bioihbjkbjnl/mcl2 huggingface dataset:
Multiple Joint, Structural Barbell Resistance Exercise Improves Information Processing Speed
Condition: Cognitive Decline; Aging
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study investigated the effect of acute multiple joint, structural barbell resistance
      exercise on information processing speed and conflict-related neural activity in older adults
      via a crossover, sham control, randomized control trial.
    


Intervention name(s): Resistance exercise; Stretching exercise (sham exercise)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Barbell back squat, press, and deadlift for three sets of five repetitions with the weight closest to 75% of their estimated 1 repetition max. The participants were instructed to execute the movement with moderate speed (2s eccentric, 2s concentric, no pause in between). The rest period between sets and exercise movements was two to three minutes.; Participants completed a passive stretching exercise session for a similar duration of time as the resistance exercise (≈ 30 min) as sham intervention, which included 15-20 stretching movements twice, holding each for 30 seconds as recommended by ACSM.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: exercise; resistance training; kinesiology; cognition; ERP; neuroimage
Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the relative bioavailability, or the degree and rate at
      which the drug is absorbed by the body of two cenobamate formulations (200 mg Oral Suspension
      and a 200 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the
      200 mg Oral Suspension. This study will also look at the safety and tolerability of the oral
      suspension and the oral tablet under both fasted and fed conditions.
    

Detailed description: 
      This study is an open-label, randomized, single-dose, single-center, three-period,
      six-sequence, balanced crossover study in healthy male and female subjects to assess the
      relative bioavailability of 200 mg of cenobamate given as an oral tablet or oral suspension
      and to evaluate the effect of food on the bioavailability of a 200 mg dose of cenobamate
      given as an oral suspension in fasting and fed conditions.

      The study consists of a 28-day screening period, followed by single dose administration of
      cenobamate (tablet or suspension) on Day 1, Day 22, and Day 43, an assessment period of 62
      days and a follow-up visit on Day 69. All subjects will be confined to the clinical site from
      Day -1 (the day before period 1 dosing) until the morning of Day 4, Day 20 (the day of the
      last PK sampling for period 1) until the morning of Day 25, and Day 41 (the day of the last
      PK sampling for period 2) until the morning of Day 46. Outpatient visits will be performed
      regularly until the 456-hour PK sampling for each period. The follow-up visit will occur on
      Day 69 (±1 day).
    

Intervention name(s): Cenobamate
Intervention type(s): Drug
Intervention description(s): Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.
Other intervention name(s): YKP3089
Intervention MeSH terms: Cenobamate
Intervention model: Single Group Assignment
Intervention model description: • This study is an open-label, randomized, single-dose, single-center, three-period, six-sequence, balanced crossover study in healthy male and female subjects to assess the relative bioavailability of 200 mg of cenobamate given as an oral tablet or oral suspension and to evaluate the effect of food on the bioavailability of a 200 mg dose of cenobamate given as an oral suspension in fasting and fed conditions
Masking: None (Open Label)
Primary purpose: Treatment
Signal Propagation and Its Relationship to Cognitive Performance in the Aging Human Brain (Focus or Spread)
Condition: Healthy Aging
Study type: Interventional

Summary: 
      In the next three decades, the world's population over 60 years old is expected to more than
      double its size. Even in the absence of an obvious pathology (i.e., healthy aging), advancing
      age is typically associated with a progressive decline in cognitive performance. Although
      pathophysiological changes in age-related neurodegenerative disorders have received much
      attention over the past years, far less is known about the neural processes affecting
      cognition in healthy ageing. One of these postulated processes is neural dedifferentiation
      (i.e., a decrease in neural selectivity, by which neural representations of processed
      information become less univocally distinguishable), possibly accompanied by the recruitment
      of additional cortical areas in the healthy aging brain. To date, these processes have been
      extensively studied on the neural level, yet their functional significance for cognitive
      behaviour remains largely unclear. This project will investigate neural dedifferentiation and
      its relationship to cognitive performance in the healthy aging brain. To this end, the
      investigators will use a combination of state-of-the-art technologies including simultaneous
      transcranial magnetic stimulation (TMS) and high-density electroencephalography (hd-EEG) as
      well as diffusion tensor imaging (DTI). Perspectives include a better understanding of the
      relationship between neurophysiological mechanisms and cognitive performance in the healthy
      aging brain.
    


Intervention name(s): single-puls TMS; sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Medical Device (MD): MagPro X100; Sham stimulation is delivered with a dedicated coil, which is magnetically shielded and thus produces only approx. 20% of the nominal magnetic field. This is not enough to reach and stimulate the cortex, but the produced sound and scalp sensation are the same as with a real TMS coil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: transcranial magnetic stimulation (TMS); high-density electroencephalography (hd-EEG); simultaneous TMS-hd-EEG; diffusion tensor imaging (DTI); neural dedifferentiation
Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions
Condition: Spinal Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      The vertebral column represents the most common bony site for metastasis with an incidence
      ranged from 30% to 70% in patients with metastatic neoplasms. The dorsal spine carries the
      highest frequent site for metastasis all over the vertebral column followed by the lumber
      spine. These metastatic lesions are clinical entities that often necessitate a complex spinal
      decompression and anterior reconstruction. Posterolateral approaches alone allow for
      excellent decompression with transpedicular fixation and safe visualization of the neural
      elements for corpectomy and reconstruction so the investigators can avoid the complications
      that can be happened with the staged surgery.

      Purpose: investigators' aim in the study is to report cases and evaluate investigators'
      approach for fixation and assess the postoperative period regarding pain improvement and
      neurological deficit.
    

Detailed description: 
      At neurosurgery department in Sohag faculty of medicine, Between August 2014 and August 2017,
      26 patients with single dorsolumbar metastatic spinal lesions with vertebral body collapse
      underwent a single-stage, circumferential corpectomy and anterior spinal reconstruction with
      a pyramesh titanium cage via a midline, posterior and lateral approach. Investigators
      included in the study patients with retropulsed fragment inside the canal that causes spinal
      cord compression with neurological manifestation. Metastatic work up was done for cases.
      Exclusion criteria include patients with more than one spinal metastases or extra-spinal
      metastasis, patients with other comorbidities as cardiac ill patients, patients with chronic
      renal failure and patients who received radiotherapy or chemotherapy within one year before
      surgery. A preoperative neurological assessment, full laboratory investigations were done.
      Investigators used the Quebec scale to assess the patients' improvement regarding pain, and
      muscle power scale to evaluate the motor.
    

Intervention name(s): Posterolateral corpectomy
Intervention type(s): Procedure
Intervention description(s): Investigators' goal in this study is to report clinical series of 26 patients in Sohag university hospital with dorsolumbar metastatic lesions from different primaries treated by single-stage posterolateral circumferential corpectomy with reconstruction by a pyramesh titanium cage and account the degree of improvement regarding the pain.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corpectomy; Pyramesh; Posterolateral; Pediculectomy; Facetectomies
Carbamazepine Treatment for Cocaine Dependence - 5
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess carbamazepine as a pharmacotherapy for cocaine
      dependence.
    


Intervention name(s): Carbamazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine
Primary purpose: Treatment
Keywords: Cocaine Dependence; Carbamazepine
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to
      4% of the general population. The patients with OSAS frequently complain of intolerance to
      exercise muscle fatigue and a significant even if they have not been fully characterized in
      the literature.

      The anomalies in the exercise of patients with OSAS could be due to metabolic changes
      (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).

      Our goal is both to determine whether these anomalies exist in patients with OSAS not obese,
      consider their relationship with the alteration of exercise capacity, and their reversibility
      in conventional PPC or by using the effects of physical activity regular.In this study
      Objectives: To establish whether the metabolic and vascular abnormalities associated with
      OSAS are associated with decreased parameters of physical fitness in relation to witnesses
      matched for age, sex and body mass index. Determine the effects of a re-training exercise on
      these parameters compared to the reference treatment, continuous positive pressure.

      Main objective: To compare the exercise capacity of OSAS patients compared with that of
      witnesses matched for age, sex and body mass index.

      Secondary objectives: To compare the effect of conventional treatment by continuous positive
      pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic
      modality most original, physical activity.

      Methodology: Test physiopathological parallel group, controlled, randomized.
    

Detailed description: 
      Study type : Physiopathology trial Study design : Prospective randomized controled trial

      Expected Total Enrollment : 45 patients + 15 control subjects

      Tested treatment : Physical exercise program (45 minutes, 3 times a week) Reference treatment
      : continuous positive airway pressure Treatment duration : 12 weeks (3 months) Total study
      duration : 2 years
    

Intervention name(s): physical exercise program
Intervention type(s): Other
Intervention description(s): 45 min, 3times a week
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Keywords: OSAS; exercise; metabolic; cardio-vascular
Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users
Condition: DIABETES Mellitus Type 2 Not Well Controlled
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized,
      open-label, parallel-group and active controlled trial
    

Detailed description: 
      Randomized, open-label, parallel-group, active controlled, phase IV study to assess the
      efficacy and safety of a 3 month treatment period with Liraglutide to Sitagliptin in type 2
      diabetes patients not well controlled at the maximum tolerated dose of metformin.The study
      has been designed with a random design as it is one of the most important techniques for
      avoiding bias in clinical trials. The study will follow a parallel group, open-label design
      as liraglutide is administered by subcutaneous injection and sitagliptin orally in tablets. A
      double-dummy design has been rejected because it is highly complicated in a phase IV study,
      and any bias of an open-label design has a lower impact on objective variables (as it is our
      primary endpoint) and it could be compensated with the proposed random design.Sitagliptin has
      been selected as the active control as it is one of the prescribed treatments for type 2
      diabetes patients not well controlled at the maximum tolerated dose of metformin.

      The study objectives will be assessed after 3 months of therapy as it is considered a
      suitable timing for identifying short-term changes on flow-mediated vasodilation
    

Intervention name(s): Liraglutide; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide is available if pre-filled pens (6 mg/ml) as a solution for injection (Victoza®). One ml of solution contains 6 mg of Liraglutide (human glucagon-like peptide-1 analogue produced by recombinant DNA technology in Saccharomyces cerevisiae). One pre-filled pen contains 18 mg Liraglutide in 3 ml.; Sitagliptin is available in 100 mg film-coated tablets (Januvia®). Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Other intervention name(s): Victoza®; Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DIABETES Mellitus Type 2; Difficult control
Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
Condition: Hypoxia; Endotoxemia; Healthy
MeSH terms: Endotoxemia; Hypoxia
Study type: Interventional

Summary: 
      The objective of the present protocol is to study whether a low level of oxygen in the blood
      will affect the immune response to as well as cerebral blood flow and metabolism during an
      infection and, conversely, whether the acute systemic and cerebral physiologic response to
      hypoxia is modified by an ongoing inflammatory response.
    

Detailed description: 
      The combination of acute infection and a low level of oxygen in the blood is a common
      phenomenon. Thus, acute hypoxia may complicate severe infections including severe sepsis.
      Conversely, healthy persons who ascend to moderately high altitudes, which will be associated
      with a lowering of the inspired oxygen level, may sustain an infection. Even so, it is
      unknown whether hypoxia modifies the systemic inflammatory response, or, conversely, whether
      the reaction to hypoxia is influenced by the presence of systemic inflammation. The present
      protocol aims to measure global cerebral blood flow, metabolism and net flux as well as the
      systemic response in healthy volunteers who are subjected to either normobaric hypoxia alone
      (N=12), low-dose IV endotoxin infusion alone (N=12), or a combination of endotoxin infusion
      and normobaric hypoxia (N=12).
    

Intervention name(s): Endotoxin infusion, Normobaric hypoxia
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Sepsis; Hypoxia; Altitude Sickness; Endotoxin; Cytokines; Cerebral blood flow; Cerebral metabolism; Reactive oxygen species
Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea
Condition: Trachebronchomalacia (TBM); Hyper Dynamic Airway Collapse (HDAC); Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Shock
Study type: Observational

Summary: 
      The investigators hypothesize that there is a strong correlation between OSA and TBM/HDAC.
      Our hypothesis is based on the similarities in mechanism (airway collapse), symptoms (daytime
      and nocturnal dyspnea) predisposing conditions (obesity and neuromuscular abnormalities of
      the chest wall and the diaphragm), and effect of interventions (CPAP and BIPAP) in these
      diseases.
    

Detailed description: 
      Tracheobronchomalacia (TBM) and HyperDynamic Airway Collapse (HDAC) are two distinct airway
      diseases that lead to airway collapse which can in turn lead to the symptoms of dyspnea,
      cough, and inability to expectorate sputum effectively. TBM entails flaccid tracheal and
      bronchial cartilages leading to airway collapse, emanating primarily from the anterior wall
      of the lumen. It is seen in conditions such as Relapsing Polychondritis and saber sheath
      tracheal deformity. HDAC on the other hand is the hyper-flaccidity of the membranous portion
      of the tracheobronchial tree leading to airway collapse. This condition is commonly seen with
      obesity and severe emphysema. TBM and HDAC frequently coexist.

      In patients with TBM/HDAC sleep disorders are common. Patients often complain of poor quality
      sleep, snoring, daytime fatigue, and somnolence. These patients are often diagnosed with
      Obstructive Sleep Apnea (OSA) upon workup.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In this pilot study we plan to recruit 30 consecutive patients with TBM/HDAC from the
        interventional pulmonology clinic at National Jewish Health (NJH). These patients will
        already have an established diagnosis of TBM and/or HDAC.
      
Keywords: Tracheobronchomalacia; TBM; HyperDynamic Airway Collapse; HDAC; Obstructive Sleep Apnea; OSA
Effects of Muscle Energy Technique in Knee Osteoarthritis Patients
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To determine the effectiveness of muscle energy technique along conventional physical therapy
      after mesenchymal stem cell transplantation in knee Osteoarthritis patients regarding Pain,
      range of motion, functional disability and quality of life.
    

Detailed description: 
      Mesenchymal stem cells (MSCs) replacement is a regenerative therapeutic procedures for the
      early treatment of cartilaginous defects in knee osteoarthritis. MSCs may improve symptoms
      and function in osteoarthritic joints but also decrease inflammation and induce cartilage
      healing by differentiating into chondrocytes, osteoblasts and indicating appropriate
      extracellular matrix proteins (i.e. collagen I and II) through the secretion of cytokines,
      chemokines, and growth factors from MSCs.
    

Intervention name(s): CONVENTIONAL PHYSICAL THERAPY; MUSCLE ENERGY TECHNIQUE
Intervention type(s): Other; Other
Intervention description(s): High frequency TENS for 10 mins, 3 days/week Ankle pumps for blood circulation 10 repetitions x1 set, 3 days/week. Heel slides10 repetitions x1 set, 3 days/week. Open chain knee flexion and extension 10 repetitions x1 set, 3 days/week. SLR (straight leg raise) 10 repetitions x1 set, 3 days/week. Calf stretch 10 repetitions x1 set, 3 days/week. Quad set 10 repetitions x1 set, 3 days/week.
Total 6 sessions each consisting of 30-45 minutes; Experimental group treated by applying Muscle energy technique along conventional physical therapy.
For MET patient is positioned at maximal comfort and lengthening while engaging the barrier and then patient is asked to perform isometric contraction with 6-10 sec hold and then release and lengthen the muscle 4-5 repetition x 1 set, 3days/week Total 6 sessions each consisting of 30-45 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Mesenchymal stem cells (MSCs),; muscle energy technique (MET),; rehabilitation protocol
Neuronal and Sensory Perception of Fat
Condition: Fat Perception in the Brain
Study type: Interventional

Summary: 
      This project will examine neuronal and sensory fat perception. Our hypothesis is that
      subjects being either hypersensitive or hyposensitive for fat will show different brain
      activities. Therefore the investigators will conduct functional magnetic resonance imaging
      (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.
    


Intervention name(s): yogurt
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will receive yogurt with varying fat concentrations
Intervention model: Single Group Assignment
Primary purpose: Basic Science
Cytoreduction Followed by Normothermic Versus Hyperthermic Intraperitoneal Intraoperative Chemoperfusion (HIPEC): a Study in Peritoneal Carcinomatosis
Condition: Peritoneal Carcinomatosis
MeSH terms: Carcinoma; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable
      patients with surgery followed by instillation of heated chemotherapy inside the abdominal
      cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or
      HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug
      active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this
      study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90 minutes)
      may be safer and at least as efficient. Patients will be treated with one of three possible
      HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min, 37.5°C; or low
      dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and pharmacodynamic: using
      specialized techniques, tissue penetration of chemotherapy and cancer cell kill effects will
      be compared in order to establish the safest and most active HIPEC regimen.
    


Intervention name(s): Hyperthermic intraoperative Peritoneal Chemoperfusion; Hyperthermic intraoperative Peritoneal Chemoperfusion; Hyperthermic intraoperative Peritoneal Chemoperfusion
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Dose: 460 mg/m², duration: 30 minutes, temperature 37°C; Dose: 460 mg/m², duration: 30 minutes, temperature 41°C; Dose: 200 mg/m², duration: 90 minutes, temperature 37°C
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peritoneal carcinomatosis from colorectal or appendiceal origin