bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Supplements and Foot Surgery
Condition: Foot Injuries and Disorders
MeSH terms: Foot Injuries
Study type: Interventional

Summary: 
      This is a prospective randomized trial wherein participants will be assigned to NutraHeal™,
      NutraHeal Plus™, or standard of care for 1 week prior to foot surgery and 3 weeks after
      surgery. The central hypothesis is that among patients undergoing surgery, nutritional
      supplements that maintain energy production, muscle structure, immune function, and response
      to pain will support recovery from surgery.
    

Detailed description: 
      Over a 6 month period the investigators will enroll 45 male and female patients undergoing
      foot surgery. This is a prospective randomized trial and participants will be assigned to
      NutraHeal™ (n=15), NutraHeal Plus™ (n=15), or standard of care (n=15) for 1 week prior to
      surgery and 3 weeks after surgery. NutraHeal™ is a nutritional supplement that contains 7.5
      micrograms (300 IU) of Vitamin D3, 80 mg of Calcium as Calcium Hydroxymethylbutyrate
      Monohydrate, 7.5 mg of Zinc, 600 mg of Calcium Hydroxymethylbutyrate Monohydrate, and 45 mg
      of Bromelain. NutraHeal Plus™ is a nutritional supplement that contains 80 mg of Calcium as
      Calcium Hydroxymethylbutyrate Monohydrate, 7.5 mg of Zinc, 600 mg of Calcium
      Hydroxymethylbutyrate Monohydrate, 45 mg of Bromelain, and 7.5 mg of reduced Nicotinamide
      Adenine Dinucleotide (NADH). Patients randomized to standard of care will not receive any of
      the ingredients in NutraHeal™ or NutraHeal Plus™.

      The foot surgeon will evaluate the patient for wound healing time, healing quality, erythema
      and new tissue quality, using a Likert rating scale against expected results from -4 (much
      worse) to +4 (much better) including the expected reference grade of zero (0). Wound healing
      will be assessed at 1 and 3 weeks after surgery. Patients will document medication compliance
      (day of surgery, 1 and 3 weeks after surgery), pain medication use (baseline, on the day of
      surgery and at 1 and 3 weeks after surgery) and rate overall satisfaction (5-point scale (1 =
      excellent; 2 = good; 3 = moderate; 4 = sufficient; 5 = unsatisfactory) at 3 weeks after
      surgery). Patients will also complete the PROMIS-29 instrument at baseline, the day of
      surgery, and at 1 and 3 weeks after surgery).
    

Intervention name(s): NutraHeal; NutraHeal Plus
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Receive NutraHeal (2 capsules twice a day) as a dietary supplement beginning 1 week prior to surgery and extending to 3 weeks after foot surgery.; Receive NutraHeal Plus (2 capsules twice a day) as a dietary supplement beginning 1 week prior to surgery and extending to 3 weeks after foot surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Nutritional supplements
Effect of Progressive Loading Protocol on Bone Mineral Density
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The aims of this study are to examine the effects of Progressive Loading Exercises Protocol
      on Bone Mineral Density in osteoporotic patient's well-being and quality of life before a
      fracture occurs in order to create remedies. In addition, the available data from health
      research and clinical studies on osteoporosis will be evaluated for their impact on patient
      well-being and quality of life, providing an up-to-date and comprehensive overview of
      evidence-based treatments.
    

Detailed description: 
      Progressive Loading Protocol (PLP): The subjects in the Progressive Loading Group will
      undergo 4-7 days of moderate to high impact loading activities per week for the duration of 6
      weeks. The PLP is adapted and modified based on Exercise and Sports Science Australia (ESSA)
      position statement on exercise prescription for the prevention and management of
      Osteoporosis. The participants in the progressive loading group will perform vertical and
      multidirectional jumping, bounding, hopping, skipping rope, drop jumps and bench stepping.
      The weight bearing intensity will be progressed by increasing heights for activities such as
      bounding and drop jumping, adding weighted vests and changing directions. To prevent the risk
      of injury, the participants would be instructed to avoid the loaded spine flexion or twisting
      movements of the spine. Frail individuals should be supervised and exercised within reach of
      a railing or other stable support.

      Intensity: Moderate-to-high weight bearing impact loads (>2 times body weight) that are
      progressive, novel, and multidirectional, within the limits of pain, increasing as tolerated.

      Frequency: 4-7 days per week

      Sets/Repetitions: Aim to work up to 50 repetitions over time (5 sets of 10 repetitions with
      1-2 min rest between sets)

      The subjects in the Control Group will undergo twelve weeks of low impact Aerobics Training
      along with a health awareness program..
    

Intervention name(s): Randomization Program; Progressive Loading Protocol (PLP):
Intervention type(s): Other; Other
Intervention description(s): The subjects in the Control Group will undergo twelve weeks of low impact Aerobics Training along with a health awareness program; he subjects in the Progressive Loading Group will undergo 4-7 days of moderate to high impact loading activities per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Quality of life; Bone Mineral
Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a
      sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led,
      web-based intervention that can help smokers quit or cut back on how much they smoke
      cigarettes and/or vape, reducing their chances of developing tobacco-related health
      conditions.
    

Detailed description: 
      OUTLINE:

      Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each
      lasting approximately 25 minutes. Participants will also receive text messages providing
      motivational messages and review information discussed in the program. At the end of the
      intervention, participants will receive an email with all of the session handouts.

      Participants are followed up with at 2 months.
    

Intervention name(s): Computer-Assisted Smoking Cessation Intervention; Text Message; Handout; Questionnaire Administration; Quality-of-Life Assessment; Survey Administration
Intervention type(s): Behavioral; Other; Other; Other; Other; Other
Intervention description(s): Use the Flexiquit+ program; Receive text messages; Receive handouts via email; Ancillary studies; Ancillary studies; Ancillary studies
Other intervention name(s): SMS Text; SMS Text Message; Text; Quality of Life Assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the ACADIA® Facet Replacement System is
      effective in the treatment of spinal stenosis. The primary objective of the study is to
      evaluate the overall success rate of the Anatomic Facet Replacement System in patients with
      spinal stenosis when compared to a posterior spinal fusion control.
    

Detailed description: 
      Spinal Stenosis continues to be a major cause of back and leg pain. The condition is
      attributed to narrowing of the space around the nerves in the lumbar spine. This is often
      caused by the degenerative process in the spine and the facet joints. The current treatment
      calls for removal of bone around the affected nerve including the facet joints and fusing the
      posterior of the spine to ensure the segments remain stable.

      The ACADIA® Facet Replacement System (AFRS) allows for an anatomic reconstruction of the
      facet joint after decompression and removal of the degenerated facet. Like the original facet
      joint, the replacement implant is designed to reproduce facet motion while restoring normal
      stability and motion.

      The ACADIA® Facet Replacement System (AFRS) has been designed on the principals that have
      allowed other total joint replacement procedures to provide significant patient benefits.
      These guiding principals include:

        -  Anatomically based implant design

        -  Reproducible surgical technique

        -  Elimination of pain

      The ACADIA® Facet Replacement System allows the surgeon to remove the offending bone while
      preserving the motion of the facet joint.

      This study will evaluate the outcomes of patients using the AFRS™ investigation compared to
      those receiving instrumented posterior fusion procedure. Patients will be required to
      complete study visits before the procedure and at 6 weeks, 3, 6, 12, 24 months post procedure
      and annually thereafter as required by FDA. Follow up visits consist of administration of
      questionnaires, radiographs and neurological assessment.
    

Intervention name(s): Non-randomized ACADIA® Facet Replacement System; Randomized ACADIA® Facet Replacement System; Randomized Instrumented posterolateral fusion (PLF)
Intervention type(s): Device; Device; Device
Intervention description(s): Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis; Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis; Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Stenosis; Lumbar Spinal Stenosis; Facet Arthroplasty; Posterior Fusion; Facet Arthritis
Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis
Condition: Breakthrough Pain; Mucositis; Radiotherapy; Chemotherapy; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis; Breakthrough Pain
Study type: Observational

Summary: 
      An open-label, non-randomized study to assess the titration, safety and efficacy of
      intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain
      secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid
      therapy for chronic pain.

      Study objectives include assessment of breakthrough pain episodes related with food intake in
      patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck
      tumors
    

Detailed description: 
      An open, non-randomized study design was used to assess the titration, safety and efficacy of
      intranasal fentanyl in pectin for the treatment of secondary breakthrough pain in patients
      with confirmed tolerance of opioid therapy for chronic pain secondary to radiation-induced
      mucositis. The study plans to include 30 evaluable patients from multiple centers throughout
      the country. The trial comprises a screening period, an open titration period, and an
      open-label treatment period in which at least 12 breakthrough pain episodes are to be
      treated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adults of either sex and over 18 and under 75 years of age, receiving continued treatment
        with long half-life or controlled release opioids, experiencing breakthrough pain secondary
        to mucositis in the context of radiotherapy or radio-chemotherapy for head and neck tumors.
      
Keywords: Mucositis; Breakthrough pain; Head Nad neck cancer; Intranasal transmucosal fentanyl in pectin
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Condition: Partial Epilepsies; Partial Onset Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to allow eligible subjects from the parent study, SP925
      [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
    

Detailed description: 
      A multicenter, open-label extension study to assess the long-term safety and tolerability of
      lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously
      enrolled in the SP925 study [NCT00655551] (intravenous lacosamide loading dose followed by
      approximately 1 week of oral lacosamide maintenance).
    

Intervention name(s): lacosamide
Intervention type(s): Drug
Intervention description(s): Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; seizures; antiepileptic; Lacosamide; Vimpat; safety; adjunctive
PNF Techniques to Improve Bed Mobility, Transfer and Early Trunk Control in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Trunk control is an important factor which is disturbed after the stroke. The literature
      reviews suggest that trunk exercises are required to achieve good trunk stability which is
      essential for balance, daily functional activities and higher function tasks. By keeping
      these facts in view present study aims at evaluating the efficacy of PNF techniques &
      conventional trunk exercise to improve trunk control in recovery stage hemiplegic patients
      Objective: To determine Proprioceptive neuromuscular facilitation (PNF) Techniques to improve
      bed mobility, transfer and early trunk control in Stroke patients
    

Detailed description: 
      50 patients was included and allocated into 2 groups, group A consisting of 25 patients who
      received PNF techniques for trunk to improve trunk control. Group B consisting of 25 patients
      who received conventional trunk exercises to improve trunk control. Trunk control was
      assessed pre and post treatment with the help of Trunk Impairment Scale and ICU mobility
      scale. Data was collected by ICU mobility scale & Trunk impairment scale
    

Intervention name(s): Proprioceptive neuromuscular facilitation; Conventional treatment
Intervention type(s): Other; Other
Intervention description(s): rocedure
Bilateral upper extremity pattern for trunk by Chopping, Lifting
Bilateral lower extremity pattern for trunk.
Trunk lateral flexion.
Combination patterns for the trunk by Upper and lower trunk flexion, Upper trunk flexion with lower trunk extension, Upper and lower trunk extension, Upper trunk extension with lower trunk flexion.; Group 2 has received conventional trunk exercise program for 45 min/day, 4 days
/ week for the period of 4 weeks the intervention includes static and dynamic functional trunk movement and strengthening exercise to the trunk muscles which includes motor developmental patterns, basic trunk movement, trunk-arm linked movements, trunk-leg linked patterns in sitting, transfer activities, with 2 minutes rest in between the repetition of each set, Progression will be made by increasing the repetition and resistance According to individual ability.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV With Hemophilia.
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Hemophilia A; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by
      HIV/HCV co-infection with hemophilia.
    

Detailed description: 
      This trial is an uncontrolled, open-label, single-center phase I study in liver cirrhosis
      patients caused by human immunodeficiency virus (HIV)/hepatitis C virus (HCV) co-infection
      with hemophilia.

      Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a
      Child-Pugh classification of A or B are included. OP-724 is intravenously administered twice
      a week (4 hours) for 12 weeks as an administration schedule.

      At 14 days before the administration of the first cycle, the dose planned for the first cycle
      will be administered once by continuous intravenous administration for 4 hours, and the
      safety and pharmacokinetics will be evaluated from the day of administration to the day after
      the administration. If an integrase inhibitor is used in combination as a key drug for
      antiretroviral drugs, its pharmacokinetics will be evaluated at the same time.

      A dose escalation study with 2 doses (cohort 1: 140 mg/m2/4hr (starting dose), cohort 2: 280
      mg/m2/4hr) will be conducted, and 3 patients in each cohort will be enrolled. Comprehensively
      investigate the safety and pharmacokinetic data after OP-724 administration, and evaluate the
      safety and tolerability of OP-724 administration.
    

Intervention name(s): OP-724
Intervention type(s): Drug
Intervention description(s): Twice a week for 4 hours continuous intravenous administration of OP-724.
Other intervention name(s): CBP-beta-catenin inhibitor; PRI-724 (former name)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver Cirrhosis; Hemophilia; HIV/HCV co-infection
Predicting ICU Mortality in ARDS Patients
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      The investigators are planning to perform a secondary analysis of an academic dataset of
      1,303 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) included in
      several published cohorts (NCT00736892, NCT02288949, NCT02836444, NCT03145974), aimed to
      characterize the best early model to predict duration of mechanical ventilation and mortality
      in the intensive care unit (ICU) after ARDS diagnosis using machine learning approaches.
    

Detailed description: 
      The acute respiratory distress syndrome (ARDS) is a severe form of acute hypoxemic
      respiratory failure in Critical Care Units worldwide. Most ARDS patients requiere mechanical
      ventilation (MV). Few studies have investigated the prediction of MV duration and mortality
      of ARDS.

      For model description, the investigators will extract data from the first two ICU days after
      diagnosis of moderate-to-severe ARDS from patients included in the de-identified database,
      which includes 1,303 mechanically ventilated patients enrolled in several observational
      cohorts in Spain, coordinated by the principal investigator (JV), and funded by the Instituto
      de Salud Carlos III (ISCIII). The investigators will follow the TRIPOD guidelines and machine
      learning tecniques will be implemented (Random Forest, XGBoost, Logistic regression analysis,
      and/or neural networks) for development of the prediction model, and the accuracy will be
      compared to those of existing scoring systems for assessing ICU severity (APACHE II, SOFA)
      and the PaO2/FiO2 ratio. For external validation, the investigators will use 303 patients
      enrolled in a contemporary observational study (NCT03145974). The investigators will evaluate
      the accuracy of prediction models by calculating the respective confusion matrices and
      several statistics such as sensitivity, specificity, positive predictive value, and negative
      predictive value for mortality and duration of MV. Investigators will select the best
      probabilistic model with a minimum number of clinical variables.
    

Intervention name(s): machine learning analysis
Intervention type(s): Other
Intervention description(s): We will use robust machine learning approaches, such as Random Forest, XGBoost or Neural Networks.
Other intervention name(s): Logistic regression; cross-validation; are aunder the ROC curves
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        De-identified dataset including 1,303 patients with moderate/severe ARDS admitted
        consecutively in a network of Spanish ICUs.
      
Keywords: outcome; mechanical ventilation; intensive care unit; machine learning
Protein Top-up Acceptability Study for Patients With Increased Protein Needs
Condition: Cancer; Neurological Injury; Respiratory Disease; Stroke
MeSH terms: Respiratory Tract Diseases; Respiration Disorders; Trauma, Nervous System
Study type: Interventional

Summary: 
      The aim of this prospective, single-arm intervention study is to evaluate the acceptability
      (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume,
      ready to use, high protein liquid in patients with elevated protein needs.
    

Detailed description: 
      Increased protein needs are frequently observed in disease and can be difficult for patients
      to achieve where oral food intake is compromised.Where a standard ONS or enteral tube feed
      cannot meet the needs of patients, a modular feed can be added to the regimen, a low calorie,
      low volume, ready to use, high protein liquid may help meet protein needs while preventing
      caloric overfeeding.

      40 patients will be recruited in an attempt to evaluate the acceptability (compliance,
      gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use,
      high protein liquid in patients with elevated protein needs. After a 1-day baseline period to
      establish patients' acceptability, gastrointestinal tolerance, compliance and dietary intake
      with their currently prescribed nutritional regimen, each patient will receive the high
      protein liquid feed daily for 28 days.
    

Intervention name(s): High protein liquid
Intervention type(s): Other
Intervention description(s): After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance, dietary intake while also capturing information related to user experience, risk of malnutrition, physical function, dietary intake, anthropometry and safety with their currently prescribed nutritional regimen, each patient will receive the high protein liquid daily for 28 days where the same measures will be replicated. The amount of the high protein liquid prescribed will always be completed by the patients' managing dietitian.
Intervention model: Single Group Assignment
Intervention model description: Single-arm intervention study to evaluate the acceptability (compliance, gastrointestinal tolerance and palatability) of the high protein liquid feed in patients with elevated protein needs.
Masking: None (Open Label)
Primary purpose: Other