bioihbjkbjnl/mcl2 huggingface dataset:
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the cholesterol lowering effect of a drinkable
      low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in
      midly hypercholesterolemic people not treated by statins.
    


Intervention name(s): 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).; 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 = Intervention 1 (1 test product/day); 2 = Intervention 2 (1 control product/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Plant sterol; Hypercholesterolemia; diet; dairy; isoprostanes; Midly hypercholesterolemic subjects
Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Description: To investigate bioavailability of two anti-viral drugs (lamivudine and
      zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric
      use.

      Interventions: 12 healthy volunteers will receive in a cross-over design two formulations
      i.e. the commercially available tablet formulation and the trial formulation. Blood samples
      (13 over 24 h) will be taken in order to determine the pharmacokinetic profile of the drugs
      from both formulations and will be compared.

      Duration of intervention: 2 days + 7 days of wash-out between both oral administrations.
    


Intervention name(s): administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation
Intervention type(s): Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Antiviral Agents
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers
Evaluation of Pharmacokinetics Profiles and Bactericidal Activity of Zabofloxacin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of
      Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy
      volunteer
    

Detailed description: 
      A Randomized, open label, single dose, crossover phase I clinical study to compare the
      pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and
      Levofloxacin 250mg after oral administration in healthy volunteer
    

Intervention name(s): Zabofloxacin 183mg; Levofloxacin 250mg; Zabofloxacin 367mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Zabofloxacin 183mg single dose; Levofloxacin 250mg single dose; Zabofloxacin 367mg single dose
Other intervention name(s): Zabolante 183mg; Cravit; Zabolante 367mg
Intervention MeSH terms: Levofloxacin; Fluoroquinolones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: healthy
Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025
Condition: HIV Infection; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Observational

Summary: 
      This laboratory-based substudy of an effectiveness trial of two Hepatitis B vaccines in
      HIV-negative youths is being done to evaluate the genetic contribution to the individualized
      immune response.
    

Detailed description: 
      This laboratory-based substudy of ATN 024 and 025 will evaluate the genetic contribution to
      highly individualized immune responses to hepatitis B vaccine in individuals and confirm the
      correlation of specific human leukocyte antigen (HLA) alleles and haplotypes with Hepatitis B
      Virus (HVB) antibody concentrations and antibody decay kinetics in vaccinated adolescents.
      Approximately 5 ml of whole blood will be collected from study participants at the time of
      the week 28 visit or at any subsequent study visit or clinic visit following successful
      completion of the week 28 visit. Peripheral blood mononuclear cells will be obtained and QIA
      amp Blood kit will be used to extract high-quality genomic DNA for polymerase chain
      reaction-based genotyping by the PEII laboratory.

      The study is expected to be available for the duration of the parent studies which is
      approximately 2 years. This study requires one visit that may be arranged to coincide with a
      study or routine clinic visit. There are no follow up visits.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All subjects who are currently enrolled or have completed ATN 024 or ATN 025 are eligible
        for participation on this substudy with the exception of those who were discontinued from
        ATN 024 or ATN 025 prior to completing the first post-vaccination serology (week 28) visit.

        Participants in ATN 024 are HIV-infected youths aged 12 to 24 years, while participants in
        ATN 025 are HIV-uninfected youths aged 12 to17 years, thus participants in this substudy
        will be HIV-infected and uninfected youth aged 12 to 24 years. All eligible youths must be
        negative for HBV core antibody, HBV surface antigen, and HBV surface antibody at the time
        of enrollment in to the parent protocols.
      
Biospecimen description: 
      Approximately 5 ml whole blood or 5 x 106 peripheral blood mononuclear cells.
    
Keywords: Hepatitis B vaccines; HIV-infected adolescents; Hepatitis B infection (negative); HIV vaccine trial
Clinical Assessment of Dental Implant
Condition: Tooth Loss
MeSH terms: Tooth Loss
Study type: Interventional

Summary: 
      Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be
      compared. Implant success rate will be evaluated by measuring the peri-implant bone
      remodeling from baseline to 1 year post insertion.

      The hypothesis is those implant survival rates of the test (V3) and control group (C1) are
      similar and that test V3 implant allows less peri-implant bone loss.

      Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1
      implants will be compared. The bone thickness will be measured in cone beam computerized
      tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.

      The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.
    


Intervention name(s): MIS Implants
Intervention type(s): Device
Intervention description(s): The implantation procedure will be carried out according to a standard surgical protocol, and according the manufacture protocol. Patient will be randomly assigned to one of the two groups after flap opening. The implant stability will be measured using the wench key and recorded in N/cm. The implants will be covered with healing abutments for trans-gingival healing for a period of 4 months. The area will be sutured with thin nylon sutures for a primary passive fit closure. Immediately after the surgery the patient will perform a CBCT of the treated area with a cotton roll on the buccal side in order to be able to evaluate the buccal soft tissue thickness.
Other intervention name(s): MIS Implants Technologies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Single missing tooth; Implants; Peri-implant bone remodeling; Bone thickness; Thickness of soft tissue
The Effect of Luteinizing Hormone (LH) Supplementation Following Gonadotropin-releasing Hormone (GnRH) Antagonist Administration in Advanced Reproductive Ageing Women Undergoing IVF and Embryo Transfer (IVF/ET)
Condition: Pregnancy Result Rape
Study type: Interventional
Phase: Phase 4

Summary: 
      To explore whether recombinant LH (rLH) supplementation (Leuveris) to recombinant follicle
      stimulating hormone (rFSH) following GnRH antagonist treatment has an advantage in infertile
      women with advanced reproductive ageing undergoing IVF-ET.
    


Intervention name(s): Leuveris; Leuveris
Intervention type(s): Drug; Drug
Intervention description(s): IV; All recruited women will be treated similarly employing the recombinant FSH and the fixed GnRH antagonist. Concomitantly, on the same day of the antagonist administration r-LH will be administered daily and continued until human chorionic gonadotropin (hCG) day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pregnancy; IVF
A Study of Evacetrapib in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether concentrations of the study drug
      (evacetrapib) in the blood stream is the same or is different when the person is also taking
      gemfibrozil (a drug used to lower lipid levels). Each participant will receive gemfibrozil
      alone, evacetrapib alone, and both drugs in combination. There is no washout period between
      doses. The safety of both of the study drugs given together will be evaluated. Information
      about any side effects that may have occurred will also be collected. This study will last
      approximately 36 days.
    


Intervention name(s): Evacetrapib; Gemfibrozil
Intervention type(s): Drug; Drug
Other intervention name(s): LY2484595
Intervention MeSH terms: Gemfibrozil; Evacetrapib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Booster Dose of Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children
Condition: EV71-associated Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused
      by viruses that belong to the enterovirus genus of the picornavirus family. Although most
      HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71
      (EV71) can present with a high rate of neurological complications, including
      meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by
      EV71 has become a major emerging infectious disease in Asia and the highly pathogenic
      potential of EV71 clearly requires the attention of world medical community.

      The phase II study of inactivated vaccine (vero cell) against EV71 has completed last month
      in Jiangsu Province in China. The data from the phase II study suggested that the inactivated
      EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese
      children and infants. But the antibody titer against EV71 was found decreased significantly
      at month 8 compared to that at day 56. Considering the similar dynamic trend had also been
      found in the antibody against poliovirus induced by polio vaccines, and whose immunization
      schedule contains a booster dose administrated at 1 to 1.5 year after the first 3 doses of
      fundamental immunity. In order to find a better immunization schedule for children, the
      investigators decided to perform this booster immunity trial among these children who had
      received two doses of EV71 vaccines (around one year after the fundamental immunity). The
      investigators do the recruitment among these children who had participated in the previous
      phase II trial and received EV71 vaccines, and randomize them in a ratio of 2:1 to receive
      either a booster dose of EV71 vaccines or placebo.
    


Intervention name(s): alum-adjuvant 160U /0.5ml; alum-adjuvant 320U /0.5ml; alum-adjuvant 640U /0.5ml; adjuvant-free 640U /0.5ml; 0/0.5ml placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): inactivated vaccine (vero cell) alum-adjuvant 160U /0.5ml EV71 vaccine; inactivated vaccine (vero cell) alum-adjuvant 320U /0.5ml EV71 vaccine; inactivated vaccine (vero cell) alum-adjuvant 640U /0.5ml EV71 vaccine; inactivated vaccine (vero cell) adjuvant-free 640U /0.5ml EV71 vaccine; 0/0.5ml placebo
Intervention MeSH terms: Aluminum Hydroxide; Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: immunogenicity; safety; inactivated EV71 vaccine
Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
Condition: Spine Disease; Spinal Fractures
MeSH terms: Spinal Diseases; Spinal Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive
      surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in
      spinal surgery.
    


Intervention name(s): surgical robot; controlled approach
Intervention type(s): Combination Product; Combination Product
Intervention description(s): The surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process.; The screw placement was performed using a controlled approach according to the surgical plan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: smart orthopedics; minimally invasive surgical systems; spinal surgery
Evaluation of the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the
      Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects
      Following Single and Multiple Oral Doses
    


Intervention name(s): BLU-5937
Intervention type(s): Drug
Intervention description(s): Single and multiple doses assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this first-into-man study were to investigate the safety, tolerability
      and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults.
      Pharmacodynamic effects (through a battery of Central Nervous System tests) were also
      assessed.
    

Detailed description: 
      The study consisted of ascending dose groups; each dose group was investigated in a new group
      of 8 healthy male subjects (6 on active drug and 2 on placebo). In addition, the study
      included a biocomparison part (dose group 2), an absolute bioavailability part (dose group
      4), and a mass balance / metabolism part (dose group 3).
    

Intervention name(s): ACT-541468 (Formulation A); ACT-541468 (Formulation B); Placebo (Formulation A); Placebo (Formulation B); 14C-labeled ACT-541468; Placebo tracer
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Hard gelatin capsules for oral administration formulated at strengths of 5 mg, 25 mg and 100 mg; Soft gelatin capsules for oral administration formulated at the strength of 25 mg; Hard capsules matching ACT-541468 Formulation A; Soft capsules matching ACT-541468 Formulation B; Tracer at a nominal dose of 250 nCi (corresponding to 2.02 µg ACT-541468) administered either orally or intravenously; Sterile NaCl 0.9% was used as placebo matching the tracer for oral and i.v. administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Evaluation of the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns
Condition: Covid19; Vaccine Reaction; Coronavirus; Menstrual Problem; Endometrium
MeSH terms: Coronavirus Infections; Severe Acute Respiratory Syndrome; Menstruation Disturbances
Study type: Observational

Summary: 
      Coronavac, one of the vaccines developed within the scope of combating the COVID-19 pandemic
      that has surrounded the world for a year, started to be applied in the first healthcare
      workers in our country. In this important step taken to end the pandemic, information on
      vaccines is still limited. Most vaccines, including the Coronavac vaccine, are applied with
      approval for emergency use before phase 3 studies are fully completed. While investigating
      the effect of the vaccine on the virus, possible side effects should also be considered. In
      this context, it is not known whether the vaccine has an effect on the menstrual cycle,
      especially of women of reproductive age.

      Our primary aim in our study is to evaluate the effect of the vaccine on the menstrual cycle
      and if the vaccine has any effect on the menstrual cycle, what kind of changes this effect
      causes.
    

Detailed description: 
      The survey contains 20 questions aimed at obtaining information about the menstrual cycles of
      health workers before and after vaccination. Demographic data of the participants are also
      taken.
    

Intervention name(s): healthcare workers with the coronavac vaccine
Intervention type(s): Other
Intervention description(s): Health workers who are vaccinated will fill in the 20-question survey electronically.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        It includes female healthcare workers between the ages of 8 and 45. For participation, 1 or
        2 doses of vaccine should be administered and at least one menstrual period after the
        match.
Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System
Condition: Vagus Nerve Autonomic Disorder
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias
Study type: Interventional

Summary: 
      High velocity low amplitude thrust applied at the vertebral level during spinal manipulation
      is thought to slide the vertebrae over each other and alter segmental biomechanics.
    

Detailed description: 
      Evidence suggests that spinal HVLA techniques may produce acute changes in skin sympathetic
      nerve activity. There are studies reporting that thoracic HVLA manipulation causes a
      statistically significant increase in cardiac vagal activity in the immediate
      post-intervention period compared to sham administration.
    

Intervention name(s): Supine practice group; Prone application group
Intervention type(s): Other; Other
Intervention description(s): The practitioner's arm was placed in the mid-thoracic region from the opposite side of the individual's torso in the form of a half fist. In this position, the SPs coincide with the space in the middle of the half fist, while the TPs coincide with the fingertips and the thenar region. With the practitioner's other hand supporting the patient's elbows, a high-speed-low-amplitude thrust is applied from front to back.; the practitioner positions the hypothenar part of his hands above the TPs in the mid-thoracic segment. From this point, a high-velocity-low-amplitude thrust is applied from the back to the front.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: manipulation
Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes
Condition: Stress, Physiological; Sport Injury
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      In our hypothesis, auricular acupoint stimulation might improve the attention and heart rate
      variability in archery athletes. The meridian activities regarding the attention and action
      in Chinese medicine systems might be influenced.
    

Detailed description: 
      During the execution of archery, attention is the key of performance in elite players,
      especially in the initial period.

      Auricular acupoint stimulation is one of the therapeutic methods of traditional Chinese
      medicine. It is widely applied in various diseases. Researches had concluded the use of
      auricular acupoint stimulation on amplifying the anesthesia effect, weight reduction and the
      cessation of substance abuse. This study aimed to investigate the immediate effect of
      non-invasive auricular acupoint stimulation on the performance and the meridian activities of
      archery athletes.

      The investigators will collect the meridian activities and balance index with Ryodoraku
      device, the continuous heart rate record and the scores of the two sections as the
      performance. The participants will rate their attention and fatigue levels through filling
      the self-reported questionnaires.
    

Intervention name(s): Auricular acupoints stimulation
Intervention type(s): Other
Intervention description(s): Noninvasive auricular acupoints stimulation with seeds
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study recruited the archery players in school teams among junior high, senior high schools, and colleges.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: archery; Ryodoraku; heart rate variability; auricular acupoint
Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes
Condition: Irritable Bowel Syndrome; Relief of Irritable Bowel Syndrome Symptoms; Quality of Life
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      To determine the effect of cultura probiotic yoghurt on number of responders to treatment
      during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura
      yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8
      weeks of treatment in comparison to placebo in IBS out patients.
    

Detailed description: 
      Recent research has shown taht probiotic may give positive effect on symptoms among patients
      with (IBS) Irritable Bowel Syndrome. The mechanism behind the positive effect are not known
      but a positive effect on different cytokines are a possible mechanism. Also effect on the
      large intestine bacterial mass could be of importance.
    

Intervention name(s): Arla Yoghurt with no probiotic; Probiotic yoghurt (Cultura)
Intervention type(s): Other; Other
Intervention description(s): two servings of 200 ml of investigational products per day; 200 ml per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IBS (Irritable Bowel Syndrome); Probiotic yoghurt; Symptom severity