bioihbjkbjnl/mcl2 huggingface dataset:
Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate
      affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the
      calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the
      progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the
      single drug approved to treat ALS).
    

Detailed description: 
      Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal
      onset)

      Memantine + riluzole x Placebo + Memantine

      Inclusion criteria:

        -  < 75 years at disease onset

        -  < 3 years of disease progression

        -  ALS-FRS > 24

        -  FVC > 60

        -  Probable or definite disease (revised El Escorial criteria)

        -  No other medical condition

        -  Normal blood tests

        -  Regular medication on riluzole > 1 month

        -  Nerve conduction studies ruling out conduction block

        -  EMG with widespread loss of motor units (revised El Escorial criteria)

        -  At least one hand with ADM strength > 2 on MRC scale

      Duration - 2 years

      Evaluation - every 3 months

      Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number
      estimation, neurophysiological index, strength (clinical evaluation); side-effects

      Intention to treat analysis

      60 patients

      number estimated for 50% change in decline rate of ALS-FRS
    

Intervention name(s): Memantine (Ebixa); riluzole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg bid; riluzole 50 mg bid
Other intervention name(s): Ebixa; rilutek
Intervention MeSH terms: Riluzole; Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: amyotrophic lateral sclerosis; motor neuron disease; memantine; clinical trial
The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This project proposes to test the hypothesis that osteopathic manipulative treatment (OMT)
      given to patients with moderate to severe chronic obstructive pulmonary disease (COPD)
      enrolled in a 12-week pulmonary rehabilitation program (PRP) will result in improved
      respiratory pump function over and above that seen in sham and control groups. Specifically,
      we will study the effects of three OMT techniques: (a) thoracic inlet indirect myofascial
      release; (b) rib raising with continued stretch of the paraspinal muscle to the L2 level; and
      (c) cervical paraspinal muscle stretch with suboccipital muscle release. The key clinical
      readouts will include: spirometry, P100 (and index of diaphragm and inspiratory muscle
      efficiency), maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), as
      well as laser evaluation of chest wall excursion. Supplementing these objective parameters
      will be several more subjective clinical outcome measures: exercise tolerance (6-minute walk
      test), dyspnea (shortness of breath questionnaire), and quality of life questionnaire.
      Finally, an attempt will be made to correlate biochemical alterations that may shed light on
      the biological mechanism underlying the OMT procedures.
    

Detailed description: 
      According to the above directions (provide a more extensice description, if desired), I am
      choosing to just submit the brief summary.

      Thank you, Sherman Gorbis, DO
    

Intervention name(s): Osteopathic Manipulative Treatment (OMT); sham omt
Intervention type(s): Procedure; Other
Intervention description(s): Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function.; Hands are placed on subjects the same as omt arm but no omt is provided.
Other intervention name(s): Other names are not applicable.; Other names are not applicable.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Osteopathic Manipulative Treatment; Pulmonary Function Tests; Biochemical Alterations
A Dose-Defining Study of CXL-1020 in Patients With Systolic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure; Heart Failure, Systolic
Study type: Interventional
Phase: Phase 2

Summary: 
      Study CXL-1020-02 employs is designed to further define suitable clinical dosages for
      CXL-1020 which will be utilized in a later Phase IIb study. The study is conducted in 3
      different stages called 'strata" and evaluates the potential utility of this drug for the
      treatment of patents who are hospitalized with heart failure.
    

Detailed description: 
      Each of the 3 strata are described below:

      Invasive Strata 1: This is a randomized, double-blinded stratum that will enroll up to 65
      patients who are hospitalized with symptomatic heart failure who have indwelling PA catheters
      allowing invasive hemodynamic evaluation. Each patient will receive a six hour intravenous
      infusion of either placebo or CXL-1020.

      Non-Invasive Strata 2: This is a randomized, double-blinded stratum which will enroll up to
      approximately 72 patients (in several cohorts with 12-24 patients each) who neither require,
      nor have in place, an indwelling PA catheter for hemodynamic monitoring, but meet study
      entrance criteria for symptoms of heart failure, (dyspnea at rest)and systolic dysfunction by
      specific echocardiography criteria. Monitoring of drug effects will be performed by
      Echocardiography.

      Invasive-Strata 3: This is a randomized, double-blinded stratum that will begin after an
      evaluation of a substantial number of patients in Strata A and B and will enroll
      approximately 15-30 patients using the same general enrollment criteria as in Invasive Strata
      A.
    

Intervention name(s): Placebo; Strata 1 CXL-1020; Strata 2 CXL-1020; Strata 3 CXL-1020
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): An infusion of an identically appearing solution of sugar water will be intravenously administered.; Intravenous infusion of CXL-1020, up-titrated, so that 3 different dosages are administered over 6 hours; One of 3 different dosages of CXL-1020 administered at a fixed dosage level for 6 hours.; A fixed dose level of CXL-1020 will be administered for the initial 6 hours of treatment in Strata 3 and then dosage will be altered up or downward based on the investigators observation of the patient's condition.
Other intervention name(s): BMS-986233; BMS-986233; BMS-986233; BMS-986233
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; ADHF
Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl
Condition: Pain
Study type: Interventional

Summary: 
      The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal
      anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the
      most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North
      America. Another drug named fentanyl is the most commonly used narcotic. This study will look
      at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal
      anesthetic with 12mg of bupivacaine and 15ug of fentanyl.
    

Detailed description: 
      There have been many studies looking at different doses and combinations of bupivacaine and
      fentanyl but there is no agreement among anesthesiologists as to the best combination of
      drugs.

      The main problem with bupivacaine is that it causes hypotension (low blood pressure). When
      fentanyl is added to bupivacaine, a lower dose of bupivacaine can be used so that there is
      less of a fall in blood pressure. The main problem with fentanyl is itchiness and sleepiness.
      In the case of an emergency Cesarean section, the extra time needed to draw-up and administer
      a second medication may make a difference to the health of the baby.

      Our goal is to determine whether high dose bupivacaine (15mg) alone will produce spinal
      anaesthesia for cesarean delivery equivalent to 12mg of intrathecal hyperbaric bupivacaine in
      combination with 15ug of intrathecal fentanyl.
    

Intervention name(s): Bupivacaine; Bupivacaine, fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): A single, 15mg, intrathecal dose of bupivacaine.; A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl
Other intervention name(s): Marcaine; Marcaine
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean section; Spinal
Ultrasonographic Assessment of Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Observational

Summary: 
      Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo
      syndromes. These patients have a genetic enzyme deficiency that results in the inability to
      degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell
      enlargement and subsequent dysfunction. The accumulation occurs in all tissues including
      cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger digits,
      and various other orthopaedic manifestations [Van Heest, White]. These children often suffer
      from severe cognitive impairment and are often unable to communicate pain or numbness. Carpal
      tunnel syndrome is almost always present, but may not become apparent until symptoms are
      severe and loss of function has occurred. The current gold standard for diagnosis consists of
      electromyographic (EMG) and nerve conduction velocity (NCV) studies under sedation or general
      anesthetic [Khanna].

      Primary Objective: The investigators plan to correlate EMG findings and median nerve
      cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is
      that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove
      to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding the
      need for EMG studies and anesthesia.

      Secondary Objective: The investigators want to determine the cross-sectional area of the
      median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The
      investigators plan to evaluate a cohort of healthy children to determine a normal
      cross-sectional area of the median nerve.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study Size: *150 total which includes the following:

        Arm 1: 25 Children with mucopolysaccharidosis

        Arm 2: 100 Control Group - Healthy children ages 3-12 with no previous history of upper
        extremity trauma or history of mucopolysaccharidosis.
Retrospective Analysis of the Geriatric Patients Underwent Unilateral Inguinal Herniorrhaphy
Condition: Inguinal Hernia
MeSH terms: Hernia, Inguinal
Study type: Observational

Summary: 
      The aim of this study is to compare the geriatric patients with the non-geriatrics undergoing
      outpatient unilateral herniorrhapy in terms of local anesthesia, sedation, recovery and early
      morbidity.
    

Detailed description: 
      A retrospective data analysis will be conducted and the patient records will be evaluated for
      patient characteristics local anesthesia, sedation, recovery and early morbidity.
    

Intervention name(s): local infiltration anesthesia and sedation
Intervention type(s): Procedure
Intervention description(s): the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents
Other intervention name(s): local anesthesia and sedation
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with a unilateral inguinal hernia
A Study To Evaluate The Difference In iPad-Based Cognitive Video Game (Akili Interactive's Project: EVO) Performance In Amyloid-Positive Versus Amyloid-Negative Healthy Elderly Volunteers
Condition: Healthy
MeSH terms: Amyloidosis
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the difference in learning and performance measures
      associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in
      healthy elderly volunteers based on amyloid status.
    


Intervention name(s): Ritalin; Placebo; Ritalin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 - 20 mg tablet taken once on Day 0 and taken once on Day 28; 1 - matching tablet taken once on Day 0 and once on Day 28; 1 - 20 mg tablet taken once on Day 0 and taken once on Day 28; 1 - matching tablet taken once on Day 0 and once on Day 28
Other intervention name(s): methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28; matched placebo tablet taken once on day 0 and once on day 28; methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28; matched placebo tablet taken once on day 0 and once on day 28
Intervention MeSH terms: Methylphenidate
Keywords: Healthy; elderly volunteers
The "Great Live and Move Challenge" Among Children Aged 7-11 Years
Condition: Physical Activity
Study type: Interventional

Summary: 
      The Great Live and Move Challenge (GLMC) study is a 2-year cluster-randomized controlled
      trial designed to evaluate a multilevel and theory-based intervention to promote PA practice
      in children aged 7-11 years from French primary schools.
    

Detailed description: 
      Recent population-based surveys have reported that a large majority of children were not
      active enough to meet the physical activity (PA) international guidelines in France, Europe
      and in the US. Therefore, there is a need to find efficient programs to improve PA habits in
      children from early age. The Great Live and Move Challenge (GLMC) study is a 2-year
      cluster-randomized controlled trial designed to evaluate a multilevel and theory-based
      intervention to promote PA practice in children aged 7-11 years from French primary schools.
      The aim of this paper is to describe the GLMC study protocol. The primary hypothesis is that
      the GLMC intervention will increase by 15% the proportion of children meeting the World
      Health Organization recommendations of 60 minutes/day of moderate to vigorous PA. Study
      recruitment goal is 5000 children . The GLMC is implemented on children and their parents and
      involves multiple local grass-roots partners, such as school teachers and municipal
      officials, as well as policy stakeholders. The Theory of Planned Behavior (TPB) constitutes
      the foundations of the intervention conception. The total duration of the intervention is 3.5
      months each year, for two years. Children and parents are evaluated at pre- and
      post-intervention every year regarding PA practice (self-reported and objectively measured in
      a subsample of 400 children), TPB variables (i.e., intentions, attitudes, subjective norms,
      perceived behavioral control) and other psychosocial variables (e.g., perceptions of active
      opportunities). This study will evaluate the effectiveness of a multilevel and theory-based
      primary school PA program and potentially provide valuable information for schools and public
      health policers looking for innovative PA programs.
    

Intervention name(s): Great Live and Move Challenge
Intervention type(s): Behavioral
Intervention description(s): Physical activity program for children
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: a 24-month (6 weeks each year) multilevel and TPB-based program aiming to promote PA practice
Masking: None (Open Label)
Primary purpose: Prevention
Study to Assess the Relationship Between Daily Dosing of NRPT and Changes in Liver Fat in Healthy Volunteers
Condition: Fatty Liver
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      The purpose of this study is to determine if there is a relationship between daily
      consumption of NRPT, over a six-month (26-week) period, and changes in liver fat
      accumulation, compared to placebo and change from Baseline in healthy volunteers. In
      addition, an exploratory assessment of markers of inflammation and liver fat metabolism will
      be examined.
    


Intervention name(s): Group 1 NRPT; Group 2 NRPT; Group 3 Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Two capsules of NRPT and two placebo will be taken once daily in the morning for 26 weeks. Each NRPT capsule will contain 125 mg NR and 25 mg PT.; Four capsules of NRPT will be taken once daily in the morning for 26 weeks. Each NRPT capsule will contain 125 mg NR and 25 mg PT.; Four placebo capsules will be taken once daily in the morning for 26 weeks.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Fluid Resuscitation With 0.9% Sodium Chloride Versus Balanced Crystalloid Solution on Renal Function of Sepsis Patients
Condition: Sepsis; Septic Shock; Acute Kidney Injury
MeSH terms: Sepsis; Toxemia; Acute Kidney Injury
Study type: Interventional
Phase: Phase 3

Summary: 
      The high chloride content of 0.9%sodium chloride (0.9%NaCl) leads to adverse
      pathophysiological effects in both animals and healthy human volunteers. Small randomized
      trials confirm that the hyperchloremic acidosis induced by 0.9%NaCl also occurs in patients.
      A strong signal is emerging from recent large propensity-matched and cohort studies for the
      adverse effects that 0.9% NaCl has on the clinical outcome in surgical and critically ill
      patients when compared with balanced crystalloids. Major complications are the increased
      incidences of acute kidney injury and the need for renal replacement therapy, and that
      pathological hyperchloremia may increase postoperative mortality.

      Fluid resuscitation with 0.9% NaCl in animals with sepsis resulted in hyperchloremic
      metabolic acidosis, worsened AKI, and increased mortality when compared with resuscitation
      with a balanced crystalloid solution.

      Furthermore, hyperchloremic acidosis also resulted in increased concentrations of circulating
      inflammatory mediators in an experimental model of severe sepsis in rats, with a
      dose-dependent increase in circulating interleukin-6, tumor necrosis factor-a, and
      interleukin-10 concentrations with increasing acidosis.

      Thus, in this study, investigators compared the effects of a balanced crystalloid solution
      with 0.9% NaCl on the renal function in severe sepsis/septic shock patients. Investigators
      hypothesized that balanced crystalloid solution resuscitation would decrease AKI incidence
      and severity and would improve immunomodulatory effect when compared with 0.9% NaCl
      resuscitation.
    


Intervention name(s): Normal saline; Ringer's Acetate
Intervention type(s): Drug; Drug
Intervention description(s): for resuscitation in sepsis patients; for resuscitation in sepsis patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Retrospective Analysis on Small Bowel Perforations
Condition: Small Bowel Perforations
MeSH terms: Intestinal Perforation
Study type: Interventional

Summary: 
      A retrospective, monocentric, code-related data analysis of patients with small bowel
      perforations was performed for the period 2010 to 2019.
    

Detailed description: 
      Analyzed parameters were etiology and timing of perforation, associated morbidity and
      mortality, type of therapy and its success, and long-term consequences for patients, such as
      the development of short bowel syndrome.
    

Intervention name(s): surgery
Intervention type(s): Procedure
Intervention description(s): interventional or surgical treatment
Intervention model: Single Group Assignment
Intervention model description: Retrospective data analysis
Masking: None (Open Label)
Primary purpose: Treatment
Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting
Condition: CVD
Study type: Interventional
Phase: Phase 4

Summary: 
      Argatroban is a selective thrombin inhibitor, and previous study had suggested that
      argatroban use post percutaneous coronary intervention could potentially prevent reocclusion.
      But there has no study on large sample of argatroban treated restenosis vertebral artery
      stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion
      and Restenosis in patients with Extracranial vertebral Artery Stenting.
    

Detailed description: 
      The risk of restenosis post intracranial and extracranial artery stenting is 20-40%,
      therefore, in the past, aspirin and clopidogrel were performed as anticoagulant therapy post
      stenting.But this treatment had limited effectiveness upon restenosis. Argatroban is a
      selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI
      could potentially prevent reocclusion. But there has no study on large sample of argatroban
      treated Occlusion and Restenosis Extracranial vertebral Artery Stenting. This study will test
      the safety and efficacy of the argatroban on prevent Occlusion and Restenosis in patients
      with Extracranial vertebral Artery Stenting.
    

Intervention name(s): Argatroban; non-argatroban treated group
Intervention type(s): Drug; Drug
Intervention description(s): Argatroban in patients undergoing load 250μg/kg, followed by 15μg/kg/min continuous intravenous infusion.5 days after surgery, take 10mg intravenous infusion of speed 2/day; Patients in control group will receive Unfractionated heparin treatment
Other intervention name(s): Unfractionated heparin
Intervention MeSH terms: Heparin; Calcium heparin; Argatroban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Argatroban; Extracranial vertebral Artery Stenting; restenosis