bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Conventional Techniques & Piezosurgery in the Management of the Nasal Bony Pyramid
Condition: Nasal Injury
Study type: Interventional

Summary: 
      It is well-known and universally acknowledged that rhinoplasty is the most demanding
      procedure in facial aesthetic surgery. Postoperatively nasal osteotomies result in variable
      degrees of edema and ecchymosis and surgeons have tried various techniques, instruments, and
      postoperative methods to diminish these uncomfortable morbidities. Piezosurgery is used
      nowadays to decrease the incidence of injured soft tissues and vital structures passing near
      the osteotomy line. Its use in rhinoplasty was advocated to prevent unwanted back fractures
      as well as to decrease bleeding while keeping the nasal mucosa intact thus minimizing
      postoperative sequelae.
    


Intervention name(s): Conventional osteotomy; Piezosurgery osteotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): The nasal skeleton was accessed using a closed approach or an open approach is done via a transcolumellar and infracartilaginous incision. Osteotomy was made using osteotomes.; full exposure of the nasal bony pyramid is needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analysis of Endotoxin Activity in Patients With ECMO
Condition: Cardiovascular Shock; Respiratory Failure
MeSH terms: Respiratory Insufficiency; Shock, Cardiogenic
Study type: Observational

Summary: 
      Extra-corporeal membrane oxygenation (ECMO) can temporarily help patients gain time to wait
      for cardiopulmonary recovery or further treatment in patients with cardiopulmonary failure.
      Whether the blood flow provided by the ECMO can maintain the perfusion of various organs is
      an important factor affecting survival. Some ECMO patients died after the complication of
      sepsis. Our previous pilot analysis has recognized several ECMO patients with complicated
      sepsis has high endotoxin activity level. Endotoxemia can also occur in heart surgery and
      after cardiopulmonary bypass, trauma, organ transplantation, and out-of-hospital cardiac
      arrest patients. These trials used endotoxin activity analysis (EAA, EAATM, Spectral
      Diagnostics Inc., Canada) to analyze endotoxin activity. In addition, studies have indicated
      that the combination of procalcitonin (PCT) concentration and EAA activity can improve the
      accuracy of predicting sepsis. The primary aim of this study is to detect endotoxin activity
      in patients with ECMO support and compare whether the prognosis was associated with different
      level of EAA activity. The secondary aims are to analyze the risk factors leading to high EAA
      activity and investigate the diagnostic value of septic shock combining PCT examination. We
      suggest that the results of this study may help the ECMO medical team identify patients at
      high risk for septic shock and conduct adequate managements to improve patient survival and
      quality of life after survival.
    


Intervention name(s): Extra-corporeal membrane oxygenation
Intervention type(s): Device
Intervention description(s): Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Paitents with extra-corporeal membrane oxygenation support
      
Biospecimen description: 
      serum
Bioequivalence Trial of Alprazolam 0.5 mg Tablets
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of alprazolam (tablets) are
      bioequivalent.

      Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 mg
      (Pharmacia & Upjohn). One tablet was the single dosage.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 28 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Alprazolam 0.5 mg; Alprazolam 0.5 mg
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): Tafil 0.5 mg Pfizer Pharmaceuticals LLC; Zamoprax 0.5 mg GLAXOSMITHKLINE MEXICO SA de CV
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Alprazolam; Anxiety disorders; Bioequivalence; Mexico
Serum Brain Natriuretic Peptide Levels and Pulmonary Hypertension in Pediatric Sickle Cell Patients
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      The purpose of this study is

        1. To determine if Brain natriuretic peptide levels correlates with elevated tricuspid
           regurgitation flow velocity levels in pediatric patients with sickle cell disease

        2. To determine the role of age, gender, steady state hemoglobin and disease type on Brain
           natriuretic peptide levels and pulmonary hypertension
    

Detailed description: 
      Pulmonary hypertension is recognized as a significant cause of morbidity and mortality in
      patients with sickle cell disease. Doppler echocardiography is a recommended noninvasive
      screening tool for sickle cell disease patients with pulmonary hypertension. Brain
      natriuretic peptide levels have been found to be a possible serum screening marker. This
      research will offer the opportunity to determine if there is any possible relationship
      between magnitude of BNP concentration and degree of TRV, if it can be used as a screening
      test in SCD pediatric patients with PHT and form the basis for a future multicenter study
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Sickle cell clinic
      
Keywords: Pulmonary hypertension; Sickle cell disease; Pediatric patients; Brain Natriuretic Peptide levels
Yoga On Dyspnea, Sleep And Fatıgue In Chronıc Respıratory Dıseases
Condition: Chronic Respiratory Disease
MeSH terms: Dyspnea; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      Although there are a limited number of studies in the literature investigating the effect of
      yoga on dyspnea, quality of life and respiratory functions of chronic respiratory patients
      There is no study examining the effect of yoga on sleep and fatigue of chronic respiratory
      patients. Therefore, this study was conducted to determine the effect of yoga on dyspnea,
      sleep, and fatigue applied to chronic respiratory patients.
    

Detailed description: 
      Chronic respiratory diseases (CSFD) are chronic diseases of the airways and other structures
      of the lung. Two of the most common of these diseases are asthma and chronic obstructive
      pulmonary disease. Asthma and chronic obstructive pulmonary disease (COPD); mortality,
      morbidity and prevalence of chronic respiratory diseases are increasingly increasing across
      countries. COPD; It has been defined as a common, preventable and treatable disease
      characterized by permanent airflow restriction, which is associated with the increased
      chronic inflammatory response of the airways and lungs to harmful gases and particles Every
      year, 3 million people die of COPD in the world and this rate constitutes 6% of all deaths If
      it is asthma; It is defined as a heterogeneous disease characterized by chronic airway
      inflammation associated with airway hyperresponsiveness to direct or indirect stimuli. Asthma
      is seen at a rate of 1-18% in the whole world population
    

Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): yoga application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Effect of Curcumin on Gut Microbiota in IBS
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      To evaluate the effect of curcumin food supplement on gut microbiota of children with
      irritable bowel syndrome (IBS) and to review any correlation between the changes in the
      microbiota with symptoms.
    

Detailed description: 
      This is a prospective, placebo-controlled, double blinded, randomized control trial. This
      study will evaluate the effect of curcumin food supplement on gut microbiota of children with
      irritable bowel syndrome. Curcumin is a commonly used spice in Asian cooking and has a very
      good safety profile. Developing preparation of this compound for targeted delivery in the GI
      tract would provide a novel way to treat common FGID. This study will provide preliminary
      data for future studies to evaluate the role of gut microbiota in the pathophysiology of pain
      predominant FGID and how food supplements can be used to manipulate the microbiota.
    

Intervention name(s): Curcumin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The curcumin food supplement will be administered in the form of capsules. Participants in the treatment arm will take 50 mg twice or three times a day, depending on their body weight. Participants will take the curcumin capsules for eight weeks.; The placebo will be administered in the form of capsules. Participants in the placebo arm will take a capsule twice or three times a day, depending on their body weight. Participants will take the placebo capsules for eight weeks. The placebo capsule will be similar in size, shape and color to the curcumin capsule and they will contain inert food powder.
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Curcumin; IBS and microbiota
Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic interaction between tegoprazan and combination of
      Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers.
    

Detailed description: 
      To evaluate the pharmacokinetic interaction between tegoprazan and combination of
      Amoxicillin, Clarithromycin and bismuth in healthy adult volunteers.
    

Intervention name(s): Tegoprazan; Bismuth; Amoxicilli; Clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet for oral administration; Capsule for oral administration; Capsule for oral administration; Tablet for oral administration
Intervention MeSH terms: Clarithromycin; Bismuth
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Cognitive Training in Subjective Memory Impairment
Condition: Memory Loss
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      This study evaluates the efficacy of cognitive training in subjects with subjective memory
      impairment. The first group will receive cognitive training and lifestyle modification in
      combination, the second group will receive only lifestyle modification, and the third group
      will receive no intervention.
    

Detailed description: 
      Subjective memory impairment is currently thought to be a risky state of progression to
      Alzheimer's disease. This study aims to confirm whether cognitive training in subjective
      memory impairment would show improvement in the subjective and objective cognition. We
      include subjects with normal cognition but complained subjective feeling of memory decline
      and conduct cognitive training programs combined with lifestyle modifications for 3 months.
      We evaluate the neuropsychological tests and questionnaires about subjective improvement
      after 3 months of interventions.
    

Intervention name(s): cognitive training; lifestyle modification
Intervention type(s): Behavioral; Behavioral
Intervention description(s): cognitive training is held 2 times a week for 3 months, 90 minutes per 1 session. It includes cognitive exercise of multiple cognitive domains such as memory, attention, calculation, executive function and visuospatial function.; education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: subjective memory impairment; cognitive training
A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioavailability, palatability, safety and tolerability of
      entrectinib in healthy volunteers. Part 1 of the study will explore the performance of
      entrectinib multi-particle formulation. Part 2 will evaluate the effect of drug substance
      particle size on entrectinib bioavailability.
    


Intervention name(s): Entrectinib 600 mg (T1); Entrectinib 600 mg (T2); Entrectinib 200 mg (R); Entrectinib 200 mg (T)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets; Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets; Reference formulation (R): entrectinib hard capsules; Test formulation (T): entrectinib HPMC capsules
Intervention MeSH terms: Entrectinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis
      function.
    


Intervention name(s): Placebo Nasal Aerosol; Prednisone capsules; Placebo Prednisone Capsules; Beclomethasone dipropionate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo nasal aerosol administered daily for 42 days of treatment; Prednisone 10 mg capsule taken each day on the last 7 days of treatment; Placebo prednisone capsule taken each day on the last 7 days of treatment; Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.
Other intervention name(s): QNASL(TM)
Intervention MeSH terms: Prednisone; Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams
Condition: Satiety; Appetite
Study type: Interventional

Summary: 
      To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very
      low energy aerated beverage with normal energy aerated beverages in healthy subjects.
    

Detailed description: 
      The primary objective of this study is to assess if a very low energy foam has the same
      effect on satiety as the same volume of a reference normal energy foam, by testing for
      equivalence of these two foams. Treatment equivalence, is met if the 90% confidence interval
      (CI) of between-treatment differences in appetite AUC is within the range of -5 to +5 mm/min
      of the reference . Two other normal energy foams with slightly different compositions are
      also compared to the reference foam to test for possible effects of differences in
      composition (carbohydrate type, emulsifier) other than energy per se.

      On each test day, volunteers will arrive at the clinic in a fasted state where they consume a
      standardized 250 kcal breakfast. Subjects receive one of the four test products 2.5 hours
      after start of breakfast and consume 400 ml of the test products with a spoon within 10
      minutes. Each subject will be randomized to a treatment order according to a balanced
      (Williams type) design, and receive one of four test products each week for 4 weeks,
      separated by a one-week washout period (consumed on the same week day).
    

Intervention name(s): Very low energy aerated beverage; Normal energy aerated beverage 1; Normal energy aerated beverage 2; Normal energy aerated beverage 3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Foams; Satiety; Appetite
Evaluate the Clinical Efficacy of Precious Metal Fiber Textile (Germanium Titanium π Element) for Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Erectile dysfunction (ED) is common, and is defined as "persistent or regular inability to
      achieve or maintain penis erection for satisfactory intercourse". Approximately 3% to 71% of
      males have this problem as they age, and it is predicted that 320 million males worldwide
      will have ED by 2025. However, sex remains a topic that is too sensitive for most people to
      discuss openly. ED therapies include oral medication, vacuum erection devices,
      intracavernosal injection, testosterone supplementation, surgery, and psychological
      counseling. In addition, germanium (Ge), titanium (Ti), and π elements are noble metals that
      can be used to produce far-infrared radiation. There has been little application of these
      metals to the treatment of ED, but their use is worth investigating. Administered as health
      textiles, the application of these metals are expected to promote blood circulation,
      especially in the reproductive system, resulting in an improved sexual performance. Hence,
      the researcher aimed to investigate the safety and efficacy of Ge-Ti-π elements fiber
      textiles as an ED treatment, assessed by using the questionnaires related to the quality of
      sexual function.
    

Detailed description: 
      This clinical trial recruited 30 subjects with ED (a test group of 21 subjects and a control
      group of 9 subjects). Cellulosic textiles, incorporating noble metals (Ge, Ti, and π
      elements), developed by Green Energy Nano Technology Co., Ltd, were used in the test group,
      while commercially available regular textiles were used in the control group. The safety and
      efficacy of the treatment to the subject's sexual function quality were assessed through the
      International Index of Erectile Function (IIEF-5) and the validated Portuguese version of the
      Quality of Erection Questionnaire (QEQ) questionnaires. In the same session, the symptoms
      related to ED were assessed through the Premature Ejaculation Diagnostic Tool (PEDT) and the
      International Prostate Symptom Score (IPSS) questionnaires. The questionnaires were completed
      once a month and followed up for 3 months. The incidence of severe adverse effects was
      analyzed to assess product safety.
    

Intervention name(s): underpants
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of single
      ascending doses of subcutaneous (SC) injections of RO7049665 in healthy volunteers. In
      addition, pharmacokinetics (PK) of RO7049665, the effects of single doses of RO7049665 on
      regulatory T-cells as well as the single dose immunogenicity of RO7049665 will be evaluated.
      This trial plans to evaluate approximately seven single dose-levels of RO7049665 or
      matching-placebo during dose-escalation in approximately 40 participants.
    


Intervention name(s): RO7049665; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A single ascending dose (starting dose 1.5 micrograms [mcg])of RO7049665 will be administered SC.; Matching placebo will be administered SC once.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Condition: Carpometacarpal Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to find out if hyaluronan, an injectable medication for knee
      arthritis, also works for arthritis at the base of the thumb. This study will also evaluate
      how good ultrasound is at visualizing medication in the thumb joint. We are no longer
      recruiting for this part of the open label trial.
    


Intervention name(s): Synvisc (hylan G-F20)
Intervention type(s): Device
Intervention description(s): 32 subjects in the pilot study have received 3 1ml injections of Synvisc intraarticular over the course of 3 weeks and then followed for 6 months post injection
Intervention MeSH terms: Hylan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Osteoarthritis; Hyaluronan; Carpometacarpal; Outcomes
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer
      Under the Supervision of Dermatologist and Pediatrician
    

Detailed description: 
      This single-center clinical trial is being conducted to demonstrate that the Sponsor's
      product does not statistically or clinically worsen eczema scores in children aged 6 months
      through 7 years after 4 weeks of treatment compared to baseline scores.

      Safety and efficacy will be assessed through clinical grading at baseline and week 4.
      Efficacy will also be assessed through Corneometer and Tewameter measurements at baseline and
      week 4. Microbiome skin swab sampling will be performed at baseline and week 4.
      Parents/guardians will complete Patient Oriented Eczema Measure and Family Dermatology
      Quality of Life Index at baseline and week 4.
    

Intervention name(s): Sponsor Test Products
Intervention type(s): Other
Intervention description(s): Baby Bee Foaming Cleanser(at least once daily but not more than twice daily), BB Baby Ultra Gentle Lotion (Once immediately after cleansing and again approximately 10-12 hours after cleansing)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care