bioihbjkbjnl/mcl2 huggingface dataset:
Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype
Condition: Dental Caries
MeSH terms: Dental Caries; Disease Susceptibility; Genetic Predisposition to Disease
Study type: Interventional

Summary: 
      Alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for
      a matrix protein could increase the susceptibility of the enamel to caries after tooth
      eruption. To identify in young patients with severe caries incidence, the occurrence of
      mutations in several candidate genes which result in an alteration of the enamel
      microstructure that could explain the high caries susceptibility of the patient.
    

Detailed description: 
      Although its prevalence has decreased dramatically in European countries, dental caries
      remains a burden for the society and especially for certain groups of the population. For
      example, 80% of the carious lesions are diagnosed in about 20% of the children. For years,
      the aetiology of this disease has been mainly related to environmental factors but recent
      data support the possibility of a human genetic contribution. Alteration of the post-
      eruptive enamel microstructure due to a mutation of a gene coding for a matrix protein could
      increase the susceptibility of the enamel to caries after tooth eruption. The main objective
      of this study will be to identify in young patients with severe caries incidence, the
      occurrence of mutations in several candidate genes which result in an alteration of the
      enamel microstructure that could explain the high caries susceptibility of the patient. With
      this aim, we will carry out a case- control multicentre European study on 250 young patients
      presenting several carious lesions and 160 young adults totally caries free. Patients with
      systemic or enamel pathologies such as amelogenesis imperfecta will not be included in the
      study. The study will consist of 2 visits, 1: inclusion and genetic test based on a salivary
      sample and 2: after 6 months, communication of the genetic test result to the patient and his
      parents. The main evaluation criteria will be the finding of a mutation on the candidates
      genes not resulting in an amelogenesis imperfecta phenotype but associated to a severe caries
      phenotype. If a direct relation between a mutation and a severe caries phenotype was shown,
      all the classical approaches, prevention protocols and treatments of caries would need to be
      reconsidered.
    

Intervention name(s): mutation
Intervention type(s): Genetic
Intervention description(s): a mutation of a gene coding
Other intervention name(s): a mutation of a gene coding
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: caries susceptibility,enamel matrix,candidate genes,mutation
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
Condition: Postmenopausal Osteoporosis; Compliance
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to compare compliance and efficacy of raloxifene and strontium
      ranelate in a group of women with postmenopausal osteoporosis.
    

Detailed description: 
      OBJECTIVE: To compare the performance of raloxifene and strontium rannelate in the management
      of women with postmenopausal osteoporosis.

      DESIGN: Prospective, open label study. SETTING: University hospital menopause unit. PATIENTS:
      80 women with postmenopausal osteoporosis were assigned to either raloxifene (60 mg/d) or
      strontium ranelate (2g/d). Participants were followed for 1 year.

      MAIN OUTCOME MEASURE(S): Compliance with each regime. Secondary objectives were parameters of
      efficacy, including changes in bone mineral density and bone biochemical markers.
    

Intervention name(s): Raloxifene; Strontium ranelate
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg/d for one year; 2 g/d, for one year
Other intervention name(s): Evista; Protelos
Intervention MeSH terms: Raloxifene Hydrochloride; Strontium ranelate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postmenopausal osteoporosis; Compliance; Bone mineral density; Bonemarkers
An 18-month Trial of a Low Glycemic Load Diet
Condition: Obesity
Study type: Interventional

Summary: 
      The primary aim of this study is to compare the effects of an experimental low-glycemic load
      diet with those of a conventional low-fat diet among obese young adults in an 18-month
      randomized-controlled trial.
    

Detailed description: 
      The prevalence of obesity has risen dramatically among children in the U.S. since the 1960s.
      Effective treatment of childhood obesity is widely recognized as instrumental to public
      health efforts to combat type 2 diabetes and heart disease. Evidence from animal studies,
      short-term human studies and epidemiology suggests that diets designed to minimize the rise
      in postprandial blood glucose, that is low glycemic index, may be useful in the treatment of
      obesity and related complications. This project proposes an month RCT comparing a low
      glycemic load diet to a conventional low fat diet. Both diet groups will receive identical
      treatment intensity, behavioral modification and physical activity recommendations. The
      primary endpoint will be change in percent body fat by dexa-scan at 18 months; other outcomes
      include insulin resistance and CVD risk factors. Compliance will be assessed by
      interviewer-administered, 24-hour dietary recalls.
    

Intervention name(s): low glycemic load diet; low fat diet
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the relative bioavailability of both an oral capsule formulation and
      an oral suspension formulation of NXP001 to Emend® in healthy male volunteers in the fasted
      state.
    


Intervention name(s): Aprepitant 125 mg
Intervention type(s): Drug
Intervention description(s): Single dose in the fasted state during treatment period 1,2 or 3
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of this study; to investigate the effects of neural therapy and kinesio taping
      treatments on pain, functional status and quality of life in women with fibromyalgia.
    

Detailed description: 
      Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep
      disturbance, cognitive impairment, and other physical symptoms that negatively affect
      physical and sensory functions and impair quality of life. Neural therapy and kinesio taping
      are treatments for musculoskeletal diseases. In this prospective, randomized controlled,
      double-blind, interventional study, 64 patients aged 18-55 years who met the eligibility
      criteria will be included in the study. Eligible participants will be randomly assigned to
      one of two groups using computer generated random numbers. Segmental neural therapy and sham
      kinesio taping will be applied to the first group. In the second group, kinesio taping with
      inhibition technique will be applied to bilateral trapezius and erector spina muscles and
      sham neural therapy will be added. Treatments will be applied once a week for a total of 6
      weeks. Both groups will be given a home exercise program consisting of stretching exercises
      and will be checked every week. During the follow-up period, patients will be asked not to
      make changes to their current medical treatment. Participants will be evaluated for pain by
      Visual Analogue Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Central Sensitisation
      Inventory (CSI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Health
      Assessment Questionnaire (HAQ), Short Form-36 (SF-36), manual algometer measurements and
      number of tender points, as well as post-treatment and post-treatment 3 month control data.
    

Intervention name(s): Neural Therapy; Kinesio taping
Intervention type(s): Other; Other
Intervention description(s): Neural therapy is a form of treatment that aims to act on the autonomic nervous system, by injecting local anesthetics into certain parts of the body.; Kinesiotape is used for injury prevention, rehabilitation and performance enhancement. It has been shown to be clinically effective in increasing joint movements, increasing muscle activity, inducing muscle maximum torque earlier, and improving functional performance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Neural Therapy; Kinesio Taping
Two-year Follow-up of a Mindfulness-based Intervention in Children.
Condition: Mental Health Issue
Study type: Interventional

Summary: 
      The primary aim of this study was to determine whether an 8-week mindfulness-based
      intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental
      health symptoms and increases resilience during a 2-year follow-up.

      Methods

      The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental
      health problems. Participants were randomised into either TMR intervention group (N=22) or
      control group, receiving best current practice (N=12). The investigators used validated
      self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour,
      self-concept, resilience, stress and mindfulness before treatment with either TMR or control,
      as well as at 6 months, 1 year and 2 years after treatment period.
    


Intervention name(s): TMR-group; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A mindfulness-based 8 week program.; Individual counselling.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Study.
Masking: None (Open Label)
Primary purpose: Other
Assessment of Safety and Satisfaction Toward COVID-19 Vaccines.
Condition: COVID-19 Vaccine Adverse Reaction
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This is a cross-sectional, web-based online survey done with the use of a Google
      Form-questionnaire to gather information from the general public regarding their knowledge,
      satisfaction, and tolerability about the COVID-19 vaccine.
    

Detailed description: 
      -  A cross-sectional study was conducted. The subjects participating in the study are
           residents in Egypt.

        -  An online questionnaire, designed on Google Forms, was written in Arabic language and
           delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin).

        -  The questionnaire comprised two categories of inquiries. The first is demographic data
           of the subject. The second is questions about COVID-19 vaccine-related data, such as
           whether had taken the vaccine or not, the type of vaccine administered, side effects
           encountered from the vaccine , if got enough information regarding the vaccine and where
           obtain the vaccine information from and if reluctant to taking the vaccine and the
           reasons for hesitancy. All participants were permitted to terminate the survey at any
           time of the study.
    

Intervention name(s): COVID-19 Vaccine questionnaire
Intervention type(s): Other
Intervention description(s): An online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin).
Other intervention name(s): Google form questionnaire
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The subjects participating in the study are residents in Egypt who complete the online
        questionnaire.
Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in
      healthy male and female subjects. This study will confirm the PK and safety profile in
      Chinese subjects. GSK1605786 is currently in clinical development for the treatment of
      Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or
      500mg twice daily) within 30 minutes after a meal. The study will consist of single and
      repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.
    


Intervention name(s): GSK1605786 capsule
Intervention type(s): Drug
Intervention description(s): Swedish Orange, size 0, hard gelatine capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy; GSK1605786; CCR9 receptor antagonist; Chinese subjects; pharmacokinetics
Human Phototoxicity Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Phototoxic
Study type: Interventional

Summary: 
      To determine the phototoxic potential of a topically applied article in human subjects
    


Intervention name(s): Bain De Soliel - Solid
Intervention type(s): Other
Intervention description(s): 0.05 gm/cm2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status,Omega-3 Fatty Acids, Malondialdehyde, and Alpha-Tocopherol in Overweight Children in East Jakarta
Condition: Complementary Feeding Recommendation; Linear Programming,; Nutritional Status; Omega-3 Fatty Acids; Malondialdehyde; Alpha-Tocopherol; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The epidemic of pediatric obesity has become a public health burden in both developed and
      developing countries, due to its serious health consequences, including an increased risk of
      type 2 Diabetes Mellitus and heart disease. Currently, dietary and exercise changes are still
      the center of preventive and treatment measures of obesity. Recently, the omega-3 group, one
      of the groups of polyunsaturated fatty acids (PUFAs), has been associated with many positive
      effects leading to the improvement of many diseases related to obesity. Nevertheless, the
      consumption of this essential nutrient requires certain ration to optimize its favorable
      result. Although previous studies have examined the efficacy of dietary counseling approach
      as treatment for obesity, none of them as explicitly explore the use of linear programming to
      create a tailored diet containing high omega-3 fatty acid food as a part of dietary
      counseling in obesity management program among children. Thus, this study is intended to
      contribute the clinical evidence regarding this area of knowledge, specifically the effects
      of enhanced counseling containing complementary feeding recommendation on nutritional status,
      omega-3 fatty acid, malondialdehyde, and alpha Tocopherol among children with risk of
      overweight aged 12 -23 months in East Jakarta.
    

Detailed description: 
      Randomized-Controlled-Trial with two arms of intervention:

        1. Control group: receive standard counseling with general existing menu recommendation

        2. Intervention group: receive enhanced counseling (additional information on omega-3 fatty
           acids) with population-based menu ganerated from linear programming (LP)

      There is a protocol on stratified block randomization. 2 blocks, stratified by: area, age,
      BMI-for-age status.

      Total sample size for analysis:

      Overall: 20 control - 18 intervention Blood sample: 18 control - 14 intervention
    

Intervention name(s): Enhanced Counseling using CFR based on Linear Programming
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Complementary Feeding Recommendation; Linear Programming; Nutritional Status; Omega-3 Fatty Acids; Malondialdehyde; alpha-Tocopherol
Pelvic Floor Muscle Function in Nulliparous and Primiparous.
Condition: Investigation or Care in A Nonpregnant Woman; Mother (Person)
Study type: Observational

Summary: 
      This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous and
      primiparous women. Subjective evaluation of PFM strength was performed vaginal digital
      palpation (TDP). The objective evaluation of PFM strength was assessed using a portable
      perineometer. All parameters were performed at one moment in G1, and in G2, during the 20th
      and 36th weeks of pregnancy, and 45 days after the delivery. Pregnancy and vaginal delivery
      may cause weakness of PFM.
    

Detailed description: 
      Objective: This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous
      and primiparous women. Populations: The sample size was established considering a
      significance level of 5%, the test power of 80%, and the estimated error of 10%. According to
      these results and considering the range between percentages of answers as the casual error,
      each group was established with approximately 50 participants. Methods: 100 women were
      prospectively distributed into: Group G1 (n = 50) comprising by healthy nulliparous women;
      Group G2 (n = 50) with primiparous ones. Subjective evaluation of PFM strength was performed
      using transvaginal digital palpation (TDP). The objective evaluation of PFM strength was
      assessed using a portable perineometer. All parameters were performed at one moment in G1,
      and in G2, during the 20th and 36th weeks of pregnancy, and 45 days after the delivery.
      Results: In G2, 14 women were excluded due to the lost follow-up. The median of age was 23
      years in G1 and 22, in G2, there was no statistical difference between the groups. In G1, BMI
      was in average 21.7 Kg/m2, and 25,0 Kg/m2 in G2, there was statistical difference between the
      groups (p= 0.0004). In G2, TDP evaluation showed a significant impairment of PFM strength at
      36th week of pregnancy (p=0,0006) and 45 days after the vaginal delivery (p=0.0001) compared
      to nulliparous. Objective evaluations of PFM strength showed a significant decrease 45 days
      after vaginal delivery compared to nulliparas. Conclusion: Pregnancy and vaginal delivery may
      cause weakness of PFM.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The sample size was established considering a significance level of 5%, the test power of
        80%, and the estimated error of 10%. According to these results and considering the range
        between percentages of answers as the casual error, each group was established with
        approximately 50 participants.
Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of
      sitagliptin in healthy volunteers.
    


Intervention name(s): Sitagliptin
Intervention type(s): Drug
Intervention description(s): Dosage form: 25mg, 50mg ,100mg
Amount: 25mg, 50mg, 100mg
Frequency and duration: once a day, for 4 days, including 5 days washout periods
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function
Condition: Healthy; Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the amount of study drug that reaches the
      bloodstream and the time it takes for the body to get rid of it when given to participants
      with renal (kidney) impairment compared to healthy participants. The study will last up to 9
      days, excluding screening.
    


Intervention name(s): Selpercatinib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY3527723; LOXO-292
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science