bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Trigger Points
Condition: Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study would be the first study to assess the immediate effects of dry needling of latent
      trigger points of the gastrocnemius muscle on muscle stiffness, gait, range of motion, and
      strength. The study has the potential to demonstrate that dry needling may have immediate
      effects on mechanical properties of muscle and may thus guide future treatment for
      individuals with changes in muscle tissue secondary to pain and/or injury.
    

Detailed description: 
      Participants will complete the following tests: muscle stiffness testing in both a relaxed
      and contracted position, GAITRite for spatial and temporal gait characteristics, the Ankle
      Lunge Test (ALT) to assess range of motion, and calf strength using a dynamometer. Subjects
      will then receive treatment according to which group they are randomized. Muscle stiffness,
      gait, motion and strength will be reassessed immediately following treatment at the first
      session. Four to10 days later, participants will complete the same tests and measures prior
      to treatment being administered a second time. Another 4-10 days after the second session,
      participants will complete the tests and measures one final time.
    

Intervention name(s): Dry Needling; Sham Dry Needlling
Intervention type(s): Other; Other
Intervention description(s): Individuals randomized to the Dry Needling Group will receive dry needling to latent trigger points of the gastrocnemius muscle; Individuals randomized to the Control group will receive sham needling to the gastrocnemius muscle
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Prospective randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Dextromethorphan; Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of a single dose of dextromethorphan in healthy adult subjects.
    

Detailed description: 
      Subjects will check-in on Day -1 and remain confined to the clinical unit until Day 13. On
      the morning of Day 1, subjects will receive a single dose of dextromethorphan. On Days 6 and
      7, subjects will receive isavuconazole three times daily (TID) administered approximately 8
      hours apart. On Day 8 through 12, subjects will receive isavuconazole once daily (QD). On Day
      10, subjects will receive a single dose of dextromethorphan. A follow-up visit will be
      scheduled on Day 21 (± 2 days).
    

Intervention name(s): Isavuconazole; dextromethorphan
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL4815; ASP9766; DXM
Intervention MeSH terms: Isavuconazole; Dextromethorphan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; dextromethorphan; dextrorphan; DXM; Healthy Volunteers; BAL4815
Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison
      to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi
      Pasteur) in healthy adult volunteers.
    


Intervention name(s): EuTCV; Typbar-TCV™; Typhim Vi®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single 0.5 mL dose of TCV of EuBiologics co., Ltd.; Single 0.5 mL dose of TCV of Bharat Biotech; Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
Masking: None (Open Label)
Primary purpose: Treatment
Empagliflozin Impact on Hemodynamics in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared
      with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients
      with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic
      etiology) who already have a CardioMEMs device (a wireless hemodynamic monitoring system)
      implanted for non-study related clinical reasons.
    

Detailed description: 
      A 12-week randomized, double-blind, placebo-controlled trial to explore the effects of
      once-daily empagliflozin 10 mg on hemodynamic parameters (pulmonary artery pressures) in
      patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic
      etiology) who already have a CardioMEMs device implanted for non-study related clinical
      reasons.
    

Intervention name(s): Empagliflozin 10 mg Tab; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Empagliflozin 10 mg Tab; Empagliflozin matching placebo
Other intervention name(s): Jardiance; Placebo
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure; empagliflozin; Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
Comparing Head and Neck Endoscopy Procedures
Condition: Comparing Head And Neck Endoscopy in Healthy Patients
Study type: Interventional

Summary: 
      Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes
      defined on this volumetric information data set. However, target delineation also depends on
      disease seen endoscopically which may not be visible on CT. We are developing imaging and
      tracking technology to improve target delineation in Radiation Therapy (RT) planning for head
      & neck cancer using quantitative registration of 2D endoscopic information with CT data.
      Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery
      are obtained with the patient in the supine position. The accuracy of the registration will
      be improved if performed in the same position to prevent mobile soft tissue structures
      shifting between the upright and supine positions. Since therapy must be performed in the
      supine position, we intend to check the feasibility of performing endoscopy in the supine
      treatment position. We will compare and assess patient comfort and endoscopic sightlines
      during an endoscopy procedure in both the upright and supine positions.
    


Intervention name(s): Endoscopy
Intervention type(s): Procedure
Intervention description(s): All patients will meet the physician at the Head and Neck centre at PMH, where they will have a topical anesthetic (lidocaine endotracheal aerosol, 10 mg/dose) sprayed into both nostrils. After allowing 5-10 minutes to let the anesthetic take effect, they will have an endoscopy procedure using a flexible scope inserted through the nostrils. The procedure will first be performed while patients are sitting up. During the procedure, patients will be asked to rate their discomfort on a 10-point scale. The endoscope will then be removed. After a short rest (15 minutes), the endoscopy procedure will be repeated with patients lying down. They will again be asked to rate their level of discomfort. After another short rest for recovery, they will meet with the physician to discuss both endoscopic procedures and to complete a questionnaire on discomfort, tolerance and acceptability
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Endoscopy; Head and Neck region; Scope
Effect of Motor Rehabilitation Treatment on Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      ErmoSLA is a multicentric, randomized, controlled trial to compare effects of an "intensive"
      or "standard" motor rehabilitation treatment on motor disability in people with ALS
    

Detailed description: 
      The study is a multicentric, randomized, controlled trial to compare effects of standard
      versus intensive motor rehabilitation treatment for people with ALS.

      Eligible patients are going to be randomly assigned to the Standard or Intensive treatment
      (controlling for ALSFRSR rates at enrollment, age and site of onset). Randomization ratio is
      1:1.

      Standard treatment: 2 sessions/week of motor rehabilitation treatment (45 minutes each one)
      for 10 weeks for a total of 20 sessions. The program consists of exercises for aerobic
      endurance, reinforcement at low load and stretching. At the end of the 20 sessions patient
      and caregiver are going to continue activity with supervision through regular follow up.

      Intensive treatment is characterized by an increased volume of the above mentioned exercises:
      5 sessions/week (45 minutes each one) for 10 weeks for a total of 50 sessions. At the end of
      the 50 sessions patient and caregiver are going to continue activity with supervision through
      regular follow up.

      Collection and analysis of data

      Recruitment: during the first 18 months of the study. Outcome measures: evaluated at
      T0-T3-T6-T9-T12-T15-T18-T21-T24. Rating scales will be administered by a neurologist in singe
      blind method with respect to the treatment.

      Data collection will be done through an ad hoc Case Report Form and entered into a database
      on a dedicated website.
    

Intervention name(s): Standard motor rehabilitation treatment; Intensive motor rehabilitation treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard treatment: 2 sessions/week of motor rehabilitation treatment (45 minutes each one) for 10 weeks for a total of 20 sessions, including exercises for aerobic endurance, reinforcement at low load and stretching. At the end of the 20 sessions, patient and caregiver are going to continue motor activity with therapist supervision through regular follow up; Intensive treatment is characterized by an increased exercises volume: 5 sessions/week)(45 minutes each one) for 10 weeks for a total of 50 sessions, including exercises for aerobic endurance, reinforcement at low load and stretching. At the end of the 50 sessions, patient and caregiver are going to continue motor activity with therapist supervision through regular follow up
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Motor Rehabilitation Treatment; Intensive versus standard; Motor Disability
Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2)
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for
      glioblastoma has shown some efficacy. This study is designed to perform a personalized
      clinical trial by first analyzing the expression of tumor associated antigens in patients
      with recurrent glioblastoma and then immunizing the patients with personalized antigen pulsed
      DCs. Immune responses to the immunized antigens will be monitored. Safety and efficacy will
      be observed in this study.
    

Detailed description: 
      This is an open label, single-arm, single-institution, Phase I study designed to investigate
      the safety and efficacy of personalized cellular vaccines for patients with recurrent
      glioblastoma (GBM). Recurrent GBM patients will undergo tumor resection. The tumors will be
      analyzed for the expression of a panel of glioma-associated antigens and immune-related
      genes. Patients will undergo leukapheresis to collect mononuclear cells for DC generation.
      Based on the expression profiles of tumor-associated antigens, in vitro transcribed mRNA will
      be generated to pulse autologous DCs. Patients will be conditioned with immune adjuvants
      before and during immunization. Patients will receive biweekly vaccines. The antitumor
      specific T cell responses will be measured. Safety and efficacy will be monitored. The
      objective is to assess the safety of the personalized cellular vaccines and T cell responses.
      The efficacy of the vaccines will be evaluated using iRANO criteria, progression-free
      survival and overall survival.
    

Intervention name(s): Personalized cellular vaccine
Intervention type(s): Biological
Intervention description(s): Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.
Other intervention name(s): Tumor antigen pulsed DC autologous cellular vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent glioblastoma; DC vaccine; tumor antigen; personalized vaccine
"ADAPT" The Adaptation to High Fat Diets Extention
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to predict weight gain overtime after a high fat diet.
    

Detailed description: 
      In the past 3 years we have identified a "thrifty-phenotype" characterized in lean men by an
      inability to adapt rapidly to a high fat diet and associated with a low maximal VO2 and high
      fasting insulin. We hypothesize that the individuals with the "thrifty phenotype" are at
      higher risk for becoming obese, and that exercise may be effective in overcoming this
      problem.

      Several questions remain to be answered regarding the "thrifty" phenotype. First, given the
      large interindividual differences, how can we identify those at the highest risk? What are
      the distinguishing biochemical, endocrine and environmental characteristics of individuals
      that store fat when exposed to high fat diets? This is important because if these individuals
      can be easily identified, then dietary interventions can be targeted to this "at-risk"
      population.

      Second, what is different about the individual with the "thrifty phenotype"? Are there
      cellular pathways that are dysregulated in the skeletal muscle of these individuals when
      compared to controls? Is the defect intrinsic, i.e. a diminished ability to conserve glucose
      and oxidize fat in skeletal muscle or alternately, is the phenotype due to environmental, and
      dietary factors such as inactivity and energy excess?

      To answer these questions, we have planned a three-year project that aims to:

        -  Characterize the biochemical, endocrine, anthropometric and environmental
           characteristics of individuals with the "thrifty" phenotype.

        -  Identify the signaling pathways in skeletal muscle that are dysregulated in individuals
           with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue.

        -  Determine the role of environmental factors such as inactivity and caloric intake vs.
           intrinsic (genetic) factors in the "thrifty" phenotype.
    

Intervention name(s): High Fat Diet; Low Fat Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Daily eating; Life style eating habits
Other intervention name(s): Measurements will be collected to help with gathering data.; Questionnairs of food frequency
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.
Condition: Healthy
Study type: Interventional

Summary: 
      The consumption of cereals-based foods with low glycemic indexes, high micronutrients and
      fibers contents are highly recommended. The target of this work is to provide new solutions
      for cereal based foods: the knowledge and understanding on the in vivo fate will be used to
      define structural features to gain in foods.
    


Intervention name(s): 20% amylose bread; 10% amylose bread; Carbohydrates
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): 20% amylose bread; 10% amylose bread; 50g of carbohydrates ingested with 400 ml of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: glycemic index
Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
Condition: Human Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, 2-period, 2-sequence crossover study to evaluate the effect of food on
      the relative bioavailability of BMN 673 during fasting and fed conditions in healthy male
      subjects.
    


Intervention name(s): BMN 673
Intervention type(s): Drug
Intervention description(s): 500mcg dose of BMN 673, 2 discrete single doses separated by 21 days
Intervention MeSH terms: Talazoparib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric
      monoclonal antibody (cA2) compared to placebo in patients with active Crohn's disease.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, dose-ranging study followed by a
      placebo-controlled, double-blind, repeated-dose extension to evaluate the effectiveness and
      safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of
      patients with active Crohn's disease. The primary efficacy outcome of the study is a
      comparison of the proportion of patients achieving a clinical response at the 4-week
      evaluation. Clinical response is defined as a reduction from baseline in the Crohn's Disease
      Activity Index (CDAI) score of at least 70 points. Additional measurements of effectiveness
      include the clinical response over time, the time to loss of response, clinical remission
      over time, and changes in the Crohn's Disease Activity Index (CDAI), Inflammatory Bowel
      Disease Questionnaire (IBDQ), Crohn's Disease Endoscopic Index of Severity (CDEIS) scores and
      C-reactive protein values.

      Anti-TNF Chimeric Monoclonal Antibody (cA2) or placebo
    

Intervention name(s): Infliximab 5 mg/kg; Infliximab 10 mg/kg; Infliximab 20 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.; Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.; Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 20 mg/kg will be administered as infusion at Week 0, 2 and 6.; Matching placebo will be adminstered at Week 0, 2 and 6.
Other intervention name(s): anti-TNF chimeric monoclonal antibody (cA2); anti-TNF chimeric monoclonal antibody (cA2); anti-TNF chimeric monoclonal antibody (cA2)
Intervention MeSH terms: Infliximab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease
Iron Fortified Beverages and Application in Women Predisposed to Anemia
Condition: Iron-deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      -  The objective of the study is to know if consumption of an iron fortified fruit juice
           containing micronized iron pyrophosphate, is useful to increase iron status in women
           predisposed to iron deficiency anemia.

        -  A secondary objective is to know if consumption of this iron fortified fruit juice
           modifies bone remodelling.
    


Intervention name(s): non-fortified fruit juices consumed as part of the usual diet; Iron fortified fruit juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ferric pyrophosphate; Fortification; Fruit juice; Functional food; Bioavailability; iron status; Women; iron-deficiency anemia
Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
Condition: Bacterial Infections
MeSH terms: Infections; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human, Phase 1, randomized, double- blind, four-part,
      dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single
      (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Repeated escalating
      doses of KSP-1007 will be co-administered with meropenem (Part 3) and single, ascending doses
      of KSP-1007 will be administered alone in healthy Japanese subjects (Part 4)
    

Detailed description: 
      Carbapenem-resistant Gram-negative bacteria are responsible for serious, life-threatening
      infections and are regarded as an urgent threat by the Centers for Disease Control and
      Prevention and the World Health Organizations. One principal mechanism of carbapenem
      resistance is bacterial production of carbapenemases, which reduce the effectiveness of
      meropenem and other carbapenem class antibiotics. Sumitovant Biopharma is developing a fixed
      combination of meropenem and KSP-1007 for the treatment of serious bacterial infections.
    

Intervention name(s): KSP-1007; Placebo:0.9% sodium chloride; Meropenem
Intervention type(s): Drug; Other; Drug
Intervention description(s): Single and multiple doses, intravenous administration; Single and multiple doses, intravenous administration; Multiple doses, intravenous administration
Intervention MeSH terms: Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Bacterial Disease; Bacterial Infection; Bacterial Infections; Bacterial; Healthy Volunteers