bioihbjkbjnl/mcl2 huggingface dataset:
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Condition: Dental Caries; Infectious Diseases
MeSH terms: Communicable Diseases; Infections; Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      Aims:

        1. To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis
           BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly
           pacifier.

        2. Test in a clinical study how feasible the method is and to study how the intervention
           affects caries occurrence.

      Main hypothesis:

      The administration of B. lactis BB12 and xylitol affects beneficially the dental health of
      the child.
    

Detailed description: 
      Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child
      transmission of ms. Possibly xylitol delivered to infants could positively influence
      colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12
      (a well known probiotic bacteria) we may be able to positively affect both gut and oral
      colonization, reflected in both dental and general health (solid data available on the latter
      aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it apparently is
      safe for the teeth, no clinical studies have looked at effects of its administration to
      infants on oral health. Our study aims to look at caries occurrence in infants who have
      received the xylitol + BB12 food supplement with a pacifier.

      Recruiting of subjects to the study is completed.
    

Intervention name(s): Sorbitol; Xylitol + BB12; Xylitol
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years; Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years; Xylitol+BB 12 delivery with a pacifier max until 2 years
Other intervention name(s): Xylitol; Bifidobacterium lactis; Sorbitol; Bifidobacterium lactis; Sorbitol; Bifidobacterium lactis
Intervention MeSH terms: Sorbitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Oral microbiology
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with
      titration (Part 2).
    

Detailed description: 
      The drug being tested in this study is called TAK-935 tablet. TAK-935 tablet is being tested
      in Japanese healthy adult men. This study will evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and
      multiple doses with titration (Part 2).

      The study will enroll up to 33 participants in total (Part 1 + 2). In Part 1, participants
      will be randomly assigned (by chance, like flipping a coin) to one of these treatment
      cohorts/groups;

        -  Cohort 1: Single dose of TAK-935 at 200 mg or placebo (fasted)

        -  Cohort 2: Single dose of TAK-935 at 600 mg or placebo (fasted)

        -  Cohort 3: Single dose of TAK-935 at 1200 mg or placebo (fasted)

      In Part 2, participants will be randomly assigned to one of these treatment groups;

      - Cohort 4: Multiple doses with titration of TAK-935 or placebo at 100 mg twice daily (BID)
      from Day 1 to Day 7, 200 mg BID from Day 8 to Day 14 and 300 mg BID from Day 15 to Day 21
      (fasted).

      This single-center trial will be conducted in Japan. The overall time to participate in this
      study is approximately 36 days for Part 1 and 63 days for Part 2. Participants will be
      hospitalized for 5 days in Part 1 and 26 days in Part 2.
    

Intervention name(s): TAK-935; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-935 Tablets; TAK-935 placebo-matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients
Condition: Acute Heart Failure; Mitral Regurgitation
MeSH terms: Heart Failure; Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to determine the prevalence of moderate-to-severe Mitral
      Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.
    

Detailed description: 
      All patients admitted with symptoms of HF- (shortness of breath (SOB), peripheral oedema,
      palpitations and irregular heart beats) will be assessed by the Research Team. The level of
      BNP will be checked using a small device (i-STAT BNP) at the bedside. If results of the test
      suggest HF they will undergo special procedure called transthoracic echocardiography (TTE).
      TTE is an ultrasound scan of the heart which will enable the investigators' to grade severity
      of Mitral Regurgitation (MR) as well as strength of the heart muscle. The investigators will
      use bi-plane Simpton's method to calculate left ventricular (LV) ejection fraction (EF).
      Colour Doppler and PISA method will be used to quantify severity of MR or valve leak.
      Simultaneously there will be recording of heart sounds to find out if auscultation is
      reliable in identifying leaky valves.
    

Intervention name(s): Transthoracic Echocardiogram (TTE) Assesment
Intervention type(s): Procedure
Intervention description(s): Transthoracic Echocardiogram (TTE) will be carried out on all heart failure patients with elevated BNP level (>30 pg/ ml) for grading of MR severity within 7 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does the Length of Hospital Stay for Rehabilitation Affect Functional Outcomes in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The purpose of this study was to evaluate whether the length of hospital stay for
      rehabilitation affects functional outcomes of stroke patients.
    

Detailed description: 
      The medical records of patients who were admitted to a rehabilitation unit were analyzed
      retrospectively. The functional output, the level of spasticity, and the level of motor
      development at admission and discharge will be determined using the Functional Independence
      Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test, respectively. Based
      on the length of hospital stay, patients will be divided into two groups: hospital stays ≤ 3
      months (Group 1) and > 3 months (Group 2). Clinical features and functional output will be
      compared between the groups.
    

Intervention name(s): Based on the length of hospital stay
Intervention type(s): Other
Intervention description(s): Based on the length of hospital stay, patients were divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2).Clinical features and functional output will be then compared between the groups.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with a stroke who received rehabilitation in an inpatient clinic between 2010 and
        2013
      
Keywords: Neurological Rehabilitation; Stroke; Rehabilitation Outcome
Fertility Restoration Using Autologous Mesenchymal Stem Cells
Condition: Chronic Endometritis; Uterus; Scar; Uterine Synechiae; Fallopian Tube Obstruction
MeSH terms: Endometritis; Gynatresia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of the patients with scarring and adhesions in the uterus resulting from caesarean
      section or chronic inflammation in the mucosa of the uterus and fallopian tubes and
      preventing the occurrence of these effects in the future
    

Detailed description: 
      The aim of the project is to develop a biomedical cell product based on autologous adipose
      tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective
      treatment and prevention of scarring and adhesions in the uterus acquired as a result of
      cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes;
      to conduct the clinical trials of the biomedical cell product in the treatment of uterus
      scarring and infertility in women.
    

Intervention name(s): Autologous mesenchymal stem cells; standard treatment
Intervention type(s): Biological; Other
Intervention description(s): Autologous adipose tissue-derived mesenchymal stem cells; standard treatment according to clinical protocols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fertility restoration; Mesenchymal stem cells
Exploring Biological Linkage Between Circadian Disruption and Cancer Progression
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms; Disease Progression
Study type: Observational

Summary: 
      The purpose of this study is to explore the possible association between the circadian
      disruption and cancer progression.
    

Detailed description: 
      The biological markers that are assumed to bridge this association are measured and analyzed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        University (Tertiary) hospital, oncology clinic
      
Biospecimen description: 
      Whole blood, serum Saliva Urine
    
Keywords: Breast neoplasms; Circadian rhythm; sleep; survival; distress; anxiety; depression; quality of life; actigraph; fatigue
Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism
Condition: Autism; Oxidative Stress
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      This study will look at the changes taking place in the blood levels of key markers of
      oxidative stress. Oxidative stress is the biological equivalent of rust on a car. It changes
      vital cell chemistry. It is known to occur at high pressure oxygen, but little is known about
      changes at pressures slightly greater than normal atmospheric pressure.

      Hyperbaric therapy is used in a variety of medical conditions. It is being tested in this
      study only for safety. It is not being assessed for the ability of hyperbaric oxygen to
      improve the clinical condition of children with autism.

      This study was felt to be important since autism appears to be associated with oxidative
      stress and hyperbarics was being used "off-label" for this condition without safety studies.
    

Detailed description: 
      Blood will be drawn immediately prior to a one hour session of hyperbarics (HBT. A catheter
      will be inserted in to a vein and converted to a heparin lock indwelling port for the next
      blood draw. The child (ages 5-12 years) will then undergo 1 hour of compression at 1.3
      atmospheric pressure (4 psi above room air pressure). Supplemental oxygen will be provided to
      the child.

      A second blood draw from the catheter site will be accomplished immediately after the child
      comes out of the HBT chamber.

      These will be sent to the laboratories for evaluation of changes in reduced glutathione and
      lipid peroxides.
    

Intervention name(s): Hyperbaric Oxygen
Intervention type(s): Other
Intervention description(s): Hyperbaric Oxygen at 1.3 ATA for one hour
Other intervention name(s): HBOT
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Oxidative Stress; Hyperbaric Oxygen; Reduced Glutathione; Lipid Peroxides
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine insulin sensitivity in individuals that are lean
      normal glucose tolerant subjects after consumption of a normal low fat diet and after a high
      fat diet and to explore the effects of high fat consumption on the intestinal microbiome, and
      metabolic endotoxemia.( Aim 1 of the protocol, a separate record is available for Aim 2)
    

Detailed description: 
      We will test the hypothesis that a high fat diet given to lean, normal glucose tolerant
      subjects will impair insulin signaling and sensitivity and modify gut microbiome composition
      and enhance intestinal permeability, which will increase plasma LPS concentration, induce an
      inflammatory response in peripheral tissues (skeletal muscle). Also we will test the
      hypothesis that the inflammatory response and insulin resistance caused by high fat ingestion
      can be ameliorated by administering

        -  a synbiotic (Bifidobacterium longum R0175 and oligofructose) which protects the
           intestinal epithelial barrier and decreases intestinal translocation of LPS; and

        -  sevelamer, an agent which sequesters lipopolysaccharide (LPS) in the gastrointestinal
           tract limiting its translocation into the circulation.

      All subjects are fed both a low fat diet (considered a normal diet) and high fat diet, first
      one and then the other in no particular sequence. After a washout period participants are fed
      the other type of high or low fat diet, depending on which diet they were first assigned to
      in order to compare the effects of the intervention on insulin sensitivity during each diet.
    

Intervention name(s): Sevelamer; Synbiotic; Maltodextrin; High Fat diet; Low Fat diet
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): 1.6 g sevelamer + 4.4 g maltodextrin three times a day; 5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.; This is a control group. Maltodextrin, 6 g three times a day; The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.; The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.
Other intervention name(s): Renvela; Isocaloric high fat diet; Isocaloric low fat (normal) diet
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery
Condition: Gastrointestinal Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective To evaluate the effect of patient-controlled intravenous analgesia combined with
      different opioid receptors for gastrointestinal surgery. Methods A total of 4342 patients who
      underwent gastrointestinal postoperative analgesia in the first affiliated Hospital of Air
      Force military Medical University from May 2018 to March 2022 were collected retrospectively.
      The patient-controlled intravenous analgesia regimen in this study was composed of different
      opioid receptor drugs：sufentanil combined with nalbuphine group (SN group) and Hydromorphone
      combined with nalbuphine group (HN group) and single opioid receptor group: sufentanil group
      (S group). SN group ,HN group and S group were treated with sufentanil 100 μ g + nalbuphine
      40 mg, hydromorphone 10 mg+ nalbuphine 40 mg, sufentanil 200 μ g, diluted to 100 ml,
      background dose 1 ml/h, PCA dose 0.5 ml, locking time 10 min. The demographic data of the
      three groups were collected, the number of patients with insufficient static and dynamic
      analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions at 24 and 48
      hours after operation, the first exhaust time and the first ambulation time were collected,
      evaluate the analgesic effect of combination of different opioid receptor drugs and single
      opioid receptor drugs in PCIA after gastrointestinal surgery.
    

Detailed description: 
      Control group：S group Test group：SN group and HN group Observation index：the number of
      patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after
      operation, the adverse reactions（drowsiness, nausea and vomiting, respiratory depression,
      dizziness） at 24 and 48 hours after operation, the first exhaust time and the first
      ambulation time were collected
    

Intervention name(s): sufentanil + nalbuphine; Sufentanil; hydromorphone + nalbuphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sufentanil 100 μ g + nalbuphine 40 mg; sufentanil 200 μ g; hydromorphone 10 mg+ nalbuphine 40 mg
Intervention MeSH terms: Sufentanil; Dsuvia; Hydromorphone; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patient-controlled intravenous analgesia; gastrointestinal surgery
Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy
Condition: Resectable Lesions Located in the Pancreatic Head or Periampullary Region
Study type: Observational

Summary: 
      This is a single, retrospective, real-world study to investigate the surgical outcomes of
      minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy, with the
      perioperative characteristics and long-term overall survival being compared. The
      investigators aimed to find out whether the minimally invasive surgery is safe and feasible
      for resectable lesions located in the pancreatic head and periampullary region. And the
      investigators also want to find out patients with what kind of characteristic can be benefit
      from the minimally invasive surgery compared with the open approach.
    

Detailed description: 
      Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted
      as the gold standard treatment for resectable lesions of the pancreatic head and
      periampullary region.To date, how surgeons can safely pass the learning curve of laparoscopic
      pancreatoduodenectomy (LPD) without potentially harming patients remains a question. Around
      this topic, the investigators designed real-world study in a single center to retrospectively
      collect the PD surgeries since July 2014. The investigators aimed to find out whether the
      minimally invasive surgery is safe and feasible for resectable lesions located in the
      pancreatic head and periampullary region. And the investigators also want to find out
      patients with what kind of characteristic can be benefit from the minimally invasive surgery
      compared with the open approach. Besides, the investigators also want to investigate the
      clinical characteristics of patients and perioperative outcomes of LPD procedures and aimed
      to develop and validate a difficulty scoring system for patient selection which could help
      facilitate a comprehensive and security understanding of LPD for surgeon during different
      stage of the learning curve.
    

Intervention name(s): pancreatoduodenectomy
Intervention type(s): Procedure
Intervention description(s): Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent PD surgeries in Tongji Hospital since January 2014 .
      
Keywords: laparoscopic; minimally invasive; open resection; Pancreatoduodenectomy
Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)
Condition: Atopic Dermatitis; Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Nanocrystalline silver (very small particles of silver) is the active ingredient in Acticoat
      dressings, which have been approved for the treatment of burns and other wounds. Silver has
      been used for decades as an effective antimicrobial agent. In animal studies, nanocrystalline
      silver cream (NPI) has also demonstrated anti-inflammatory activity. Thus, nanocrystalline
      silver cream is being evaluated in the treatment of inflammatory skin conditions such as
      atopic dermatitis (eczema).

      Approximately 180 study subjects with a definitive diagnosis of mild to moderate eczema will
      be enrolled in this study. Subjects will be randomly assigned to treatment with placebo, 0.5%
      NPI or 1% NPI for the 6-week treatment period. Assessments of treatment effect and safety
      will be performed weekly. Upon completion of the study, subjects may be eligible for 12 weeks
      of open-label treatment with 1% NPI.
    


Intervention name(s): Nanocrystalline silver cream (NPI)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Eczema
Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations
Condition: Schizophrenic Disorders
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating.
      Behavioral disorders associated with them can have serious social repercussions. However, in
      25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective.

      Fifteen subjects will be included after collection and signed their informed consent.

      The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency
      of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay
      below the risk of occurrence of seizures, the only serious side effects identified.
      Furthermore the rTMS treatment is almost painless: tension headaches are the main side
      effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The
      LEFT stimulation site will be established through a anatomofunctional imaging before
      treatment (between D-7 and D0).

      Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the
      first 2 weeks of starting treatment.
    


Intervention name(s): Transcranial magnetic stimulation: rTMS
Intervention type(s): Device
Intervention description(s): 4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; auditory hallucinations; TMS