bioihbjkbjnl/mcl2 huggingface dataset:
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Flanks
Condition: Fat Burn
Study type: Interventional

Summary: 
      This study will evaluate the clinical safety and the performance of the BTL-899 device (with
      its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as
      "love handles"). The study has a single-arm, open-label, interventional design. The subjects
      will be enrolled and assigned into one study arm and will be required to complete four (4)
      treatment visits.

      Both flanks will be treated simultaneously for 30 minutes per session. The flanks' fat
      thickness reduction will be documented by ultrasound.

      At the baseline visits health status will be assessed and, if needed, additional tests will
      be performed. Inclusion and exclusion criteria will be verified and informed consent will be
      signed.

      The treatment administration phase consists of four (4) treatment visits, delivered 5 - 10
      days apart.

      At every treatment visit after the first, prior to the procedure, the participants will be
      assessed for adverse effects resulting from the previous treatment(s) with the BTL-899
      device.

      Safety measures will include documentation of adverse events (AE) during and after the
      procedures.

      Follow-ups visits at 1 month and 3 months after the final treatment will be held.
    


Intervention name(s): HIFEM+RF
Intervention type(s): Device
Intervention description(s): Combination of High-Intensity Focused Electromagnetic Field (HIFEM) and a high radio frequency (RF) field.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Renal Function During Pediatric Anesthesia
Condition: Renal Failure; Anesthesia
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears
      more pronounced in children. However, the mechanisms for this effect is unknown and it is not
      clear if the commonly used anesthetic propofol does the same. In this study the investigators
      want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a
      pediatric setting and also investigate humoral changes induced by these anesthetics.
    

Detailed description: 
      Prior studies by the investigators research group have shown water and sodium retention in
      experimental animals undergoing sevoflurane anesthesia. Preliminary data suggest that this is
      not as obvious with propofol anesthesia. The investigators aim to study if this difference is
      present in children.

      Subjects are collected from ordinary routine operations of hypospadia. By routine, all boys
      undergoing this surgery get a sacral blockade and a urine catheter. The children are
      randomized to either sevoflurane or propofol anesthesia. Before or immediately after
      induction of anesthesia baseline blood samples are collected for analysis of sodium,
      potassium, creatinine, osmolality, angiotensin II, arginine-vasopressin and aldosterone.
      Perioperative fluids are started, a balanced glucose infusion with 132mmol sodium content,
      covering basal fluid need + 20%. This infusion is continued until the end of the protocol at
      the ward. At the induction of anesthesia the investigators start measuring urine output every
      20th minute. The same blood samples as above are collected again during mid-operation. At the
      end of anesthesia the investigators collect all the urine and send a sample for urine
      analysis of sodium, potassium, osmolality and creatinine.

      In the postoperative ward the investigators again start collecting urine every 20 minutes for
      120 minutes. All urine after 120 minutes are collected, and a sample sent for analysis. After
      60 minutes at the postoperative ward, blood samples are again collected for analysis.

      In the childrens ward the protocol for the postoperative ward is repeated, with urine
      collection and sample, as well as blood samples. After 120 minutes the protocol ends.
    

Intervention name(s): Sevoflurane; propofol
Intervention type(s): Drug; Drug
Intervention description(s): anesthetic agent; anesthetic agent
Other intervention name(s): sevorane; diprivane
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF)
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      This study is being conducted to determine the percentage of patients with solid spinal
      fusions after being treated with Osteocel Plus in a PLIF procedure. Due to the unique
      processing conditions, Osteocel Plus retains a high concentration of stem cells attached to
      the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will
      be comparable to published data for autograft. The Osteocel product family has already been
      used in approximately 20,000 cases worldwide.
    

Detailed description: 
      This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus
      in subjects who receive PLIF surgery at one or two levels. These subjects will present with
      degenerative conditions in the lumbar spine that are amenable to surgical treatment and will
      be screened prior to study enrollment. Subjects will receive Osteocel Plus during their PLIF
      operation. Subjects will be followed for 24-months following surgery to determine the number
      of study subjects that are solidly fused at or before 24 months postoperatively, and to
      determine the mean time to fusion. This data will be compared to published and/or
      retrospective data for autograft, synthetic ceramics and BMP.
    

Intervention name(s): Osteocel Plus
Intervention type(s): Biological
Intervention description(s): biologic
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Existing clinic patients
      
Keywords: biologics; fusion rates; PLIF; lumbar fusion
A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study is a phase IIa, multi-center, randomized, double-blind,
      placebo-controlled, parallel group study to evaluate two doses of orally administered
      GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR
      mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.

      Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must
      be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days
      at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active
      doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days.
      Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from
      screening until the follow-up visit.
    


Intervention name(s): GLPG2222 150 mg q.d.; GLPG2222 300 mg q.d.; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GLPG2222 150 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days; GLPG2222 300 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days; Placebo administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Techniques in Repair of Unilateral Cleft Lip
Condition: Unilateral Cleft Lip
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      Over the past century, there have been major advances in unilateral cleft-lip repair
      techniques toward the method's modern form. The first documented cleft-lip repair involved
      simple freshening and approximation of the cut cleft edges, followed by the use of curved
      incisions to allow lengthening of the lip. Straight-line closure repairs were used in the
      early 1900; however, straight-line closures had the disadvantage of creating a vertical scar
      contracture, leading to notching of the lip. This led to the development of several methods
      in the mid-twentieth century that are grouped as quadrangular flaps, triangular flaps, and
      rotation-advancement techniques.

      The two basic techniques that are most commonly used for unilateral cleft lip (UCL) closure
      are the Tennison-Randall and the Millard rotation_advancement techniques. both techniques
      address the importance of repositioning the lip muscle (orbicularis oris) in the correct
      anatomic orientation for optimal aesthetic and functional outcomes.

      The ultimate goal of cleft lip surgery is to achieve a perfectly symmetrical lip and nose. It
      has been shown that for the general population, the more symmetrical the face, the more
      attractive the face is. The appearance and symmetry of the nasolabial region is also seen as
      one of the most important characteristics when evaluating the results of any facial surgery.

      Measurement of treatment outcome is vital to evaluate the success of cleft management and the
      degree of improvement, especially in the present age of evidence-based medicine where
      treatment guidelines for best practice are becoming an integral part of contemporary clinical
      practice.

      The good goal of cleft lip repair is a symmetrical and balanced lip with minimal scar
      restoring the natural contours of the face, as well as correcting functional anatomy.

      Objectives To evaluate the quantitative (anthropometric) assessment of modified Millard
      technique in comparison to Tennison_ Randall technique in unilateral cleft lip (ucl) repair.
    


Intervention name(s): modified Millard technique vs Tennison-Randall technique
Intervention type(s): Procedure
Intervention description(s): evaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison-Randall technique in unilateral cleft lip (ucl) repair. Inclusion criteria: Patient with ages from 2 months old to 6 months old, Patient with unilateral cleft lip complete or incomplete type.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Probiotics in Periodontal Disease
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      In this randomized controlled trial, it was aimed to evaluate the effect of probiotics
      (chewable tablets) and kefir consumption in the initial periodontal treatment of
      periodontitis patients on the change of oral microbiota and treatment. In this clinical
      trial, 36 systemically healthy volunteers who were diagnosed with periodontitis who were
      admitted to Gazi University Faculty of Dentistry, Department of Periodontology were included.
      Besides the inclusion criteria, the nutritional habits of the patients were evaluated by
      questionnaire. For diagnosis, plaque index, gingival index, bleeding on probing, periodontal
      probing depth and clinical attachment level were examined. Patients were randomly divided
      into 3 groups; probiotic, kefir and control group. Following the periodontal diagnosis,
      clinical index records of the patients and subgingival microbial samples were obtained. The
      supragingival plaque sample was removed and the subgingival microbial dental plaque sample
      was gently taken with a sterile Gracey curette. In the same session, periodontal initial
      treatment was started. According to the groups, they were involved simultaneously with the
      treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days;
      probiotics group was advised to consume as a chewable tablet once a day in 14 days; the
      control group was advised without additional food supplements. Periodontal indexes were
      repeated in the 1st and 3rd months. Subgingival plaque samples were taken at baseline and at
      3 months and DNA sequencing was performed for Tanneralla forsythia (T. forsythia),
      Porphyromonas gingivalis (P. gingivalis), and Treponema denticola (T. denticola).
    


Intervention name(s): Probiotics; AOÇ Kefir; Food without additional food supplements
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; the probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements.; AOÇ Kefir; Food without additional food supplements
Other intervention name(s): Probest Defense
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Periodontal disease; Probiotics; Prebiotics
Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burns
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is a difference in frequency of wound infection, mean pain score, mean of time for skin
      grafting and hospital stay in pediatric 2nd and 3rd degree burns, between amniotic membrane
      and duoderm dressings
    

Detailed description: 
      After informed consent of the patients, patients who will fulfill the inclusion and exclusion
      criteria will be enrolled in the study from Department of Pediatric Surgery, Mayo Hospital
      Lahore and will be randomly allocated by lottery method into 2 groups by the doctor. Group A
      and B with 86 patients in each group. Group A patients will be undergoing amniotic membrane
      dressing, while group B patients will undergo colloid gel foam dressing. Basic demographic
      information will be noted. Effect modifiers (hemoglobin level, weight and height) will be
      noted.

      In group A, the wounds will be washed with normal saline and then covered with amniotic
      membrane over which a layer of Vaseline gauze will be applied and dressing with gauze and the
      crape bandage will be applied. Every 3-4 days these dressings will be changed and assessed
      for pain, wound infection and wound c/s will be sent. Placentas from clean vaginal deliveries
      and elective C-sections will be taken. Blood of mother will be screened. Amniotic membrane
      will be separated from placenta in a clean sterile bowl. Bowl will be put in refrigerator at
      4 degrees.

      In group B, wound will be washed with normal saline . The wound site will be covered with
      Colloid Gel Foam and gauze, and crape bandage will be applied. Dressing will be changed after
      3-4 days. The outcome (pain score, wound infection,time for skin grafting and hospital stay)
      will be compared in both groups.
    

Intervention name(s): amniotic membrane; duoderm dressing
Intervention type(s): Combination Product; Combination Product
Intervention description(s): amniotic membrane is a biological dressing; duoderm dressing is a synthetic dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: pediatric burns, dressings, amniotic membrane, duoderm
Differences in Pain Processing Between Men and Women
Condition: Central Sensitisation
Study type: Interventional

Summary: 
      Many chronic pain conditions show clear differences between between men and women, such as
      reported pain intensities or treatment effects, with chronic pain conditions being generally
      more frequent in women. Yet, the underlying mechanisms causing these differences are poorly
      understood. Central sensitization (CS) is considered one important mechanism in pain patients
      which differs between female and male patients. The central hypothesis is that already in the
      healthy population CS processes are more pronounced in women than in men.
    


Intervention name(s): Cutaneous thermal stimuli
Intervention type(s): Other
Intervention description(s): Application of thermal stimuli of different intensities to the skin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: central sensitisation; central sensitization; nociception; withdrawal reflex; heat pain; secondary hyperalgesia
Acupuncture for Residual Insomnia Associated With Major Depressive Disorder
Condition: Insomnia; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment
      on residual insomnia in major depressive patients.
    

Detailed description: 
      This is a randomized single-blinded controlled trial. Patients will be randomly assigned to
      one of the three groups. One is the traditional acupuncture treatment group, one is the
      non-traditional acupuncture treatment group and the other is an acupuncture-like placebo
      treatment. Patients will be put into groups and then compared. The chance of getting into
      each group is 1:1:1, i.e. equal chance.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Other intervention name(s): Electroacupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Insomnia; Depression; Electroacupuncture; Acupuncture; Randomized Clinical Trial; Traditional Chinese Medicine
Effect of Microbiome Modulation by Diet in Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Current medications and behavioral modifications have limited success in the treatment of
      functional constipation (FC). An individualized diet based on microbiome analysis may improve
      symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome
      modulation on chronic constipation. patients fulfilling Rome IV criteria for functional
      constipation were randomized into two groups. The Control group received sodium picosulfate
      plus conventional treatments (i.e., laxatives, enemas, increased fiber, and fluid intake).
      The study group underwent microbiome analysis and received an individualized diet with the
      assistance of a soft computing system (Enbiosis Biotechnology®, Sariyer, Istanbul).
      Differences in Patient Assessment Constipation-Quality of Life (PAC-QoL) score and complete
      bowel movements per week (CBMpW) were compared between groups after 6 week-intervention.
    


Intervention name(s): Artificial intelligence-assisted personalized diet
Intervention type(s): Other
Intervention description(s): The AI-based nutritional recommendations system is based on the eating rates of the individual in a certain period, to ensure the homeostasis of the microbiome and increase the microbial diversity.
After the microbiome analysis reports of the study group are released, a 6-week diet was designed regarding AI-based food scores specific to constipated individuals in accordance with the individual's lifestyle and comorbidities. Diet lists are updated according to the individual's feedback, recovery level, and wishes with weekly meetings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Microbiome; Artificial intelligence; Diet; Functional bowel disorders; Brain-gut diseases
Contact Lens in Pediatrics (CLIP) in an Asian Population Study
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      To evaluate the safety, efficacy and physiological performance of daily disposable spherical
      and toric soft contact lenses in a vision-corrected population of children ages 8-11 years of
      age. To evaluate the ability of the practitioner to fit these lenses and for the children to
      wear and manage these lenses.
    

Detailed description: 
      This is a bilateral, open-label dispensing evaluation of two daily lens types. Eligible
      subjects will wear the study lenses for 3-months daily wear. 1-Day Acuvue will be worn by
      spherical subjects and 1-Day Acuvue for Astigmatism will be worn by astigmats.

      There is a total of 4 study visits (baseline, contact fitting and dispensing, 1 week, 1 month
      and 3 month follow-up). Tests conducted include manifest refraction and over-refraction,
      keratometry, visual acuity, ACA ratio, lens fit assessment, slit lamp biomicroscopy and
      parent/patient questionaires.

      Each child was provided with a supply of lenses to last until the next scheduled follow-up
      visit, unit-dose rewetting drops for rinsing their lenses if necessary, and a daily log to
      complete each day until the next follow-up visit.

      Informed consent was obtained from all subjects after the nature of the study had been fully
      explained. The study gained approval from the Ethics Committee of the Singapore Eye Research
      Institute.
    

Intervention name(s): Johnson&Johnson Acuevue daily disposable lenses
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Safety; Efficacy; Adaptation; myopia and contact lens wear in children