bioihbjkbjnl/mcl2 huggingface dataset:
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
Condition: Mitral Valve Regurgitation of Any Grade
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      The study primarily aims to collect standard of care clinical data in a wide spectrum of
      simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing
      stand-alone software prototype (QFlow), developed by Philips Research Paris (Medisys).

      Investigator does not intervene in the care of the patient, but simply collects standard of
      care images and measurements that are needed for the validation of the investigational
      software.
    


Intervention name(s): TransEsophageal Echocardiography and TransEsophageal Echocardiography; Cardiac Magnetics Resonance; MitraClip
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): imaging as standard practice; imaging as standard practice; imaging as standard practice
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Mindfulness in Adolescents With Obesity
Condition: Mindfulness; Usual Care
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The goal of this study is to conduct a single arm open trial to examine the feasibility of a
      brief, adjunctive mindfulness intervention tailored to the needs of adolescents with severe
      obesity.
    

Detailed description: 
      The purpose of this study is to examine whether it is feasible to integrate a brief,
      adjunctive mindfulness intervention with the standard medical management of obesity in
      adolescents with severe obesity. Mindfulness refers to the experience of paying attention to
      the present moment in a nonjudgmental manner. Mindfulness training enhances one's ability to
      cope with negative emotions and one's awareness of decision-making processes and internal
      experiences.

      The proposed study has two specific aims: 1) to conduct a single arm open trial to examine
      the feasibility and acceptability of the mindfulness intervention in a sample of 15
      adolescents with severe obesity; and 2) to examine the preliminary efficacy of the
      mindfulness intervention on BMI, emotion regulation, eating and weight-related behaviors,
      impulsivity, waist circumference, and blood pressure in comparison to the standard of care.
    

Intervention name(s): Mindfulness; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. The mindfulness intervention consists of 6 weekly sessions focused on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.; Participants will receive the recommended standard of medical management of overweight and obesity. The clinic team conducts a comprehensive evaluation of the patient to assess dietary and activity behavior change needs of each patient and family, as well as obesity-associated comorbidities. In addition to management of comorbidities, goals for improved physical activity and dietary behaviors are set with the patient and family at each visit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
Condition: Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms
Study type: Interventional

Summary: 
      This study will evaluate the efficacy and safety of Impact Oral in Patients undergoing
      Surgery for Gastrointestinal Cancer, half of the participants will receive Impact Oral
      nutrition therapy, the other half will receive Enteral Nutrition Emulsion(TPF-T) therapy.
    

Detailed description: 
      The present protocol describes a randomized, active-controlled, open labelled study in which
      either IMPACT Oral or Enteral Nutrition Emulsion(TPF-T) will be given to surgical patients
      for 5 days before surgery and 7 days after surgery. Both of the study products include
      immunonutrition, but the nutrient proportion is different.

      Prealbumin, C-reaction protein (CRP), Albumin，immunology parameters, the results of physical
      examination, vital signs, relevant nutrition- and safety-related laboratory parameters and
      the number, severity, seriousness, relatedness and outcome of Adverse Events (AEs) will be
      evaluated in this study.
    

Intervention name(s): Impact Oral; Enteral Nutrition Emulsion(TPF-T)
Intervention type(s): Other; Other
Intervention description(s): Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.; TPF-T
Other intervention name(s): Changnei Yingyang Ruji(TPF-T)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Introduction: Current rates of postoperative nausea and vomiting (PONV) experienced by
      outpatient surgery patients are as high as 20-30%. Electroacustimulation (EAS) therapy has
      been demonstrated to be effective in controlling these symptoms, but trials identifying their
      efficacy in the outpatient surgery population are lacking. This study integrates conventional
      pharmacotherapy with alternative medicine in prevention of PONV.

      Materials and Methods: One hundred twenty two patients undergoing surgery procedures at an
      outpatient surgery center were randomized to two treatment arms. The first arm was
      standardized pharmacologic PONV prevention typical for patients undergoing outpatient
      surgery, while the second arm employed the use of ReliefBand, an FDA-approved
      electroacustimulation (EAS) device with pharmacologic treatment to relieve symptoms of PONV
      and pain. EAS is a derivative of acupuncture therapy that uses a small electrical current to
      stimulate acupuncture points on the human body and is thought to relieve nausea, vomiting and
      pain. Outcomes measured were post-op questionnaires evaluating pain and nausea symptoms,
      emetic events, the need for rescue medications and the time to discharge.
    


Intervention name(s): Electroacustimulation
Intervention type(s): Device
Intervention description(s): Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.
Other intervention name(s): ReliefBand (Aeromedix, Jackson, WY)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Observational

Summary: 
      Based on published data and according to the approved product label for ankylosing
      spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days
      should be effective in psoriatic arthritic patients with axial involvement.
    

Detailed description: 
      A recent review from GRAPPA group evaluates therapies for PsA including peripheral and axPsA.
      Analysing particularly the results with present biologic therapies it has been proven that
      outcome data at 24 weeks show excellent results in the treatment of peripheral forms of PsA
      with either of the three biologics disposable in the market, that is to say infliximab,
      etanercept and adalimumab.

      However when it comes to analyse data on PsA patients with axPsA there are not results at
      all. The design of clinical trials did not evaluate axial outcomes and therefore there is not
      a possibility of knowing whether these therapies are useful in axPsA.

      This is an open label multicenter study designed to evaluate the effectivity of adalimumab 40
      mg every 2 weeks during 24 weeks in patients with active axial PsA despite receiving
      Methotrexate, Sulfasalazine, Leflunomide or Cyclosporine, plus NSAIDs and no more than 10 mg
      of corticosteroids.
    

Intervention name(s): Adalimumab (HUMIRA®)
Intervention type(s): Drug
Intervention description(s): Prefilled syringes containing 40 mg Adalimumab in 0.8 ml injection solution. Study drug will be subcutaneously self-administered every 2 weeks during 24 weeks.
Other intervention name(s): HUMIRA®
Intervention MeSH terms: Adalimumab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with active axial forms of psoriatic arthritis
      
Biospecimen description: 
      Samples recollected for analysing IL6 and MMP3 from patients blood serum.
    
Keywords: Axial psoriatic arthritis; Adalimumab; Humira; anti-TNF
The Effects of a Relaxation Intervention on College Students' Social-emotional Competence
Condition: Stress
Study type: Interventional

Summary: 
      Objective: To examine the impact of a psychomotor relaxation program on college students'
      social-emotional competence, personal and professional development. Participants: Twenty
      female college students participated. Methods: In this non-random one-group repeated measures
      study with a mixed approach (quantitative and qualitative analysis), participants were tested
      on two occasions 4 weeks apart (baseline measure), and then engaged in the psychomotor
      relaxation program twice weekly for 8 weeks. Participants were tested again after the
      intervention program (post-test).
    

Detailed description: 
      This was a non-random one-group repeated measures study with a mixed approach (quantitative
      and qualitative analysis), where participants served as their own controls.

      The investigators examined the chronic effects of the intervention program, collecting the
      instruments online at week 1 (pretest 1) and week 5 (pretest 2), to establish the baseline
      measures, and at the end of the 8-week period (post-test). In the post-test evaluation,
      participants also completed the questionnaire with open-ended questions. Investigators also
      measured salivary cortisol at the beginning and end of the 1st and the 15th sessions to
      evaluate the acute effects of the intervention program.

      Students participated in a psychomotor relaxation program comprised by two 20-minute sessions
      per week for 8 weeks, combining body awareness, muscle tone regulation and breathing
      exercises
    

Intervention name(s): Psychomotor Relaxation
Intervention type(s): Other
Intervention description(s): Psychomotor relaxation sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: social-emotional development; body-oriented intervention; stress; higher education
A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of
      DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).
    


Intervention name(s): DA-1229_01; E+M
Intervention type(s): Drug; Drug
Intervention description(s): complex single administration; co-administration of 2 drugs
Other intervention name(s): Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets; Evogliptin 5 mg + Metformin XR 1000 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Longitudinal Study of Outcomes Measures in ALS Trials
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Observational

Summary: 
      A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was
      developed to precisely and conveniently measure static limb strength in patients with ALS.
      The investigators will compare ATLIS data with data from two commonly used ALS outcomes
      measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in
      a prospective, longitudinal study. All three outcomes measures will be performed on 100
      subjects collected preferably at bi-monthly clinic visits during the study period.
    

Detailed description: 
      Four sites will participate in data collection for this study and will enroll approximately
      20-30 subjects per site. Subjects will be tested every 1 to 4 months for up to two years.
      Subjects will be tested at each visit using ATLIS, ALSFRS-R questionnaire and slow vital
      capacity testing.

      Inclusion criteria:

        -  Subjects 18 years or older diagnosed with clinically possible, laboratory supported
           probable, probable or clinically definite ALS according to the World Federation of
           Neurology Revised El Escorial Criteria.

        -  Capable of providing informed consent and complying with trial procedures.

      Exclusion criteria:

      - Patients, judged by the site clinical investigator to have medical conditions that may
      limit their ability to safely exert maximal force using the muscles in their arms and legs
      will be excluded from this study (e.g. unstable hypertension, significant cardiac disease,
      significant musculoskeletal disorders, or other medical conditions).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults with ALS
      
Keywords: outcomes measures; strength measurement; disease progression
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
Condition: Chronic Hepatitis B Virus, Pediatric
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric
      patients with chronic hepatitis B virus infection
    


Intervention name(s): Entecavir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response; Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response
Other intervention name(s): Baraclude; BMS-200475
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Investigating the Effect of E7337 on Tumor Like Lesions in Computed Tomography (CT) of the Liver
Condition: Lesions of the Liver
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicenter, randomized, open-label study to investigate the superiority of the
      contrast enhancement effect of E7337 on tumor-like lesions in the Dynamic CT of the liver.
    


Intervention name(s): E7337
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Analgesic Effect of Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach
Condition: Laparoscopic Cholecystectomy
Study type: Interventional

Summary: 
      This study will define the postoperative analgesic effect of ultrasound-guided bilateral
      modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) and compare
      the control group in patients undergoing laparoscopic cholecystectomy.
    

Detailed description: 
      Laparoscopic cholecystectomy is the most common laparoscopic procedure and causes moderate to
      severe postoperative pain. The M-TAPA block was described by Tulgar et al. for postoperative
      analgesia of abdominal surgeries. However, studies showing the analgesic efficacy of this
      block are lacking. In this prospective interventional trial, the investigators aim to define
      the efficacy of M-TAPA block for laparoscopic cholecystectomy surgeries under general
      anesthesia.

      This study will be conducted as a single-center, prospective, randomized, double-blinded
      trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy
      will be screened for enrollment in the study. After randomization, the patients in the Group
      M-TAPA will receive bilateral M-TAPA block at the beginning of the operation defined by
      Tulgar et al or no intervention (Group N). An anesthesiologist who performed M-TAPA block
      will not involve in the data collection. Other health care workers who will involve in the
      evaluation of postoperative pain scores, vital parameters, nausea and vomiting, anti-emetic
      and opioid consumption will be blinded to group assignment.
    

Intervention name(s): M-TAPA block; Standard perioperative and postoperative multimodal analgesia
Intervention type(s): Procedure; Other
Intervention description(s): After tracheal intubation, a high-frequency linear probe will placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.; The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol.
Other intervention name(s): Global Quality of Recovery-40 score; Standard Pain Followup and Monitorization; Global Quality of Recovery-40 score; Standard Pain Followup and Monitorization
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Modified-thoracoabdominal nerves block; Acute pain; laparoscopic cholecystectomy
Study Evaluating IMA-026 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMA-026
      administered subcutaneously (SC) or intravenously (IV) in healthy adults.
    


Intervention name(s): IMA-026
Intervention type(s): Biological
Intervention description(s): SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adult
Vercise Implantable Stimulator for Treating Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to document patient outcomes, including effectiveness, safety,
      and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS)
      Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment
      of moderate to severe idiopathic Parkinson's Disease (PD).
    

Detailed description: 
      This is a multi-center, prospective, open label, non-randomized study which will use a
      within-patient control (each patient serves as his/her own control) to document patient
      outcomes, including effectiveness, safety, and health economic data for the Boston Scientific
      implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the
      subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's
      Disease (PD).
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Rechargeable Deep Brain Stimulation System
Intervention model: Single Group Assignment
Intervention model description: Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep Brain Stimulation; Parkinson's Disease
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
Condition: Dose Finding Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single oral doses of
      TAK-828 in healthy non-Japanese and Japanese participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate
      the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single oral
      doses of TAK-828 in healthy non-Japanese and Japanese participants.

      The study enrolled 36 healthy participants. An interleaving crossover design with placebo
      substitution was used for Cohorts 1 and 2, and a crossover design was used in Cohort 3. Each
      cohort consisted of 12 participants, and participants were randomized to treatment sequence
      to receive TAK-828 or placebo after undergoing a fasting stage of at least 8 hours through
      intervention periods 1-4 for Cohorts 1 and 2 and through intervention periods 1 - 3 for
      Cohort 3. The assigned treatment sequence will remain undisclosed to the participant and
      study doctor during the study (unless there is an urgent medical need). An additional
      interventional period 5 (fed state) is planned to be conducted in either cohort 1 or 2, based
      on the dose of TAK-828 that will be chosen to be studied under fed conditions. Cohorts 1 and
      2 were conducted in non-Japanese participants and Cohort 3 in Japanese participants.

      This multi-center trial was conducted in the United States. Participants remained confined to
      the study site from check-in (Day -1) through Day 4 of each intervention period and returned
      7 to 10 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-828; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-828 oral solution; TAK-828 placebo-matching oral solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug therapy