bioihbjkbjnl/mcl2 huggingface dataset:
A Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy
Condition: Vulvo Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Based on previous data published on the SERM properties of Femarelle, the investigators
      hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA)
      symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA
      symptoms in symptomatic post-menopausal women.
    

Detailed description: 
      Post-menopausal women aged 54-77, with vaginal atrophy (< 5% superficial cells on cervical
      cytology) with at least one moderate-to-severe VVA symptom (dryness, irritation, soreness,
      dysuria, dyspareunia, or bleeding with coitus), will be recruited for a 12-week open-label
      pilot study. The study protocol was approved by Schulman Associates IRB.Femarelle will be
      given twice daily and subjective symptoms as well as objective measures like inspection and
      vaginal pH will be measured.
    

Intervention name(s): Femarelle
Intervention type(s): Dietary Supplement
Intervention description(s): Twice daily oral treatment with Femarelle
Other intervention name(s): DT56a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vulvo vaginal atrophy; Femarelle
Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones
Condition: Urinary Calculi; Urinary Stones; Urinary Tract Stones; Renal Calculi; Kidney Stones
MeSH terms: Kidney Calculi; Nephrolithiasis; Urinary Calculi; Urolithiasis; Calculi
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of the study are to assess the systemic exposure, safety and efficacy of three
      concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper
      urinary tract stones.
    

Detailed description: 
      The main objective is to estimate the systemic exposure of OMS201 in retrograde ureteroscopic
      treatment of upper urinary tract stones. Safety will be assessed by vital signs, laboratory
      values and adverse events. Exploratory efficacy measures will assess the effect of OMS201 on
      postoperative pain, duration of surgery and ease of placement of a ureteral access sheath.
    

Intervention name(s): OMS201; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery
Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery; Stages 1-2: Vehicle irrigation solution during surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Urinary Calculi; Urinary Stones; Urinary Tract Stones; Renal Calculi; Kidney Stones; Calculi; Urolithotomy; Ureteroscopy
3 Dimensional Sonography Imaging
Condition: New Imaging Modality
Study type: Observational

Summary: 
      The study is designed to evaluate a new imaging modality, 3-dimmensional sonographic
      volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is
      currently in place. Those patients who are scheduled to have an ultrasound as part of their
      infertility treatment will be offered the opportunity to have additional measurements done at
      the time of their ultrasound; these additional measurements will take less than 2 minutes and
      do no require any additional sonograms, tests, or interventions. All patients are eligible
      (oocyte donors and autologous oocyte patients) and only patients with a serum estradiol >
      2000pg/ML will be enrolled in the study. After the additional measurements are obtained, the
      results will be digitally stored. The results of the 3D sonographic volumetric analysis will
      then be correlated with the patients' IVF performance.
    

Detailed description: 
      The benefits of the study is that 3-dimensional sonographic volumetric analysis may be a
      superior imaging modality for sonographically assessing oocyte maturity and may lead to
      change in clinical practice. The lone risk of the study is rooted in protecting the patients'
      protected health information.
    

Intervention name(s): 3D Sonography analysis
Intervention type(s): Other
Intervention description(s): Those patients who are scheduled to have an ultrasound as part of their infertility treatment will be offered the opportunity to have additional measurements done at the time of their ultrasound; these additional measurements will take less than 2 minutes and do not require any additional sonograms, tests, or interventions.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In Vitro fertilization patients and donor egg patients of the Ronald O. Perelman and
        Claudia Cohen Center for Reproductive Medicine who at the day of monitoring (having an
        ultrasound and blood work drawn) have an estradiol level greater than 2000pg/ML.
This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.
Condition: Obstetric Labour, Premature
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover
      study design in healthy male and female subjects. The study consists of screening (28 days),
      treatment (1 day/dosing session) and follow-up (7 to 14 days) period and the total duration
      of study participation for each subject will be approximately 9 weeks. Each subject will
      participate in 4 dosing sessions separated by a minimum 7-day washout period. All subjects
      will receive single doses of retosiban 100 mg, (treatment A) retosiban 800 mg (Treatment B),
      moxifloxacin 400 mg (Treatment C) and placebo (Treatment D) in one of the four treatment
      sequences (ABDC, BCAD, CDBA, DACB) following a Williams design Twelve-lead ECGs and
      continuous Holter monitoring, clinical laboratory safety tests, vital sign measurements,
      physical examinations, adverse event reports, and pharmacokinetic samples will be collected
      throughout the study. In each study period, cardiac conduction will be measured using a
      24-hour continuous 12-lead Holter monitor from the morning of Day 1 (dosing) until the
      morning of Day 2.
    


Intervention name(s): Retosiban 100 mg; Retosiban 800 mg; Placebo; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be administered with single dose of one moxifloxacin placebo tablet, one 100 mg tablet of retosiban and 7 retosiban matched placebo tablets; Subjects will be administered with single dose of one moxifloxacin placebo tablet and eight 100 mg tablets of retosiban; Subjects will be administered with one moxifloxacin placebo tablet and eight retosiban matched placebo tablets; Subjects will be administered with one 400 mg moxifloxacin tablet and eight retosiban matched placebo tablets
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
Condition: Right Heart Failure; Left Ventricular Assist Device
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess
      safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an
      LVAD.
    

Detailed description: 
      The study will be conducted over a 40 day time period inclusive of screening and follow up
      time periods. Eligible subjects will receive oral CRD-102 for 14 days.
    

Intervention name(s): CRD-102
Intervention type(s): Drug
Intervention description(s): 14 mg CRD-102 capsules administered twice daily orally for 14 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?
Condition: Pancreatic Ductal Adenocarcinoma
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to compare outcomes of patients undergoing standard or extended
      lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer
    


Intervention name(s): Pancreaticoduodenectomy with Standard lymphadenectomy; Pancreaticoduodenectomy with Extended lymphadenectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Pancreaticoduodenectomy：child's digestive reconstruction standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b; Pancreaticoduodenectomy：child's digestive reconstruction extended lymphadenectomy: No8p 12a 12p 14c 14d 16
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Standard lymphadenectomy; extended lymphadenectomy; pancreaticoduodenectomy
MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.
    


Intervention name(s): MK0928, gaboxadol / Duration of Treatment 3 Weeks; Placebo / Duration of Treatment 3 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gaboxadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating the Effectiveness of the Reader Organisation's Get Into Reading Intervention
Condition: Language Development
Study type: Interventional

Summary: 
      The investigators will evaluate the effectiveness of a parent-child shared reading
      intervention run by The Reader Organisation. The investigators will be asking parents and
      children across Liverpool to either (i) attend a weekly shared reading programme or (b) to
      attend a weekly children's reading group at a library. The investigators will look at how the
      reading groups affect children's language development, by comparing children's language
      development before having gone to these groups and after they have attended these groups.
    

Detailed description: 
      This is a Randomised Control Trial to test whether The Reader Organisation's Shared Reading
      Programme is more effective at improving the language development of children than a free
      library reading group. Intervention group: Fifty parents of children (3 to 4-years of age)
      will be recruited to take part in a 8 weeks long shared reading programme. The shared reading
      programme is comprised of two different modules: a) 'Magical Storytimes', in which a
      collection of shared book reading sessions are led by a project worker and b) 'Stories for
      You and Yours', in which parents will be taught how to choose books and read interactively
      with their child. Control group: Fifty further families, matched for age and background will
      be recruited to a reading control group and asked to attend a weekly shared reading group at
      a library where parents/children will read in a shared pre-school library reading group,
      coordinated by a group facilitator. Location: The Shared Reading Programme will take place in
      the child's nursery (in nurseries across Liverpool). Control group parents and children will
      attend a weekly reading group at a library. All standardised tests, for all children, will
      take place in the child's nursery. Language gains from pre- to post- intervention will be
      measured.
    

Intervention name(s): The Reader Organisation's Shared Reading Programme; Shared Reading control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In The Reader Organisation's Shared Reading Programme, parents and children will attend weekly shared book reading sessions for 8 weeks which focus predominately on how to read interactively with children.; Parents and children will attend a weekly shared reading group at a library for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Shared Book Reading; Vocabulary; Language Development; Young Children; Randomised Control Trial
Aquatic and Land Exercises in Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Aquatic and Land Exercises on Chronic Low Back Pain
    

Detailed description: 
      The Effect of Aquatic and Land Exercises on Pain, Health Related Quality of Life,
      Kinesiophobia and Disability in Chronic Low Back Pain
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): exercise for low back pain
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Aquatic Exercises; Chronic Low Back Pain,; Land Exercises; Pain,; Functional status
Efficacy of Circadin® 2 mg in Patients With Mild to Moderate Alzheimer Disease Treated With AChE Inhibitor
Condition: Alzheimer's Disease; Sleep Disorder
MeSH terms: Alzheimer Disease; Sleep Wake Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this exploratory randomized, placebo controlled study is to evaluate the efficacy
      of Circadin® 2mg in patients with mild to moderate Alzheimer Disease (AD) treated with the
      acetylcholinesterase (AChE) inhibitor. The effects of add-on Circadin® 2mg vs. placebo on the
      decline in cognitive skills and global functioning, as well as on daytime somnolence and will
      be assessed.
    


Intervention name(s): Circadin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Prolonged Release melatonin (Circadin) 2mg tablets; Matched placebo tablets, with identical features to the Circadin tablets
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Acetylcholinesterase inhibitor; cognitive function; Circadin; Sleep disturbances
Evaluation of Use of Brain Activity Monitoring Dynamics in ADHD
Condition: ADHD
Study type: Interventional

Summary: 
      This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD
      subjects with an easy to use EEG Device.
    

Detailed description: 
      The study will be conducted in two arms (arm I and arm II). In arm I, participants diagnosed
      with ADD/ADHD. In arm II, healthy participants.

      The status of the participants will be evaluated with questionnaires computerized test and
      EEG characteristics will be collected for all study participants. .
    

Intervention name(s): EEG monitoring (MindWave by NeuroSky); EEG monitoring (EPOC by Emotiv); Methylphenidate
Intervention type(s): Device; Device; Drug
Intervention description(s): EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises. Additional EEG monitoring will be performed during performance of a computerized test using MindWave Headset.; EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.; Methylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly.
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Optic Nerve and Retinal Functions With Bevacizumab
Condition: Choroidal Neovascular Membrane
Study type: Observational

Summary: 
      The purpose of this study is to investigate the possible affection of optic nerve and retinal
      functions following intravitreal bevacizumab injection in human eyes.
    

Detailed description: 
      To evaluate the retinal and optic nerve functions of bevacizumab when injected intravitreal
      in human eyes using electrophysiological tests; Electroretinogram (ERG) and Visual Evoked
      Potentials (VEP). Forty five eyes of 45 patients with choroidal neovascular membrane (CNV)
      who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG
      and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.
    

Intervention name(s): Electrophysiology
Intervention type(s): Procedure
Intervention description(s): Visual Evoked Potential and Elctroretinogram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared
        for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both
        eyes before, and at 1 and 4 weeks after the intravitreal injections.Mean age was 50 years
        ranging from 24-62 years with 25 females, with 28 AMD and 17 myopic patients.
      
Keywords: Bevacizumab; VEP; ERG; Optic nerve and retinal functions following intravitreal bevacizumab
Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial)
Condition: Chronic Myocardial Ischemia
MeSH terms: Cardiomyopathies; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate whether endocavitary intramyocardial injection of
      autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events,
      with follow-up assessments extending up to 1 year after enrolment.
    

Detailed description: 
      This will be a Phase I study investigating the safety and preliminary efficacy of
      endocavitary injection of bone-marrow-derived CD133+ cells in 15 patients with ischemic heart
      failure (IHF) not eligible for conventional revascularization. Patients eligible will undergo
      bone-marrow aspiration. On the day following bone-marrow aspiration patients will undergo
      fluoroscopy-based endocavitary intramyocardial injections of the target areas previously
      identified by gated-SPECT/CMR. CD133+ cells suspended in physiological saline supplemented
      with 5% human albumin solution will be injected into the myocardium via the endocardial
      route.

      After discharge, efficacy follow-up will last 6-months safety follow-up (FU) will be extended
      up to 1 year.
    

Intervention name(s): Autologous bone marrow derived-CD133+ cells
Intervention type(s): Other
Intervention description(s): Cell therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Macadamia Nut on Cardiometabolic Risk Factors
Condition: Cardiovascular Risk Factor; Heart Diseases; Inflammation
MeSH terms: Heart Diseases; Inflammation
Study type: Interventional

Summary: 
      This research study will test the effects of macadamia nuts on adiposity, and traditional and
      emergent risk factors of cardiometabolic disease in adult men and women
    

Detailed description: 
      Purpose of this study is to investigate the effects of Macadamia nuts on body weight,
      adiposity, , oxidative stress, glucose, insulin an lipid levels. it will a randomized cross
      over study that will include two study diets (Macadamia nut diet and control diet) with a
      wash out period of 4 weeks in between. 40 subjects will be selected and randomized into
      either of the two phases. During the Macadamia nut diet phase subjects will be provided the
      appropriate portion of Macadamia nuts (15% of daily calories or 30-45 grams based on kcal
      requirement of the individual, instructions will be provided on how to incorporate nuts into
      the diet. this phase will last for 8 weeks. During the control diet phase, subjects will
      continue with their normal diet and abstain from eating nuts. subjects will be tested for
      various outcomes at baseline and twice at the end of each phase. The intervention will last
      for 5 months in total.
    

Intervention name(s): Macadamia Nut; Control Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will be provided with the appropriate portion of macadamia nuts [15% of daily calories or 30-45 grams based on kcal requirement of the individual]; Participants will continue with their Habitual Diet during this part of the intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Macadamia Nuts; Cardiovascular Disease; Inflammation
A Study to Assess the Validation and Mapping of the Suicide Ideation and Behavior Assessment
Condition: Suicidality
MeSH terms: Suicide
Study type: Observational

Summary: 
      The main purpose of this cross-sectional study is to generate data to support the
      psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and
      validate its use in participants at imminent risk of suicide.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No Intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants in this study will be selected from emergency room, acute inpatient
        psychiatric hospital unit, or psychiatry clinical research office settings. Participants
        who agree to be interviewed regarding their symptoms of suicidality will be screened and
        selected if they meet selection criteria for this study. Participants with various levels
        of suicidality will be included based on the severity of their suicidality assessed
        globally (without extensive interview).