ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01804036
Conditions: Primary Insomnia Secondary Insomnia
Sponsor: University of Utah
Start date: 2013-03-01; Completion date: 2016-11-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc, compared with that of Zolpidem.

Detailed description:
Sleep disturbance in active duty military personnel is highly prevalent and contributes to reduced performance of military duties. Under extreme conditions, army personnel could endanger themselves and their comrades. Increasingly, non-pharmacological treatments for insomnia are showing promise as complementary and alternative medicine treatments. Many of these awareness training programs (ATPs) perform as well as, or even better than, medications. This study will determine whether Mind-Body Bridging (MBB), an ATP that teaches awareness/mindfulness and cognitive skills, is more effective than a common sleep medication, Zolpidem. The study will also determine whether MBB exhibits additional benefits in co-morbid mental health conditions, including, stress, PTSD, depression, etc, compared with that of Zolpidem. This will offer soldiers additional treatment options for insomnia in the hope that it will improve both sleep and other common comorbidities.

Arms: arm 1: A three week treatment of Zolpidem arm 2: An awareness training program using mindfulness-based techniques.
Interventions: intervention 1: Zolpidem intervention 2: Mind-Body Bridging
Intervention descriptions: intervention 1: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed. intervention 2: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session

Protocol documents:
Clinical trial NCT01816048
Conditions: Prostatic Neoplasms Prostate Cancer
Keywords: prostate, prostate cancer
Sponsor: University of Wisconsin, Madison
Start date: 2013-05-01; Completion date: 2016-11-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate treatment response in bone metastases in subjects with prostate cancer treated with the investigational drug, TAK-700.

Detailed description:

Arms: arm 1: TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.

The most common way of assessing bone metastasis is planar bone scintigraphy or single photon emission computed tomography (SPECT), though both lack high spatial resolution and thus make small metastases detection inaccurate. Positron emission tomography (PET) is a successful imaging modality with a higher resolution than SPECT, but has not been widely adopted in bone imaging. One of the most promising PET imaging agents for detection of bone metastasis is 18F-Sodium Fluoride (Fluorine F 18 Sodium Fluoride, or NaF). NaF uptake is characterized by high and rapid bone uptake accompanied by very rapid blood clearance, which results in a high bone-to-background ration in a short time.
Interventions: intervention 1: TAK-700 intervention 2: Fluorine F 18 Sodium Fluoride intervention 3: Positron Emission Tomography intervention 4: Computed Tomography
Intervention descriptions: intervention 1: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles intervention 2: Undergo NaF F18 PET/CT scan intervention 3: Undergo 18F NaF PET/CT scan intervention 4: Undergo 18F NaF PET/CT scan

Protocol documents:
Clinical trial NCT01846507
Conditions: Heavy Menstrual Bleeding
Keywords: Heavy Menstrual Bleeding HMB Lysteda
Sponsor: Nationwide Children's Hospital
Start date: 2013-04-01; Completion date: 2016-11-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and lead to an increase in the quality of life.

Menorrhagia in young women with bleeding disorders is typically treated with a combination of treatments including hormonal contraceptives. However, there are barriers to hormonal contraception use in younger adolescents.

Tranexamic acid is taken orally during the first 5 days of menstrual bleeding.

The purposes of this study include:

To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda works in decreasing menstrual blood loss. To see if parents and children participating in this study think the drug is improving their quality of life.

Lysteda has been approved by the Food and Drug Administration for use in patients \> than 18 years of age but not for younger patients.

Detailed description:
This is a multi-center (5 sites) open-label, single-arm, efficacy study of Lysteda in the treatment of adolescent females (10-19 years of age) with heavy menstrual bleeding (HMB). Each subject will receive oral Lysteda 1.3 grams three times daily during the first five days of menses. Subjects will be monitored over the course of four menstrual cycles (1 pre-treatment cycle and 3 treatment cycles). During all cycles, assessments of menstrual bleeding will be performed using the Menorrhagia Impact Questionnaire (MIQ) and Pictorial Blood Assessment Chart (PBAC).

The study will begin as a currently funded pilot study to assess the efficacy of Lysteda in 32 patients followed to study completion.

Arms: arm 1: Subjects will complete a baseline menses (no treatment) followed by 3 menses using tranexamic acid.
Interventions: intervention 1: Tranexamic Acid
Intervention descriptions: intervention 1: Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.

Protocol documents:
Clinical trial NCT01855607
Conditions: Breast Cancer Colon Cancer Neuropathy
Keywords: chemotherapy induced neuropathy
Sponsor: Columbia University
Start date: 2013-08-01; Completion date: 2016-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective: To assess whether six-week treatment with twice daily topical Menthol application will decrease neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF worst pain score), following or during neoadjuvant/adjuvant chemotherapy with taxane or platinum-based regimens among breast, gastrointestinal or gynecologic cancer patients.

Secondary objectives:

* To compare change in patient-reported outcomes: overall BPI-SF scales, EORTC-CIPN20, European Organization for Research and Treatment of Cancer Chemotherapy Quality of Life Questionnaire (EORTC QLQ-C30), Patient-Reported Outcomes Measurement Information System (PROMIS-29) scores between study groups.
* To compare changes in dose delivery and early treatment discontinuation rates between study groups.
* To compare objective sensory and motor functional change from baseline with the use of quantitative neurosensory testing.
* To perform an exploratory analysis evaluating the interaction between treatment and chemotherapy type.

Detailed description:
Chemotherapy induced peripheral neuropathy (CIPN): CIPN is a debilitating and often irreversible toxicity associated with various chemotherapy agents widely used in the treatment of both solid tumors and hematologic malignancies. Clinical trials with Taxane-based forms of chemotherapy, commonly used in the adjuvant treatment of breast cancer, have reported up to 33% grades 2-3 sensory neuropathy and up to 14% of motor neuropathy. Severity is closely related to chemotherapy dose and schedule. CIPN may also develop in up to 64% of patients treated with 12 cycles of Oxaliplatin based adjuvant chemotherapy, when assessed clinically and electro physiologically. Patients develop an axonal, predominately sensory peripheral neuropathy, of mild to moderate severity. Thermal hyperalgesia with cold allodynia was found to be a clinical marker of early oxaliplatin neurotoxicity and may predict severe neuropathy

Arms: arm 1: Patients with neuropathic pain will receive topical menthol following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer. arm 2: Patients with neuropathic pain will receive placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Interventions: intervention 1: topical menthol intervention 2: placebo lotion
Intervention descriptions: intervention 1: 7.5% Methylsalicylate / 2% Menthol Lotion intervention 2: The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.

Protocol documents:
Clinical trial NCT01880593
Conditions: Depression
Keywords: Ketamine glutamate N-methyl-D-aspartate depression major depressive disorder treatment resistant antidepressant lithium
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2013-07-01; Completion date: 2016-11-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention strategy for patients with treatment-resistant depression (TRD) who respond to an initial series of ketamine infusions. Ketamine is a Food and Drug Administration approved anesthetic (a drug used to produce loss of consciousness before and during surgery). Ketamine is not approved for the treatment of major depressive disorder and is considered experimental in this study. An additional purpose of this study is to research the effects of ketamine on brain function.

You may qualify to take part in this research study because you have been diagnosed with major depressive disorder (MDD) and have not responded to past treatments.

Detailed description:
Major Depressive Disorder (MDD) is a disabling medical illness and current monoaminergic treatments are slow to act and possess only limited efficacy. In this context, the discovery that the glutamate NMDA receptor antagonist ketamine is rapidly antidepressant (onset of action within hours) -- even in patients suffering from treatment-resistant depression (TRD) -- has ignited tremendous enthusiasm among clinicians, scientists and patients alike. A critical obstacle to the translation of this discovery into a novel treatment, however, is the limited duration of action following a course of ketamine (e.g. 1-2 weeks). The current project will address this important gap in medical knowledge by testing a rational neuropharmacological strategy designed to optimize and sustain the rapid antidepressant effects of ketamine. Driven by the recent characterization of the molecular mechanisms underpinning the antidepressant and neuroplasticity effects of ketamine, we will test the combination of ketamine plus lithium in patients with TRD using a randomized, double blind, placebo-controlled design. The primary aims of the project are (1) to test the efficacy of lithium-plus-ketamine compared to placebo-plus-ketamine as an antidepressant combination strategy in TRD and (2) to gather data on the safety and tolerability of the lithium-plus-ketamine.

Arms: arm 1: Subjects in this arm take 600-1200mg of Lithium pills at night for duration of the study arm 2: Subjects in this arm take placebo pills at night for duration of the study.
Interventions: intervention 1: Lithium intervention 2: Ketamine intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects in this arm take 600-1200mg of Lithium pills at night for duration of the study. intervention 2: None intervention 3: Subjects in this arm take placebo pills at night for duration of the study.

Protocol documents:
Clinical trial NCT01896895
Conditions: Bilateral Blepharospasm (BEB)
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2013-11-01; Completion date: 2016-11-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase 3 study will serve to collect efficacy and safety data of two different doses of NT 201 in subjects suffering from Bilateral Blepharospasm (BEB) who are BTX treatment-naïve.

In this study, BTX treatment-naïve subjects are defined as those who have not received BTX treatment within the last 12 months for the treatment of BEB. This definition aims to avoid bias by comparison of treatment effects in the subject's assessments. Furthermore, this study will substantiate the existing efficacy and safety database for the indication BEB.

Detailed description:
Subjects to receive one injection with NT 201 or placebo at baseline of the placebo-controlled first cycle. Thereafter, all subjects entering the Open-Label Extension Period (OLEX) to receive a second injection of NT 201 (second injection cycle).

Arms: arm 1: Main Period: one injection session, 25 Units per eye. Open-Label Extension: one injection session, up to 35 Units per eye. Mode of administration: intramuscular injection. arm 2: Main Period: one injection session, 12.5 Units per eye. Open-Label Extension Period: one injection session, up to 35 Units per eye. Mode of administration: intramuscular injection. arm 3: Main Period: Placebo to IncobotulinumtoxinA (Xeomin)(12.5 or 25U/eye), one injection session.

Open-Label Extension: IncobotulinumtoxinA (Xeomin), one injection session, up to 35 Units per eye. Mode of administration: intramuscular injection.
Interventions: intervention 1: IncobulinumtoxinA (Xeomin), 25 Units intervention 2: IncobotulinumtoxinA (Xeomin), 12.5 Units intervention 3: Placebo intervention 4: IncobotulinumtoxinA (Xeomin), 35 Units
Intervention descriptions: intervention 1: IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 25 Units per eye. intervention 2: IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 12.5 Units per eye. intervention 3: Main Period: Placebo to IncobotulinumtoxinA (Xeomin), powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). intervention 4: IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Open-Label Extension: up to 35 Units per eye.

Protocol documents:
Clinical trial NCT01903252
Conditions: Acute Ulcerative Colitis
Keywords: UC
Sponsor: Tillotts Pharma AG
Start date: 2013-07-01; Completion date: 2016-11-01
Enrollment: 817 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study was to compare the medication TP05 to the medication Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and tolerability of TP05. This study investigated whether TP05 is as good as (non-inferior to) Asacol™(1).

(1)The trademark Asacol™ is registered in over 55 countries as Asacol™ and as Octasa™, Fivasa™, Lixacol™, Asacolon™ in the United Kingdom, France, Spain and Ireland, respectively. The rights to Asacol, including the rights to the trademark, are owned by Tillotts Pharma AG in various countries except for the following: Switzerland, USA, United Kingdom, Canada, Italy, Belgium, the Netherlands and Luxembourg.

Detailed description:
This is a Phase 3, randomised, double-blind, active-controlled, multi-centre, non-inferiority trial evaluating the safety and efficacy of 3.2 g of TP05/day compared to 3.2 g/day of Asacol™ with an open label extension to assess the long-term safety and tolerability of TP05 administered over a 26 week period. A total of 817 subjects with mildly to moderately active UC were evaluated. Eligible subjects were randomly assigned in a 1:1 ratio to receive 3.2 g/day of TP05 (administered once daily(OD)) or 3.2 g/day of Asacol™. The primary efficacy outcome was assessed at Week 8. All subjects who respond to TP05/Asacol™ (response or remission) continued receiving blinded study treatment for up to 12 weeks. After that, subjects could enroll in an Open Label Extension (OLE) for 26 weeks duration to receive TP05. Subjects failing to respond to study drug at the Week 8 visit could enroll in the OLE at week 8 and received 4.8 g/day of TP05.

Arms: arm 1: week 1 - week 12 (blinded), week 13 - week 38 (OpenLabel) arm 2: week 1 - week 12 (blinded), switch to TP05 for weeks 13-38 (open label)
Interventions: intervention 1: TP05 intervention 2: Asacol 400 mg
Intervention descriptions: intervention 1: 3.2g/day once daily for 12 weeks (blinded), 1.6g/d - 4.8g/d up to week 38 (open label) intervention 2: 3.2g/d twice daily for 12 weeks (blinded), switch to 1.6g/ - 4.8g/d TP05 up to week 38 (open label)

Protocol documents:
Clinical trial NCT01948505
Conditions: Post-operative Craniotomy Patients Carotid Endarterectomy and Carotid Artery Stenosis Patients Post-op Spine Patients Admitted to the NCCU Endovascular Patients Undergoing Intracranial Intervention Traumatic Brain Injuries NPO for at Least 12 Hours
Keywords: Craniotomy
Sponsor: University of Utah
Start date: 2013-08-01; Completion date: 2016-11-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain.

To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.

To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.

Detailed description:

Arms: arm 1: IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication arm 2: IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Interventions: intervention 1: Intravenous acetaminophen intervention 2: Placebo for IV acetaminophen
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01969058
Conditions: HIV-1 Infection
Keywords: Isotretinoin HIV-1 immunology markers immune activation viral suppression
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2014-07-02; Completion date: 2016-11-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II study was done in HIV-infected participants on antiretroviral therapy to evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of severe acne) on the immune system. The immune system helps the body fight infections. When the immune system is not working well, one may be at greater risk for diseases that are common in aging, like heart disease, weaker bones, and kidney disease.

Detailed description:
Isotretinoin was administered to participants in the Isotretinoin arm at approximately 0.5 mg/kg PO once daily for 4 weeks, then increased to approximately 1.0 mg/kg PO once daily for 12 weeks. Follow-up continues to week 28 to evaluate the duration of effect. Randomization was stratified by willingness to participate in the gut biopsy substudy, A5330s. The study population included HIV-1 infected adults whose virus was suppressed on ART, excluding women of child bearing potential.

Arms: arm 1: Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks. arm 2: No Isotretinoin treatment
Interventions: intervention 1: Isotretinoin
Intervention descriptions: intervention 1: Isotretinoin is a drug that is approved for use in the treatment of severe acne. The aim of this study is to evaluate the role of Isotretinoin on immune activation and inflammation.

Protocol documents:
Clinical trial NCT01993667
Conditions: Prophylaxis of Acute Mountain Sickness
Sponsor: University of Utah
Start date: 2012-03-01; Completion date: 2016-11-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.

Detailed description:
Acetazolamide, or Diamox, is the standard medical prophylaxis agent for high altitude illness. The medication is effective in preventing acute mountain sickness (AMS), high altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE). Its mechanism is via inhibition of the carbonic anhydrase enzyme which counteracts the respiratory alkalosis which occurs during ascent to altitude. It facilitates the excretion of bicarbonate in the urine. As a result, acetazolamide hastens acclimatization and helps prevent high altitude disorders.

Current recommended dosing is 125 mg, orally twice daily, started 24 hours prior to ascending in elevation. Side effects include tingling of the fingers and toes and perioral numbness which may be erroneously interpreted as stroke symptoms. Since acetazolamide is a mild diuretic, frequent micturition may occur leading to interruption of daytime activities as well as broken sleep. These effects can affect safety at high altitude. Acetazolamide is normally discontinued 2 days after the user has reached their highest elevation or a plateau in elevation.

A lower dose may be just as effective in preventing high altitude illnesses while preventing the disconcerting side effects resulting from its use. A smaller dose has not been studied, however. We will compare the common dose of 125 mg twice daily with a lower dose of 62.5 mg twice daily.

Arms: arm 1: Experimental : Acetazolamide 125 mg twice daily arm 2: Experimental: Acetazolamide 62.5 mg twice daily
Interventions: intervention 1: Low Dose Acetazolamide intervention 2: Normal Dose Acetazolamide
Intervention descriptions: intervention 1: Administration of low dose acetazolamide intervention 2: Administration of normal dose acetazolamide

Protocol documents:
Clinical trial NCT02009397
Conditions: Metastatic Melanoma
Sponsor: University of Louisville
Start date: 2012-02-01; Completion date: 2016-11-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.

Detailed description:

Arms: arm 1: IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles
Interventions: intervention 1: Ipilimumab intervention 2: GM-CSF
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: