bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of the present study is to determine the effectiveness of probiotic and prebiotic
      treatments in patients with fibromyalgia syndrome.
    

Detailed description: 
      Fifty-three, fibromyalgia syndrome participants were randomized to receive either: 1)
      probiotic 4×1010 CFUs per day 2) 10 g dose prebiotic (inulin) per day or 3) placebo for 8 wk.
      Fibromyalgia Impact Questionnaire (FIQ), Visual Analogical Pain Scale (VAS), Beck Depression
      Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburg Sleep Quality Index (PSQI) and
      quality of life (SF-36) were measured during the baseline, 4 weeks and 8 weeks intervention
      phases. Finally, the adverse effects will be evaluated.
    

Intervention name(s): Probiotic; Prebiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Oral probiotic supplementation was provided by iHealth; Cromwell, USA. Each sachet included a 1×1010 CFUs dose of four viable microbial cell preparation strains: there are two strains of lactobacillus genus (Lactobacillus acidophillus L1 (2.9×109) and Lactobacillus rhamnosus liobif (2.9×109)), Bifidobacterium longum (2.9×109) and Saccharomyces boulardii (1.3×109). Each participant took a total daily dose of 4×1010 CFUs.; The prebiotic was made up of inulin from the chicory plant and provided by the Fibrelle (Belgium) company. Five grams packs were given to the participants in boxes. Each participant was requested to take a total daily 10 g dose.; It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 8-week randomized, double-blind, parallel-group, placebo-controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: probiotics; prebiotics; fibromyalgia
Immune Modulation by Misoprostol
Condition: Gynecological Infection
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The present study is designed to address the null hypothesis that there is no difference in
      the local and systemic immunomodulatory effects of buccally or vaginally administered
      misoprostol in healthy, reproductive-age women.
    


Intervention name(s): Misoprostol - buccal; Misoprostol - vaginal
Intervention type(s): Drug; Drug
Intervention description(s): buccal administration; vaginal administration
Other intervention name(s): Cytotec; Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: misoprostol; mucosal; cervical; immune; buccal; vaginal
Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir
      Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male
      volunteers.
    

Detailed description: 
      A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and
      Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet
      (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
    

Intervention name(s): CKD-390; Viread® tablet
Intervention type(s): Drug; Drug
Intervention description(s): Tenofovir Disoproxil Aspartate 1T PO; Tenofovir Disoproxil Fumarate 1T PO
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B virus, HIV-1 infection; Healthy Male Volunteer; Tenofovir Disoproxil Fumarate
Effectiveness of the Treatment With Continuous Positive Airway Pressure(CPAP)in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing
Condition: Heart Failure; Sleep Respiratory Disorders
MeSH terms: Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Heart Failure
Study type: Interventional

Summary: 
      The respiratory sleep disorders are a major cardiovascular risk factor. In fact there is
      enough scientific evidence that supports the association between apnea-hypopnea syndrome
      (SASH) and cardiovascular disease (hypertension, stroke, heart failure ....The objective of
      this study is to estimate the effectiveness of the continuous positive pressure airway (CPAP)
      in patient with chronic heart failure with normal ejection fraction but dyastolic dysfunction
      and sleep disordered breathing during the sleep.
    


Intervention name(s): CPAP
Intervention type(s): Procedure
Intervention description(s): Treatment with CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      The present study has the objective of being a first approach of the full feasibility study
      in order to find out whether the Full Pulpotomy performed by a general practice dentist in a
      primary care dental clinic at the public health system with limited armamentarium could be
      suitable and present an appropriate success rate as well as patient satisfaction.
    

Detailed description: 
      The present study has the objective of being a first approach of the full feasibility study
      in order to find out whether the Full Pulpotomy performed by a general practice dentist in a
      primary care dental clinic at the public health system with limited armamentarium could be
      suitable and present an appropriate success rate as well as patient satisfaction. This
      information will help to decide if a multi-center non-randomized intervention designed study
      is carried out to determine if it is feasible to provide Full Pulpotomy as a routine
      treatment to symptomatic irreversible pulpitis or caries pulp exposure at the primary care
      dental clinics of the public health system in Mexico.
    

Intervention name(s): Full pulpotomy
Intervention type(s): Procedure
Intervention description(s): After applying the rubber dam. Caries, and weak tissues were removed, and the endodontic access was prepared with a carbide bur. Most of the pulp was removed with a sterile high-speed diamond bur under sterile saline solution irrigation and amputated to the canal orifices level. Hemostasis was achieved by irrigation of the cavity with the same solution and an application of small cotton pellets for max.10 min. White Mineral Trioxide Aggregate was mixed according to the manufacturer´s instructions and was placed against the wound after successful hemostasis using an amalgam carrier and packed using an amalgam standard condenser. The material was adapted and a moistened cotton pellet was placed directly over the Mineral Trioxide Aggregate. After 15 minutes, the cotton was removed and the tooth was restored with amalgam. A postoperative radiograph was taken after restoration, general care instructions were given to the patients, and the recommendation of three analgesic intakes.
Intervention model: Single Group Assignment
Intervention model description: Longitudinal prospective single-arm cohort clinical study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: symptomatic irreversible pulpitis; full pulpotomy; mature teeth
Vitamin E and Male Infertility
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Observational

Summary: 
      The goal of this study is to determine whether there is a correlation between the levels of
      Vitamin E in sperm and sperm DNA fragmentation.

      Previous research has shown that damage to the DNA in sperm may cause infertility or increase
      the chances of miscarriage, if the damage is extensive (eg. present in the overwhelming
      majority of sperm). Some studies suggest that DNA damage can be caused by oxidative stress.
      Antioxidants, such as Vitamin E, which are present in some foods, can prevent damage to cells
      from "free radicals", which are naturally present by-products of metabolism. We ask whether
      there is a correlation between sperm DNA damage and Vitamin E
    

Detailed description: 
      Sperm DNA damage is an emerging cause of male infertility that is likely to be more common
      among men with increased reactive oxygen species in the ejaculate. Vitamin E can protect the
      sperm membrane from oxidative damage and increased levels are associated with low levels of
      reactive oxygen species. This is a study of Vitamin E levels in the spermatozoa and sera of
      48 infertile men, and 20 fertile men as a control group, to look for correlations between
      sperm vitamin E levels and the degree of sperm DNA fragmentation. Dietary intake of
      antioxidants will also be included.
    

Intervention name(s): behavior, procedure
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertility clinic, community sample
      
Biospecimen description: 
      whole blood, serum, semen
    
Keywords: male; infertility
Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)
Condition: Anesthesia
Study type: Observational

Summary: 
      The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the
      prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on
      general anesthesia.
    

Detailed description: 
      Measurement of analgesia/nociception index at different time points during procedure and
      assessment of analgesia/nociception index to predict hemodynamic reactivity by building
      receiver observer's characteristic curve.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients underoing suspension laryngoscopy performed on general anesthesia
      
Keywords: Analgesia/nociception index; Bispectral index; Propofol; Remifentanil; Suspension laryngoscopy; Endoscopy; Ear-nose-throat
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the
      pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan
      in Autosomal Dominant Polycystic Kidney Disease subjects with chronic kidney disease (CKD) in
      stages CKD1, CKD2 or CKD3.
    

Detailed description: 
      Therapeutic interventions aimed at counterbalancing the effect of vasopressin and/or
      normalizing intracellular levels of cAMP may be effective in delaying disease progression in
      autosomal dominant polycystic kidney disease (ADPKD).

      The primary objectives of this study in subjects with ADPKD are:

        -  To characterize the safety and tolerability of lixivaptan following multiple doses in
           ADPKD subjects with relatively preserved kidney function (chronic kidney disease CKD1
           and CKD2) and moderately impaired renal function (CKD3).

      The secondary objectives of this study are:

        -  To characterize the PK profile of lixivaptan and its major metabolites following
           multiple doses of lixivaptan in ADPKD subjects with relatively preserved kidney function
           (CKD1 and CKD2) and moderately impaired renal function (CKD3).

        -  To characterize the pharmacodynamic effect of lixivaptan on urine output, urine
           osmolality, total kidney volume, serum vasopressin, and serum creatinine following
           multiple doses of lixivaptan in ADPKD subjects with relatively preserved kidney function
           (CKD1 and CKD2) and moderately impaired renal function (CKD3).
    

Intervention name(s): Lixivaptan
Intervention type(s): Drug
Intervention description(s): Oral vasopressin V2 receptor antagonist
Other intervention name(s): VPA-985
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy People to Test if Taking Different Formulations of BI 425809 Tablets Influences the Amount of BI 425809 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of batch 1 of
      the intended commercial tablet formulation (iCF1) of BI 425809 vs batch 2 of the intended
      commercial tablet formulation (iCF2) of BI 425809 vs BI 425809 (TF2) formulation.
    


Intervention name(s): BI 425809 (Treatment T1); BI 425809 (Treatment T2); BI 425809 (Treatment R)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intended commercial formulation tablet from batch 1 (iCF1); Intended commercial formulation tablet from batch 2 (iCF2); Trial formulation 2 tablet (TF2)
Intervention MeSH terms: BI 425809
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery
Condition: Body Temperature Changes
MeSH terms: Body Temperature Changes
Study type: Interventional

Summary: 
      A prospective double-blinded randomized controlled study to determine efficacy of ephedrine
      in preserving core temperature in patients under neuraxial spinal anesthesia for knee and
      ankle arthroscopic surgery.
    

Detailed description: 
      To determine the effect of ephedrine on preserving core temperature (tympanic) when given at
      finishing of local anesthetic administration for spinal neuraxial anesthesia comparing to
      normal saline (120 minutes period)
    

Intervention name(s): Ephedrine; NSS
Intervention type(s): Drug; Drug
Intervention description(s): 9 mg of ephedrine (3 ml); 3 ml of normal saline
Other intervention name(s): Experimental; Control
Intervention MeSH terms: Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ephedrine; core temperature; tympanic temperature; heat loss; spinal anesthesia; neuraxial; hypothermia; shivering
HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of HSK7653 (as monotherapy) compared with
      placebo after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with
      Type 2 diabetes who are insufficient glycaemic control with diet and exercise.
    

Detailed description: 
      The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week
      open-label period (week 25-52). During the double-blind period, participants will receive 10
      mg or 25 mg dose of HSK7653 and matching placebo, or placebo only. During the open-label
      period, all participants will receive 25 mg dose of HSK7653.
    

Intervention name(s): HSK7653 10 mg Q2W; HSK7653 25 mg Q2W; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.; HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.; Placebo 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: T2DM
Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy
Condition: Takotsubo Cardiomyopathy
MeSH terms: Cardiomyopathies; Takotsubo Cardiomyopathy
Study type: Interventional

Summary: 
      Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense
      emotional or physical stress. Recovery of this condition varies and many patients continue to
      suffer from symptoms such as fatigue and breathlessness for a protracted period after their
      event. The purpose of this study is to establish whether following a structured exercise
      program or a mental wellbeing program compared to usual care for 12 weeks after an episode of
      Takotsubo will result in significant improvement in the brain activity, general and mental
      wellbeing of patients.
    

Detailed description: 
      Takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction
      precipitated by major stress. This neuro-cardiac condition has a 5-year morbidity and
      mortality comparable with acute myocardial infarction and no current therapies exist. The
      psycho-somatic basis of Takotsubo suggests that its neuro-biology could be amenable to
      modulation. Here, the investigators propose a mechanistic three-arm pilot feasibility trial
      of standardised physical exercise training, cognitive behavioural therapy and current
      standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy.
    

Intervention name(s): Exercise program; Cognitive behavioural therapy; Standard clinical care
Intervention type(s): Other; Other; Other
Intervention description(s): Exercise program; Cognitive behavioural therapy; Standard clinical care
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Three arm pilot feasibility study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Takotsubo Cardiomyopathy
Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study
Condition: Selenium Status; Selenium Uptake From Fish and Shellfish
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to investigate, whether higher intake of selenium rich food
      items such as fish and shellfish, is associated with higher selenium blood levels.

      The secondary aim is to investigate the uptake of selenium from fish and shellfish and the
      incorporation of selenium from those foods into proteins in the human body. Furthermore, the
      impact of the natural variation in the genes that are responsible for the accumulation of
      selenium in the proteins will be investigated.
    

Detailed description: 
      Selenium is an essential trace element that is incorporated into proteins in the human body
      and it hereby plays a major role in several important cellular processes. Previous studies
      have indicated that the selenium status of the Danish population is below the levels required
      to optimize the suggested protective effects of selenium towards major diseases including
      cancer. In Denmark, important natural sources of selenium are fish and shellfish.
    

Intervention name(s): Fish and shellfish
Intervention type(s): Dietary Supplement
Intervention description(s): Intake of 1000 grams of fish and shellfish per week for six months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Selenium; Selenoprotein P; Fish; Shellfish; Bioavailability
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will aim to evaluate the immunogenicity, safety and reactogenicity of
      GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when
      co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy
      Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of
      age.
    


Intervention name(s): Pneumococcal vaccine GSK1024850A; DTPa
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 4 doses; Subcutaneous injection, 4 doses
Other intervention name(s): Synflorix; DPT "KAKETSUKEN" Syringe
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal disease; Immunogenicity; Booster vaccination; Pneumococcal vaccine; Primary vaccination; Safety
A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
Condition: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to study the pharmacology (how the body handles this drug) of
      valacyclovir in children receiving treatment for cancer. This study will last approximately 7
      days.
    

Detailed description: 
      In this study, patients will receive a single dose of oral valacyclovir. Blood samples will
      be drawn to evaluate the pharmacology (how the body handles the drug). Blood samples (less
      than one teaspoon each) will be obtained before receiving the drug and at 0.5, 1, 1.5, 2, 5,
      6, and 8 hours after receiving the drug. The total amount of blood drawn from patients for
      all blood work including routine blood tests as well as pharmacokinetics will not be greater
      than 5% of the total blood volume.

      We will also have all urine output collected for 8 hours starting at the time patients
      receive the dose of valacyclovir. A 5cc sample of urine will be collected and analyzed to
      determine how the body handles the drug at hours 2, 4, 6, and 8.
    

Intervention name(s): Valacyclovir
Intervention type(s): Drug
Intervention MeSH terms: Valacyclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer