bioihbjkbjnl/mcl2 huggingface dataset:
Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Non-alcoholic fatty liver disease (NAFLD), one of the most common liver dysfunctions, affects
      about one-fourth of the global adult population and has a significant mortality rate between
      6.3% and 33%.NAFLD can lead to other serious illnesses. The disease is associated with a
      group of metabolic comorbid conditions, including type 2 diabetes mellitus (T2DM), obesity,
      hypertension, and hyper-cholesterolemia, which are potential risk factors for progressive
      liver disease.This study sought to evaluate the therapeutic effect of berberine on the liver
      function and metabolic profiles of patients with NAFLD. In this context,A six week,
      open-label randomized controlled trial was conducted in a single medical center at Takestan
      Hospital, Iran. A total of 281 patients with NAFLD were enrolled and randomly assigned to
      treatment arm with (n=24) or without (n=24) berberine. All patients had received
      pre-randomization lifestyle training including recommendations on low-fat diet. Blood
      examinations were performed to evaluate glucose, lipid profile, and liver enzymes both at the
      beginning of the study and upon the completion of the trial (day 45). To assess tolerability
      of the study intervention and any possible adverse events, patients in both groups were
      required to attend weekly follow-up visits.
    

Detailed description: 
      A seven-week (45-day), open-label, randomized controlled trial was conducted in a medical
      center affiliated with the Ministry of Welfare and Social Security in Iran to study the
      impact of berberine on liver function and metabolic profiles of patients with NAFLD. Hospital
      employees who met the enrollment criteria were identified through electronic health records
      (EHRs) available in a human resource database of employee routine annual examinations. Using
      a computer-generated random-allocation sequence, eligible employees were equally assigned
      (1:1) to berberine 6.25 g per day (arm A) or no intervention (Arm B). Berberine was
      administered orally (100 g dried berberine in 5 Liter water boiled at 167°F until 4Liter).).
      To control the potential impact of confounders on outcome measures, and to balance the daily
      dietary and physical activity among the study groups, all participants were trained by
      skilled experts on lifestyle and behavior improvement.
    

Intervention name(s): Berberine
Intervention type(s): Other
Intervention description(s): 24 Patient consumed 6,25 g/day Berberine for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study , samples were randomly divided into two groups receiving and not receiving supplement
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NAFLD, Berberine, ALP, AST, ALT, FBS, HDL,LDL
The Influences of Dry Eye Disease on Optical Quality
Condition: Dry Eye; Vision; Disturbance, Hysterical
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Observational

Summary: 
      DED could result in visual disturbance and damage optical quality. We aimed to evaluate the
      influences of dry eye disease (DED) on optical quality and their correlations.
    

Detailed description: 
      This study is aimed at evaluating changes of optical quality in dry eye patients with
      superficial punctate keratopathy after being treated by artificial lubricant and
      anti-inflammatory eye drops.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Aged between 18-65 years old.
The Effect of Kinesio Taping® on Motor Control in Patients With Patellofemoral Pain Syndrome
Condition: Knee Injuries; Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Knee Injuries; Somatoform Disorders
Study type: Interventional

Summary: 
      Background: Recently, several professionals are using the Kinesio Taping® in the treatment of
      pathologies related to the knee, aiming to improve the motor control, increase the response
      of muscle activation and promoting better joint stability.

      Purpose: The objective of this study is to evaluate the effect of the application of Kinesio
      Taping® in motor control of patients with patellofemoral pain syndrome.

      Methods: This is a 2-arm, randomized with a blinded assessor. We selected 40 women with
      patellofemoral pain (age 25.2±4,years) were randomly assigned to one of two groups: placebo
      group (n= 20) and the Kinesio Taping® group (n=20). The placebo group received the
      application of a non-stretchable tape (Micropore) crosswise on the thigh and the Kinesio
      Taping® group followed all the criteria of the method in placing the bandage. All patients
      received the evaluation of the motor control banding pre and post a patch, by means of the
      method Y balance test.
    


Intervention name(s): Application of Kinesio Taping®; Kinesio Taping® placebo application
Intervention type(s): Other; Other
Intervention description(s): The technique was applied following the methods described in the original method for patellofemoral instability; Simulation of the application of the Kinesio Taping® technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Interoception and Sense of Movement in the Patient With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      To evaluate the effectiveness of an experimental rehabilitative protocol with specific tasks
      for the improvement of body awareness and the motor scheme in the patient with multiple
      sclerosis (EDSS <2.5).

      Primary outcome: improvement of the interoception (awareness of the body) and of the related
      motor capacity Secondary outcomes: improvement of balance and postural self-correction
      control
    

Detailed description: 
      Multiple sclerosis (MS) is a chronically progressive, disabling, autoimmune disease that
      affects the central nervous system causing a wide spectrum of sensory, motor, and
      neuropsychiatric signs and symptoms. In the great part of patients with MS, there is a
      cognitive deficit that can start already in the early stages of the disease. Disability
      related to the disease is usually investigated through the Expanded Disability Status Scale
      (EDSS), however, the scale does not evaluate some very disabling aspects of the disease such
      as diplopia, fatigue and the impact of cognitive disorders.

      The posture and postural self-correction are dependent on the image that anyone have of his
      own body and on the perception of it in the space, both internal and external. In multiple
      sclerosis proprioception and interoception are often altered due to motor and cognitive
      impairment.

      The investigators propose a rehabilitative protocol that combine postural rehabilitation with
      specific visual-spatial tasks, relaxation sessions with self-awareness improvement and
      cognitive rehabilitation.
    

Intervention name(s): Rehabilitative treatment protocol
Intervention type(s): Other
Intervention description(s): A combination of: postural exercise with visual spatial tasks, relaxation, balance exercise, motricity improvement and cognitive rehabilitation.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Interoception; Sense of movement; Posture; body scheme
Effects of Overload Progressive in the Treatment of Shoulder
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will
      be recruited and randomized into two groups of treatment. The group "a" will receive a
      strenghtening protocol with progressive overload during 20 sessions and group "b" will
      receive the same protocol with minimal load, without change during the 20 sessions. The
      primary outcomes measures will be pain, function, quality of life, global impression of
      recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6
      months (follow-up). The secundary outcomes will be disability, quality of life measure by
      other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these
      data, change will be measure from baseline at 10 weeks (after 20 sessions).
    


Intervention name(s): Strengthening protocol with progressive load; Strengthening protocol without progressive load
Intervention type(s): Other; Other
Intervention description(s): Strengthening protocol for scapular and shoulder muscles; Strengthening protocol for scapular and shoulder muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort
Condition: Low Intensity Knee Gonalgia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the daily eating of a yogurt supplemented
      with Mobile is effective in improving joint function and quality of life of individuals with
      low intensity gonalgia.
    

Detailed description: 
      The prevalence of low intensity gonalgia is relatively high in western population. The
      purpose of the present intervention study is to determine whether the daily consumption of a
      yogurt supplemented with Mobile is effective in improving joint function and quality of life
      of individuals with low intensity gonalgia. Previous research using in vitro and animal
      models have demonstrated the efficacy of Mobilee in reducing inflammation and promoting
      anabolic responses in joint tissues. In addition, in two previous human intervention trials,
      the effects of Mobilee in joint function had been assessed using isokinetic tests. The
      present trial aims to confirm those previous results.
    

Intervention name(s): Yogurt supplemented with Mobilee; Yogurt
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One yogurt (125mL) per day including 80mg of Mobilee; One yogurt (125mL) per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Joint discomfort; Functional Food; Joint function; Mobilee
Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer
Condition: Fertility Issues; IVF; Embryo Transfer
MeSH terms: Infertility
Study type: Observational

Summary: 
      The primary outcome of the study is to determine if a difference in terms of pregnancy rate
      exists between direct and afterload embryo transfer (ET) techniques.

      The secondary end points include the evaluation of the difficult transfer rates.
    

Detailed description: 
      The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers
      performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by
      using the direct and afterload protocols.

      Any blastocysts that underwent preimplantation genetic testing will be excluded from the
      analysis, as well as embryos derived from gamete donation or those imported from other
      centers.

      Data are gathered using a specific internal web-based database, which allows to organize,
      store and readily retrieve information about patients and IVF cycle.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers
        performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by
        using the direct and afterload protocols.
Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans
Condition: Pain; Oral Surgery; Third Molar Extraction
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This randomized clinical trial was designed to assess the clinical efficacy of Pulsed
      electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain
      and quality of healing after mandibular third molar extraction.

      The sample included 120 patients undergoing unilateral mandibular third molar extraction. The
      devices were positioned over the area corresponding to the extraction site and wearers were
      asked to keep them in place for 7 days. All patients were asked to record pain (on a visual
      analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics.
      At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain
      on palpation, postoperative bleeding, alveolitis) were recorded blindly.
    

Detailed description: 
      Introduction: Pulsed electromagnetic field (PEMF) therapy is a noninvasive method for
      delivering pulsed radiofrequency energy to tissues to treat postoperative pain and edema.
      This randomized clinical trial was designed to assess the clinical efficacy of PEMF delivered
      with a wearable device in terms of postoperative pain and quality of healing after mandibular
      third molar extraction.

      Materials and methods: The sample included 120 patients undergoing unilateral mandibular
      third molar extraction. At the end of the surgical procedure, patients were randomly assigned
      to a test (T) or placebo (P) group and fitted with enabled or disabled PEMF devices,
      respectively, or to a control (C) group not fitted with a PEMF device. The devices were
      positioned over the area corresponding to the extraction site and wearers were asked to keep
      them in place for 7 days. All patients were asked to record pain (on a visual analog scale
      [VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days,
      healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on
      palpation, postoperative bleeding, alveolitis) were recorded blindly.
    

Intervention name(s): RecoveryRx™
Intervention type(s): Device
Intervention description(s): Appliance of the device after surgery
Other intervention name(s): Pulsed electromagnetic fields
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulsed electromagnetic fields; post operative morbidity; third molar; extraction; pain
Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The purpose of this study is to describe visual outcomes, in particular spherical equivalent
      by manifest refraction and visual acuity across a range of distances, 6 months post
      implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with
      corneal astigmatism. Additionally, patient reported outcomes will be assessed.
    

Detailed description: 
      Each subject completed a preoperative examination of both eyes, implantation of IOL at the
      operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2,
      with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The
      second implantation generally occurred within 30 days of the first.
    

Intervention name(s): AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Intervention type(s): Device
Intervention description(s): Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Other intervention name(s): Models SND1T3, SND1T4, SND1T5
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intraocular lens; multifocal; toric
Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      To assess the diagnostic validity and cost-effectiveness of an infrared thermography system
      in adults with clinical suspicion of Obstructive Sleep Apnea (OSA).
    

Detailed description: 
      AIMS: To assess the diagnostic validity and cost-effectiveness of an infrared thermography
      system, integrated in an expert diagnostic algorithm (TIS), to determine the sleep stages and
      identify respiratory events, compared to conventional polysomnography (PSG) in adults with
      clinical suspicion of Obstructive Sleep Apnea (OSA).

      METODOLOGY: DESIGN: Prospective, unicentric, randomized and blinded study carried out into
      two phases: Phase I: Development of the tool in 99 full valuable adults with suspected OSA
      (PSG recruitment, coordination and quality control, image capture, Information and
      development of the expert system); Phase II: Validation of the tool compared with the PSG in
      another group of 99 full valuable adults with suspected OSA. INSTRUMENTALIZATION: a) Clinical
      history and anthropometric variables; b) Sleep and quality of life questionnaires; c) PSG; d)
      TIS; e) Cost-effectiveness study.

      ANALYSYS : The validity of the results of the TIS will be analyzed compared with the results
      of the PSG. The agreement measure will be established according to the different categories
      of the Apnea-Hypopnea Index (AHI), using ROC (Receiver Operating Characteristic) curves and
      the area under the curve. The investigators will also validate the therapeutic decisions made
      with PSG compared to those performed with the TIS. Finally, a cost-effectiveness study will
      be performed.
    

Intervention name(s): Therapeutic decision PSG; Therapeutic decision Infrared thermgraphy system
Intervention type(s): Other; Other
Intervention description(s): Randomizing for therapeutic decision taken with Standard Polysomnography (PSG); Also randomizing for Infrared thermography system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Infrared thermography system; Standard Polysomnography; Validity; Cost-effectiveness
Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study
Condition: Depression; Suicidal Ideation
MeSH terms: Depression; Depressive Disorder; Suicidal Ideation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study uses functional magnetic resonance imaging (fMRI) to investigate the effects of
      two different antidepressant medications (Paxil CR versus Wellbutrin XL) on reward processing
      in depressed patients who have attempted suicide or are currently experiencing suicidal
      thoughts.
    

Detailed description: 
      Major depressive disorder (MDD) is a common and serious psychiatric illness. It is among the
      leading causes of disability and is the psychiatric disorder most often associated with
      suicide. The treatment of MDD with antidepressant medication remains largely trial and error.
      Little empirical evidence exists to guide the treatment of MDD when suicide risk is a major
      factor.

      The study uses functional magnetic resonance imaging (fMRI) to compare the effects of
      paroxetine, an SSRI, versus bupropion, a non-SSRI, on brain activity in depressed patients
      with a past suicide attempt and/or current suicidal thoughts. Participants are randomly
      assigned to either paroxetine or bupropion treatment for 8 weeks, with fMRI scans involving a
      reward processing task at baseline and Week 8. Weekly study visits include interviews with a
      psychologist, self-report scales, and medication monitoring. All participants will then be
      offered 4 additional months of open clinical treatment. If original medication assignments
      prove to be ineffective, participants will have the option to switch to another medication.
      After completing the study, participants will be referred for ongoing treatment.
    

Intervention name(s): Paroxetine CR for Major Depressive Episode; Bupropion XL for Major Depressive Episode
Intervention type(s): Drug; Drug
Intervention description(s): Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.; Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.
Other intervention name(s): Paxil CR; Wellbutrin XL
Intervention MeSH terms: Bupropion; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Reward; BOLD signal; Suicide
Low-dose Gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
Condition: Ascendant Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm
Study type: Interventional

Summary: 
      We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without
      contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements.
    

Detailed description: 
      The actual protocol used in aorta evaluation consist of two CT-scans on the same study. The
      first scan that detects calcifications is using parameters with low-dose current, non
      EKG-gated and without contrast. The second scan uses iodine-contrast, EKG-gating and higher
      current dose to obtain higher image quality of diagnostic value.

      The study will optimize the first scan parameters and compare the measures of the aorta
      diameters from the standard protocol.

      By modifying the first scan parameters, we would demonstrate that the follow-up of an aortic
      aneurysm can safely be made with lower radiation exposure.
    

Intervention name(s): Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm
Intervention type(s): Other
Intervention description(s): On the same day, the subject will do :
Modified low-dose, EKG-gated CT without contrast
Usual high-dose, EKG-gated CT with contrast
Comparing aortic diameters from the two protocols.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse
Condition: Uterovaginal and Vaginal Vault Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This prospective interventional randomized controlled trial is conducted to compare a new
      technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament
      fixation technique for treatment of uterovaginal and vaginal vault prolapse.
    


Intervention name(s): Sacrospinous-Sacrotuberous fixation
Intervention type(s): Procedure
Intervention description(s): Sacrospinous-Sacrotuberous fixation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment