bioihbjkbjnl/mcl2 huggingface dataset:
Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients
Condition: Protein Metabolism; Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      A prospective, randomized and controlled study is proposed to establish whether an enteral
      nutrition support regimen based on pressurized whey protein and glucose improves the
      postoperative utilization of amino acid substrates compared to a drink based on glucose
      alone. The kinetics of protein metabolism (protein breakdown, protein synthesis and amino
      acid oxidation) will be investigated using stable isotope methodology before and after
      surgery in patients undergoing colon resection. Stable isotope infusions will be conducted
      one week before surgery and on the second postoperative day for two hours in the fasted state
      and for four hours while sipping the enteral nutrition support regimen. Patients will consume
      one of two enteral nutrition support regimens consisting of a drink containing either
      pressurized whey protein and glucose or glucose alone. It is hypothesized that an enteral
      nutrition support regimen based on pressurized whey protein and glucose promotes positive
      protein balance through increased protein synthesis or reduced protein breakdown compared to
      glucose alone.
    


Intervention name(s): Oral Nutrition Support
Intervention type(s): Dietary Supplement
Intervention description(s): The patients will sip the oral nutrition support (in the form of a drink) over the course of 4 hours within each 6 hour study. Each patient will be studied once before surgery and once after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Condition: Stroke; Secondary Prevention
MeSH terms: Neoplasm Metastasis; Stroke; Embolic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown
      source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1
      ratio) and have visits every three months. The study doctor may prescribe blinded concomitant
      ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs),
      Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when
      the required number of stroke events are positively adjudicated which is estimated to take 3
      years (including 2.5 years of enrollment).
    


Intervention name(s): optional ASA as comedication; placebo to ASA; placebo to optional ASA as comedication; placebo to dabigatran etexilate; ASA 100 mg; dabigatran etexilate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.; placebo to comparator drug; optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.; placebo; active comparator drug; active drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of umbilical cord blood
      mesenchymal stem cells with peripheral arterial disease.
    

Detailed description: 
      The present study is designed to implant UCB-MSC in patients with CLI, which are resulted
      from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis
      obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation
      procedure.
    

Intervention name(s): umbilical cord mesenchymal stem cells
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mobile Self-Management of Irritable Bowel Syndrome for Adolescents
Condition: Irritable Bowel Syndrome; Abdominal Pain
MeSH terms: Irritable Bowel Syndrome; Syndrome; Abdominal Pain
Study type: Interventional

Summary: 
      The objective of the proposed research is to conduct user testing of a mobile-based
      self-management support intervention for adolescents and young adults with Irritable Bowel
      Syndrome (IBS), a chronic digestive condition. The application (app; BodiMojo Buddy) uses a
      virtual coach that can serve to increase patient engagement through interactive
      skill-building, self-care, and mindfulness-based cognitive behavioral activities. If the
      BodiMojo Buddy mobile app is successful, it will have a significant public health impact by
      providing a mobile resource to the 10-15% of the US population who suffer from IBS and
      potentially improving health outcomes and reducing significant costs to the US healthcare
      system.

      Study participation involves participants downloading and using the app for 30 days. During
      the 30 days, participants will interact with the app by inputting their current mood,
      receiving supportive feedback from the app, reading messages, and doing brief activities
      (such as relaxation activities, etc.). Before and after the 30 days of user testing,
      participants will complete a few brief questionnaires about their behavior, how their
      symptoms affect their life, and how they receive support from others. These questions will
      take around 20 minutes to complete at each administration.
    


Intervention name(s): BodiMojo Buddy for IBS
Intervention type(s): Behavioral
Intervention description(s): Mobile application focusing on emotional coping skills for teens and young adults with IBS. Components of the module include: mood recorder and "mood cloud," with supportive feedback given based on mood choice; health behavior change support messages informed by mindfulness and self-compassion; quizzes with tailored feedback; library of meditations; an interactive coping skills advice section; and a link to an optional social support feature.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects on placebo-corrected change from baseline
      QT interval corrected for individual heart rate (QTcI) of JNJ-64565111 close to steady state
      on Day 26 and on electrocardiogram morphology at supratherapeutic exposures in otherwise
      healthy overweight/obese adults after 4 weeks of treatment with JNJ 64565111 administered
      subcutaneously once weekly.
    


Intervention name(s): JNJ-64565111; Moxifloxacin; JNJ-64565111-matching Placebo; Moxifloxacin-matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-64565111, subcutaneously on days 2, 9, 16, and 23.; Participants will receive moxifloxacin capsule on days 1 or 27 in a nested crossover manner.; Participants will receive JNJ-64565111-matching Placebo vehicle solution subcutaneously on days 2, 9, 16, and 23.; Participants will receive moxifloxacin-matching placebo capsule on days 1 and 27 in treatment group 1 and on day 1 or 27 in treatment group 2.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Pilates Exercises on Gross Motor Function and Balance
Condition: to Determine the Effect of Pilate's Exercises on Gross Motor Function and Balance
Study type: Interventional

Summary: 
      the study aimed to asses the effect of Pilate exercise on motor function and balance in
      diplegic children
    


Intervention name(s): PILATES EXERCISES
Intervention type(s): Other
Intervention description(s): The experimental group will receive Pilates exercises focusing on lower limb strength, flexibility and coordination in addition to exercises given to control group. Exercises or movements were done on a mat, on an exercise ball or in standing position while emphasizing on spinal and pelvic alignment, maintaining core contraction and the rhythm of respiration. All exercises were done for 10 repetitions with a rest period of two minutes before commencing the next exercise, and lasted for about 45 minutes. All the groups will receive the above mentioned interventions thrice in a week for a period of 10 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate
Condition: Phase 1
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study to Examine Pharmacodynamic Interaction Between Tesofensine and Metoprolol on
      24-hours Mean Heart Rate
    

Detailed description: 
      In this study, the dose-response relationship between tesofensine and metoprolol will be
      examined and thus the optimal dose of metoprolol to mitigate the effects of tesofensine on
      heart rate (HR) will be determined. HR is the primary endpoint because in the previous
      studies it has been shown to be the most affected safety endpoint by the effects of
      tesofensine.

      After enrolment of 37 subjects, 2 Subjects (0115 and 0147) in dose cohort 2 experienced
      prolonged tachycardia (> 120 beats per minute (bpm) lasting for 30 min) documented in Holter
      Electrocardiogram (ECG) recording (a stopping criteria of the study). Therefore, the study
      was temporarily halted on 22 November 2018. Subsequent to the temporary halt, Saniona
      reviewed all the available data in January and February 2019 and determined that the results
      obtained from the completed participants were sufficiently robust to answer the questions for
      which the trial was designed. Therefore, Saniona decided to permanently end the trial on 20
      February 2019.
    

Intervention name(s): Metoprolol Succinate 25 MG; Metoprolol Succinate 50 MG; Metoprolol Succinate 100 MG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of 25 mg metoprolol ER in the morning of Day 15, Day 18 or Day 21 approximately 30 minutes after start of a standard breakfast and together with the tesofensine dose.; A single dose of 50 mg metoprolol ER in the morning of Day 15, Day 18 or Day 21 approximately 30 minutes after start of a standard breakfast and together with the tesofensine dose.; A single dose of 100 mg metoprolol ER in the morning of Day 15, Day 18 or Day 21, approximately 30 minutes after start of a standard breakfast and together with the tesofensine dose.
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject will participate in a Screening Period (Day 28 to Day 3), a Baseline Period (Day -2 to Day -1) and a Treatment Period (Day 1 to Day 24) and will have two Follow-up phone calls (Day 30 and Day 50).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
Condition: Nail Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine the efficacy and safety of topical application of the
      gel compared to placebo in nail psoriasis.
    


Intervention name(s): Experimental Tazarotene Gel; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dietary Prevention of Photodamage in Skin With Grapes
Condition: Non-melanoma Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      To assess the effect of orally administered grape powder on the sunburn reaction in humans.
    

Detailed description: 
      To determine whether oral grape powder will result in a reduction in biomarkers associated
      with basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs). Biomarkers taken from
      non-sun-exposed skin and UV-exposed skin before and after treatment will be compared.

      The ultimate goal of this study will be to generate new knowledge of the photoprotective
      effect of grape powder on UV exposure. The results may be employed as the basis for a larger
      clinical trial to evaluate the potential of grapes to prevent non-melanoma skin cancers
      (NMSCs) and sun damage.
    

Intervention name(s): Reconstituted grape powder
Intervention type(s): Other
Intervention description(s): To prevent UV-induced skin cancers. Each subject's will have one arm exposed to 6 separate doses of UV (J/m2) [114, 217, 343, 500, 619, 848].
Other intervention name(s): Grape powder
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is
      generally safe and well tolerated in the Chinese population.
    


Intervention name(s): Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Intervention type(s): Biological
Intervention description(s): HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.
Other intervention name(s): V501
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Outcome After Lumbar Epidural Steroid Injection
Condition: Disc Disease
Study type: Observational

Summary: 
      prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for
      radiculopathy with HNP
    

Detailed description: 
      We will measure levels of the protein complex in the epidural space of patients undergoing
      lumbar ESI for radiculopathy with HNP. We assess functional outcomes at baseline and after
      treatment with the Medical Outcomes Study Short Form-36 instrument (SF-36). Our hypothesis
      was that the complex is present in patients with clinically significant functional
      improvement after ESI.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients considered candidates for ESI were 18 years of age or greater with a history of
        leg sensory complaints primarily dictated by pain with associated sensory symptoms and/or
        low back pain for two weeks or more who had failed expectant management with NSAIDS,
        activity modification, and/or physical therapy.
      
Biospecimen description: 
      lavage fluid from epidural space
    
Keywords: biomarker; epidural steroid; radiculopathy; hnp
Breathing Training to Improve Human Performance at High Altitude
Condition: Mountain Sickness Acute
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Individuals traveling to altitudes above 8,000 feet may suffer from impaired exercise and
      cognitive performance, and acute mountain sickness (AMS). Decreased barometric pressure,
      which leads to low blood oxygen levels, is the primary cause of these disorders. Symptoms of
      AMS are characterized by headache, nausea, vomiting, dizziness, fatigue, and difficulty
      sleeping. The goal of this research is to identify whether Respiratory Muscle Training will
      improve physical and cognitive performance, and reduce the symptoms of AMS, at simulated high
      altitude.
    


Intervention name(s): Respiratory Muscle Training; Sham Breathing Training
Intervention type(s): Device; Device
Intervention description(s): Subjects will breathe through a custom isocapnic Respiratory Muscle Training method developed in-house. The initial breathing frequency will be 30 breaths per minute. Subsequent sessions will begin with 20 minutes of breathing at the highest rate attained on the previous training day. During the last 10 minutes of each session, breathing rate will increase by 1-2 breaths/min.; Each subject in the sham group will be prompted to hold his breath for 10 seconds every 30 seconds (two times each minute) while breathing on a circuit visibly identical to that used in Respiratory Muscle Training. The subject will breathe ambient air normally after each breath hold. Each sham session will last 30 minutes total.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Exercise; Aerobic; Cognitive Function
Quality of Life and Self-esteem After Botox® Injections in Depressed and Non-depressed Patients
Condition: Depression; Quality of Life
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine the alterations in quality of life and
      self-esteem after BOTOX® injections in the glabella in depressed and non-depressed patients.

      The secondary objective of this study are:

        -  to assess wrinkles improvement

        -  to evaluate depressive symptoms using Beck Depression Inventory before and after Botox®
           injections.

        -  to elucidate that depression is not a contraindication for botulinum toxin injections.
    

Detailed description: 
      The study consists of two groups: one with diagnosis of depression (diagnostic criteria from
      DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0) and
      other without diagnosis of depression.

      Subjects with depression will be part of group 1. They must be using a therapeutic dose of
      antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

      Subjects with no diagnosis of depression will be part of group 2. Subjects included in the
      study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A
      (BOTOX®, Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5
      points of glabellar area as the treatment.

      Four visits will be scheduled. Visit 0 (baseline), Visit 1 (intervention), visit 2 (4 weeks),
      visit 3 (8 weeks) visit 4 (12 weeks).

      The scales for the assessment of depressive symptoms, Beck Depression Inventory (BDI), will
      be applied at visits 1,2,3,4; WHOQOL BREF will be applied at baseline visit and 4.

      Rosenberg Self-Esteem Scale will be applied in all visits. Photographs will be taken as well
      as the dermatological evaluation of the wrinkles and folds will be assessed using a 4-points
      validated Severity Wrinkles Scale, and psychiatric evaluation as well, in both groups.
    

Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Drug
Intervention description(s): Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.
Other intervention name(s): Botox®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Botulinum toxin; Glabella; Quality of life; Self-steem
Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation
Condition: Kidney; Complications, Allograft
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the effectiveness of eculizumab in recipients of kidney
      transplantation with donor-specific antibodies (DSA) and worsening kidney function and to
      assess if eculizumab improves endothelial cell injury in the kidney.

      The investigators hypothesize that complement inhibition with eculizumab will reduce
      allograft injury, resulting from less complement-mediated injury of endothelial cells and
      less endothelial cell activation.
    

Detailed description: 
      This study will address the clinical challenge that currently exists in the management of
      kidney transplant recipients who have developed de novo DSA, have deteriorating graft
      function, yet have no established treatment alternative.

      This is a randomized, open-label, pilot intervention trial. Post transplant patients with
      deteriorating renal function (defined as 20% reduction in GFR) will be screened for the
      development of DSA and biopsied for the presence of C4d deposition. All patients with DSA and
      those meeting inclusion/exclusion criteria will undergo protocol renal biopsy and will be
      assessed for C4d deposition. Participants will be randomized to treatment with eculizumab
      plus standard of care (SOC) or SOC only. Randomization will be stratified by C4d status
      (C4d+/C4d-) with 10 subjects (7 eculizumab, 3 SOC only) in each stratum.

      Eculizumab is an antibody that has been developed to inhibit the complement protein C5.
      Eculizumab will be delivered via IV according to the following schedule:

        -  Eculizumab Induction 600mg IV every 7 days for 4 doses

        -  Eculizumab 900mg IV 7 days later

        -  Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks
    

Intervention name(s): eculizumab
Intervention type(s): Drug
Intervention description(s): Eculizumab Induction 600mg IV every 7 days for 4 doses
Eculizumab 900mg IV 7 days later
Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks
Other intervention name(s): h5G1.1-mAb; Soliris
Intervention MeSH terms: Eculizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic kidney allograft injury; complement protein; eculizumab; Kidney transplantation