bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of treatment with oral capecitabine or
      intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide,
      prior to surgery in participants with breast cancer. The participants will receive 4 cycles
      of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin +
      Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85).
      After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast
      surgery with regional lymph node dissection will be performed, followed within a maximum of 6
      weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study
      arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by
      IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period,
      participants will enter the post-treatment follow-up period which will last for 5 years from
      the initial date of participant randomization. During this period participants will be
      evaluated once a year on the anniversary date of randomization.
    


Intervention name(s): 5-Fluorouracil; Capecitabine; Cyclophosphamide; Docetaxel; Epirubicin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5-FU will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle during neoadjuvant treatment period for 4 cycles.; Capecitabine will be administered at 900 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.; Cyclophosphamide will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.; Docetaxel will be administered at 100 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.; Epirubicin will be administered at 100 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
Other intervention name(s): Xeloda
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Capecitabine; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Examining the Efficiency of Neurofeedback Therapy on Adults With Sensory Over Responsivity
Condition: Sensory Modulation Disorder; Sensory Over-Responsivity
Study type: Interventional

Summary: 
      Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory
      stimuli and can significantly impact pain perception and restrict daily participation and
      quality of life. Altered neurophysiological processes in SOR are documented, revealing
      reduced electroencephalogram at rest and P300 amplitudes, the latter tested through
      event-related potentials (ERP). Both may explain the failure to regulate incoming sensory
      stimuli. Neurofeedback (NF) therapy, a remedial treatment approach, aims at self-regulating
      the brain's neural activity and has proven its efficiency in treating comorbid SMD syndromes.

      Our study aims to investigate NF therapy efficiency in decreasing pain sensitivity, enhancing
      auditory ERP components of P300, increasing the power of the alpha band, life-satisfaction
      and Goal Attainment Scaling (GAS) scores in adults with SOR.
    

Detailed description: 
      In this serial experimental research design, 10 individuals with SOR aged 21-45 years will
      participate. A medical and demographic questionnaire and the Sensory Responsiveness
      Questionnaire-Intensity Scale (SRQ-IS) will be applied to screen for participation
      eligibility. Outcome measures will be conducted at 4-time points (1. baseline- 3 weeks
      pre-treatment; 2. before the first treatment session; 3. after the last treatment session;
      and 4. a month post-treatment) applying: The Goal Attainment Scaling (GAS), the P300
      component using a neurophysiological assessment of the 'Oddball paradigm', the alpha power
      using electroencephalogram resting state, and electronic versions of the Satisfaction with
      Life Scale, the World Health Organization Disability Assessment Schedule, and the Pain
      Sensitivity Questionnaire. Sixteen individually therapy sessions of 45 minutes each, twice a
      week, will be held at the same time of day.

      Repeated measures ANOVA or a non-parametric equivalent will be used to analyze the dependent
      variables measures change over time.
    

Intervention name(s): Neurofeedback treatment
Intervention type(s): Device
Intervention description(s): A treatment that developed to train adults with sensory modulation disorder by applying EEG (Curry 7 EEG system, Neuroscan-Compumedics). This treatment will aim to normalize the Alpha power (amplitude).
Intervention model: Single Group Assignment
Intervention model description: it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurofeedback; Sensory Modulation Disorder; Sensory Over-Responsivity
Effects of Hernia Repair on Men's Sexual Functions
Condition: Hernia, Inguinal; Men; Sexual Dysfunction
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      In the literature, there are several studies that compare Laparoscopic totally
      extraperitoneal hernia repair (TEP) with Lichtenstein hernia (LH) repair. There are no
      studies that compare sexual functions on men's health and quality of life. Our aim was to
      study the sexual functions of men, who underwent TEP or LH repair according to Health Survey
      Scoring Demonstration (SF36) and The International Index of Erectile Function (IIEF).
    

Detailed description: 
      176 men with unilateral inguinal hernia were randomized into two groups. Group T (n=88)
      underwent TEP and Group L(n:88) underwent LH repair. Patients demografigs, perioperative
      findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF
      36 and IIEF were filled up.
    

Intervention name(s): Inguinal Hernia Repair
Intervention type(s): Procedure
Intervention description(s): Inguinal hernia repair is surgery to repair a hernia in the groin. A hernia is tissue that bulges out of a weak spot in the abdominal wall. The intestine may bulge out through this weakened area. During surgery to repair the hernia, the bulging tissue is pushed back in. The abdominal wall is strengthened and supported with sutures (stitches), and sometimes mesh. This repair can be done with open or laparoscopic surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 176 men with unilateral inguinal hernia were randomized in two groups. Group T(n=88) were operated TEP and Group L(n:88) were operated by LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.
Masking: None (Open Label)
Primary purpose: Treatment
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Polio; Human Immunodeficiency Virus Infection
MeSH terms: Hepatitis B; Acquired Immunodeficiency Syndrome; HIV Infections; Whooping Cough; Tetanus; Diphtheria; Hepatitis; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to assess and confirm the adequate immunogenicity and safety profile of the
      Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered
      in HIV-exposed uninfected infants and in HIV-exposed infected infants.

      The primary objectives of the study are:

        -  To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary
           series in HIV-exposed infected and in HIV-exposed uninfected infants.

        -  To describe the persistence of all antibodies before receipt of the booster dose in
           HIV-exposed infected and in HIV-exposed uninfected infants.

        -  To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in
           HIV-exposed infected and in HIV-exposed uninfected infants.

      The secondary objectives of the study are:

        -  To describe the safety profile after each and all doses of the study vaccine
           administered as a 3-dose infant primary series in HIV-exposed infected and in
           HIV-exposed uninfected infants.

        -  To describe the safety profile of the study vaccine administered as a booster in
           HIV-exposed infected and in HIV-exposed uninfected infants.
    

Detailed description: 
      Male and female infants born from HIV-infected mothers will be tested for HIV infection from
      birth to 6 weeks of age. HIV infected and HIV uninfected participants will be enrolled into
      two groups at Day 0. Some infants detected HIV-exposed infected outside of the hospital
      center facilities and the trial screening procedure may also be enrolled. All participants
      will receive primary vaccinations with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at
      6, 10 and 14 weeks of age and a booster dose at approximately 15 to 18 months of age will
      receive a booster dose of the Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine.
    

Intervention name(s): Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine; Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months; 0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
Other intervention name(s): Hexaxim®; Hexaxim®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B; DTaP IPV HB PRP-T Combined Vaccine; Human Immunodeficiency Virus
Cumulative Stress and Mental Health in Young Adults
Condition: Stress, Psychological; Stress-related Problem; Cumulative Trauma; Mental Health Issue; Mental Stress; Psychological Well-Being
MeSH terms: Stress, Psychological
Study type: Observational

Summary: 
      The goal of this observational study is to learn about the needs of young adults -
      "policrisis generation", exposed to cumulative stress during 2020-2023, in terms of quality
      of mental health, the psychosocial resources, protective factors for cumulative stress
      effect, and the standards for effective prevention. The main questions to be answered are:

        -  How does cumulative stress affect young adults?

        -  Is there a specific cumulative stress syndrome that can be described?

        -  What are the risk and the protective factors for cumulative stress?

        -  How does the "policrisis generation" deal with the cumulative stress they have been
           exposed to? Participants will complete psychological questionnaires
    

Detailed description: 
      Background: Epidemiological data are not sufficient to determine the mental health outcomes
      of exposure to cumulative stress of 2020-2023. Holistic knowledge of risk and protective
      factors, pathways leading to symptoms (not yet observed), and stress management strategies
      for the generation living under cumulative stress conditions (pandemic, war, refugee
      migration, economic crisis) is needed.

      Participants: 400 young adults, recruited among university students.

      Research methodology: Analysis of data collected by screening questionnaires, psychological
      scales, and questionnaires, related to mental health conditions.
    

Intervention name(s): Psychological tests and psychosocial questionnaires
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment of psychological functioning (including well-being, mental health conditions, coping skills), and socio-demographics, academic performance, home, relationships, general health, habits, and attitudes.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        University students participating in active learning.
      
Keywords: cumulative stress; mental health; young adults; stress syndrome; risk factors; protective factors
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to investigate the short-term antiviral potency of
      bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and
      participants who are ART-experienced but integrase strand transfer inhibitor (INSTI) naive.
    


Intervention name(s): Bictegravir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bictegravir tablet(s) administered orally once daily; Placebo to match bictegravir administered orally once daily
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV-1 Infected; Adults; Treatment Naive
Functional Activity of Airway Eosinophils in Allergic Disease
Condition: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to determine how a special white blood cell, the eosinophil, can
      contribute to asthma. One of the characteristics of asthma is airway inflammation. Airway
      inflammation in asthma may occur when an allergen is inhaled and sets up an allergic reaction
      in the bronchial tubes. This reaction may lead to chest tightness, cough and wheeze. To
      better understand the way in which the eosinophil can cause inflammation, the investigators
      plan to study eosinophils that move in to the lung following an allergic reaction.
    


Intervention name(s): Segmental Allergen Challenge
Intervention type(s): Biological
Intervention description(s): Segmental allergen challenge: Briefly, this procedure will be done during a bronchoscopy. Two airway tubes of the lung will have about 1 teaspoon of allergen put in it while the scope is wedged in an airway tube segment. The allergen will stimulate this portion of the airway tube to produce eosinophils. The scope will then be removed. The bronchoscopy will be repeated two days later to collect lung fluid and biopsy samples from the parts of the lung where the allergen solution was placed.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Well-controlled allergic subjects with mild-intermittent asthma will be identified and
        undergo inhaled allergen provocation to demonstrate an allergen-specific airway response.
Evaluation of The Effect of Crowns Applied With Hall Technique on Occlusion
Condition: Child, Only; Quality of Life
Study type: Interventional

Summary: 
      This study aims to evaluate and compare the change on occlusion after placing stainless steel
      crowns (SCC) using Hall technique and conventional technique in children between the ages of
      5-8. In addition, the investigators planned to analyze the change in oral health-related
      quality of life between SCC applied with the Hall technique and SCC applied with the
      conventional method, before and after clinical application.
    

Detailed description: 
      First, the participants who met the inclusion criteria were included in 2 study groups
      according to age, gender, dental experience, tooth number, applied stainless steel crown
      technique, Decayed, Missing due to caries, and Filled teeth in the permanent teeth/decayed,
      missing due to caries, and filled teeth in the deciduous teeth (DMFT/dmft index) values and
      International Caries Detection and Assessment System (ICDAS II) and radiographic evaluation
      criteria. In the experimental group, stainless steel crowns were placed on the teeth of 39
      participants using the Hall technique. In the control group, stainless steel crowns were
      placed on the teeth of 39 participants using conventional technique.
    

Intervention name(s): Hall technique; Conventional technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Prepless crown technique; 1 or 1,5 mm preparation on mesial, distal and occlusal of the tooth
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled, double-blind clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hall technique; Paediatric dentistry; Stainless Steel
A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation
Condition: Chronic Obstructive Pulmonary Disease; Chronic Respiratory Hypercapnic Failure; Neuromuscular Disease; Obesity Hypoventilation Syndrome
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases; Hypercapnia
Study type: Interventional

Summary: 
      Noninvasive ventilation (NIV) is a form of ventilation delivered by a mask and is an
      important mode of treatment in patients with both acute and chronic respiratory (breathing)
      failure. Humidification is widely accepted as an essential part of the ventilation strategy
      in patients receiving invasive ventilation (i.e. via a tube inserted into the mouth), but its
      role during NIV use is not proven. Consequently, there is a variation in practice with regard
      to humidification during NIV. Humidification is important in maintaining upper and lower
      airway mucosal function and patients requiring NIV often report symptoms, such as throat
      dryness, due to a lack of airway humidity. Success of NIV in the acute setting is dependent
      on many factors including, patient tolerance of NIV during the acute phase. In patients with
      chronic obstructive airways disease (COPD), poor tolerance results in NIV failure, which
      necessitates endotracheal intubation or treatment failure. Furthermore, invasive ventilation
      increases the risk of a hospital acquired pneumonia, which is associated with a worse
      outcome. In the long term setting of NIV use, again patients frequently report symptoms due
      to drying of the airways and adherence to NIV can be highly variable. Adherence in these
      patients is important in improving both quality and length of life. Humidification devices
      may be technically effective, but clinicians have concerns regarding potential negative
      effects of these devices. There is a requirement to evaluate the use of humidification in
      both the acute and long term use of NIV, particular, in terms of patient ventilator
      interaction, which will impact on comfort and adherence to NIV. This will effect the overall
      effectiveness of ventilation. The investigators propose a randomised controlled trial to
      investigate the effects of a humidification system during noninvasive ventilation.
    


Intervention name(s): non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
Intervention type(s): Device
Intervention description(s): Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic respiratory hypercapnic failure
Trial of Vitamin D Supplementation in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study null hypothesis is that vitamin D supplementation will not influence time to upper
      respiratory tract infection or time to severe asthma exacerbation in adult and adolescent
      patients with asthma.
    


Intervention name(s): Cholecalciferol; Miglyol oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year; Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics
      (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects
    

Detailed description: 
      This is a 2-part study with each part is an open-label study in healthy adult subjects.

      Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part
      B), 14 subjects in each part. With each part, the subject will be receive study drug per the
      defined treatment periods of Day 1~7 and Day 13~19.
    

Intervention name(s): HEC74647; HEC110114
Intervention type(s): Drug; Drug
Intervention description(s): Administered HEC74647 200 mg orally once daily in fed state; Administered HEC110114 800 mg orally once daily in fed state
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment