bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Manual Therapy Combined With an Exercise Programme VS Combined Electrotherapy on Football Players With Adductor Tendinopathy
Condition: Tenopathy; Lower Limb
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      Background: Groin pain associated with adductor tendinopathy is the second cause of muscle
      pathology in a football player (20%), so a good treatment taking into account both internal
      and external factors that may influence the pathology of our patient, would be the key to an
      improvement in the symptoms he may have. Material and methods: Firstly, the pain threshold is
      measured by performing the Copenhagen compression test, and in a palpation at the proximal
      level of the adductors, the hip joint range (ROM) is measured and the HAGOS questionnaire is
      passed. Then, a sample of 20 participants (N = 20) is selected and randomly divided into two
      groups, a control group of 10 participants (n = 10), with a treatment based on electrotherapy
      combined with an exercise programme; and an experimental group of 10 participants (n = 10)
      with a treatment based on manual therapy combined with an exercise programme. Finally, they
      performed all measurements.
    


Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): The aim is to test two treatment techniques against each other to see how effective they are.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: manual therapy,; electrotherapy,; groin pain and adductors.
Study of Eyes and Attention Deficit (SEAD)
Condition: ADHD; Convergence Insufficiency; Accommodative Insufficiency
MeSH terms: Ocular Motility Disorders
Study type: Observational

Summary: 
      Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent
      chronic health conditions in children. It affects between 4% and 12% of young children. A
      relationship between convergence insufficiency (eye teaming) and ADHD has been shown.
      However, the effect of ADHD medications on focusing and eye teaming has not been previously
      investigated. Therefore, the purpose of this study is to determine the effect of ADHD
      medication on focusing and eye teaming skills.
    


Time perspective: Prospective
Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)
Condition: Iatrogenic Perforation of Primary Molars
Study type: Interventional

Summary: 
      Furcal perforation is one of the most challenging procedural accidents during pulpotomy of
      primary molars and should be sealed as soon as possible to prevent bacterial invasion at
      perforation site and subsequent tooth extraction. The aim of the study is to compare
      bioceramics versus MTA as root repair material for treatment of furcal perforation in primary
      molars
    


Intervention name(s): Bioceramics
Intervention type(s): Other
Intervention description(s): root repair material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Smoking on Bronchial Epithelium
Condition: Asthma; Copd
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory airway
      diseases affecting millions of people worldwide. Inhaled corticosteroids (ICS) are by far the
      most effective treatment with a broad anti-inflammatory spectrum. Nevertheless, most COPD
      patients and a proportion of severe asthma patients are corticosteroid-resistant (CR) and to
      fail to respond to ICS even when higher doses are given. These corticosteroid-resistant
      patients suffer from persistent symptoms and repeated asthma exacerbations. It has been
      suggested that smoking and oxidative stress may induce corticosteroid-resistance. The
      reactive oxygen species (ROS) responsible for oxidative stress can be generated exogenously
      (air pollutants, cigarette smoke) and endogenously by metabolic reactions. After inhaling air
      pollutants or cigarette smoke, the bronchial epithelium is exposed. Preliminary data from our
      own lab suggest that smoking and oxidative stress may decrease epithelial cell-cell contact
      formation. This results not only in a decreased barrier function, but also in an increased
      production of pro-inflammatory mediators.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        30 patients with asthma; 30 patients with COPD
      
Biospecimen description: 
      Bronchial biopsies Bronchial brushes Blood
    
Keywords: Inflammation; epithelial; integrity; ECIS
Immunosuppressive Effects of Smoking and HIV-1 on the Development of Lung Disease
Condition: HIV; Smoking; COPD
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      This study plans to learn more about pulmonary complications of human immunodeficiency
      virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART)
      has dramatically decreased the number of opportunistic infections and deaths in HIV infected
      patients, pulmonary complications (including chronic obstructive pulmonary disease (COPD)
      development and pneumonias resulting in decreased lung function) of HIV/AIDS continue to be a
      major cause of morbidity and mortality in this population. The mechanisms underlying the
      increased risk of COPD and decreased lung function in HIV infected individuals is not well
      understand and needs to be studied.

      The investigators hypothesize that the immunoregulatory consequences and immunosuppressive
      lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung
      infection and injury in HIV infected smokers, hastening the development of COPD. The
      mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells from
      smokers and nonsmokers with and without HIV infection.
    

Detailed description: 
      The first component of this study will be a longitudinal, prospective, 24 weeks study of the
      effects of HIV-1 infection on innate and acquired immunity in the lung (Cohort A). The second
      component of this study will be a cross-sectional, case-control study of lung function and
      immune dysregulation of HIV-1 infected persons on long-term ART (Cohort B).

      Cohort A will consist of 120 subjects, stratified by HIV-1 and smoking status

      Cohort B will consist of 90 subjects stratified by chronic obstructive pulmonary disease
      (COPD) and HIV-1 infection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV positive (smokers and non-smokers) and negative subjects (smokers and non-smokers) will
        be recruited. HIV positive (with and without COPD) and HIV negative with COPD will also be
        recruited. All subjects will be between ages 18 and 70.
      
Biospecimen description: 
      Blood and bronchoscopy (BAL) samples will be collected
The Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children.
Condition: Caries
Study type: Interventional

Summary: 
      The aim of this RCT was to verify the caries preventive efficacy of toothpastes containing
      biomimetic hydroxyapatite (H.A.) complex in children compared to traditional fluoridated
      toothpastes. In total 610 children of two age groups (4-5 years and 6-7 years at baseline)
      were enrolled. Four toothpastes, two containing fluoride-substituted hydroxyapatite (H.A.F.)
      (1000 and 1450 ppm F-) and magnesium-, strontium-, carbonate-substituted hydroxyapatite, in a
      chitosan matrix and two traditional fluoridated toothpastes (1000 and 1450 ppm F-) without
      other active components were administered randomly to two groups with younger children
      (Gyoung) and to two groups with older children those containing1450 ppm F (GOLD) during 24
      months. A standardized questionnaire was administered to parents/caregivers to gain
      information regarding caries risk factors. Caries evaluation was performed at school using
      ICDAS, scoring lesions as initial (up to score 2), moderate (scores 3-4) and severe (scores
      5-6).
    


Intervention name(s): Toothpaste use
Intervention type(s): Other
Intervention description(s): Brushing three times a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Toothpaste, hydroxyapatite, Fluoride, Dental Caries, RCT, Children
Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      In this study, the investigators aim to determine the health benefits of red raspberry
      ellagitannin consumption on cardiovascular health. The study population is stratified
      according to the urolithin metabotypes (gut-microbial metabolic profile): UM-0, UM-A and
      UM-B.

      The investigators will evaluate changes in blood pressure, endothelial function, arterial
      stiffness, lipid profile, cognitive performance and gut microbiome composition.
    

Detailed description: 
      Red raspberries are a good source of polyphenols including ellagitannins. Previous work
      suggests that urolithins, gut microbial metabolites derived from ellagitannins contained in
      raspberries, can improve vascular health. It has also been observed that the capacity of the
      gut microbiome to metabolize urolithins can influence the cardiometabolic response to
      ellagitannin consumption. In this work the investigators aim to investigate whether urolithin
      metabotypes (UM-A, B and 0) can influence the vascular response to a (poly)phenol-rich
      breakfast containing red raspberry ellagitannins in a healthy UK population.

      You will be stratified by metabotype in a first phase (NCT03573414) and are then randomly
      allocated to treatment or placebo. Outcomes are measured at baseline and after 12 weeks
      consumption of the study product.
    

Intervention name(s): Red Raspberry Ellagitannin Extract; Matching Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Purified red raspberries ellagitannins extract 560 mg (4 capsules/day); Placebo treatment matching intervention (no ellagitannin) 560 mg (4 capsules/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind placebo randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiovascular system; Polyphenols
S-ketamin Premedication in Pediatric EENT Surgery
Condition: Emotions; Separation Anxiety; Pain, Procedural
MeSH terms: Pain, Procedural; Anxiety, Separation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      We aim to investigate the effects of premedication (intranasal or intravenous administration)
      of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT
      surgery.
    

Detailed description: 
      Three hundred children aged between 2 and 12 years were randomly allocated to one of five
      groups: 0.3 μg/kg intravenous injection s-ketamin; 0.5 μg/kg intravenous injection s-ketamin;
      2 μg/kg intranasal s-ketamin group; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal
      dexmedetomidine group; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
      group.

      The modified Yale Preoperative Anxiety Scale (m-YPAS) was used to assess preoperative anxiety
      at 1, 5, 10, 20, and 30min after premedication. A 4-point emotional state score was used to
      evaluate participators when they were separated from their parents and their response to
      intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthesia
      Emergence Delirium [PAED] scale) and POV was assessed in the postanesthetic care unit (PACU).
      Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU, and
      patients' satisfaction degree were also assessed.
    

Intervention name(s): S-ketamine 0.3; S-ketamine 0.5; S-ketamine 2; S-ketamine 1+Dexmedetomidine 1; S-ketamine 0.5 +Dexmedetomidine 2
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.3 μg/kg intravenous injection s-ketamin; 0.5 μg/kg intravenous injection s-ketamin; 2 μg/kg intranasal s-ketamin; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
Other intervention name(s): Jiangsu Hengrui Medicine Co.,Ltd.; Jiangsu Hengrui Medicine Co.,Ltd.; Jiangsu Hengrui Medicine Co.,Ltd.; Jiangsu Hengrui Medicine Co.,Ltd.; Jiangsu Hengrui Medicine Co.,Ltd.
Intervention MeSH terms: Dexmedetomidine; Ketamine; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS),
      which plays a dominant role in leading to CHD.

      Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus).
      It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino
      acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in
      a guideline for China adult dyslipidemia prevention.

      This study aims to evaluate the benefit and side effect of Xuezhikang, a potential
      alternative drug of statins, for patients with dyslipidemia, and thus provide further
      evidence for clinical application.
    


Intervention name(s): Xuezhikang capsule
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Xuezhikang Dyslipidemia chinese medicine RCT
RSYR for Fatigue Reduction in Cancer Survivors
Condition: Cancer-related Problem/Condition
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized Phase II trial to establish the efficacy of traditional Chinese medicine
      (TCM) herbal products above control group for treating fatigue in patients with cancer.
    

Detailed description: 
      Patients who were randomized and been enrolled in, had stable disease and no anemia, and
      reported moderate to severe fatigue over two months (rated ≥4 on a 0-10 scale). Patients took
      TCM decoction Renshen Yangrong decoction (RSYR),Which containing 12 TCM herbs, twice a day
      for 6 weeks. RSYRT aims to correct Qi deficiency. Fatigue was assessed before and after RSYRT
      therapy.
    

Intervention name(s): RSYRT decoction; Astragalus membranaceus
Intervention type(s): Drug; Drug
Intervention description(s): Compound granules of traditional Chinese medicine; One herb
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomized Phase II trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fatigue, Cancer
Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers
Condition: Hyperalgesia; Allodynia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a
      significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with
      placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Additionally
      we are going to assess changes in mood/affect and cognitive function of subjects following
      administration of fenobam and after cutaneous sensitization compared to baseline.
    

Detailed description: 
      All subjects will receive a topical dose of capsaicin cream 0.1%(Capzasin-HP) to the forearm
      at the start of the study visit. The order of the 2 treatment regimens indicated below will
      be randomized and blinded to subjects and researchers.

      Treatment Regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine)
      urea hydrate]: administration of one 150 mg gelatin capsule.

      Treatment Regimen 2: Placebo (lactose monohydrate): administration of one 150 mg gelatin
      capsule.
    

Intervention name(s): Fenobam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fenobam 150 mg will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.; A placebo will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.
Other intervention name(s): [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]; Lactose monohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: fenobam; heat; capsaicin; hyperalgesia; allodynia; mood; cognitive function
Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL).
Condition: HIV; Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      Depression is the most common mental health disorder among HIV-patients. Recognizing and
      treating depression is important in order to improve quality of life and health outcomes in
      those living with HIV. In clinical practice selective serotonin reuptake inhibitors (SSRIs)
      are used most frequently in HIV patients with depressive symptoms. A complicating factor in
      the concomitant use of antiretroviral agents and antidepressant therapy is the occurrence of
      drug-drug interactions. Citalopram can be seen as one of the preferred SSRIs in HIV-infected
      patients because citalopram has a relatively favourable drug interaction profile compared to
      other SSRIs. Raltegravir is an HIV-1 integrase inhibitor and is frequently being used as
      antiretroviral agent in combination with tenofovir/emtricitabine in HIV-patients. Raltegravir
      has shown sustained antiretroviral activity, is generally well tolerated and has little
      propensity to interact with other drugs because it does not inhibit or induce CYP450 enzymes.
      Theoretically, no clinically relevant drug interaction is expected between raltegravir and
      citalopram as raltegravir is not a CYP2D6 substrate and thus will not be affected by the
      possible inhibition of CYP2D6 by citalopram. Raltegravir is metabolized by UGT but citalopram
      is not known to influence UGT. A possible interaction may occur through inhibition of P-gp
      mediated transport of raltegravir by citalopram. However, even when no drug interaction is
      expected theoretically, it may be recommended to collect sufficient clinical evidence to
      support this hypothesis because unexpected interactions with raltegravir have been observed
      in the past. In order to be able to recommend raltegravir and citalopram concomitant use, a
      pharmacokinetic study in healthy volunteers is proposed.
    


Intervention name(s): raltegravir; citalopram
Intervention type(s): Drug; Drug
Other intervention name(s): isentress
Intervention MeSH terms: Raltegravir Potassium; Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: raltegravir; citalopram; pharmacokinetics; drug-drug interaction
Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending
      dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study
      to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of
      CKD-510.
    


Intervention name(s): CKD-510 single dose; CKD-510 food effect; CKD-510 multiple dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Investigational drug; Investigational drug; Investigational drug; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Drug: CKD-510 Drug: Placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neo-Synalar Modified 48 Hour Patch Test
Condition: Allergy
Study type: Interventional
Phase: Phase 4

Summary: 
      A 48 hour patch test performed in healthy volunteers to determine the presensitization
      (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base),
      fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium
      Lauryl Sulfate) and a negative control (Saline).

      The primary objective of this study is to determine if any subjects exhibit an allergic
      reaction which may be indicative of a pre-existing sensitization.
    

Detailed description: 
      Following approximately 48 hours of continuous skin contact, the patch units and test
      material are removed at the testing facility. The test sites are evaluated for a significant
      reaction according to the ESS (Erythemal Scoring Scale).

      The test sites are also re-evaluated at 96 and 168 hours post-application (for late reaction)
      using the ESS.
    

Intervention name(s): Neo-Synalar Cream; Sodium Lauryl Sulfate Aqueous Solution (0.40%); Saline
Intervention type(s): Drug; Other; Other
Intervention description(s): Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.; Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.; Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
Other intervention name(s): NS 0.5%(0.35% neomycin base)/ FA 0.025% Cream; SLS
Intervention MeSH terms: Neomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neo-Synalar; Patch Test; Sodium lauryl sulfate; Saline; Presensitization
Observational Study on Efficacy of Alvesco(Ciclesonide) in Asthma Children and Adolescent in Real Practice
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This is a prospective, non-comparative, open, observational study.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        outpatients