bioihbjkbjnl/mcl2 huggingface dataset:
Dietary Fructose on Microbiota and Hepatosteatosis
Condition: Hepatic Steatosis; Dietary Fructose Exposure
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      The consumption of sugar-sweetened beverages (SSB) has increased steadily over the past
      decades, resulting in the dramatic increase of fructose intake as it is one of the main
      ingredients of artificial sweeteners. Recently, large epidemiological studies have documented
      the association between a high-fructose-diet and hepatic steatosis, and other metabolic
      disorders. So it is interesting for scientists to explore the underlying mechanism. This
      study aims to investigate the effect of dietary fructose and gut microbiota and the
      hepatosteatosis in healthy men. Serum and fecal metabolomics will be investigated.
    

Detailed description: 
      This is a single center, randomized, controlled study. 60 healthy men will be recruited
      according to the inclusion criteria. All subjects are randomly allocated to Group A and Group
      B, who orally takes 75g and 150g fructose daily respectively. Subjects in Group A will be
      instructed to drink fructose solution containing 75g fructose per day, and those in Group B
      will be instructed to drink fructose solution containing 150g fructose per day. The
      intervention will last four weeks. The anthropomentric data will be collect with
      questionnaire and serum and fecal samples collected at baseline and the end of the
      intervention. The effect and mutual interaction of dietary fructose and microbiota will be
      explored. The effect of dietary fructose on hepatosteatosis will be investigated as well.
    

Intervention name(s): 75g fructose solution; 150g fructose solution
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will drink a bottle of 350 ml solution containing 75g fructose per day for 4 weeks.; Subjects will drink a bottle of 700 ml solution containing 150g fructose per day for 4 weeks.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 60 healthy men will be recruited according to the inclusion criteria. All the participates are randomly allocated to Group A and Group B. Subjects in Group A will be instructed to drink fructose solution containing 75g fructose per day and those in Group B will be instructed to drink 150g fructose per day.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fructose; Microbiota; NAFLD
Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis
Condition: Anesthesia, Spinal; Anesthesia, Epidural; Antisepsis
Study type: Interventional

Summary: 
      Context: The neuraxial blocks, spinal anesthesia and epidural anesthesia are among the most
      frequently performed procedures worldwide, and despite the advancements of medical equipment,
      remain dependent on experience and practice of the anesthesiologists. Although antisepsis
      takes part of the daily routine, there are still no solid scientific evidence of the most
      appropriate antiseptic for these procedures.

      Objective: To compare the 70% alcohol and 0.5% chlorhexidine alcohol solution in skin
      antisepsis for the neuraxial blocks.

      Methods: This is a clinical trial, a prospective, randomized study. There will be selected,
      consecutively, 70 patients candidates for neuraxial blocks. Patients will be randomly
      assigned to group A (n = 35), in which the antisepsis will be performed with alcohol 70%, and
      to group B (n = 35), in which the antiseptic will be performed with the 0.5% chlorhexidine in
      alcoholic solution. Samples will be collected with swabs in an area of 25 cm² for bacterial
      cultures three times: in pre-antisepsis moments, in the second minute after antisepsis, and
      immediately after the puncture. The number of colonies forming units per square centimeter
      (CFU / cm²) will be counted. The data will be analyzed statistically.
    


Intervention name(s): alcohol antisepsis; chlorhexidine antisepsis
Intervention type(s): Other; Other
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: microbiota; ethanol; chlorhexidine
AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      There is inconclusive evidence whether acupuncture treatment is effective in the treatment of
      seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in
      SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of
      acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the
      DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of
      acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to
      investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic
      function in a sub-group of ACUSAR patients. Baseline values were compared to data from
      matched healthy controls.
    

Detailed description: 
      In AUTO-ACUSAR a subsample of ACUSAR patients from acupuncture or sham acupuncture groups
      were included. Tests of autonomic functions included measurement of heart rate variability
      during paced breathing, blood pressure, heart rate and salivary alpha amylase response to a
      cold pressure test (CPT) and cortisol awakening response before the first and the last of
      twelve treatment sessions. Healthy matched controls underwent the same measurement once only
    

Intervention name(s): sham acupuncture
Intervention type(s): Other
Intervention description(s): 12 sessions of sham acupuncture over 8 weeks
Other intervention name(s): acupuncture
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: acupuncture; autonomic nervous system; seasonal allergic rhinitis
Trial of Homeopathy on Management of Menorrhagia
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional

Summary: 
      The purpose of this study is to compare outcomes and quality-of-life issues in the treatment
      of menorrhagia, this randomized double blind controlled trial compared homeopathy and
      placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the
      condition was performed during one pre-treatment and three treatment cycles. outcome measures
      were bleeding days, intensity. average pads used during menstrual cycle, abdominal & back
      pain, General health and overall satisfaction.
    


Intervention name(s): Homeopathy; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each homeopathic medication was given as 1 g dose of homeopathic preparation in 30c potency. The dose is prepared as lactose globules on which the homeopathic preparation.; corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania
Condition: Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to
      assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components
      (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and
      children.
    

Detailed description: 
      Volunteers will be screened, enrolled, injected with the vaccine or comparator and followed
      by the clinicians at the Bagamoyo Research and Training Unit of the the Ifakara Health
      Research and Development Center (BRTU-IHRDC).

      First, 10 adult males will be enrolled and randomized in 2 groups: Group AV (n=8) will be
      injected with the vaccine combination and group AP (n=2) will be vaccinated with the
      placebo=comparator (Inflexal V). 5 weeks later, 8 children will be enrolled first and
      randomized in 2 groups: Group CV (n=6) will be injected with the vaccine combination and
      group CP (n=2) will be vaccinated with comparator. 1 week later, the rest of the cohort
      (n=32) will be enrolled and randomized in 2 groups: Group CV (n=26) will be injected with the
      vaccine combination and group CP (n=6) will be vaccinated with comparator.

      Immunogenicity assessments for humoral immune response will be made at baseline (days -10 to
      -2), day 30 (+4), day 90 (+4) (day of 2nd vaccination), 120 (+4), 180 (+7), and 365 (+14).

      Cellular immune responses will be assessed before 1st vaccination (day 0), two weeks after
      2nd vaccination (day 104 ±2), and one year after the 1st vaccination (day 365) Safety
      assessments will be made by the investigator at baseline (days -10 to -2, before the 1st
      immunization) and at day 1, 2, 3, 7, 14, 30 after each vaccination.
    

Intervention name(s): PEV 301& 302 in virosomes; Inflexal V (active comparator)
Intervention type(s): Biological; Biological
Intervention description(s): PEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90; Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; Vaccine; Falciparum; Trial; Phase I; Safety; Immunogenicity
Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury
Condition: TMJ Disorder
MeSH terms: Temporomandibular Joint Disorders; Wounds, Penetrating
Study type: Interventional

Summary: 
      This study is aiming to investigate the effect of magnetic therapy in combination with
      traditional physical therapy on the pain and mouth opening, after facial penetrating wound
      injury with no facial fractures, that treated conservatively
    


Intervention name(s): Pulsed Electromagnetic Field therapy (PEMFT); TMJ physical therapy program
Intervention type(s): Device; Other
Intervention description(s): PEMFT was connected to electrical mains supplying 220v. Pair of applicators sized 16x10x3 cm was adjust to be over TMJ, on both sides of the face; the appliance was adjusted to the frequency of 50 HZ and intensity of 90 Gauss. Twelve PEMF treatment sessions of 30 min duration were provided 3 times per week TMJ mobilization techniques and isometric exercises against resistance for muscles of mastication; TMJ manual physical therapy program (mobilization and gentle isometric exercises) for 30, 3 times a week, for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Critical Patients Mobilization on Respiratory and Peripheral Muscle Strength and Functional Capacity.
Condition: Intensive Care Unit Syndrome; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      To analyze changes on respiratory muscle strength, peripheral and functional capacity of
      critically ill patients with clinical and surgical etiology, breathing spontaneously and
      bedridden, within 48 hours of admission to the intensive care unit (ICU) and if there are
      correlations among these variables. This is an observational study. Respiratory muscle
      strength will be assessed through the maximum inspiratory pressure (MIP) and maximal
      expiratory pressure (MEP) and peripheral muscle strength, by the Medical Research Council
      score (MRC) and hand grip test and functional capacity through the Functional Independence
      Measure (FIM) and Physical Function ICU Test Score (PFIT-s) in the period between 24h and 48h
      of hospitalization in the adult ICU. For descriptive purposes, the sample will be stratified
      according to clinical and surgical characteristics. Correlations will be determined using the
      Pearson test, with significance level of p <0.05.
    


Intervention name(s): Early ambulation
Intervention type(s): Procedure
Intervention description(s): Procedure to accelerate the ability of a patient to walk or move about by reducing the time to ambulation. It is characterized by a shorter period of hospitalization or recumbency than is normally practiced.
Other intervention name(s): Early mobilization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine how teriparatide or denosumab affects the bone of
      postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone
      biopsy sample taken from the iliac crest (upper part of the pelvis).
    


Intervention name(s): Teriparatide; Denosumab; Demeclocycline; Tetracycline; Calcium Supplement; Vitamin D
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered orally; Administered orally; Administered orally; Administered orally
Other intervention name(s): LY333334; Forteo; Forsteo
Intervention MeSH terms: Vitamin D; Denosumab; Teriparatide; Tetracycline; Demeclocycline; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration
Condition: Fluconazole; Candidiasis; Invasive Fungal Infections; Obesity
MeSH terms: Candidiasis; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The pharmacokinetics of fluconazole are expected to be different in obese patients compared
      to non-obese patients. The investigators will determine fluconazole and free fluconazole
      concentrations in 16 obese patients and 8 healthy volunteers, who will receive oral and
      intravenous fluconazole in a semi-simultaneous design.

      A full pharmacokinetic curve will be obtained until 48 hours after intravenous
      administration.
    

Detailed description: 
      The pharmacokinetics of fluconazole are expected to be different in obese patients compared
      to non-obese patients. Therefore, extrapolation of data from healthy volunteers and is not
      possible.

      To investigate these differences 16 obese patients and 8 healthy subjects will be studied.

      Patients will receive fluconazole by semi-simultaneous design. Blood sampling for
      pharmacokinetic analysis will be retrieved through a central venous catheter. A maximum of
      100 milliliter blood in total will be drawn for this study. Patients will be monitored daily
      during the treatment period for adverse events of the study drug.

      Full pharmacokinetic curves will be taken after oral and intravenous administration. This
      pharmacokinetic analysis will enable the determination of bioavailability and enable the
      determination of intra-individual variability.
    

Intervention name(s): Fluconazole 200mg tab; Fluconazole 2 MG/ML
Intervention type(s): Drug; Drug
Intervention description(s): PO dose of 400mg; IV dose of 400mg
Other intervention name(s): Diflucan; Diflucan
Intervention MeSH terms: Fluconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparing a 2 groups of obese subjects vs 1 group of non-obese subjects
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fluconazole; candidiasis; invasive fungal infections; mycoses; antifungal agents
Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients
Condition: Ketogen-based Therapeutic Diet; Pancreaticobiliary Cancer
Study type: Interventional

Summary: 
      Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary
      surgery contribute impaired nutritional status in postoperative period. It can also affect
      perioperative and oncologic outcomes negatively. Therefore it is important to improve
      nutritional status in postoperative period by supply tailor-made optimal diets. The
      investigators have developed customized postoperative diets for pancreaticobiliary cancer
      patients. The investigators expect that customized diets for pancreaticobiliary patients will
      increase the food intake rate and contribute a improvement of perioperative outcomes and even
      oncologic outcomes.
    


Intervention name(s): Ordinary Diet; Modified Atkin's Diet; Ketogenic Diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is
      associated with poor quality of life and high health care expenditure of 8 Billion Dollars a
      year.

      Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological
      issues may cause NCCP.

      The mechanism(s) for pain continue to be explored and include central and peripheral
      hypersensitivity, and mechanophysical abnormalities. Treatment of NCCP has focused on
      relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone,
      or adenosine receptor antagonist, theophylline. Typically, only 40-50 % respond and clearly
      there is a large unmet therapeutic need.

      Cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. The main
      component of Cannabis acts through specific receptors, that are located primarily on central
      and peripheral neurons (including the enteric nervous system) and myenteric plexus where they
      modulate neurotransmitter release. Activation of these receptors reduces excitatory enteric
      transmission and may improve esophageal hyperreactivity and hypersensitivity, the hallmarks
      of NCCP.

      STUDY PROTOCOL: The investigators will randomize 40 subjects with non-cardiac, non-reflux
      chest pain to receive dronabinol (5 mg Bid), or placebo for 4 weeks. Chest pain symptoms and
      esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom
      diary and impedance planimetry. The primary outcome measure will be the frequency of chest
      pain episodes. Secondary outcome measures include improvement in esophageal sensory
      thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and
      global improvement of symptoms.

      HYPOTHESIS: Cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in
      NCCP patients, when compared to placebo.

      AIM: To perform a randomized double blind study to investigate the effects of Dronabinol, a
      CB1 and CB2 agonist, in the treatment of patients with NCCP and examine its mechanism of
      action.
    


Intervention name(s): Marinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg BID, orally for 1 month; 5mg BID, orally for 1 month
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section
Condition: Anesthesia; Sexual; Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The goal of this prospective randomized study was to compare the efficacy of transversus
      abdominis plane block and transversalis fascia plane block for postoperative analgesia in
      patients undergoing elective cesarean section under spinal anesthesia.

      The main question[s] it aims to answer are:

      [Is transversalis fascia plane block more effective in postoperative analgesia? ]

      [Is there a difference between the duration of postoperative first analgesia requirement? ]
      Since the pain scores after the block at the end of the operation will be evaluated during
      the postoperative 24 hours, the participants will be asked to give a value between 0 and 10
      in certain time periods.
    

Detailed description: 
      This prospective, randomized trial was conducted at Başakşehir Çam and Sakura City Hospital
      by the Declaration of Helsinki. After ethics committee approval (decision no: 2022-74, date:
      09.03.2022) and written informed consent was obtained from all patients, the trial was
      conduct-ed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.A
      total of 150 patients were divided into two groups: transversal fascia plane block (TFPB
      group) and Transversus abdominis plane block (TAPB group).VAS values, time to first analgesic
      requirement, analgesic requirements, nausea & vomiting and pruritus were evaluated for 24
      hours postoperatively (6th hour (T2), 12th hour (T3), 24th hour .
    

Intervention name(s): Patients undergoing transversalis fascia plane block; Patients undergoing transversus abdominis plane block
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators applied a transversalis fascia plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.; The investigators applied a transversus abdominis plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomize study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: anesthesia recovery period; cesarean section; obstetric anesthesia; spinal anaesthesia; postoperative analgesia