital
Start date: 2015-03-01; Completion date: 2016-03-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects) on genioglossus muscle activity (EMG GG) during sleep in healthy control participants.

Detailed description:
Two overnight sleep studies, a placebo night and a drug night, will be performed approximately one week apart in random order. The placebo or drug will be administered 2 hours before lights out. At least 15 minutes of quiet wakefulness will be recorded to quantify the participant's awake EMG GG activity. Participants will then sleep in the lateral position to minimize pharyngeal resistance similar to previous studies of this kind.

The same will be done for stable non-rapid eye movement (NREM) and rapid eye movement (REM) sleep (free of arousals and other artifacts). Both NREM and REM sleep will be analyzed, recognizing that REM is less frequent on these drugs.

During the second part of the night, the participants will be connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness).

Arms: arm 1: Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night. arm 2: Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
Interventions: intervention 1: Desipramine intervention 2: Placebo
Intervention descriptions: intervention 1: 200 mg administered 2 hours before normal sleep time intervention 2: Placebo-matching desipramine administered 2 hours before normal sleep time

Protocol documents:
Clinical trial NCT02432261
Conditions: Healthy
Keywords: spermatogenesis androgen male contraception
Sponsor: Kimberly Myer
Start date: 2015-04-01; Completion date: 2016-03-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.

Detailed description:
A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment groups. A description of each group is as follows:

* Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders
* Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied each day to the arms and shoulders

The total duration of treatment will be 28 days followed by a 72 hour sampling period to assess half-life and a recovery period of at least 28 days, at which point the subjects will return to the clinic for an end of study visit.

Arms: arm 1: 5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders arm 2: 4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders
Interventions: intervention 1: Nestorone® /testosterone gel intervention 2: Testosterone only gel
Intervention descriptions: intervention 1: Nestorone® /testosterone combined gel intervention 2: Testosterone only gel

Protocol documents:
Clinical trial NCT02436031
Conditions: Sleep Apnea, Obstructive
Sponsor: Brigham and Women's Hospital
Start date: 2015-04-01; Completion date: 2016-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects) on upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA patients.

Detailed description:
Two overnight sleep studies, a placebo night and a drug night, will be performed approximately one week apart in random order. The placebo or drug will be administered 2 hours before lights out. At least 15 minutes of quiet wakefulness will be recorded to quantify the participant's EMG GG activity while awake and at sleep onset (alpha-theta transition at the electroencephalogram).

During the second part of the night, the participants will be connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure and measure pharyngeal critical collapsing pressure (Pcrit), ventilation at 0 cmH2O when UA muscle are passive and active as well as change in EMG GG as a function of epiglottic pressure (muscle responsiveness).

Apnea-hypopnea index (AHI) will be calculated in each night from the part of the study off CPAP.

Arms: arm 1: Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night. arm 2: Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
Interventions: intervention 1: Desipramine intervention 2: Placebo
Intervention descriptions: intervention 1: 200 mg administered 2 hours before normal sleep time intervention 2: Placebo-matching desipramine administered 2 hours before normal sleep time

Protocol documents:
Clinical trial NCT02462720
Conditions: Varicose Veins
Sponsor: Boston Scientific Corporation
Start date: 2015-05-01; Completion date: 2016-03-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.

Detailed description:
A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.

Arms: arm 1: Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used. This was followed by RFA treatment. arm 2: RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use. This was followed by treatment with Varithena.
Interventions: intervention 1: Varithena® intervention 2: Radiofrequency ablation
Intervention descriptions: intervention 1: Varithena® treatment in accordance with full prescribing information and instructions for use intervention 2: Radiofrequency ablation conducted per physicians' standard of care.

Protocol documents:
Clinical trial NCT02486757
Conditions: Menstruation Disturbances
Sponsor: Massachusetts General Hospital
Start date: 2015-04-01; Completion date: 2016-03-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Irregular menstrual cycles are common in girls for several years after their first menstrual period. The cause of abnormal menstrual cycles during this time is not well-understood. The purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls with a short course of low-dose estrogen and progesterone.

Detailed description:

Arms: arm 1: estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
Interventions: intervention 1: micronized progesterone intervention 2: transdermal estradiol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02498522
Conditions: Polycystic Ovary Syndrome
Sponsor: Ain Shams University
Start date: 2015-08-01; Completion date: 2016-03-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).

Detailed description:
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility

* The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS
* Research question:

In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?

-Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.

Arms: arm 1: 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) arm 2: 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: 83 patients will continue metformin until end of 1st trimester

Protocol documents:
Clinical trial NCT02502487
Conditions: Pain
Keywords: Analgesia Cystoscopy Dorsal nerve of penis Nerve block Ropivacaine
Sponsor: West China Hospital
Start date: 2015-06-01; Completion date: 2016-03-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.

Detailed description:
Pain is common in men undergoing rigid cystoscopy. Even with application of a lubricant containing 2% lidocaine, about 76% men suffer from mild to severe pain when undergoing rigid cystoscopy, and approximately 27% men could still feel mild to moderate pain 7 days after the procedure. The most painful part of the procedure for men is when the cystoscope passes through the membranous urethra. Song et al did autopsy on males found dorsal nerve of the penis (DNP), the terminal branch of the pudendal nerve, innervates the membranous urethra in 53.3% specimens. In addition, urethral mucosa has branches of DNP innervated. Dorsal penile nerve block (DPNB) is usually used for circumcision in children and it has been shown to provide effective analgesia for penile surgeries. According to the evidence that some DNP branches innervate membranous urethra and urethra mucosa and most pain originates from cystoscope passing through membranous urethra, we speculated that DPNB could overall reduce pain level in men during rigid cystoscopy.

Arms: arm 1: Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy arm 2: Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy arm 3: Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Interventions: intervention 1: Dorsal Penile Nerve Block intervention 2: Ropivacaine intervention 3: Tetracaine
Intervention descriptions: intervention 1: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis intervention 2: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis intervention 3: 1% Tetracaine gel instilled into urethra

Protocol documents:
Clinical trial NCT02530281
Conditions: Hyperhidrosis
Sponsor: Journey Medical Corporation
Start date: 2015-07-01; Completion date: 2016-03-01
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.

Detailed description:
This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis.

Safety will be assessed through lab tests, ECG, physical exams and vital signs.

Arms: arm 1: glycopyrronium Topical Wipes arm 2: glycopyrronium Topical Wipes, Vehicle
Interventions: intervention 1: glycopyrronium Topical Wipes intervention 2: Vehicle
Intervention descriptions: intervention 1: Topical wipes containing glycopyrronium intervention 2: Vehicle (placebo) topical wipes

Protocol documents:
Clinical trial NCT02534129
Conditions: Radiodermatitis
Keywords: breast cancer radiation dermatitis
Sponsor: ProTechSure Scientific, Inc.
Start date: 2015-08-01; Completion date: 2016-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.

Detailed description:
The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.

Arms: arm 1: Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor
Interventions: intervention 1: Difinsa53 intervention 2: Aquaphor
Intervention descriptions: intervention 1: Difinsa53 cream is applied to one half of radiation field intervention 2: Aquaphor is applied to one half of radiation field

Protocol documents:
Clinical trial NCT02557035
Conditions: Chemotherapy-Induced Nausea and Vomiting
Sponsor: Helsinn Healthcare SA
Start date: 2015-10-01; Completion date: 2016-03-01
Enrollment: 441 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy

Detailed description:

Arms: arm 1: Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. arm 2: Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Interventions: intervention 1: Palonosetron intervention 2: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02565810
Conditions: Rheumatoid Arthritis
Sponsor: Samsung Bioepis Co., Ltd.
Start date: 2015-09-01; Completion date: 2016-03-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Adalimumab PFS and Pen
Intervention descriptions: intervention 1: None

Protocol documents: