bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519
      Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.
    

Detailed description: 
      Open label, single-site
    

Intervention name(s): HTS-519 Insert
Intervention type(s): Drug
Intervention description(s): Maximum feasible dose of HTS-519 Insert per diseased nail
Other intervention name(s): HTS-519 Biodegradable Micro Insert
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Screening and Analysis of Plasma Biomarkers in Irreversible PAH-CHD
Condition: Hypertension,Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to analyse the sensitivity and specificity of circulating
      endothelial cells to predict irreversible pulmonary arterial hypertension associated with
      congenital heart disease.
    

Detailed description: 
      predict to recruit 100 patients with pulmonary arterial hypertension (PAH)associated with
      CHD，under the commitment of the children's parents，take 3-4ml central venous blood before the
      corrective surgery，then calculate the number of the circulating endothelial cells by flow
      cytometer AND detect the expression of micro RNAs to screen out the biomarker，through the 6
      months follow-up, separated the reversible and irreversible PAH,then to carry on the
      statistics.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        those patients with systolic PAP (sPAP) >65mmHg before surgery were included.
      
Keywords: biomarkers，pulmonary arterial hypertension
Flaxseed Intervention on Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is
      effective in the treatment of metabolic syndrome (MetS).
    

Detailed description: 
      Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central
      obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the
      development of type 2 diabetes and CVD. It has become one of the major public health
      challenges in China due to rapidly nutrition transition and the nature of obesity epidemic.
      Treatment of MetS in China is very important for the prevention of the epidemic of its
      consequences (such as CVD and type 2 diabetes).

      Compelling evidence from recent human studies has demonstrated that diet and lifestyle
      modifications are effective means in MetS management. Flaxseed is a complex food source
      containing high amounts of alpha-linolenic acid (ALA) - an omega-3 fatty acid - as well as
      fiber, lignan precursors and other substances that may have an impact on our health.
      Therefore, the aim of this study is to investigate the effect of flaxseed supplementation on
      the management of MetS in adult Chinese men and women in a randomized, controlled clinical
      trial. A total of 200 participants with MetS (defined by NCEP-ATPⅢ criteria) will be randomly
      assigned to a flaxseed-supplemented diet (30 grams/day) or an isocaloric control diet for 12
      weeks. Effects of flaxseed supplementation will be evaluated by measuring metabolic profile
      (BMI, blood pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and
      insulin, HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function
      (E-selectin, ICAM-1 and VCAM-1), and fatty acid profile.
    

Intervention name(s): flaxseed; Health lifestyle counseling
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): 30 grams/day of flaxseed for 12 weeks; Health lifestyle counseling accroding to AHA reccommendation
Other intervention name(s): Health lifestyle counseling accroding to AHA reccommendation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: flaxseed; lignans; alpha-Linolenic Acid; LDL Cholesterol
Tibialis Posterior Fatigue and Plantar Pressure
Condition: Muscle Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to find out the changes in the measurable parameters of the
      dynamic and static position of the foot, caused by the tibialis posterior muscle which is
      activated by the fatigue protocol. The study includes 30 healthy patients whose
      socio-demographic and descriptive characteristics are held. The changes in the dynamic and
      static position of foot were measured by pedobarography whereas the level of fatigue was
      measured by Borg Fatigue Scale.
    

Detailed description: 
      The purpose of this study is to find out the changes in the measurable parameters of the
      dynamic and static position of the foot, caused by the tibialis posterior muscle which is
      activated by the fatigue protocol. The study includes 30 healthy patients whose
      socio-demographic and descriptive characteristics are held. The changes in the dynamic and
      static position of foot were measured by pedobarography whereas the level of fatigue was
      measured by Borg Fatigue Scale. The variables were investigated using Shapiro-Wilk's test to
      determine the normality. The student's t-test for paired samples were used to analyse, means
      (X), standard deviations (SD), 95% confidence intervals (95%CI), mean difference and Cohen's
      d-effect size were calculated. The significance level was set at .05. The effect size was
      considered 'small' if d= .20; 'medium' if .d=.5; 'large' if d= .8.
    

Intervention name(s): Muscle fatigue protocol
Intervention type(s): Other
Intervention description(s): Tibialis posterior was fatigued using 2 exercises:
Unilateral heel raise exercise
Close chain resisted foot adduction exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Plantar pressure distribution; muscle fatigue; tibialis posterior
Salivary Bacteria and Oral Health Status in Children With ADHD
Condition: Attention Deficit Hyperactivity Disorders; Caries, Dental; Xerostomia
MeSH terms: Xerostomia; Dental Caries; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Attention deficit and hyperactivity (ADHD) affect 6% of school-aged children. Few studies
      reported higher prevalence of caries and restorations among children with ADHD.
      Methylphenidate is the drug of choice to treat ADHD. according to the medical literature
      methylphenidate can cause xerostomia.

      Our study will investigate saliva parameters (such as quantity, bacteria in saliva, buffer
      capacity), oral hygiene and diet habits and their influence on caries among children with
      ADHD and among healthy children.

      Our hypothesis is:

        -  Children with ADHD will have more caries.

        -  Children with ADHD will have more detrimental oral hygiene and diet habits.

        -  There will be a difference in the saliva parameters between children with ADHD and
           healthy children.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with ADHD, treated by medications or not, treated in the neurologic clinic at
        Hadassah.

        The control are healthy children visiting the pediatric dental clinic at Hadassah.
      
Biospecimen description: 
      saliva
    
Keywords: ADHD, saliva, caries
Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy
Condition: Carotid Artery Thrombosis; Carotid Artery Stenosis; Stroke
MeSH terms: Carotid Stenosis; Carotid Artery Thrombosis; Thrombosis
Study type: Interventional

Summary: 
      This study examines the risk of thrombogenicity of the carotid patches in polyurethane
      compared to carotid patches in polyester including death, any stroke, carotid thrombosis at
      30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.

      This study was run at the University of Roma, La Sapienza and at the University of Poitiers,
      randomisation was done in both enters after approval by the Ethical committee of the
      University of Roma (Record uploaded)
    

Detailed description: 
      This study examines the risk of thrombogenicity of the carotid patches in polyurethane
      compared to carotid patches in polyester including death, any stroke, carotid thrombosis at
      30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.

      598 patients were considered for randomisation between January 1995 and January 2004. The
      following patients were excluded for randomisation (Redo carotid surgery: N=34, radiation
      induced carotid stenosis:N=45, indication for carotid bypass: N=65, Refusal of randomisation:
      N=4).

      In total, 450 patients were randomized in two groups, 225 received a polyester patch and 225
      received a polyurethane patch.

      All patients were operated under general anaesthesia and all received an intraoperative
      angiography. A shunt was selectively used in patients with a recent stroke (<15 days) or with
      a contralateral carotid occlusion
    

Intervention name(s): CEA
Intervention type(s): Procedure
Intervention description(s): Patients in both groups received an intra-operative angiography
Other intervention name(s): Carotid endarterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Lung Diseases; Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness of multiple dosages of
      INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis
      (CF) lung disease. Study drug will be administered through a nebulizer (a device that
      delivers medication as a mist by breathing it in).
    

Detailed description: 
      The purpose of this study is to:

        -  assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo
           over 28 days in subjects with mild to moderate CF lung disease;

        -  explore evidence of activity of INS37217 and placebo administered via PARI LC STAR
           nebulizer;

        -  identify dose(s) that will be studied in subsequent trials.
    

Intervention name(s): denufosol tetrasodium (INS37217)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cystic fibrosis
Bladder Diary for Female Storage LUTS
Condition: Urinary Urge Incontinence; Urinary Frequency More Than Once at Night; Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Lower Urinary Tract Symptoms; Nocturia
Study type: Observational

Summary: 
      Storage urinary symptoms are the most complained of lower urinary tract symptoms (LUTS) and
      need further classification. This original study aims to derive a novel classification
      algorism for female storage LUTS according to a 3-day bladder diary (BD). Further feasibility
      of the application was also evaluated.
    

Detailed description: 
      Between July 2009 and December 2021, all women with storage lower urinary tract symptoms
      (LUTS) who visited the urogynecological department of a medical center were included. Women
      without complete data of a 3-day bladder diary (BD) were excluded from this study. The women
      were allocated into 12 groups according to the study flowchart based on their LUTS, including
      urinary urgency, stress urinary incontinence, urgency urinary incontinence, nocturia and
      frequency. MedCalc software was used for statistical analysis. Analysis of variance (ANOVA)
      was applied, and a P-value of less than 0.05 was considered as statistically significant.
      Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons
      with p < 0.05 after ANOVA.
    

Intervention name(s): Bladder diary
Intervention type(s): Diagnostic Test
Intervention description(s): 3-day bladder diary record including fluid intake, urine amount, urgency and incontinence.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Between July 2009 and December 2021, all women with storage LUTS who visited the
        urogynecological department of a medical center were included. Women without complete data
        of a BD were excluded from this study. The women were allocated into 12 groups according to
        the study flowchart based on their LUTS, including urinary urgency (UU), stress urinary
        incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F).
        MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was
        applied, and a P-value of less than 0.05 was considered as statistically significant.
        Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons
        with p < 0.05 after ANOVA.
      
Keywords: Storage; Lower urinary tract symptom; Female; Bladder diary
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of
      JNJ-55308942 in healthy participants after administration of single and multiple oral doses.
    


Intervention name(s): JNJ-55308942 0.5 mg; JNJ-55308942 1.5 mg; JNJ-55308942 4 mg; JNJ-55308942 12 mg; JNJ-55308942 36 mg; JNJ-55308942 100 mg; JNJ-55308942: Fed State; JNJ-55308942: MAD Part; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1.; Participants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1.; Participants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1.; Participants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1.; Participants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1.; Participants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1.; Participants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts.; Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.; Participants will receive matching placebo in all cohorts.
Intervention MeSH terms: JNJ-55308942
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Bowel Preparation and Pelvic Organ Prolapse Surgery
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The purpose of this study is to find out if performing a bowel preparation prior to pelvic
      organ prolapse surgery has any effect on the return of bowel function after surgery.
    


Intervention name(s): Bowel preparation (Fleets enema)
Intervention type(s): Other
Intervention description(s): Use of Bowel preparation (Fleets enema)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pelvic organ prolapse; Bowel preparation
Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the
      model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the
      parasympathetic nervous system and a decrease of the sympathetic system. Various explanations
      of this these dysfunctions are proposed in literature, mainly malnutrition, physical
      hyperactivity, anxiety, that are known characteristics of anorexia nervosa.

      The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety
      in anorexia nervosa.

      Other objectives of this study are firstly to evaluate correlation between ANS dysfunction
      and others parameters (weight, body mass index, depression, physical activity, purgative ou
      restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if
      HRV is a predictive parameter of the evolution of anorexia nervosa.
    


Intervention name(s): Heart rate monitor
Intervention type(s): Other
Intervention description(s): The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Heart rate variability; anxiety; Autonomic dysfunction
Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery
Condition: Tooth Loss
MeSH terms: Tooth Loss
Study type: Interventional

Summary: 
      In this split-mouth controlled study, implants placed using the alveolar ridge expansion
      technique will be compared to those placed in native bone with sufficient horizontal bone
      width.

      The Piezosurgery device and Bone expanders (Mectron,Italy) will be employed in an alveolar
      ridge expansion technique.
    

Detailed description: 
      The success rate of endosseous implant placement in native bone has been proven to be highly
      predictable. Reliable long term result requires sufficient bone thickness surrounding the
      implant's body. This is especially true in the maxillary aesthetic zone where buccal bone
      thickness of 2mm or more is necessary to prevent loss of buccal bone margin and maintain the
      integrity of the gingival architecture.

      Ridge expansion technique, an alternative to bone graft, widens the alveolar ridge prior to
      implant placement, thus permits the preservation of buccal and lingual bone thickness.

      Narrow atrophy edentulous alveolar ridges (study site) in the maxillary aesthetic zone will
      be split lengthwise using piezo-electric surgery (Piezosurgery, Mectron, USA). The prepared
      osteotomy will subsequently be expanded using threaded osteotomes (Bone Expanders, Mectron,
      Italy). Implants will immediately be inserted in the prepared osteotomy. In the edentulous
      alveolar ridges with sufficient thickness (controlled site) in the maxillary aesthetic zone,
      implants will be placed directly using conventional drilling technique. Outcome measures will
      be compared.
    

Intervention name(s): Ridge Splitting; Implants placed using drilling technique
Intervention type(s): Procedure; Procedure
Intervention description(s): To measure the horizontal bone width before and after implant insertion and 6 months post-op.
To measure BLI measured using PA radiographs taken immediately and 6 months post-op.
To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op.
To measure implant success rate. The implants used in this study: NobelActive 3.5 - 4.3mm diameter, 10 - 13 mm in length.; To measure the horizontal bone width before and after implant insertion and 6 months post-op.
To measure BLI measured using PA radiographs taken immediately and 6 months post-op.
To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op.
To measure implant success rate. The implants used in this study: NobelActive 3.5-4.3mm diameter, 10 - 13 mm in length.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental implants, Ridge splitting, Ridge expansion
Effects of Psilocybin in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed pilot study will assess whether people with major depressive disorder experience
      psychological and behavioral benefits and/or harms from psilocybin. This study will
      investigate acute and persisting effects of psilocybin on depressive symptoms and other
      moods, attitudes, and behaviors. The primary hypothesis is that psilocybin will lead to rapid
      and sustained antidepressant response, as measured with standard depression rating scales.
    


Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): Participants will receive a moderately high psilocybin dose in the first session and will receive either a moderately high or high psilocybin dose in the second session.
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment