bioihbjkbjnl/mcl2 huggingface dataset:
Circulating IL-6, Clusterin and Irisin in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      evaluate the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes
      who had different classes of obesity and their sexual dimorphism also identify the
      association of IL-6, clusterin and irisin with insulin resistance.
    

Detailed description: 
      Aim: Firstly, this study aimed at assessing the circulating levels of IL-6, clusterin and
      irisin in obese subjects of both sexes who had different classes of obesity and evaluating
      their sexual dimorphism and secondly evaluate the association of IL-6, clusterin and irisin
      with insulin resistance.

      Method: This study was conducted on 176 non-diabetic subjects of both sexes. Participants
      were classified according to their sex into two groups; the male and female groups. The male
      group (88 men) was classified according to BMI into; group 1 (22 lean men), group 2 (22 class
      I obese men), group 3 (22 class II obese men), and group 4 (22 class III obese men). The
      female group (88 women) was also classified according to BMI exactly as the male group.
      Fasting blood glucose, fasting insulin, lipid panel, serum IL-6, clusterin and irisin levels
      were measured. One-way analysis of variance followed by Tukey's as post hoc test was used for
      comparison of variables.
    

Intervention name(s): IL-6, Clusterin, Irisin Level
Intervention type(s): Diagnostic Test
Intervention description(s): Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects included in the study were classified according to their sex into two main group
        the male group and the female group. The male group contained 88 men which subdivided
        according to the BMI into the following groups; group 1 (22 lean men), group 2 (22 class I
        obese men), group 3 (22class II obese men), and group 4 (22 class III obese men). The
        female group contained 88 adult women which sub-classified according to BMI into the
        following subgroups; group 1 (22 lean women), group 2 (22 class I obese women), group 3 (22
        class II obese women), and group 4 (22 class III obese women).
Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction
Condition: Temporomandibular Joint Dysfunction Syndrome
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Temporomandibular dysfunction (TMD) consists of a series of multifactorial signs and symptoms
      that occur in the orofacial region, with pain being the most common symptom. There is a close
      biomechanical and anatomical relationship between the cervical region and the
      temporomandibular joint (TMJ) through the trigemino-spinal nucleus.

      Objectives: To comparatively assess the improvement in subjects with TMD when adding cervical
      manual therapy to a postural treatment. Additionally, to determine if both cervical
      treatments separately produce changes in the TMJ.

      Materials and methods: An experimental study of randomized controlled clinical trial type was
      conducted. The study involved 30 wind instrument players randomly assigned to an experimental
      group (EG) and a control group (CG). After obtaining consent, measurements were taken for
      maximum mouth opening (MMO), cervical range of motion, and pain threshold to pressure (PTP)
      in the masseter and temporalis muscles. Both groups underwent active cervical postural
      treatment for 4 weeks, and the EG additionally received a cervical manual therapy protocol.
      An initial assessment was conducted before the intervention, and a final assessment was done
      one week after the last intervention. The statistical program SPSS was used for data
      analysis.
    


Intervention name(s): Manual therapy; Postural exercises
Intervention type(s): Other; Other
Intervention description(s): Within the manual therapy protocol carried out in the experimental group, we performed a series of passive maneuvers. The patient remains in supine position on a treatment table throughout the treatment, while the therapist sits at the head of the patient on a stool. The sequence of application is as follows:
Suboccipital inhibition technique Cervical spinal mobilization Posterior fascia stretching; The treatment plan includes active postural exercises for the cervical spine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The present study is an experimental, analytical, longitudinal, and prospective controlled randomized clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TEMPOROMANDIBULAR JOINT; Cervical Posture; wind Musician
¡Vivir Mi Vida! Pilot Study
Condition: Healthy Lifestyle
Study type: Interventional

Summary: 
      Rationale: By the year 2050, the number of older adults in the US will more than double.
      Because older adults are more likely to develop chronic conditions such as cardiovascular
      disease and arthritis, society is facing a healthcare crisis if effective ways to prevent
      such diseases is not found. This is especially urgent for Latinos because they are the
      nation's fastest growing ethnic group and they are in many cases at greater risk for chronic
      disease. Objectives: ln this proposed pilot project, the goal is to understand if a lifestyle
      intervention - iVivir Mi Vida! (iVMV!) - is feasible, acceptable, and shows preliminary
      promise in helping late middle-aged Latinos experience better health. The investigators will
      accomplish this goal by pilot testing the implementation of iVMV! in collaboration with
      community health service partners in Antelope Valley. Methods: ln this study, 40 patients,
      aged 50-65 years who are enrolled in Antelope Valley health centers will receive the iVMV!
      lifestyle-based health program. This program lasts four months and will be delivered by
      promotores (respected lay heath workers from the Latino community). Intervening promotores
      will be supervised by an occupational therapist and a senior promotora. Within the program,
      patients will participate in small group sessions at their local community healthcare
      facilities and will also receive numerous visits from the promotores in their homes. The
      program will involve weekly sessions in which the participants will be taught how to practice
      healthy lifestyle choices, such as exercising, eating healthy food, and reducing stress.
      Initially and at the end of the four-month program, the investigators will measure health
      outcomes such as self-rated quality of life, diet and exercise, cholesterol and glucose
      levels, blood pressure, and weight. The investigators will also ask participants, promotores,
      and other research staff about their overall experiences during the study so that the
      investigators can improve our program for the future. Mixed-methods procedures will be used
      to analyze qualitative data (e.g., interview transcripts) and quantitative data (e.g.,
      pre-post intervention health outcomes and 12-month follow-up). Anticipated lmpact: The study
      will provide critical information about the feasibility and acceptability and preliminary
      data on the health impact of the iVMV! intervention on late middle-aged Latino adults who are
      at risk for disease. Information collected from this study will inform the design of a
      larger-scale implementation study.
    


Intervention name(s): ¡Vivir Mi Vida! Lifestyle Intervention
Intervention type(s): Behavioral
Other intervention name(s): VMV
Masking: None (Open Label)
The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of
      moderate to severe glabellar lines.
    


Intervention name(s): Cunox; Botox
Intervention type(s): Drug; Drug
Intervention description(s): Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.; Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      This study conducted a retrospective analysis of 64 patients with mild cognitive impairment
      of the kidney deficiency phlegm and stasis type who underwent treatment with Naohuan Dan
      combined with Idebenone. The patients' cognitive function was evaluated using the Mini-Mental
      State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) before and after
      treatment. Daily living abilities were assessed using the Activities of Daily Living (ADL)
      scale, depression status was evaluated using the Geriatric Depression Scale (GDS), and the
      severity of Traditional Chinese Medicine (TCM) syndrome was assessed using the TCM diagnostic
      scale. Peripheral blood from the patients was also collected for analysis of neuron-specific
      enolase (NSE) and inflammatory factors. The aim was to evaluate the safety and feasibility of
      using Naohuan Dan combined with Idebenone for the treatment of mild cognitive impairment of
      the kidney deficiency phlegm and stasis type.
    


Intervention name(s): Idebenone; Naohuan Dan and Idebenone
Intervention type(s): Drug; Drug
Intervention description(s): The control group took Idebenone orally for 12 weeks.; The treatment group took Naohuan Dan combined with Idebenone for treatment. Naohuan Dan is a granular preparation taken once a day, while Idebenone is a tablet taken three times a day for a total of 12 weeks.
Intervention MeSH terms: Ubiquinone; Idebenone
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The participants were selected at the Traditional Chinese Medicine's and Rehabilitation
        Medicine's out-patient clinic or inpatient department of Sun Yat-sen Memorial Hospital of
        Sun Yat-sen University, Guangzhou, Guangdong, China.
A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
Condition: Drug Drug Interaction; Warfarin; Midazolam
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open label phase I clinical study to characterize the DDIs
      potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study
      also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and
      Midazolam.
    


Intervention name(s): ZSP1273
Intervention type(s): Drug
Intervention description(s): Drug Warfarin oral Drug midazolam oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in
      otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety
      and tolerability, efficacy, and pharmacokinetics of MHAA4549A.
    


Intervention name(s): MHAA4549A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MHAA4549A will be administered as a single dose by IV administration.; Placebo will be administered as a single dose by IV administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Trial for the Evaluation of Three Regimens of Influenza Vaccination in Kidney Transplant Recipients
Condition: Human Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be an open label, parallel, randomized clinical trial that will evaluate the
      immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented)
      produced by Instituto Butantan among adult kidney transplant recipients, when administered in
      three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two doses
      administered with a 21 day interval.

      The randomization ratio among the three groups of kidney transplant recipients will be 1:1,
      and 60 participants will be included in each group. After vaccination all participants will
      be followed for 26 weeks.

      In addition, 15 healthy adults will be included as a control group, and will receive the
      recommended dose.

      The study hypothesis is that a different vaccination regimen can improve the immune response
      of kidney transplant recipients after vaccination with the trivalent influenza vaccine
      (inactivated and fragmented).
    


Intervention name(s): Trivalent influenza vaccine (inactivated and fragmented).
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza vaccine
Dexmedetomidine Improves the Surgical Field and Postoperative Recovery of Nasal Endoscopic Surgery
Condition: Dexmedetomidine; Bleeding; Surgical Field
Study type: Interventional
Phase: Phase 3

Summary: 
      Studies showed dexmedetomidine (DEX) could improve surgical field, but the effect for
      functional nasal endoscopic surgery (FESS) was unclear. The investigators explored IV
      administration of a single loading dose DEX (0.5μg/kg) for FESS, and IV administration of
      midazolam (0.05mg/kg) as a control with comparision of surgical field, haemodynamics,
      ventilation parameters and recovery.
    

Detailed description: 
      The participants received an induction of anesthesia with propofol 2-3 mg/kg, sufentanyl 0.2
      μg/kg, and rocuronium 0.6 mg/kg, and then insertion of a flexible laryngeal mask airway was
      conducted using the index finger insertion technique by anesthesia providers with a minimum
      of four years endotracheal intubation experience. Mechanical ventilation parameters were as
      follows: pressure-controlled ventilation mode, ventilation pressure: 12, respiratory rate:
      12, oxygen concentration: 50%. The maintenance of general anesthesia was performed with
      sevoflurane at minimum alveolar concentration of 1.3. After induction, a single loading dose
      DEX (0.5μg/kg) was IV infusion within 10 minutes, or IV administration of midazolam
      (0.05mg/kg). Heart rate, blood pressure, tidal volume, ventilation pressure and ETCO2 after
      insertion of a LMA, 10 minutes, 20 minutes, 30 minutes after drug infusion and transferred to
      PACU, besides heart rate and blood pressure were recorded before and after induction.
      Surgical field was evaluated at the time of 10 minutes and 20 minutes after drug infusion.
      Blood gas analysis was performed just transferred to PACU and before transferred to ward.
    

Intervention name(s): IV administration of DEX to investigate the effects for functional nasal endoscopic surgery; IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery
Intervention type(s): Drug; Drug
Intervention description(s): IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes.; IV administration of midazolam (0.05mg/kg) after induction.
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Study type: Observational [Patient Registry]

Summary: 
      Objective:

        1. to investigate reliability, validity and responsiveness of shearwave elastography (SWE)
           to assess muscle stiffness of overactive upper or lower limb muscles in different angle
           joint positions in patients with neurological condition

        2. to investigate the relationship between muscle stiffness measured by SWE and by
           MyotonPro

        3. to investigate the correlation between muscle stiffness measured by SWE and clinical
           outcomes

      Methods: each patient will be assessed three times: two times at an interval of 15 minutes on
      the same day and one time at an interval of one week at the same time of the day. The
      following measurements will be made at each evaluation: SWE, MyotonPro, clinical evaluation.
      SWE and MytotonPro will be taken at different angle joint position.

      Outcomes: muscle stiffness measured by SWE and MyotonPro at different angle joint positions,
      and clinical evaluation (passive range of motion, modified ashworth scale, tardieu scale,
      fuglmeyer) Hypothesis: SWE is a valid, reliable, and resposive method to assess muscle
      stiffness in neurological population with muscle overactivity. The results of SWE will be
      correlated with the results of MyotonPro and with clinical outcomes.
    


Intervention name(s): shearwave elastography
Intervention type(s): Device
Intervention description(s): shearwave elastography on upper or lower limb
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In- or outpatients of the physical rehabilitation unit of the Cliniques universitaires
        Saint-Luc
      
Keywords: spasticity; sonoelastography
Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars
Condition: Dentin Bridge
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human
      treated dentin matrix in young permanent molars compared to MTA.
    

Detailed description: 
      The study was conducted as a split-mouth randomized clinical trial, approved by research
      ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric
      Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was
      conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20
      children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious
      young permanent mandibular first molars that are indicated for vital pulp therapy.The
      selected deeply carious molars were randomly divided into two groups as follows:

      Group I (Study group): 20 molars were treated with human TDM. Group II: (Control group): 20
      molars were treated with White MTA. The participating cases were evaluated clinically and
      radiographically after 6, 12 and 18 months. Tomographic evaluation was performed immediate
      postoperatively and at 18 months.
    

Intervention name(s): human treated dentin matrix; Mineral Trioxide Aggregate
Intervention type(s): Drug; Drug
Intervention description(s): human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis; mineral trioxide aggregate was used as control
Other intervention name(s): human partially demineralized treated dentin matrix; MTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in
      combination with allopurinol compared to allopurinol alone when administered orally once a
      day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol
      alone.
    


Intervention name(s): Arhalofenate; Allopurinol; Colchicine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Arhalofenate 400 and 600 mgs over-encapsulated tablets once daily for 4 weeks or Allopurinol 300 mg once daily for 4 weeks; Allopurinol 300 mg as active comparator; 0.6 mg colchicine daily as flare prophylaxis; Placebo
Intervention MeSH terms: Colchicine; Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hyperuricemia
A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus
      5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with
      advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at
      least 6 weeks and continued up to disease progression, and the target sample size is 300
      individuals.
    


Intervention name(s): 5-Fluorouracil; Capecitabine; Cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.; Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.; Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.
Intervention MeSH terms: Capecitabine; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment