bioihbjkbjnl/mcl2 huggingface dataset:
Sleep Apnea and Obesity Affects on Morphine Pharmacokinetics
Condition: Pediatric Sleep Apnea; Obesity; Morphine Metabolism
MeSH terms: Apnea; Sleep Apnea Syndromes; Obesity
Study type: Interventional

Summary: 
      Adenotonsillectomy (AT) is one of the most common pediatric surgeries performed, and is
      estimated to comprise 530,000 procedures in children under 15 years of age. Historically, the
      leading cause for these procedures was recurrent infections; however, more recently surgical
      indications include sleep disordered breathing and obstructive sleep apnea (OSAS).
      Pre-operative polysomnography (PSG) is recommended for all children with suspected OSAS prior
      to undergoing AT, although it is unclear whether sleep disordered breathing characteristics
      predict post-operative outcomes or complications.

      Obesity has become an epidemic in the pediatric population. More recently, an increased
      population of obese children are presenting for AT with upper airway obstruction with or
      without tonsillar hypertrophy, which is similar to the adult etiology of OSAS. Obesity is a
      multisystem disease, causing fatty liver and cardiac disease, defects in glucose metabolism,
      insulin resistance, leptin resistance, and creates a state of chronic inflammation. Markers
      for inflammation, including tumor necrosis factor (TNF)-α, C-reactive protein (CRP), leptin,
      interleukin (IL)-6 and IL-10, are abnormal in obese patients and have also been linked to
      more severe OSAS disease in children even after controlling for BMI.

      In pediatrics, medication dosing is based on an actual body-weight calculation, however,
      recent reports suggest that this dosing method is over-dosing patients with obesity.
      Therefore, increased respiratory complications after surgery may be related to inappropriate
      intra-operative opioid dosing.

      Specific Aim 1 (SA1): To compare morphine pharmacokinetics in normal children <=12 years of
      age, non-obese children with severe OSAS, and obese children with severe OSAS. The
      investigators hypothesize that obesity independently enhances morphine pharmacokinetics.

      Specific Aim 2 (SA2): To determine whether biomarkers related to obesity, chronic
      inflammation, and OSAS predict changes to morphine pharmacokinetics. The investigators
      hypothesize that inflammatory and obesity-related biomarkers are elevated in overweight
      children with OSAS, more so in obese children with OSA, compared to lean children with OSAS.
      In addition, the investigators hypothesizes that leptin independently is linked to altered
      morphine pharmacokinetics.
    


Intervention name(s): Morphine pharmacokinetic evaluation
Intervention type(s): Other
Intervention description(s): Each group received morphine and blood drawn to evaluate morphine PK
Intervention MeSH terms: Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes of Pain Sensitivity During Rehabilitation of Patients Suffering From Whiplash Associated Disorders
Condition: Whiplash; Whiplash Injury; Neck Pain; Healthy
MeSH terms: Neck Pain; Whiplash Injuries
Study type: Observational [Patient Registry]

Summary: 
      This study investigates the sensory profile of people suffering from whiplash associated
      disorders (WAD) during rehabilitation.
    

Detailed description: 
      Altered pain sensitivity is commonly reported in WAD populations when compared to a healthy
      control group but how/if this changes over time during rehabilitation is unclear. This study
      investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group
      suffering from WAD compared to a healthy control group.
    

Intervention name(s): Conservative rehabilitation
Intervention type(s): Other
Intervention description(s): WAD participants underwent 2-weeks rehabilitation.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Acute WAD following a motor vehicle accident (MVA) and age- and sex-matched healthy
        controls.
      
Keywords: WAD; rehabilitation; whiplash; neck pain; pain sensitivity
CyPep-1 in Cutaneous Warts
Condition: Cutaneous Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is intended to explore the safety, tolerability, pharmacodynamics and
      efficacy of topical CyPep-1 as a potential treatment for HPV-associated conditions. Since
      this is a first-on-human study of a topical formulation, the first subjects will be monitored
      more frequently in order to establish the safety profile. Because clinical outcomes (i.e.
      reduction/clearance of the lesion) often require lengthy treatment / observation periods, the
      study design will primarily utilize clinical measurements of wart dimensions, along with HPV
      viral load as a biomarker of anti-viral effect.
    

Detailed description: 
      This study has a phase 1, randomized, vehicle-controlled, double-blind, single center design
      to explore the safety, tolerability and pharmacodynamics (PD) of topically applied CyPep-1 in
      otherwise healthy patients with cutaneous warts.

      The study will entail two parts. Part 1 will follow a target area of 5x5 cm healthy skin to
      study tolerability and safety of the formulation. During this study part also a maximum of 3
      common warts, preferably at the dorsal or palmar side of the hand / finger(s), will be
      treated. Several assessments will be done to determine pharmacodynamics and to explore
      possible efficacy after a treatment period of 1 week.

      Part 2 will evaluate the pharmacodynamics and efficacy of CyPep-1 after a treatment period of
      4 weeks. Study part 2 will commence after an interim analysis, e.g. a blind data review, of
      study part 1 has been conducted.
    

Intervention name(s): Cypep-1
Intervention type(s): Drug
Intervention description(s): Eligible subjects will be randomized to one of the two treatment groups in a ratio of 1:1 (active:placebo).
The treatment groups are:
CyPep-1 topical formulation 1% (w/w)
Vehicle topical formulation (placebo) The minimum set of studied warts is 1 treated common wart per subject. The subjects will be randomly assigned to treatment. During the treatment period topical formulation will be applied daily on to a maximum of 3 warts. One selected wart will serve as target wart, i.e. the primary wart, for detailed analysis. Selection of warts will be based on the feasibility to conduct treatment application and pharmacodynamics (including biopsy sampling) on the region of interest.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blind phase I study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare febuxostat allopurinol in subjects with gout.
    

Detailed description: 
      A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study
      comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects
      will receive treatment for 24 weeks.
    

Intervention name(s): Febuxostat; Allopurinol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gout; Uric Acid; Xanthine oxidase; Febuxostat
Effects of Pursed Lip Breathing With and Without Mat Pilates Training in Obese Women
Condition: Obese Women
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is defined as BMI more than or equal to 30kg/m2. It is responsible for manifestation
      of serious health problem. Accumulation of adipose tissue in thorax and abdomen causes
      stiffness of chest, reduction in lung compliance and favoring airway closure. As result,
      reduction in lung volume and capacity occurs which requires increased breathing to maintain
      adequate oxygenation. These changes lead to limitations in activities of daily life. A
      Randomized Control study will be conduct to see the effects of Pilates exercise and pursed
      lip breathing to improve the breathing and thoracoabdominal expansion. The study will be
      completed within 10 months after approval of synopsis. The sample size of 34 subjects will be
      taken: 17 with Pilates method and 17 without Pilates method with 12% attrition rate. Pre
      assessment and Post assessment will be made through IPAQ questionnaire for physical activity
      measurement, Borg's scale (CR-10) for dyspnea measurement and Cirtometry for thoracoabdominal
      expansion. Study will be conducted at Star gym for women Al-Rehman Garden community, Lahore.
      Data will be analyzed through SPSS 25.
    


Intervention name(s): Pursed lip Breathing along Mat Pilates; pursed lip breathing without Mat Pilates Training
Intervention type(s): Other; Other
Intervention description(s): Experimental Group: will be treated with Pursed lip Breathing along Mat Pilates Training.; Control Group will be treated pursed lip breathing without Mat Pilates Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Borg's scale; Dyspnea; IPAQ; Mat Pilates; obese women; Thoracoabdominal expansion
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
Condition: Advanced Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the relationship between fulvestrant dose and efficacy in
      postmenopausal women with oestrogen receptor positive advanced breast cancer.
    


Intervention name(s): Fulvestrant
Intervention type(s): Drug
Intervention description(s): intramuscular injection 250 mg & 500 mg
Other intervention name(s): Faslodex; ZD9238
Intervention MeSH terms: Fulvestrant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oncology; cancer; breast cancer
Study of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced-dose Cyclosporine Microemulsion (CsA-ME) Compared to EC-MPS Plus Standard Dose CsA-ME in Eldery de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids
Condition: Denovo Renal Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      All patients of the core study who are interested of being treated with EC-MPS will be
      included in an open-label extension study to collect further information on the long-term
      safety, tolerability and efficacy of this drug.

      The aim of this study is to compare the renal function, 6 months after transplant, in de novo
      old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with
      EC-MPS plus standard dose CsA-ME, both in combination with basiliximab and short-term oral
      steroids.
    


Intervention name(s): Enteric-Coated Mycophenolate Sodium
Intervention type(s): Drug
Intervention description(s): Enteric-Coated Mycophenolate Sodium
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Renal transplantation, EC-MPS
Osteoporosis and Fall Prevention Education
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      Objective: The study is to increasing osteoporosis awareness with fracture risk assessments
      and management as well as fall prevention among elderly in northern region of Taiwan.

      Method: Six community osteoporosis and fall prevention educational programme will be held at
      northern region of Taiwan. A questionnaires design including demographic variables , FRAX
      variables, nutritional variables and osteoporosis and fall knowledge variables as well.The
      pretest-posttest method was used to analyse the effect on education.

      Expected outcomes : (1)Fall prevention educational programme will hold in northern region of
      Taiwan at different communities in order to increasing osteoporosis awareness with fracture
      risk assessment tool, establishing fall knowledges among elderly and some fall prevention
      skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than
      20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk
      of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend
      for BMD measurement.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults who attending the fall prevention educational programme.
      
Keywords: Osteoporosis; fall prevention; high risk population
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is open to adults with type 2 diabetes who take metformin but still have too high
      blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces
      blood sugar. The study also looks at whether BI 456906 helps the participants lose weight.

      Participants are in the study for about 23 weeks. During this time, most participants visit
      the study site about 13 times. Some participants visit the study site about 20 times. At the
      start of the study, the participants are put into 7 groups. The participants in groups 1 to 6
      get injections under the skin once or twice every week. Some participants get different doses
      of BI 456906 and other participants get placebo. Placebo injections look like the BI 456906
      injections, but contain no medicine. Participants in group 7 get semaglutide injections every
      week. Semaglutide is another medicine for adults with type 2 diabetes.

      During the study, the doctors regularly take blood samples from the participants and measure
      their body weight. The changes in blood sugar levels and body weight are compared between the
      groups. The doctors also check the general health of the participants.
    


Intervention name(s): BI 456906; Placebo; Semaglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution for Injection; Solution for Injection; Solution for Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Strong Connections
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to compare two talking forms of therapy designed to help reduce
      depressive symptoms in teenagers: Interpersonal Psychotherapy for Adolescents and Treatment
      as Usual.
    

Detailed description: 
      Interpersonal Psychotherapy for Adolescents (IPT-A) is a manualized short-term therapeutic
      intervention that has been shown to be efficacious in a number of randomized control trials
      for adolescent depression. The primary aim of the present study is to evaluate the
      feasibility of incorporating Interpersonal Psychotherapy for Adolescents (IPT-A) into routine
      psychotherapeutic treatment at Strong Behavioral Health: Child and Adolescent Outpatient. The
      second aim of the present investigation is to examine changes in adolescent symptomatology,
      interpersonal functioning, perceived stress, and social support throughout the course of
      treatment. The third aim of the present study is to compare the effectiveness of IPT-A versus
      treatment as usual (TAU) at reducing depressive symptoms among adolescents.
    

Intervention name(s): Interpersonal Psychotherapy for Adolescents; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Experimental: Interpersonal Psychotherapy for Adolescents (IPT-A) IPT-A is a manualized intervention for depression that targets adolescents' interpersonal context and social supports as mechanisms of change. It will be provided in accordance with the treatment manual by Child and Adolescent Outpatient Service clinicians over the course of 12-16 50-minute sessions.; Treatment as usual will consist of the standard care for adolescent depressive symptoms at CAOS. TAU is not manualized; it is consistent with care typically provided in community settings. Therapists establish a working alliance, are empathetic, reflect expressed affect, and discuss options for coping with concerns as initiated by the adolescent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Performances of Spectral Domain Optical Coherence Tomography (OCT) for Distinguishing Glaucomatous Eyes
Condition: Glaucoma Patient; Glaucoma Suspect Patient; Normal Population; RNFL Thickness by Location; Macular Thickness by Location
MeSH terms: Glaucoma; Ocular Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to evaluate performances of each parameters of spectral domain
      (Cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma
      suspect and glaucomatous eyes
    

Detailed description: 
      Aim to determine which parameter of cirrus OCT is best sensitivity and specificity for
      glaucoma detection
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        glaucoma patient from glaucoma clinic that is POAG Glaucoma suspect cases normal population
        case
      
Keywords: OCT; spectral domain cirrus; glaucoma; glaucoma suspect; normal population
Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.
Condition: Sensory Profiles, Nociplastic Pain, Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational [Patient Registry]

Summary: 
      This study conducts prognostic research to develop, validate, and evaluate the predictive
      role of sensory profiles in the development of sensory profiles over time. Therefore, a type
      3 prognostic model research will be conducted in the low back pain population.
    

Detailed description: 
      This is a longitudinal multi-centre prospective cohort study design with two measurements.The
      STROBE statement is used as guideline and the results are reported according to the TRIPOD,
      and REMARK checklists. The study is a type III prognostic model research study, following the
      PROGRESS framework to assess the outcome by the development, validation, and evaluation of
      the impact of incorporating single or multiple prognostic factors, and their prognostic value
      at baseline in the development of CS over a period of 12 weeks.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -primary physiotherapy practices in the Netherlands.
      
Keywords: sensory profiles, central sensitization, low back pain.
Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy
      of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of
      radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial
      fibrillation.

      One group of subjects will have the procedure performed with intracardiac echo maneuvers to
      assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of
      subjects who will receive the standard medical treatment with fluoroscopy and angiography.
    

Detailed description: 
      Surgical and catheter based technologies target triggers that initiate atrial fibrillation
      located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency
      energy or freezing is used to destroy the atrial tissue which propagate electrical impulses
      into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a
      patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and
      efficacious under fluoroscopic guidance with contrast angiography. The objective of this
      study is to identify methods to reduce radiation dose and radio opaque contrast use while
      maintaining PVI efficacy and safety.
    

Intervention name(s): Cryoballoon Pulmonary Vein Isolation - PVI
Intervention type(s): Procedure
Intervention description(s): A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.
Other intervention name(s): Atrial Fibrillation Ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Condition or Disease: Paroxysmal atrial fibrillation
Procedure: Cryoballoon Pulmonary Vein Isolation
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cryoballoon; Atrial fibrillation; pulmonary vein isolation