bioihbjkbjnl/mcl2 huggingface dataset:
Place Controlled Study to Treat Recurrent Herpes Labialis.
Condition: Recurrent Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      About 80% of the worldwide population is positive on HSV antibodies. In the United States the
      lifetime prevalence of recurrent herpes labialis is estimated at 20% to 40%, with
      approximately 100 million episodes occurring in the country every year. In Switzerland about
      70% of the adult population is positive on HSV-1 and about 20% is positive on HSV-2.

      The Herpes simplex virus has a lipid bilayer (virus-envelope), which causes the
      sensitiveness, to any kind of detergents. Within this bilayer cholesterol molecules are
      integrated and play a crucial role in virus entry into host cells. In vitro experiments have
      clearly shown that the depletion of cholesterol in HSV-envelope with 2- HPßCD has inhibited
      the ability of the virus to infect host cells.

      The aim of this clinical trial is to reduce the number of Herpes labialis relapse and to
      provide patients with recurrent Herpes labialis a real benefit, concerning the simple
      mechanism of action and the negligible side effects. Patients having problems in swallowing
      the antiviral pills of standard treatment, will find with 2- HPßCD a drug, that just has to
      be applied on the lips, which increases patient's quality of life tremendously.

        -  Trial with medicinal product
    


Intervention name(s): Ointment
Intervention type(s): Drug
Intervention description(s): Each time about 1.5 cm ointment have to be applied on the upper lip and 1.5 cm on the lower lip, twice daily for prophylaxis for e period of 6 month.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Effects of PCSK9 Inhibition by Evolocumab on Postprandial Lipid Metabolism in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Postprandial lipemia is highly prevalent in type 2 diabetes subjects even with normal fasting
      triglyceride values. Humans are mostly in a postprandial rather than in a fasting state and
      therefore non-fasting triglyceride values reflect more accurately the continuous exposure of
      arterial wall to the substantial cholesterol load from remnant particles. Evolocumab lowers
      blood LDL-cholesterol. This study evaluates the effect of evolocumab on postprandial lipid
      metabolism in type 2 diabetes. All participants in this study receive evolocumab treatment.
    


Intervention name(s): Evolocumab
Intervention type(s): Drug
Other intervention name(s): Repatha
Intervention MeSH terms: Evolocumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: apolipoprotein, CVD, chylomicrons, evolocumab, kinetics
Linear Growth Study (0476-097)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effect of montelukast with placebo and
      beclomethasone on the average rate of linear growth over a period of 56 weeks in children
      with mild asthma.
    


Intervention name(s): MK0476, montelukast sodium / Duration of Treatment : 56 Weeks; Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Beclomethasone; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
Condition: Post-stroke Spasticity of the Upper Limb
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether injections of Botulinum toxin type A into
      muscles of the upper limb are effective in treating spasticity in patients after stroke.
    

Detailed description: 
      The study consists of a randomized, double-blind, placebo-controlled, parallel-group,
      single-dose main period followed by an open-label, non-controlled, repeated-dose extension
      period (Open-Label Extension Period - OLEX).
    

Intervention name(s): IncobotulinumtoxinA (400 Units); Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection; Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
Other intervention name(s): Xeomin
Intervention MeSH terms: incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Carpal Tunnel Release Via Two Small Incisions Comparing With Via Standard Incision And Under Endoscope
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under
      Endoscope.
    

Detailed description: 
      Carpal tunnel syndrome (CTS) affects over 60 million people worldwide. If a regimen of
      conservative management has failed, surgical release of the median nerve is warranted.
      Numerous approaches for carpal tunnel release have been described that range from an open
      technique to a limited incision to endoscopic release. In addition, partial excision of the
      flexor retinaculum is advocated by some surgeons because of obtaining better outcomes.
      However, the procedure is difficult to be accomplished through small incisions owing to poor
      visualization. Currently, balance of incision, visualization, and partial excision of the
      flexor retinaculum is still controversial.

      The objective of this report is to introduce carpal tunnel release with partial excision of
      the flexor retinaculum through two small incisions. The procedures were performed under
      lighted head magnifier. This is the first report on the use of our technique. For comparison,
      the investigators also included two other groups of standard open carpal tunnel release with
      partial excision of the flexor retinaculum and endoscopic carpal tunnel release without
      excision of the flexor retinaculum.
    

Intervention name(s): Carpal Tunnel Release via limited approaches; Carpal Tunnel Release via standard approach; Endoscopic Carpal Tunnel Release; endoscope or an arthroscopic device
Intervention type(s): Procedure; Procedure; Procedure; Device
Intervention description(s): Carpal tunnel release with partial excision of the flexor retinaculum via two small incisions.; Carpal tunnel release with partial excision of the flexor retinaculum via the standard incision.; Carpal tunnel release under endoscope.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
Condition: Spondylosis; Spondylolisthesis; Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration; Spondylolisthesis; Spondylosis
Study type: Interventional

Summary: 
      This is a single-arm post-market study in patients requiring lumbar fusion using allograft
      interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with
      degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10
      sites. After subjects have signed an informed consent, the baseline visit and examinations
      will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and
      24 month visit after surgery.
    

Detailed description: 
      Map3 is an allogeneic bone matrix which also contains demineralized cortical cancellous bone
      and multipotent adult progenitor cells (MAPC). MAPC-based cells are derived from allograft
      bone marrow, isolated from other cells and cryopreserved. Both the scaffold and cellular
      constituents are processed from the same donor but are provided in separate containers.
      Scaffold and cells combined constitute the implant and must be used together. The map3
      implant is available in Strips allograft and Chips allograft configurations.
    

Intervention name(s): map3® Cellular Allogeneic Bone Graft
Intervention type(s): Other
Intervention description(s): Patients will receive map3® Cellular Allogeneic Bone Graft
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals
      relative to time-matched placebo in healthy subjects
    

Detailed description: 
      Evaluate multiple doses of 400 mg per day of sertraline on QTc, and evaluate the safety and
      tolerability of sertraline in healthy subjects.
    

Intervention name(s): Sertraline; Moxifloxacin; Drug - Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple doses of sertraline for 14 days; A single dose of 400 mg Moxifloxacin; Placebo administered for 14 days
Other intervention name(s): active drug; Positive control; Placebo control
Intervention MeSH terms: Moxifloxacin; Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
OGX-011 and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011
      may help docetaxel kill more tumor cells by making tumor cells more sensitive to the drug.

      PURPOSE: This phase II trial is studying how well giving OGX-011 together with docetaxel
      works in treating women with locally advanced or metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of OGX-011 and docetaxel, in terms of objective tumor response
           rate, in women with locally advanced or metastatic breast cancer.

      Secondary

        -  Determine the tolerability and toxicity of this regimen in these patients.

        -  Determine the time to progression and overall survival of patients treated with this
           regimen.

      OUTLINE: This is an open-label, nonrandomized, multicenter study.

      Patients receive OGX-011 IV over 2 hours on days -7, -5, -3, 1, 8, and 15 of course 1 and on
      days 1, 8, and 15 of all subsequent courses. Patients also receive docetaxel IV over 1 hour
      on days 1 and 8 of all courses. Treatment repeats every 21 days* for up to 10 courses in the
      absence of disease progression or unacceptable toxicity.

      NOTE: *Course 1 is 28 days in length and all subsequent courses (courses 2-10) are 21 days in
      length.

      After completion of study treatment, patients are followed at 4 weeks and then periodically
      until disease progression.

      PROJECTED ACCRUAL: Approximately 42 patients will be accrued for this study.
    

Intervention name(s): custirsen sodium; docetaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; recurrent breast cancer
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
Condition: Trichomoniasis
MeSH terms: Trichomonas Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Tinidazole 500 mg Tablet under fed conditions.
    


Intervention name(s): Tinidazole; Tinidazole
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg tablet; 500 mg tablet
Other intervention name(s): Tindamax®; Tindamax
Intervention MeSH terms: Tinidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
Condition: Healthy Volunteers: Asian, Non-Asian
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or
      itraconazole (Part B) on the pharmacokinetics of BGB-3111
    

Detailed description: 
      This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A
      will receive a single dose of BGB-3111 before and during consecutive daily doses of strong
      cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of
      BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose
      of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor,
      itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.
    

Intervention name(s): BGB-3111 (Arm A); Rifampin; BGB-3111 (Arm B); Itraconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 320 mg BGB-3111 single oral dose; 600 mg rifampin once daily; Up to 80 mg BGB-3111 single oral dose; 200 mg itraconazole once daily
Other intervention name(s): Rifadin, Rimactane; Sporanox, Orungal
Intervention MeSH terms: Itraconazole; Rifampin; Zanubrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      There are over 2 million breast cancer survivors in the US today. Along with extended
      survival, many women experience short and long-term after effects of treatment, which may
      decrease their quality of life and contribute to other health problems. Cognitive
      complaints---difficulties with memory, concentration, and planning-are commonly reported
      after adjuvant treatments for breast cancer. This study is designed to test the efficacy of a
      5 week group-based cognitive rehabilitation intervention on improving cognitive complaints
      and test performance, in comparison to women who will receive the same intervention at a
      later time (wait-list control). Women will also have an EEG test performed before and after
      the intervention program to see if improvements in cognitive complaints and performance can
      be documented by examining the EEG.
    

Detailed description: 
      Previous pilot work (non-randomized, pre-post design) has shown that this intervention was
      effective in improving post-intervention cognitive complaints and neuropsychological (NP)
      test performance. Because practice effects may influence NP performance, it is important to
      compare the intervention participants to women who are not exposed to the intervention. Thus,
      this randomized controlled trial will compare the active intervention to a control group of
      patients who will receive the intervention at a delayed time point. The primary outcomes are
      improvements in cognitive complaints and NP test performance 2 months after completion of the
      intervention program. Quantitative EEG (QEEG) measurements will be used as a secondary
      exploratory endpoint to see if this may be an effective biomarker of cognitive performance.
    

Intervention name(s): Improving Cognition with group intervention
Intervention type(s): Behavioral
Intervention description(s): Participants attend 5 weekly group sessions that are 2 hours each, delivered by a trained therapist. Sessions focus on specific aspects of attention, memory, multi-tasking and encoding. Homework assignments are practiced between classes. Goals are set for improved functioning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Reduce Cognitive Complaints; improve cognitive function; post-treatment breast cancer patients
Software Treatments for Actively Reducing Severity of Cognitive Deficits in MDD (STARS-MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of videogame-like digital therapies as
      adjunct therapy to antidepressant medications on cognitive deficits associated with major
      depressive disorder.
    

Detailed description: 
      The study will be a randomized, parallel group, controlled trial of two videogame-like
      (iPad-based) digital therapies. The study will consist of 3 primary phases: Pre-screening,
      Baseline, and Treatment. During the Pre-screening Phase (Day -28 to Day 0), participants will
      undergo pre-screening to evaluate eligibility for the study. Pre-screening may take place up
      to 28 days before the Baseline Visit (Day 0). Pre-screening may take place either over the
      phone, or in the clinic. On Day 0, the Baseline visit will occur wherein additional
      eligibility criteria will be established. The Treatment Phase (Day 1 to Day 42) will involve
      using the digital therapy at home for each participant followed by an In-Clinic assessment on
      Day 42 to assess key outcomes. During the Treatment Phase participants will be instructed to
      play their videogame-like intervention for approximately 25 minutes per day for 5 days per
      week. Compliance with treatment/use requirements will be monitored remotely during this
      phase.
    

Intervention name(s): HOLD: Videogame
Intervention type(s): Device
Intervention description(s): Videogame-like digital therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety, tolerability and activity of
      Fampridine-SR in subjects with multiple sclerosis who have previously participated in either
      an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible
      regardless of whether they received active drug or placebo during their participation in the
      previous study.
    

Detailed description: 
      Under the original protocol, patients were to have their treatment dose titrated upwards from
      a starting dose of 10mg b.i.d. to 15mg b.i.d. and then to a stable (maintenance) dose of 20mg
      b.i.d. The protocol was subsequently revised to lower the maximum maintenance dose. In the
      most current protocol, all patients were down-titrated to 10mg b.i.d. and maintained at this
      dose for the greater part of the duration of the study.

      Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central
      nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal
      cord, providing communication between the brain and the arms and legs. In people with MS, the
      fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates,
      causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience
      periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of
      coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the
      ability to think and/or remember. These periods of illness may come (exacerbations) and go
      (remissions). Fampridine-SR is an experimental drug that has been reported to possibly
      improve muscle strength and walking ability for some people with MS. This study will evaluate
      the effects and possible risks of taking Fampridine-SR in MS patients over a long period of
      time.
    

Intervention name(s): Fampridine-SR b.i.d. (Twice Daily)
Intervention type(s): Drug
Intervention description(s): Dosage form - tablets.
Other intervention name(s): 4-aminopyridine
Intervention MeSH terms: 4-Aminopyridine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; MS; walking; leg strength; demyelination
Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
Condition: Pregnancy; Weight Gain
MeSH terms: Body Weight; Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      The investigators will test the efficacy of a tailored behavioral lifestyle modification
      program to support cardiovascular health in postpartum women with excessive gestational
      weight gain. This program will include a mobile health texting component postpartum to
      support changes in nutrition and physical activity. The investigators will randomize women
      into either the control arm (usual care) or the intervention (usual care + mobile health
      program postpartum). The women will be recruited during their 3rd trimester once they have
      been identified as gaining too much weight according to the 2009 IOM guidelines during
      pregnancy.
    


Intervention name(s): behavioral intervention; Usual Prenatal Care
Intervention type(s): Behavioral; Other
Intervention description(s): Behavioral intervention will include a group class for women in their 3rd trimester followed by a mobile texting program to support behavior change postpartum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy; Obesity/Overweight; postpartum; mobile health; cardiovascular disease