bioihbjkbjnl/mcl2 huggingface dataset:
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis
Condition: Adenomyosis; Elastography; Transvaginal Ultrasound; Fibroid Uterus
MeSH terms: Leiomyoma; Myofibroma; Adenomyosis
Study type: Interventional

Summary: 
      In this prospective cohort study, the patients who were diagnosed with either uterine fibroid
      (control group) or adenomyosis (study group), were examined with transvaginal ultrasound and
      shear wave elastography. Definitive diagnosis was established by pelvic MRI. Shear wave
      elastography data of both groups were compared. Features of adenomyosis on transvaginal
      ultrasound were also recorded for study group.
    

Detailed description: 
      In this prospective cohort study, the patients who applied to the Gynecology and Infertility
      Outpatient Clinic in Istanbul University Faculty of Medicine between October 2018 and October
      2021 due to abnormal uterine bleeding, pelvic pain, infertility were evaluated. The patients
      who were diagnosed with adenomyosis and uterine myoma according to clinical evaluation were
      included and grouped. Clinical diagnosis were confirmed with contrast enhanced pelvic
      magnetic resonance imaging. No histopathological confirmation were included in this study. 34
      patients were included in adenomyosis group and 31 patients were included in myoma group. All
      patients were evaluated with shear wave elastography; 3 regions of interest were selected for
      each elastographic evaluation. Average shear values were determined automatically; then,
      minimum and maximum mean shear values were recorded accordingly. Elastography values of both
      groups were compared in order to detect any statistically significant difference between 2
      groups. In addition to elastography evaluation, the compatibility of transvaginal ultrasound
      and magnetic resonance were evaluated.
    

Intervention name(s): Shear wave elastography
Intervention type(s): Device
Intervention description(s): Both groups were examined with shear wave elastography.
Other intervention name(s): elastography
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the safety, tolerability, and efficacy of
      IONIS-GHR-LRx in up to 60 participants with acromegaly.
    

Detailed description: 
      This short-term study assessed changes in serum insulin-like growth factor 1 (IGF-1) over a
      16-week treatment period in a participant population diagnosed with acromegaly being treated
      with long-acting somatostatin receptor ligands (SRL).
    

Intervention name(s): IONIS-GHR-LRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IONIS GHR-LRx administered subcutaneously.; Placebo administered subcutaneously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acromegaly, IONIS-GHR-LRx
Embryo Implantation After Induced Endometrial Injury
Condition: Sterility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Some studies have revealed that an induced endometrial injury could improve embryo human
      implantation in patients with implantation failure.

      The purpose of this study is to determine whether the induced endometrial injury could be
      beneficial for regular patients undergoing IVF
    

Detailed description: 
      Endometrial induced injury has been suggested that could improve embryo implantation in cases
      of patients with recurrent implantation failure. The mechanisms that induce that improvement
      remain unknown.

      We want to analyse if the endometrial induce injury could be useful in cases of standard
      patients who require assisted reproductive techniques.

      For that purpose we will start a randomized controlled trial with the ideal background in
      implantation in ART, the egg donation programme.
    

Intervention name(s): Scratching
Intervention type(s): Procedure
Intervention description(s): Endometrial biopsy
Other intervention name(s): Endometrial induced injury
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scratching; Endometrial biopsy; Ongoing embryo implantation; Assisted reproductive techniques
Pediatrician-lead Motivational Counselling to Control BMI in Overweight Children: a RCT in Primary Care
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Obesity is one of the leading causes of morbidity and mortality in the industrialised world.
      Evidence is growing that early life nutrition can play a role in behavioural and cognitive
      problems in children and adolescents and is well documented that being overweight and obese
      during childhood can have short- and long-term physical and psycho-social health
      implications.

      This is an individually randomised trial to evaluate the efficacy of a family
      pediatrician-lead counselling intervention in reducing the BMI of over-weight children aged
      4-7 years old. As secondary objectives the investigators evaluate the effect of the
      counselling on dietary behaviours and physical activity.

      The investigators targeted the intervention to overweight children, while obese children were
      referred to specialised care. The counselling targeted diet, physical activity, and sedentary
      behaviours.
    


Intervention name(s): motivational counseling
Intervention type(s): Behavioral
Intervention description(s): A family pediatrician-lead counselling was offered to children assigned to the intervention group. The counselling program consisted of 5 motivational interviews based on Stages of Change Theory. Child and family always had to leave the meeting having agreed two objectives, one concerning food and one physical activity improvements, clearly defined and achievable. During each subsequent interview was assessed the degree of achievement of the objectives of the previous meeting. Based on the assessment the objective could be reinforced or redefined. After each change the objectives were recorded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: overweight; obesity; children; BMI; counseling; pediatrician
Transfer Accuracy of 3D-printed Indirect Bonding Trays
Condition: Dental Bonding
Study type: Interventional

Summary: 
      This study evaluates the transfer accuracy of 3D-printed trays for indirect bonding of
      orthodontic brackets in vivo. Accurate placement of orthodontic brackets at the beginning of
      treatment improves treatment efficiency and shortens treatment time. Indirect bonding is a
      method of placing orthodontic brackets on a plaster or digital model of the dentition,
      followed by the transfer of these brackets to the patients' teeth using a transfer tray.
      Various indirect bonding methods have been developed with the aim of improved bracket
      positioning and reduced chair time. The success of these methods ultimately depends on how
      reliably the precise positioning of the brackets on the model can be transferred to the
      patient's teeth.
    


Intervention name(s): 3D printed tray
Intervention type(s): Device
Intervention description(s): 3D printed tray
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Effect of Treating Sleep Apnea on Cognition in Patients With Dementia
Condition: Dementia; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Dementia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether treating sleep apnea with continuous
      positive airway pressure would result in improvements in cognition in patients with
      Alzheimer's disease.
    

Detailed description: 
      Patients with sleep disordered breathing (SDB) experience nighttime sleep fragmentation and
      often become hypoxic during the night. The fragmentation and hypoxemia can frequently result
      in daytime impairments including impairments in cognitive functioning. The state-of-the-art
      treatment for SDB is Continuous Positive Airway Pressure (CPAP). Many SDB patients who are
      successfully treated with CPAP show improvement in memory and other cognitive functions. Data
      have shown that there is a strong relationship between SDB and dementia with patients with
      Alzheimer's Disease (AD) having a high rate of SDB. This proposal will examine whether
      treating SDB with CPAP in patients with AD will result in improvement in cognitive
      functioning. The specific aims are to assess whether patients with mild AD and SDB will
      tolerate CPAP and be compliant with treatment; to examine the effect of CPAP treatment on SDB
      in patients with mild AD and SDB; to examine the effect of CPAP treatment on cognitive
      functioning in patients with mild AD and SDB; to examine whether improvement is greater after
      six weeks of CPAP treatment than after three weeks of treatment. Since caregivers are often
      disturbed by the patients poor sleep, we will also evaluate the effect of the patients'
      treatment on their caregivers. Specifically, the secondary aims are to evaluate whether
      caregivers feel that CPAP improves the patient's sleep and to evaluate whether caregivers
      feel that their own sleep improves as the patient's sleep improves. Patient identified as
      having mild AD and SDB will have an extensive neuropsychological battery. Half will be
      randomized to CPAP treatment and the other half to shamCPAP. After three weeks
      neuropsychological tests will be repeated. The shamCPAP will be switched to CPAP and the CPAP
      group will remain on CPAP for an additional three weeks. Neuropsychological tests will again
      be repeated. The long-term goal of this line of research is to find a new approach that might
      improve the quality of life, delay the dementing process, postpone institutionalization and
      save millions of dollars in nursing care costs.
    

Intervention name(s): Continuous positive airway pressure
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Supportive Care
Keywords: sleep apnea; dementia; excessive sleepiness; cognition
Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the comparability of lens fit and lens power of a
      new contact lens to the lens fit and lens power of two marketed lenses.
    


Intervention name(s): galy A Plus; seno A; galy A
Intervention type(s): Device; Device; Device
Intervention description(s): galyfilcon A Plus, BC: 8.3 or 8.7; senofilcon A, BC:8.4 or 8.8; galyfilcon A , BC: 8.3 or 8.7
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Biological Characterization Study of an Autograft Nanofat (Nanocarabio)
Condition: Rhizarthrosis
Study type: Interventional

Summary: 
      Rhizarthrosis (trapeziometacarpal osteoarthritis) is the most common primary osteoarthritis
      of the hand, and a source of major functional impact, as it affects the thumb. Non-surgical
      therapeutic means are currently limited to wearing an immobilization splint, analgesics and
      oral non-steroidal anti-inflammatory drugs. These symptomatic treatments are of limited
      effectiveness and do not prevent from progression of the osteoarthritis disease. The most
      effective treatments currently recognized are surgical, but they also have their limits.

      Cell therapy is considered as a promising approach to treat tissue damage including
      osteoarthritis. Mesenchymal stromal cells are excellent candidates for achieving this type of
      result, because they can differentiate into the different tissues from the mesoderm
      (cartilage, bone, muscle, tendons, fat, dermis, conjunctive matrix, etc.). In addition,
      unlike cells from the embryonic cord, the risk of teratoma or tumor does not exist.

      Mesenchymal stem cells have regenerative and immunomodulatory properties but the methods of
      collection, preparation, combination with substances such as hyaluronic acid, or PRP, or
      platelet concentrates, will obviously influence the effectiveness of the results. .

      Nanofat autografts are obtained in a simple way, in a closed circuit, preserving the stromal
      mesenchymal cells in large numbers with a minimum impact on the cellular elements. The
      preparation remains simple and inexpensive, but it is nevertheless necessary to characterize
      these emulsified preparations biologically before using them as cell therapy.

      The main objective of this study is to characterize a nanofat autograft on a biological
      level.
    


Intervention name(s): collecting a Nanofat-type microfat autograft
Intervention type(s): Procedure
Intervention description(s): Collecting and preparing a Nanofat autograft.
The protocol provides for the fat sample to be taken in a doctor's office during a consultation. The preparation will then be carried out at the MEARY center for cell and gene therapy of the AP-HP, at the Saint Louis hospital in Paris.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Infections; Acquired Immunodeficiency Syndrome; Cytomegalovirus Retinitis; Retinitis
Study type: Interventional

Summary: 
      The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of
      cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that
      30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a
      common dose-limiting problem in about 50 percent of patients. Since in vitro data have
      suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a
      reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse
      without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon
      beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in
      a subsequent protocol.
    


Intervention name(s): Interferon beta-1b; Ganciclovir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Interferon-beta; Ganciclovir; Ganciclovir triphosphate; Interferon beta-1b
Primary purpose: Treatment
Keywords: Retinitis; AIDS-Related Opportunistic Infections; Ganciclovir; Drug Therapy, Combination; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Interferon Type I
Combined Agent Randomized Trial of Induction of Labor
Condition: Labor Induction; Cervical Ripening
Study type: Interventional

Summary: 
      To compare sequential dinoprostone and oxytocin for induction of labor at term with intact
      membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings
      from smaller trials and add to data on fetal safety.
    

Detailed description: 
      This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: >36
      weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's
      score <6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed
      by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous
      oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate
      oxytocin. Primary outcome measure was the rate of vaginal delivery <24 hours. Secondary
      outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non
      reassuring fetal status (NRFS) and rate of uterine hyperstimulation.
    

Intervention name(s): dinoprostone
Intervention type(s): Drug
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Labor; Labor induction; Cervical ripening; Dinoprostone; Fetal safety; Oxytocin; Cesarean delivery
Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This proposed research will use randomized control trial (RCT) methodology and compare
      micronutrients with placebo in 135 children with ADHD.
    

Detailed description: 
      This study examines a broad spectrum micronutrient treatment for children with ADHD. The goal
      is to broaden the scope of evidence-based treatments, and to address the public desire for
      non-pharmacological treatment options. This study will use a randomized controlled trial
      design, comparing micronutrients with placebo in 135 children, ages 6-12, with ADHD plus
      irritability or anger based on parent-report of symptoms. The study will also collect
      biological samples (saliva, stool, urine, hair, and blood) from the children to examine
      physiological mechanisms of micronutrient effects. If the micronutrient treatment
      successfully diminishes symptoms, the clinical implication is to offer this as a legitimate
      non-pharmacological alternative to stimulant medication.
    

Intervention name(s): Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants; Placebo
Intervention type(s): Combination Product; Dietary Supplement
Intervention description(s): 60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks; 40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
Other intervention name(s): Daily Essential Nutrients (DEN)
Intervention MeSH terms: Micronutrients; Trace Elements; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; ODD; DMDD; Inattention; Impulsivity; Irritability; Anger; Micronutrients; Emotional Dysregulation
Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
Condition: Cancers, Pain; Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone
      ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe
      pain.
    


Intervention name(s): Oxymorphone ER
Intervention type(s): Drug
Intervention description(s): Open label
Intervention MeSH terms: Oxymorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Practicality of Intermittent Fasting and Its Effect on Markers of Aging and Oxidative Stress
Condition: Aging; Metabolism
Study type: Interventional

Summary: 
      Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover
      trial. The trial will consist of two, three-week periods of intermittent fasting, where
      subjects receive either antioxidant supplementation or placebo, the ordering of which will be
      randomly determined. A one-week preconditioning will precede each invention period, and a two
      week "wash-out" period will follow the first intervention period. Serum-based assays will be
      performed to assess levels of reactive oxidant species, antioxidant genes, sirtuins, and
      markers of mitochondrial biogenesis and aging.

      The investigators hypothesize that an intermittent fasting diet in healthy young volunteers
      will improve these markers of cellular aging and that these beneficial effects will be
      abrogated by the supplementation of antioxidants. This study is a proof-of-principle study
      that will shed light on the mechanism and effects of IF as an anti-aging dietary intervention
      in the absence of weight loss. It will inform the design of dietary interventions that are
      both effective in improving markers of aging and feasible for patients to practice on a
      long-term basis.
    


Intervention name(s): Intermittent Fasting; 400 IU Vitamin E; 1000 mg Vitamin C
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): The intermittent fasting paradigm used in this study will require participants to alternate between days of feasting (175% of normal caloric intake) and fasting ( 25% of normal caloric intake). Food will be provided by University of Florida Clinical Research Center with macronutrient composition prepared according to the 2010 Dietary Guidelines for Americans.; once each day in morning; oral pill form; 500mg twice each day; morning and evening; oral pill form
Intervention MeSH terms: Vitamins; Vitamin E
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Sirtuins; Calorie Restriction; Intermittent Fasting; Antioxidant; Aging; Metabolism; Mitochondria; Oxidative Stress