bioihbjkbjnl/mcl2 huggingface dataset:
The Investigation of Mechanical Properties in Obesity.
Condition: Body Fat Disorder; Obesity; Muscular Tone; Viscoelasticity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The study will demonstrate the relation between muscle tone and viscoelastic properties with
      the body mass index.
    

Detailed description: 
      Obesity is an increasingly important health problem. It can be defined as excessive fat
      accumulation. Obesity is a low-severity systemic inflammatory condition that predisposes to
      chronic diseases.Obesity is closely related to adipose tissue, it can have direct or indirect
      effects on physical activity and musculoskeletal system. The systems working with oscillation
      techniques, subcutaneous tissue thickness may affect the probe stroke of the device and
      oscillation in the tissue. In previous studies were investigated mechanical properties, and
      BMI used as exclusion criteria is over 30 kg/meter square or keeping it at certain intervals
      (18-28 kg /meter square) but this proof is not demonstrated and still lack.This study is
      planned to determine the relation of mechanical properties (tone, stiffness and elasticity)
      obtained by myotonometric assessment with body mass index.
    

Intervention name(s): Myotonometric assessment
Intervention type(s): Diagnostic Test
Intervention description(s): MyotonPro device is vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.These stimulations induce damped natural oscillations in the tissue and the device records these oscillations using an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The people will assigned to groups depend on body mass index. The biceps brachii (BB), biceps femoris (BF) tone, and viscoelastic properties (stiffness and elasticity) will be evaluated bilaterally using the ''MyotonPRO'' device.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Body mass index; Tone; Viscoelasticity; Obesity
Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.
Condition: Autonomic Nervous System Activity
Study type: Interventional
Phase: Phase 4

Summary: 
      Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general
      anaesthesia and for analgesic and sedative effect in intensive care units (ICU) patients.
      Registration for anesthesia includes bolus dose and continuous infusion, in ICU only infusion
      regimen is allowed. Pharmacokinetic/pharmacodynamic parameters of RMFNT results in rapid
      onset and offset of clinical effect, which makes this drug almost ideal in many situations.
      Unfortunately, its vagomimetic influence on cardiac activity may result in decrease of heart
      rate. It may be hypothesized that patients with parasympathetic predominance may be prone to
      more intense parasympathomimetic effect of this opioid. An optimal method for assessment of
      autonomic nervous system activity and assessment of influence of RMFNT on that activity is
      Heart Rate Variability (HRV) analysis. Parasympathetic predominance is expressed as high
      frequency (HF) power and HF/(LF+HF) (LF-low frequency) ratio in frequency domain and Root
      Mean Square of the Successive Difference (RMSSD), the number of pairs of successive NNs that
      differ by more than 50 ms (NN50), the proportion of NN50 divided by total number of NNs
      (pNN50) in time domain. The aim of this study is to verify the hypothesis that patients with
      predominance of parasympathetic activity are more subject to vagomimetic effect of RMFNT. HRV
      based on 5 minutes electrocardiogram (ECG) recorded before and after bolus dose of RMFNT will
      be analyzed. The occurrence of heart rate decrease will be than compared between patients
      with sympathetic and parasympathetic predominance measured prior to drug injection.
    


Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): 1mcg/kg iv dose, followed by 5 minutes ECG recording
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: remifentanil; heart rate; autonomic nervous system; heart rate variability; autonomic nervous activity; vagotonic effect; single dose
Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to understand whether participants can mount an immune response
      to SARS-CoV-2 modRNA vaccines administered either during continuous siponimod treatment or
      during a treatment break.
    

Detailed description: 
      This is a three cohort, multicenter, open-label, prospective study of 60 (optionally up to
      90) multiple sclerosis (MS) patients currently treated with siponimod or a first-line disease
      modifying therapy (DMT) or without MS treatment in clinical routine planning to undergo a
      SARS-CoV-2 modRNA vaccination as part of clinical routine. The maximal duration of the study
      for an individual patient is 14 months.

        -  The first cohort in this study will be participants not interrupting their current
           siponimod therapy for the purpose of a SARS-CoV-2 modRNA vaccination.

        -  The second cohort will be participants interrupting their current siponimod therapy for
           the purpose of a SARS-CoV-2 modRNA vaccination for approximately 2-3 months.

        -  The third cohort will be participants receiving modRNA vaccine while on treatment with
           the following first-line DMTs (dimethylfumarate, glatirameracetate, interferons,
           teriflunomide) or no current treatment in clinical routine.

      The study will investigate the development of functional anti-SARS-CoV-2 antibodies and
      T-cell titers for six months after the participants' vaccination.
    

Intervention name(s): BAF312; Baseline disease modifying therapies (DMTs)
Intervention type(s): Drug; Drug
Intervention description(s): taken orally once per day (dose depends on CYP2C9 genotype); DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC
Other intervention name(s): Siponimod
Intervention MeSH terms: Siponimod
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; SARS-CoV-2 mRNA vaccine; Siponimod; Secondary Progressive Multiple Sclerosis; SPMS; adult; MS
Acupressure and Comfort at Childbirth
Condition: Pain, Labor
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Aims: Non-pharmacological methods employed for management labor pain also help pregnant women
      to cope with labor pain and increase their childbirth comfort. The aim of this study is to
      determine the effect of cold and hot acupressure applications, applied to the acupressure
      point LI4 of primiparous women during labor, on their childbirth comfort.

      Methods: This study was designed a randomized controlled experimental study. The sample
      consisted of 129 healthy pregnant women including 44 pregnant women in the hot acupressure
      group, 44 pregnant women in the cold acupressure group, and 41 pregnant women in the control
      group. The "Personal Information Form", the "Labor Monitoring Form", the "Visual Analog
      Scale", and the "Childbirth Comfort Questionnaire" were all used to gather the data.
    


Intervention name(s): Cold Acupressure; Warm Acupressure
Intervention type(s): Other; Other
Intervention description(s): For the cold acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference. Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout. Lastly, the cold acupressure pouches were kept in a freezer for 40 minutes.; For the warm acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference. Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout. Lastly, the warm acupressure pouches were heated in a microwave at 600 W for one minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Pain, Labor, Comfort
Improving Diabetes Outcomes for Persons With Severe Mental Illness
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Mental Disorders
Study type: Interventional

Summary: 
      Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM).
      Unfortunately, persons with mental illness and T2DM are less likely to receive recommended
      diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to
      microvascular and macrovascular complications later in life. Evidence-based diabetes
      self-management education and support interventions have yet to be adapted for persons with
      mental illness and there have been no randomized controlled trials (RCTs) to examine their
      feasibility and efficacy. The purpose of this study is to assess the feasibility of
      conducting a RCT of a diabetes self-management intervention for persons with severe mental
      illness and T2DM.
    


Intervention name(s): Diabetes self-management and education
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
LIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury
Condition: Chronic Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The LIFT Home Study is an observational, single-arm study designed to assess the safety of
      non-invasive electrical spinal stimulation (ARC Therapy) administered by the LIFT System to
      treat upper extremity functional deficits in people with chronic tetraplegia.
    

Detailed description: 
      The primary goal of this study is to report on the safety of the study device when used at
      home. In addition, the study will report on observed changes in upper extremity function and
      strength after a period of home use.

      The LIFT Home Study will enroll subjects who have recently completed participation in the
      Up-LIFT Study. The study includes a set of baseline assessments to be completed in the
      clinic, a four-week home use treatment program prescribed by the investigator, and a final
      set of clinic-based assessments at the end of the study.

      At the baseline visit, the subject and caregiver will be trained on the use of the device and
      prescribed a specific training regime for its use at home. The subject will be issued a
      device that is uniquely programmed to operate within a limited set of parameters as specified
      by the investigator.

      Throughout the study, subjects will be prompted to report all adverse events (AE) regardless
      of relatedness to the device.

      At baseline and the final clinic visit, UE strength and function will be measured with
      stimulation off using a comprehensive set of assessment tools including CUE-T, GRASSP, Pinch
      and Grasp Force, as well as patient and caregiver global impression of change questionnaires.
    

Intervention name(s): LIFT System
Intervention type(s): Device
Intervention description(s): The LIFT System delivers the Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SCI, Tetraplegia, ARC therapy
Efficacy and Safety of BP1.4979 in Smoking Cessation
Condition: Tobacco Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy
      and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by
      subject diary and confirmed by exhaled CO (abstinent < 10 ppm).
    

Detailed description: 
      BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on
      phase I studies.

      This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with
      parallel group to assess safety and efficacy of BP1.4979 in smoker.
    

Intervention name(s): BP1.4979; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tobacco addition
Effects of Dietary Fatty Acids on Octadecanoid Production and Biological Actions in Obesity-induced Inflammation
Condition: Obesity; Inflammation
MeSH terms: Obesity; Inflammation
Study type: Interventional

Summary: 
      This is a single site, double-blind, randomized, crossover study designed to compare the
      effects of dietary supplementation with flax oil rich in alpha-linolenic acid (ALA) and fish
      oil rich in docosahexaenoic acid (DHA) on oxylipin profiles over time (0 to 4 weeks) and
      among obese females varying in their inflammatory state. Additional assessments will include
      plasma fatty acid composition, adipokines, markers of adipocyte dysfunction and inflammation;
      immune cell/monocyte fatty acid composition, and functional properties including their
      metabolism and oxylipin production; and vascular function.
    

Detailed description: 
      A single site, double-blind, randomized, cross-over study designed to compare the effects of
      flax oil and fish oil supplementation on the oxylipin profile in females with obesity (n=24).
      Eligible participants will complete two supplementation phases (flax oil and fish oil rich in
      DHA) and will be asked to attend 3 in-person clinic visits (0, 3, and 28 days) for blood and
      urine collection during each phase. In addition to oxylipin profiles, assessments will
      include plasma fatty acid composition, adipokines, markers of adipocyte dysfunction and
      inflammation; immune cell/monocyte fatty acid composition, and functional properties
      including their metabolism and oxylipin production; and vascular function. If participants
      sign an optional consent form, vaginal fluid samples will be obtained at 0 and 28 days of
      each Supplementation Phase and analyzed for oxylipin and immune cell profile.
    

Intervention name(s): Capsules containing flax oil; Capsules containing DHA-enriched fish oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules containing flax oil to provide 4 grams ALA per day for 4 weeks; Capsules containing fish oil to provide 4 grams DHA per day and 0.8 grams EPA per day for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Obese females
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound
Condition: Bowel Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of
      abdominal pain and suffering during women's menstrual periods. A subgroup of patients with
      DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth
      pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to
      assess the need for follow-up with transvaginal ultrasound during medical treatment.

      Hypotheses:

      Symptoms will follow growth of rectosigmoid endometriosis.

      Material and methods:

      Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and
      treatment with hormonal intrauterine device or continuous oral contraceptives will receive a
      questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion,
      (6) and 12 months later.

      Perspectives:

      Patients treated conservatively may be followed by questionnaires, thereby reducing the need
      for time consuming clinical controls.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with bowel endometriosis
Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy
Condition: Recurrent or Progressive Glioblastoma
MeSH terms: Glioblastoma; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to
      test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy ,
      and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and
      treatment response.
    


Intervention name(s): Bevacizumab; Chemotherapy; Fractionated radiosurgery
Intervention type(s): Drug; Drug; Radiation
Other intervention name(s): Either irinotecan or temozolomide or carboplatin or etoposide
Intervention MeSH terms: Bevacizumab; Carboplatin; Irinotecan; Etoposide; Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glioblastoma
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended
      release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories,
      Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg)
      manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP
      Wilmington, DE 19850 in healthy, adult, male, human subjects under fasting condition.
    

Detailed description: 
      All the subjects were subjected to breath test for alcohol and test for drugs of abuse
      (opioids and cannabinoids) prior to admission in each period. Only subjects with negative
      results in these tests were preceded for further activities.

      Following an overnight fast of at least 10 hour, a single oral dose of felodipine extended
      release tablet (containing felodipine 10 mg) of either test or reference formulation was
      administered during each period of the study, along with 240 mL of drinking water at ambient
      temperature under low light condition .

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry (except blood
      glucose and cholesterol) were repeated at the end of the study.
    

Intervention name(s): Felodipine; PLENDIL®
Intervention type(s): Drug; Drug
Intervention description(s): Extended Release Tablets, 10mg; Extended Release Tablets, 10mg
Intervention MeSH terms: Felodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effect of Stent Size on Dyssynchrony
Condition: Left Ventricular Function
Study type: Observational

Summary: 
      the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI
      using drug eluting stent is not clear enough
    

Detailed description: 
      Background: the effect of stent size and number on left ventricular mechanical dyssynchrony
      after PCI using drug eluting stent is not clear enough Aim: to study short term effect of
      stent size and number on left ventricular mechanical dyssynchrony after elective PCI to LAD
      artery.

      Patients and methods: the study included 150 adult patients with electively stented LAD
      lesion with DES. Patients were evaluated pre PCI then follow up at 1m and 3m using tissue
      synchronization image (TSI).
    

Intervention name(s): coronary artery stents
Intervention type(s): Device
Intervention description(s): Coronary angiography was done for all the patients according to the Judkins technique. All images were evaluated by an experienced operator, significant coronary artery disease was defined as > 70 % luminar diameter stenos. The following data was obtained:
Site of stent implantation within LAD. The first Diagonal branch serves as the boundary between the proximal and mid portion of the LAD. Thus, the portion of the artery prior to the origin of the 1st diagonal is known as the proximal LAD, while the segment just below the1st diagonal branch is the mid LAD. The distal segment of the LAD is the terminal third of the artery (Cao et al., 2017).
Length, diameter and number of stents.
TIMI flow after stent deployment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult patients with electively stented LAD lesion with DES were enrolled in the study
      
Keywords: Stent length; Stent diameter
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label study that will be conducted at a single site in China to evaluate the
      safety,tolerability and PK/PD profile of multiple dose of recombinant human serum
      albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration
      of study participation is up to 22 weeks for each subject,including 4 weeks screening period.
    


Intervention name(s): Human Serum ALbumin/interferon alpha2a; Pegasys
Intervention type(s): Biological; Biological
Intervention description(s): 600,750 or 900 mcg dosing every 2 weeks; 180 mcg dosing every week
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment