bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of TBCT Compared to ERP in the Treatment of OCD Patients, by the Assessment of Magnetic Resonance.
Condition: OBSESSIVE COMPULSIVE DISORDER (OCD)
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This is a sample made up of ninety-six adult individuals of both sexes to be divided into
      three groups: the experimental group of thirty-two patients with OCD who will be undergone
      Trial-Based Cognitive Therapy; the gold standard, with thirty-two people with OCD subject
      Exposure and Response Prevention and the control group of thirty-two healthy individuals.
      Interviews and therapeutic intervention occur in private practices researchers or medical
      schools accredited by UESPI.

      Experimental group: Will be eligible adults of both sexes with educational level equal to or
      higher education complete primary, aged between 18 and 60 years with OCD diagnosis confirmed
      according to criteria DSM-IV (APA, 1994). It is going to be excluded patients who had
      previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.
    

Detailed description: 
      OBJECTIVES

      Evaluate the effectiveness of Trial-Based Cognitive Therapy (TBCT) compared to Exposure and
      Response Prevention (ERP) in the treatment of OCD patients, by neuroimaging tests such as
      MRI.

        1. Describe the neuroanatomical profile of the sample participants before and after the
           psychotherapeutic intervention by MRI;

        2. Compare the profile neuroanatomical between the experimental group and the control group
           by MRI;

        3. Identify possible neuroanatomical differences in the participating sample of pre and
           post-treatment, both among individuals and among psychotherapeutic intervention groups;

        4. To investigate associations between the results of MRI scans and indexes the scales
           currently used to assess severity of OCD.
    

Intervention name(s): Cognitive Therapy; Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Trial-Based Cognitive Therapy (TBCT) is a three-level, three-phase, case formulation approach. TBCT's foundation is in cognitive therapy (CT); however, it has a unique approach to conceptualization and techniques that make it a distinct intervention in modifying patients' core beliefs, especially those about the self. All the individuals will be submitted to MRI.; The Behavioral therapy employs the technique of Exposure and Response Prevention ( ERP ).The technique involves directly exposing patients to recall stimulation of obsessive thoughts and prevent them from performing the compulsive rituals. All the individuals will be submitted to MRI.
Other intervention name(s): Trial-based cognitive therapy; Exposure and Response Prevention (ERP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      During 3D-conformal external beam radiation therapy treatments for prostate cancer, the
      prostate gland moves. The purpose of this study is to determine whether the placement of a
      prostate immobilization device into the rectum during radiation treatments will decrease the
      risk of rectal bleeding that is sometimes seen as a late effect from radiation.
    

Detailed description: 
      -  MRI using an endorectal coil done prior to treatment for staging.

        -  Baseline Quality of Life (QOL) assessment will be completed prior to treatment.

        -  Total androgen suppression is initiated and will continue for at least 6 months.

        -  Prostate Immobilization Device (PID) placed during the planning session.

        -  PID will be placed daily for the first 15 3D external beam radiation treatments.

        -  QOL assessment and follow-up will take place every 6 months for 3 years.
    

Intervention name(s): Prostate Immobilization Device
Intervention type(s): Device
Intervention description(s): Device placed during radiation treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Androgen Suppression; Simulation; 3-D Conformal External Beam Radiation Therapy; Intra-rectal immobilization device; Quality of Life Assessment Questionnaire; Rectal Bleeding; Late effects
Cooling Vest in Men With Hot Flashes
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      This study is intended to determine the efficacy of the Cooling Vest in reducing the
      frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy
      treatment for prostate cancer.
    

Detailed description: 
      The Cooling Vest is a vest manufactured by Nanohealth, Inc. It is a cool therapy device
      intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat.
      The material in the vest is safe, non-toxic, and eco-friendly.

      This study attempts to collect data on the effects of the Cooling Vest in men with hot
      flashes and night sweats due to the side effects of chemotherapy. Participants will use the
      vest for 4 weeks and questionnaires will be used to determine effect.
    

Intervention name(s): Cooling Vest
Intervention type(s): Device
Intervention description(s): A cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging
Condition: Coronary Artery Disease; Stable Angina; Unstable Angina
MeSH terms: Coronary Artery Disease; Angina Pectoris; Angina, Stable; Angina, Unstable
Study type: Interventional

Summary: 
      MRI has the ability to visualize the arterial vessel wall. Wall thickening and
      atherosclerotic plaque components can be visualized in the carotid arteries and the aorta.
      Previous studies also demonstrated the ability of MRI to visualize the coronary vessel wall.
      The ultimate goal of coronary vessel wall imaging is to detect vulnerable atherosclerotic
      plaque thereby. This might prevent complications, e.g., chest pain (angina) or myocardial
      infarction.

      The goal of this study was to validate MRI of the coronary vessel wall by comparing it to
      intravascular ultrasound (IVUS), to detect atherosclerotic plaque in the coronary vessel wall
      and to look at the uptake of the albumin-binding contrast agent gadofosveset in
      atherosclerotic plaques. The main hypothesis is that due to the albumin binding
      characteristics, uptake of the contrast agent will take place in the more vulnerable plaques
      compared to less vulnerable plaques. MRI will be compared to X-ray coronary angiography and
      intravascular ultrasound, two techniques currently considered as the standard of reference
      for imaging of the coronary arteries and vessel wall.
    


Intervention name(s): Contrast enhanced MRI with Gadofosveset
Intervention type(s): Other
Intervention description(s): 0.03 mmol/kg bodyweight of gadofosveset will only once be administered during MRI procedure via an intravenous catheter
Other intervention name(s): Vasovist; MS-325
Primary purpose: Diagnostic
Keywords: coronary artery; MRI; vessel wall imaging
Spatial Repellent Products for Control of Vector Borne Diseases - Malaria - Indonesia
Condition: Malaria
MeSH terms: Malaria; Vector Borne Diseases
Study type: Interventional

Summary: 
      The primary objective of the study is to demonstrate and quantify the protective efficacy
      (PE) of spatial repellent products in reducing the incidence of malaria infection in human
      cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between
      intervention and control arms.
    

Detailed description: 
      The primary epidemiological endpoint will be the incidence density of first time malaria
      infections among human cohorts during the follow-up period as detected by polymerase chain
      reaction assay (PCR). This measure will inform PE (the reduction of incidence) between
      intervention and control study arms using the formula: PE =[(Ip - Ia)/Ip]* 100%; based on an
      expected minimum effect size of 30%. First time infections in these subjects will offer
      relatively unambiguous evidence of the extent of exposure to infectious mosquito bites. The
      primary entomological endpoint will be adult densities of vector species via human-landing
      catch (HLC) from sentinel households from intervention and control arms over the follow-up
      period.

      Secondary epidemiological endpoints will be the incidence density of first time malaria
      infections among human cohorts during the follow-up period as detected by microscopy and the
      total number of cases averted (i.e., all Plasmodium spp. infections in cohort subjects).
      Secondary entomological endpoints include number of sporozoite infected mosquitoes, parity
      and species-specific effects of the spatial repellent product.

      Both epidemiological and entomological endpoints will be utilized to look at the relationship
      between SR and PE based on product coverage (to include diversion and community effects) and
      insect behavior. The prospect of SR associated temporal cumulative effects on study endpoints
      (epidemiological and entomological) over transmission seasons will also be investigated by
      using the cumulative incidence of infection over the season and applying a survival curve
      analysis of the cohort data.
    

Intervention name(s): Spatial Repellent product with active ingredient (SHIELD); Active ingredient; Spatial Repellent product without active ingredient (SHIELD)
Intervention type(s): Device; Device; Device
Intervention description(s): Spatial Repellent Product; Transfluthrin (Active ingredient); Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
Other intervention name(s): SHIELD; Transfluthrin; Placebo SHIELD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; Spatial Repellents; Plasmodium
Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycaemic Levels
Condition: Glucose Metabolism Disorders (Including Diabetes Mellitus)
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      The goal of this study was to perform a clinical trial to compare the impact of herbal
      chickpea pulao (cooked Indian-Pakistani rice dish) on improving postprandial blood glucose
      levels in type-2 diabetic people. The main questions it aims to answer are:

        -  Whether Indian rennet and fenugreek seed extract can modulate blood sugar levels or not?

        -  At what concentration the flavor, taste, and blood sugar impact were acceptable?

      Participants were provided with control and intervention herbal chickpea pulao for a period
      of 21 days and asked to provide feedback on taste, flavor, and over-acceptability, and their
      postprandial blood glucose levels were checked.
    


Intervention name(s): Fenugreek Seeds and Indian Rennet
Intervention type(s): Dietary Supplement
Intervention description(s): Food herbs like fenugreek Seeds and Indian rennet to formulate rice dish.
Intervention MeSH terms: Fenugreek seed meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Chickpea pulao; Fenugreek seeds; Indian rennet; Glucose modulating
The Role of Low Level Laser Therapy in Acceleration of Teeth Alignment in Lingual Orthodontic Patients
Condition: Malocclusion, Angle Class I; Crowding
MeSH terms: Malocclusion; Malocclusion, Angle Class I
Study type: Interventional

Summary: 
      We will treat patients with class I malocclusion who have moderate crowding (4-6 mm)
      according to Little's irregularity index and asses the efficacy of low level laser therapy in
      accelerating orthodontic tooth movement .

      There is two groups :

        1. treated with Low level laser therapy (LLLT)

        2. treated traditionally without any irradiation Patients will be randomly allocated in any
           group and all data will be collected through photographs when leveling and alignment
           completed.

      Also pain levels will be assessed using numeric rating scale to compare between the two
      groups and if laser really can relief pain or not .
    

Detailed description: 
      The time of orthodontic treatment is considered to be one of the most concerns for patients.
      The study will investigate the effect of low level laser therapy on the speed of orthodontic
      tooth movement during the correction of moderately crowded anterior upper teeth using lingual
      orthodontic appliance.

      The study will be accomplished with two arms, the first is LLLT arm and the other is the
      control arm without any active intervention.

      Low level laser with a wave length of 830 nm, output of 150 mW, energy of 2 J per point and
      application time of 15 seconds per point will be applied on each tooth of the six upper
      incisors according to this protocol: the root will be divided into 2 halves; gingival and
      cervical. Laser will be applied in the center of each half from both the buccal and palatal
      sides which means 4 application points and a total energy of 8 j per each tooth.

      Within the limits of our knowledge, this is the first study in the world that will study
      acceleration of orthodontic tooth movement with lingual orthodontic .
    

Intervention name(s): low level laser therapy; Lingual Orthodontics
Intervention type(s): Radiation; Device
Intervention description(s): low level laser therapy will be used in order to induce tooth movement. low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 Joules/each tooth.; Lingual braces will be used to conduct the orthodontic treatment of patients with moderate level of crowding on the upper dental arch.
Other intervention name(s): LLLT; soft tissue laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Multimodal Cognitive Enhancement Therapy (MCET) for Ealy Dementia
Condition: Mild Cognitive Impairment; Dementia, Mild
MeSH terms: Dementia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the effects of Multimodal Cognitive Enhancement Therapy (MCET) for
      people with mild cognitive impairment and early stage dementia by a randomized, controlled
      (mock-therapy), double-blind, cross-over trial
    

Detailed description: 
      Multimodal Cognitive Enhancement Therapy (MCET) was developed for cognitive rehabilitation of
      mild cognitive impairment or ealy dementia. MCET consists of cognitive training, cognitive
      stimulation, reality orientation, physical therapy, reminiscence therapy and music therapy
      that obtained 'A' grade of recommendation by SIGN(Scottish Intercollegiate Guidelines
      Network) for their efficacy (one of the followings: global cognition/specific cognitive
      domain/mood/activities of daily living/behavioral and psychological symptoms/quality of life)
      based on the systematic review and meta-analysis performed by our research team.

      This study investigated the efficacy of MCET compared with mock-therapy that consisted of
      random activities that were not based on clinical evidences (e.g., watching TV, conversation
      etc.).
    

Intervention name(s): Period I MCET (8 wks); Washout (4 wks); Period II MCET (8 wks)
Intervention type(s): Other; Other; Other
Intervention description(s): MCET_Mock group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk) Mock_MCET group: mock-therapy (3 sessions/wk); 4 weeks wash-out period in both arms and cross-over; MCET_Mock group: mock therapy (MCET) (3 sessions/wk) Mock_MCET group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild cognitive impairment; Dementia; Cognitive training; Cognitive rehabilitation; Cognitive therapy
Neutrophil Extracellular Traps as a Biomarker to Predict Portal Vein Tumor Thrombosis in Patients With Hepatocellular Carcinoma
Condition: Neutrophil Extracellular Trap Formation; Portal Vein Tumor Thrombosis
MeSH terms: Carcinoma, Hepatocellular; Thrombosis
Study type: Observational

Summary: 
      The aim of this study was to investigate whether NETs markers can enhance predict portal vein
      tumor thrombosis in patients with live cirrhosis, so as to establish a novel predictor to
      guide clinical decision-making.
    

Detailed description: 
      Eighty-six patients with patients treated at the Affiliated Hospital of Qingdao University
      (China) from September 2020 to January 2021 were recruited for this study, including 14
      patients with portal vein tumor thrombosis, 28 patients without portal vein tumor thrombosis
      and 44 patients without hepatocellular carcinoma. NETs markers (Myeloperoxidase, Neutrophil
      elastase, Citrate histone H3), and anti-β2 glycoprotein I were detected in plasma using
      capture ELISA and specific ELISA kits. T-test was performed to analyze whether there was a
      statistical difference between the two groups, and regression analysis was performed between
      NETs markers and tissue factor and anti-β2 glycoprotein I to investigate whether there was a
      correlation. This study without any intervention measures, will not cause harm.
    

Intervention name(s): test NETs markers
Intervention type(s): Other
Intervention description(s): NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Eighty-six patients with patients treated at the Affiliated Hospital of Qingdao University
        (China) from September 2020 to January 2021 were recruited for this study, including 14
        patients with portal vein tumor thrombosis, 28 patients without portal vein tumor
        thrombosis and 44 patients without hepatocellular carcinoma.
      
Keywords: Neutrophil Extracellular Trap; Portal Vein Tumor Thrombosis
Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)
Condition: Undifferentated Shock
MeSH terms: Hypotension
Study type: Observational

Summary: 
      The objective of the study is to observe the change in hemodynamic variables (i.e. CO, SV,
      HR, SV) as assessed during rapid fluid bolus.
    

Detailed description: 
      The Noninvasive Starling SV (Baxter Healthcare) is a portable, non-invasive, cardiac output
      detector system. The Starling SV system measures the cardiac output by employing electrical
      bioreactance. Bioreactance is a measure of the electrical characteristics of a volume of
      tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes
      the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

      The objective of the study is observe the change in hemodynamic variables (i.e. CO, SV, HR,
      SV) as assessed during the initial resuscitation of 30 ml/kg of fluid, to evaluate the
      feasibility of performing a larger prospective RCT of SV-guided resuscitation in patients who
      undergo a dynamic assessment of fluid responsiveness to help guide fluid administration.

      This study is a prospective feasibility study. Patients will be evaluated by the Emergency
      Room team for Inclusion/Exclusion criteria. If the patient is found to fit the study
      inclusion and exclusion criteria, then the fully non-invasive Starling monitor will be
      applied to the patient and the patient's hemodynamic data will be prospectively collected
      during the initial fluid resuscitation.
    

Intervention name(s): Starling SV
Intervention type(s): Device
Intervention description(s): The Starling SV will monitor the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial fluid resuscitation in individuals with hypotension related to infection.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be drawn from all patients who undergo present to the Emergency
        Room with symptoms of suspected or confirmed septic shock, and who are identified to
        receive a 30cc/kg fluid bolus of resuscitation fluid as part of treatment.
      
Keywords: Resuscitation
Empagliflozin-based Quadruple Combination vs Insulin Glarine-based Combination Therapy in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared
      to insulin glargine-based antidiabetic agents (OADs) combination thearpy in patients with
      type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The targeted population consists of adult patients with type 2 diabetes mellitus treated in
        outpatient setting by specialists.
      
Keywords: Type 2 diabetes; Sodium glucose cotransporter 2 inhibitor; Empagliflozin; Insulin glargine