bioihbjkbjnl/mcl2 huggingface dataset:
Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19
Condition: Coronavirus Infections; Vaccine; Polio
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Respiratory Tract Infections; Poliomyelitis
Study type: Observational

Summary: 
      Observational program, double-blind, placebo-controlled to study the preventive efficacy of
      the BiVac polio (Oral polio vaccine, divalent, live attenuated of types 1 and 3 vaccine
      against the incidence of acute respiratory infections, including COVID-19
    

Detailed description: 
      To carry out a comparative assessment of the indices of humoral, cellular immunity and
      cytokine profile in patients with acute respiratory infections.

      Current Program Population: 1500 healthy male and female volunteers, aged of between 18 and
      65 will be included in the program.

      All included volunteers will be divided into groups:

      Group 1 - 750 volunteers who will be vaccinated with BiVac polio vaccine; post-vaccination
      observation period of 12 months.

      Group 2 - 750 volunteers, placebo will be administered, post-vaccination observation period
      of 12 months.

      The probability of getting into one of the two groups for each volunteer will be 50%.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy volunteers will be invited to participate in the program. The concept of "healthy"
        is defined as the absence of deviations detected during the collection of a medical
        history, during standard clinical and instrumental examinations, as well as in the absence
        of clinically significant deviations (from the reference values of the laboratory) in
        laboratory blood and urine tests.
      
Keywords: Covid-19; SARS-Cov-2; Coronavirus Infections; Immunobiological medicine
The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate.
Condition: Impact of Legislation on Cumulative Delivery Rate
Study type: Observational

Summary: 
      Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high
      cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive
      Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher
      than the 1% after natural conception, related to the number of embryos transferred, and
      preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART
      cycles are reimbursed for female patients younger than 43 with a Belgian insurance number
      since July 2003, but only if a limited number of embryos is transferred depending on female
      age and cycle rank. Although this policy has resulted in a significant reduction in the MPR
      after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if
      the cumulative delivery rate per patient is affected by this legislation. The aim of this
      study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab
      reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when
      compared to the situation before 2003.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing IVF/ICSI cycles
The Effect of Biofeedback-Based Virtual Reality Game on Children
Condition: Pediatric Cancer
Study type: Interventional

Summary: 
      The needles of port catheters, which are often used in childhood cancer treatment, must be
      changed every 5-7 days, which causes pain, anxiety, and fear in children every 5-7 days In
      recent years, the usage of virtual reality has grown to distract children during port
      catheter needle insertion. But it's not always easy for children to switch their attention to
      something else. A good child distractor must be sensory-stimulating, developmentally
      appropriate, and highly interactive.
    

Detailed description: 
      Today, virtual reality applications have advanced, and software that provides biofeedback
      with breathing has improved engagement with the user. Our aim in this study is to examine the
      effect of biofeedback-based virtual reality games on pair, fear and anxiety levels during
      insertion of port needle insertion in children.

      The randomized control trial design will be used, and The CONSORT list will be used to guide
      the research. This study will be conducted at the 140 pediatric oncology patients (70
      experiment/ 70 control) aged 6-12 years. This study will be carry out in a university
      hospital in Istanbul, Turkey between January 2023, and June 2023. The research data will
      collect from the children's self-reports and parents through a survey form and scales.
      Children's pain will evaluate by the children and parent with Wong-Baker Faces Pain Rating
      Scale, child fear will evaluate by the children and parent with 'Child Fear Inventory', and
      child anxiety will evaluate by the children and parent with 'Child Anxiety Statement Scale'.
    

Intervention name(s): Biofeedback-based virtual reality game
Intervention type(s): Device
Intervention description(s): The application will be a biofeedback-based virtual reality game developed by the researchers in collaboration with engineering in line with the literature review.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Study
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: port catheter; pediatric oncology; pain; anxiety; fear; biofeedback; virtual reality
A Pilot Bioequivalence Study of Pomalidomide
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This
      pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted
      condition.
    


Intervention name(s): Pomalidomide 4 MG Oral Capsule; Pomalidomide 4 MG Oral Capsule-Pomalyst
Intervention type(s): Drug; Drug
Intervention description(s): per os,capsule,4mg,1 capsule per period; per os,capsule,4mg,1 capsule per period
Intervention MeSH terms: Thalidomide; Pomalidomide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pomalidomide; Multiple myeloma; Bioequivalence
Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia
Condition: Falls; Balance; Insomnia; Aging
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      To examine the change in balance that occurs in older individuals when exposed to different
      colored lights at night.
    


Intervention name(s): White light exposure; Dim white light exposure; Very dim white light exposure; Dim orange light exposure
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): ~200 lux of broad spectrum white light; ~28 lux of broad spectrum white light; <0.5 lux of broad spectrum white light; ~28 lux of orange light
Intervention model: Crossover Assignment
Intervention model description: The order of the interventions were randomized to the four visits.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Postural Balance; Sleep Initiation and Maintenance Disorders
Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia
Condition: Post Operative Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators noticed that Body Fat Ratio might have great influence on the efficacy of
      different lipid soluble anesthetics. The objective of this clinical trial was to compare the
      effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.
    

Detailed description: 
      The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the
      efficacy of different lipid soluble anesthetics.
    

Intervention name(s): Sufentanil (R30730, brand name Sufenta); Sufentanil (R30730, brand name Sufenta) + Morphine; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sufentanil 1ug/ml; sufentanil 0.5ug/ml+morphine 0.25mg/ml; morphine 0. 5mg/ml
Intervention MeSH terms: Sufentanil; Morphine; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: sufentanil; morphine; postoperative pain control; body fat percentage; gynecology laparoscopic surgery; lipid solubility
Effect of I/R Injuries by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Hepatectomy
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      This is a multi-centre prospective randomized controlled trial to explore the influence of
      ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the
      prognosis of Hepatocellular Carcinoma (HCC) patients.
    

Detailed description: 
      Until now there are two popular procedures during the radical excision of primary liver
      cancer in our country.One is to give a pringle manoeuvre to control the operative blood
      loss,the other is using a combination of CUSA and Tissue-link to control the bleeding while
      without liver ischemia.According to the recent experimental studies in rats,we know that the
      ischemia and reperfusion injury may contribute to the metastasis of the tumor.In order to
      test the actual contribution of ischemia on human,we conduct this prospective clinical trial
      to compare the two popular procedures' effect on the prognosis of liver cancer patients
      undergoing radical excision.
    

Intervention name(s): curative resection without Pringle; curative resection with Pringle manoeuvre
Intervention type(s): Procedure; Procedure
Intervention description(s): Radical excision of liver cancer without the procedure of pringle manoeuvre; curative resection liver cancer under pringle manoeuvre
Other intervention name(s): Experimental group; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ischemia; liver cancer; radical excision; prognosis
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
Condition: Allergic Asthma; Allergy to House Dust; Allergy
MeSH terms: Asthma; Hypersensitivity
Study type: Interventional

Summary: 
      This is a randomized, double blind, cross-over study designed to determine the concentration
      of airborne house dust mite allergen inducing bronchial response in asthmatic subjects
      allergic to mite, during allergen exposures in the Alyatec environmental exposure chamber
      (EEC).

      The study was also designed to validate the specificity of the asthmatic reaction induced by
      exposure to airborne house dust mite allergen in Alyatec EEC.
    


Intervention name(s): Exposure to placebo in EEC; Exposure to three concentrations of HDM allergen in EEC; Exposure to a single concentration of HDM allergen in EEC
Intervention type(s): Other; Other; Other
Intervention description(s): Patients are exposed to placebo (saline solution) in the EEC for 4h maximum; Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum; Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double blind, cross-over study including two study groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Allergy; Asthma; House dust mite
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of
      YH12852 after oral administration in healthy subjects
    


Intervention name(s): YH12852; Prucalopride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Prucalopride; YH12852
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; tolerability; pharmacokinetics; pharmacodynamics
Study to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The BCN02-Romi study aims to evaluate a combined "kick and kill" strategy using the most
      immunogenic candidate vaccine available so far (HIVconsv) with the strongest latency reversal
      agent available at present time (romidepsin) in a cohort of early-treated HIV positive
      individuals.
    

Detailed description: 
      The combined use of therapeutic vaccination and specific drugs that can reactivate latent
      virus from the reservoir (Kick and kill strategies) hold the promise to achieve functional
      cure and viral eradication of HIV infection. The present project consists of a
      proof-of-concept clinical trial in a cohort of 24 early treated HIV-1 infected individuals
      rolled-over from the BCN01 vaccine clinical trial in which participants received the most
      immunogenic vaccines tested to date, ChAd and modified vaccinia Ankara (MVA).HIVconsv
      vaccines. All individuals will be given a booster immunization with MVA.HIVconsv in
      combination with romidepsin (RMD), a potent histone deacetylation inhibitor (HDACi) and will
      later undergo a monitored antiretroviral pause. HIVconsv vaccines have specifically been
      designed to stimulate a broad and potent cytotoxic T cell (CTL) response towards the most
      conserved viral regions of the HIV-1 proteome, which have recently been suggested to have a
      crucial role when targeting HIV variants harboured in the latent reservoir with mutations to
      escape T-cell immune responses. The study includes the development of a population
      pharmacokinetic/pharmacodynamic (PK/PD) substudy to analyse the in vivo effects of RMD in the
      induction of HIV expression in resting cells, deeply investigate any unintended effect on the
      CTL function as well as predict the relationship between RMD exposure and such effects. The
      investigators' results will allow investigators to optimize RMD dosing, to evaluate the
      clinical efficacy of this eradication strategy after the cART interruption and to identify
      better correlates of control of rebound viremia after cessation of treatment.
    

Intervention name(s): MVA.HIVconsv vaccine; Romidepsin
Intervention type(s): Drug; Drug
Intervention description(s): Dose: 2x10e8 pfu, Interval: weeks 0 and 9.; Dose: 5mg/m2 over 4hours, Interval: weeks 3, 4 and 5
Intervention MeSH terms: Romidepsin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV infection; Early treatment; Romidepsin; HDACi; Therapeutic Vaccines; HIVconsv; HIV reservoir; Population PK/PD analysis
Trastuzumab Administered Concurrently or Sequentially to Anthracycline-containing Adjuvant Regimen for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Most of the published data support the preferential use of an anthracycline-containing
      adjuvant regimen for individuals with HER2-positive tumors. Concurrent anthracyclines and
      trastuzumab, however, are contraindicated due to the observation of unacceptably high rates
      of cardiotoxicity in a large randomized trial in the metastatic setting. However, in
      neoadjuvant setting, trastuzumab concurrently with an anthracycline-containing chemotherapy
      regimen had shown high pathological complete response (pCR) and very low cardiotoxicity. All
      large adjuvant trials have evaluated only the sequential strategy of administering
      anthracyclines and trastuzumab. The safety and efficacy of trastuzumab concurrently with an
      anthracycline-containing chemotherapy regimen has never been evaluated in adjuvant setting.
      Given the similar patients characteristics, the investigators hypothesize that trastuzumab
      concurrently with an anthracycline-containing chemotherapy regimen would not increase
      cardiotoxicity but efficacy.
    


Intervention name(s): concurrent; sequential
Intervention type(s): Drug; Drug
Intervention description(s): Trastuzumab will be administered concurrently with any anthracycline-containing regimen for breast cancer adjuvant chemotherapy. Trastuzumab will be given intravenously 8mg/kg loading dose, followed by 6mg/kg every 3 weeks for one year.; Trastuzumab will be administered sequentially to any anthracycline-containing regimen for breast cancer adjuvant chemotherapy. Trastuzumab will be given intravenously 8mg/kg loading dose, followed by 6mg/kg every 3 weeks for one year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; adjuvant chemotherapy; trastuzumab; anthracycline
Frequent Activity Snacks Breaks
Condition: Obesity; Insulin Resistance; Sedentary Lifestyle
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      There is a growing health burden in Sweden and Europe arising from the interrelated sequelae
      of metabolic disorders comprising impaired glucose tolerance (IGT), obesity and T2DM. Obesity
      and inactivity are the main drivers of IGT and T2DM and are responsible for up to 8% of
      health costs and 13% of deaths in Europe, with the risk of co-morbidities rising in parallel
      with increasing body weight. IGT and T2DM are the paradigm of inactivity-related disorders:
      the majority of people who have IGT or T2DM are overweight and inactive, with up to 80% being
      obese. A recent meta-analysis of 42 studies concluded that sedentary time was independently
      associated with a greater risk of T2D, all-cause mortality, cardiovascular disease incidence
      and mortality, and cancer incidence and mortality (breast, colon, colorectal, endometrial and
      epithelial ovarian cancers) (Ann Intern Med. 2015;162:123-32). A recent systematic review of
      trials published up to April 2014 identified 16 separate studies and concluded that there is
      considerable evidence of the positive effects of breaking up prolonged sitting time with
      light-intensity ambulatory physical activity and standing on postprandial metabolic
      parameters, including glucose, insulin and triglyceride levels (Med Sci Sports Exerc.
      2015:47:2053-61). However, to date, all of the published experimental trials describing the
      beneficial effects of breaking up sitting time on metabolic risk markers have been restricted
      to acute exposure periods (1-5 days). We will perform a RCT intervention study, which
      examines the efficacy (clinically relevant responses) and practical implementation of
      low-impact training in sedentary obese individuals during the day.
    


Intervention name(s): Normal lifestyle; Exercise; muscle and fat biopsy; Continuous glucose monitoring; Activity monitoring (ActivePal)
Intervention type(s): Behavioral; Behavioral; Procedure; Device; Device
Intervention description(s): Normal lifestyle; Mild exercise 3 min every half hour; Biopsy under local anesthesia; Glucose concentrations during the study period; Objective measurements of standing and sitting time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of LY2157299 Monohydrate in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate
      in healthy participants. The study will determine how the body eliminates the radioactivity
      and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal
      females, or sterile males. This study is approximately 8 to 15 days.
    


Intervention name(s): [^14C]-LY2157299
Intervention type(s): Drug
Intervention description(s): [^14C]-LY2157299 monohydrate administered as oral solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in IVF Cycles
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect on LH levels of the 5-day CC
      administration during luteal phase in oocyte donors, to investigate whether the CC corrects
      the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the
      agonist triggered antagonist cycles.
    


Intervention name(s): Clomifene Citrate
Intervention type(s): Drug
Intervention description(s): Clomiphene citrate 100 mg daily for 5 days
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Comparison of Different Ratio of Ketofol (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Condition: Analgesia
Study type: Interventional

Summary: 
      Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who
      underwent ERCP
    

Detailed description: 
      Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in
      various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP).
      The addition of ketamine to propofol may counteract the effect of respiratory and
      cardiovascular depression of propofol. There has been limited studies evaluating the sedation
      effect of different ketofol dose ratios associated with hemodynamic changes, recovery time,
      dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1
      and 4:1 ratio in patients who underwent ERCP
    

Intervention name(s): Propofol and Ketamine Mixture (Ketofol)
Intervention type(s): Drug
Intervention description(s): Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care