bioihbjkbjnl/mcl2 huggingface dataset:
Adipose Tissue Expandability and Type 2 Diabetes
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The goal of the study is to analyze deviations in adipogenic potential and metabolic
      properties of preadipocytes in subjects with genetic predisposition to type 2 diabetes, and
      thus identify factors that underlie hypertrophic growth of adipose tissue associated with the
      development of this disease.
    

Detailed description: 
      Adipose tissue (AT) expands in response to excessive energy intake by hyperplasia or
      hypertrophy. While hyperplasia is associated with preservation of insulin sensitivity,
      hypertrophic AT exerts a number of metabolic defects. The mechanisms by which hyperplasia is
      suppressed at the expense of AT hypertrophy remain unknown, but it is expected that the
      hypertrophy of adipocytes is primarily driven by insufficient recruitment and differentiation
      of available preadipocytes. The limitation of hyperplasia occurs already in non-obese healthy
      subjects who are genetically predisposed to Type 2 Diabetes. Using these and control
      subjects, the LIMEX project aims to analyze the mechanisms of AT expandability. The project
      will combine in vivo characterization of AT and in vitro studies on human preadipocytes
      derived from AT biopsies obtained during clinical study. In vitro, proliferation,
      adipogenesis and lipogenesis of adipose cells will be monitored and these properties will be
      related to the degree of AT hypertrophy in vivo, insulin sensitivity and genetic
      predisposition to metabolic complications.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        50 healthy lean men (age 30-45, BMI <26). Two groups of subjects (n=25) matched for BMI,
        fat mass and age.
      
Biospecimen description: 
      adipose tissue plasma / serum preadipocytes (cells)
    
Keywords: Type 2 Diabetes; adipose tissue; preadipocytes; expandability; hypertrophy; hyperplasia; lipogenesis; adipogenesis; insulin sensitivity
Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2
Condition: Muscular Dystrophy, Facioscapulohumeral
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional

Summary: 
      The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles
      of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2
      FSHD study. For this, the investigators relied on observational components: FSHD2 patients
      appear more often present with psychiatric comorbidities and seem to have lower cognitive
      performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small
      sample population of patients. It seems to exist mainly executive dysfunction associated with
      attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low
      in relation to their socio-educational and compared with patients FSHD1 level.
    


Intervention name(s): Psychiatric test
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of a Lipolytic Cream in an Overweight and Obesity Treatment
Condition: Lipolysis; Overweight and Obesity; Diet Modification; Physical Activity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The coadyouvant efficacy of a combination of cosmetics ingredients in the form of a lipolytic
      cream with hypocaloric diet and physical activity were assessed and compared with with
      hypocaloric diet and physical activity for overweight and obesity treatment in patients.
    

Detailed description: 
      The coadyouvant efficacy and safety of a combination of cosmetics ingredients in the form of
      a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with
      with hypocaloric diet and physical activity for overweight and obesity treatment in patients
      of both gender and different age groups. DESIGN: In a monocenter, open-label, randomized,
      parallel-group study of 102 patients that consulted for overweight and obesity treatment were
      analyzed in perimeters and body composition for 12 consecutive weeks that were medically
      prescribed a weekly hypocaloric diet and physical activity for one group of 51 patients, and
      hypocaloric diet, physical activity and the lypolitic cream at least twice per day for the
      other group of 51 patients. Efficacy was evaluated by comparing intial and final of all
      values in both groups. Safety was monitored by the incidence of adverse events. Patients also
      assessed the acceptability of the cream presentation.
    

Intervention name(s): Dr.K. Treatment
Intervention type(s): Combination Product
Intervention description(s): Overweight and obesity treatment response
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open-label, randomized, parallel-group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; overweight; fat percentage; body fat; lipolytic cream
The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional

Summary: 
      Liver tumors are hard to treat with radiation because the liver moves every time you breathe.
      The purpose of this study is to test a new and possibly more accurate way of treating liver
      tumors. When a person is asleep under anesthesia, it is safe to stop breathing motion for a
      while. The liver will stop moving and radiation can be given to a liver tumor. The study is
      being done to see if radiation can be given to liver tumors safely and accurately in this
      way.
    


Intervention name(s): image guidance with general anesthesia and suspended ventilation during treatment delivery
Intervention type(s): Procedure
Intervention description(s): All study patients will undergo marker implantation approximately 2 weeks prior to the PET-CT simulation and treatment planning. PET-CT is performed for treatment planning purposes. This part of the process is in routine clinical use at MSKCC.
Three cone beam imaging scans and an IV contrast injection just prior to the first cone beam scan will be added to the standard procedure. The use of these two techniques is investigational.
The treatment delivery will make use of general anesthesia and suspension of mechanical ventilation to render the patient apneic during both target localization and dose delivery. This will allow the dose to be delivered more precisely than the techniques currently in use, thus allowing the use of smaller treatment margins and reducing the high dose exposure of healthy liver tissue. These measures have not previously been used for treatment delivery.
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anesthesia; suspended ventilation
Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma
Condition: Asthma; Obesity
MeSH terms: Pneumonia; Asthma; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to gain understanding of mechanisms whereby bariatric surgery
      modulates pulmonary inflammation and pulmonary microbiome composition and how these changes
      direct the pathobiology of human obese asthma.
    


Intervention name(s): Blood draw; Sputum collection; Pulmonary function test
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 23 ml of blood collected; Induced sputum sample collected; Pulmonary function testing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort of 15-20 obese, early-onset asthmatic, 15-20 obese, late-onset asthmatic, and 15-20
        obese non-asthmatic subjects will be recruited. Subjects in each group will undergo an
        initial screening visit (V0) to establish the subject groups according to asthma diagnosis,
        asthma onset age and type of scheduled surgery.
      
Biospecimen description: 
      Blood and sputum
Pilot Feasibility Study of Neurofeedback for Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Neurofeedback is increasingly advocated for treatment of ADHD despite a thin evidence base.
      The numerous open and partially controlled studies suffer serious design flaws. In
      particular, there is no published double-blind randomized clinical trial (RCT), which would
      control for experimenter and participant biases. The primary aim of this R34 pilot study is
      to conduct a small-scale pilot with 39 8-12 year-olds with ADHD to prepare for such a larger
      RCT.
    

Detailed description: 
      Thirty-nine boys and girls aged 6-12 with rigorously diagnosed DSM-IV ADHD not currently
      taking medication will be twice-randomized: first to active neurofeedback (n=26) vs. sham
      neurofeedback (n=13), and simultaneously to 2 vs. 3 times a week treatment frequency (at
      least 18 in each frequency, 12 active and 6 sham) for 40 treatments. At treatment 24, major
      assessments will include measures of satisfaction and blinding, and subjects will be given
      the option of switching to the opposite treatment frequency for the remaining 16 treatments
      to generate a practical measure of schedule palatability. Major assessments (at baseline,
      treatment 12, treatment 24, treatment 40, and follow-up) will include measures of symptoms,
      functional impairment, academic performance/achievement, and neuropsychological tests of
      attention, vigilance, and executive functioning. Every 3 treatments parents will rate ADHD
      symptoms and every 6 treatments teachers will rate, to track the response curve over time.
      Baseline EEG arousal and ADHD subtype will be examined as possible moderators. By determining
      the optimal frequency and number of treatments and demonstrating feasibility of double
      blinding, this pilot study should pave the way for a definitive large RCT of neurofeedback.
    

Intervention name(s): Active Neurofeedback; Sham neurofeedback
Intervention type(s): Device; Device
Intervention description(s): A comparison of active neurofeedback to sham neurofeedback and of two treatment schedules: twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.; Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.
Other intervention name(s): Electroencephalographic biofeedback, EEG biofeedback; Electroencephalographic biofeedback or EEG biofeedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurofeedback
Shoulder Corticosteroid Injection in Diabetic Patients
Condition: Shoulder Pain; Corticosteroid Injection; Type2 Diabetes Mellitus
MeSH terms: Shoulder Pain; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      In type 2 diabetic patients affected by chronic shoulder pain, subacromial injection with
      corticosteroid could be an effective treatment. The aim of this study was to measure the
      risk-benefit ratio of this treatment.Twenty patients with well-controlled diabetes were
      included in a prospective study. In a first pre-injection phase, patients were asked to
      measure glycemia for 7 days, before breakfast and dinner, then 2 hours after lunch and
      dinner. Baseline data including Constant Score (CS), Subjective Shoulder Value (SSV) and
      Numerical Rating Scale (NRS) for pain were collected. Patients were treated with subacromial
      injection with 40mg of Methylprednisolone Acetate and 2ml of Lidocaine. At discharge,
      patients were asked to re-measured glycemia for the following week.
    


Intervention name(s): MethylPREDNISolone Acetate 40 MG/ML
Intervention type(s): Drug
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type-2 diabetic patients affected complaining of chronic shoulder pain resistant to at
        least 6 months of conservative therapy (NSAIDs, painkillers and physiotherapy).
      
Keywords: shoulder pain; type 2 diabetes; subacromial corticosteroid injection; glycemia; efficacy; safety
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, multi-center, open-label study of PTI-125 in mild-to-moderate Alzheimer's
      disease patients.
    

Detailed description: 
      This is a Phase 2a, multi-center, open-label study of PTI-125 in mild-to-moderate AD
      patients, 50-85 years of age. A total of twelve (12) patients will be enrolled into the
      study. Patients will receive 100 mg b.i.d. of PTI-125. The objectives of this study are to
      investigate the safety, pharmacokinetics and effect on biomarkers of PTI-125 following 28-day
      repeat-dose oral administration.
    

Intervention name(s): PTI-125, 100 mg tablets
Intervention type(s): Drug
Intervention description(s): PTI-125, 100 mg tablets taken twice a day for 28 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MEDI-557 Adult Dosing
Condition: Respiratory Syncytial Virus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects
      (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or
      placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed
      for safety from the time of Informed Consent through 360 days post dose.
    

Detailed description: 
      A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and
      tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of
      42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose,
      12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects
      are evaluated for safety from time of Informed Consent through Study Day 360 post dose.
    

Intervention name(s): Placebo; MEDI-557; MEDI-557
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; MEDI-557 low-dose; MEDI-557 high-dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Respiratory Syncytial Virus
Comparison of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Inguinal Hernia Repair
Condition: Postoperative Pain
MeSH terms: Hernia, Inguinal
Study type: Interventional

Summary: 
      Multimodal analgesia is used to control postoperative pain in inguinal hernia repair.
      Transversus abdominis plane block is an effective regional anesthesia technique for
      postoperative analgesia in inguinal hernia repairs. The erector spinae plane block applied to
      thelow thoracic region was also reported to provide effective analgesia in these surgeries.
      In this study, we aimed to determine and compare the effects of transversus abdominis plane
      block and lumbar erector spinae plane block on postoperative pain in inguinal hernia repairs.
    


Intervention name(s): ESP Block; TAP Block; Standard Pain Followup and Monitorization
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): ESP block will be performed at the finishing of surgery under spinal anesthesia. A convex ultrasound transducer will be placed in a longitudinal parasagittal orientation 2-3 cm lateral to T10 spinous process. The erector spinae muscles will be identified superficial to the tip of T10 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of bupivacaine/lidocaine mixture will be injected.; TAP block will be performed at the finishing of surgery under spinal anesthesia. A linear ultrasound transducer will be placed to lateral aspect of abdomen. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane between transversus abdominis and internal oblique muscles..A total of 30 mL of bupivacaine/lidocaine mixture will be injected.; Numeric Rating Scale (NRS) pain score will be recorded and followed by 0., 1.-3.-6.-12.-18.-24.hours. it is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)
Condition: Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to investigate the safety and feasibility of daily subcutaneous
      injections of recombinant IGF1 complexed with IGF binding protein 3 (SomatoKine-INSMED) as a
      treatment for muscle wasting and weakness in myotonic dystrophy type 1.
    


Intervention name(s): SomatoKine/IPLEX
Intervention type(s): Drug
Intervention description(s): Cohort 1: self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
Cohort 2: consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of Transcranial Direct Current
      Stimulation (tDCS) on appetite control related brain regions.
    

Detailed description: 
      Transcranial direct current stimulation (tDCS) is emerging tool for brain modulation in a
      variety of clinical conditions. In addition, recent neuroimaging studies suggest that
      modifying the activity of brain circuits involved in eating behavior could provide
      therapeutic benefits in obesity.

      The investigators aim to assess whether modulation of the dorsolateral prefrontal cortex
      (DLFPC) using tDCS, modifies behavioral response and brain activity while watching visually
      presented food cues in obese subjects.

      Subjects will receive tDCS two times, one is active stimulation and the other is sham
      stimulation. Both stimulations will be separated at least one week and the order of sham and
      active tDCS will be counterbalanced across subjects.

      Subjects will perform functional MRI experiments with visual food cues. Questionnaire with
      behavior measures, body compositions, blood tests will be performed.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): For active tDCS, a 2 mA current will be delivered for 20 minutes with 20 second up and down ramp times. The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function. The electrodes used for tDCS are saline-soaked sponges (25 cm2).
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream
Condition: Eczema; Allergy Symptoms; Psoriasis; Itch
MeSH terms: Psoriasis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, open-label study to evaluate whether participants follow the duration
      of use instructions for short-term use of alclometasone dipropionate in a population of
      participants with itchy skin conditions who would use OTC treatments for relief. The study
      population will be composed of two different cohorts: chronic condition sufferers (eczema or
      psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison
      ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or
      soaps) where an anti-itch medication would be used.
    

Detailed description: 
      Approximately 313 participants who are currently suffering from an itchy skin condition
      caused by eczema or psoriasis or any occasional itchy skin experiences will be enrolled into
      the study to get 250 participants who complete the study (at least 100 to each of the
      cohorts). After evaluation of the study criteria, the site staff will dispense product and a
      diary card to the subject to use over the next 14 days. At the end of the 14 days, each
      participant will come to the research site to return the remaining product and undergo the
      study termination interview with the Concentrics nurse via telephone. The study will be
      conducted in approximately 15 research sites located throughout the United States (US).
    

Intervention name(s): Alclometasone dipropionate cream
Intervention type(s): Drug
Intervention description(s): Alclometasone dipropionate cream 0.05% (15 g)
Intervention MeSH terms: Alclometasone dipropionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alclometasone dipropionate; Eczema; Psoriasis; Itch