bioihbjkbjnl/mcl2 huggingface dataset:
Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether cognitive behaviour therapy is effective in
      the treatment of children and adolescents with dental anxiety. Our hypothesis is that
      children and adolescents who have been offered CBT shows significant better performance on
      outcome measures compared with patients in control group who have received treatment as
      usual.
    


Intervention name(s): Cognitive Behavioral Therapy; Treatment As Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The treatment group is offered cognitive behavior therapy(CBT) by psychologists/psychotherapists. CBT is offered according to a treatment manual and consists of 10- sessions during 12-15 weeks.; Treatment as usual consist of strategies such as habituation, tell-show-do, premedication with midazolam, nitrous oxide sedation and general anesthesia. All offered by dentists and dental hygienist and/or dental assistants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental Fear; Dental Phobia; Cognitive Behavior Therapy; Specific Phobia; Children and Adolescents anxiety; Self Efficacy
Whey Protein Intake With and Without Exercise on Visceral Fat: The P+RISE Study
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Dietary manipulation is proving to be an effective lifestyle strategy to combat the obesity
      epidemic. Increased dietary protein is one effective strategy. For example, increased whey
      protein ingestion with and without exercise training is associated with enhanced weight loss,
      body composition and subjective hunger in overweight and obese individuals. Our findings
      suggest that the effects of whey protein ingestion occur independent of a calorie-restricted
      diet and to a greater extent in individuals following a combined exercise program of
      resistance exercise, sprint intervals, stretching/yoga/pilates, and aerobic exercise training
      compared to standard resistance training.
    

Detailed description: 
      This study was a 16 week whey protein and exercise training intervention in middle aged
      overweight/obese adults. Subjects were randomized into 3 groups: Whey protein only consumed
      as 20 grams per serving three times per day (total 60 grams per day) (WP); Whey protein and
      resistance exercise training (WP-RT); and Whey protein and combined exercise training
      (P+RISE). All outcomes, including the primary outcome of visceral fat was measured at
      baseline (week 0) and post-intervention (week 17) in all study subjects.
    

Intervention name(s): Whey Protein; Whey Protein and Resistance Exericse; Whey Protein and RISE exercise routine
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Whey protein provided in 20 gram servings administered three times per day. once in the morning upon waking; a second serving in the mid-afternoon; and a third serving within 2 hours of going to sleep at night.; Subjects will receive 20 grams of whey protein three times per day along with 4 days per week of resistance exercise training throughout the 16 week intervention.; Subjects will consume 20 grams of whey protein three times per day (total of 60 grams) and perform a combination of exercise involving functional resistance exercise (R); sprint intervals (I); stretching/pilates/yoga (S); and endurance exercise (E); RISE four days per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: whey protein intake; obesity; visceral fat; resistance exercise training; sprint interval training; endurance exercise training; yoga training; healthy eating; healthy lifestyle strategies; leptin; hunger
Diet, Exercise and/or Rosiglitazone for HIV-Associated Insulin Resistance
Condition: HIV Infections; Insulin Resistance; Obesity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to determine if, in men and women with excess abdominal fat and
      insulin resistance, people with HIV infection respond differently than people without HIV to
      interventions that typically improve body fat distribution and insulin resistance. The
      specific interventions are:

        1. Diet + exercise program.

        2. Rosiglitazone treatment.

        3. A combination treatment of diet + exercise program and rosiglitazone.
    

Detailed description: 
      A constellation of nutritional alterations in HIV-infected patients receiving highly active
      antiretroviral therapies (HAART), including body fat redistribution with subcutaneous adipose
      tissue (SAT) wasting and visceral adipose tissue (VAT) accumulation, hyperlipidemia, and
      insulin resistance (IR) has been described. There is a major concern that these developments
      will be associated with adverse clinical outcomes related to atherosclerosis, as suggested by
      several case reports (Henry 1998, Behrens 1998, Gallet 1998, Vittecoq 1998). Although there
      are well documented associations among body fat distribution, insulin resistance, and adverse
      health outcomes, especially accelerated atherosclerosis, in non-HIV infected individuals, it
      is unclear if the relationships are affected by HIV infection, or if they reflect the same
      outcomes. This information is important, since understanding the interrelationships between
      body fat distribution and metabolism may guide the development of treatment strategies.

      The specific hypotheses to be tested are:

        1. HIV infection does not affect the relative reductions in visceral (VAT) and subcutaneous
           adipose tissue (SAT) resulting from diet + exercise, but decreases the effect of this
           therapy on insulin resistance.

        2. HIV infection decreases the changes in insulin resistance and body composition (increase
           in SAT and decrease in VAT) expected with rosiglitazone.

        3. The combination treatment of diet+exercise and rosiglitazone will reduce VAT to a
           greater extent than rosiglitazone alone, and will improve insulin resistance to greater
           extent than diet and exercise alone, however these effects will be blunted in
           HIV-infected subjects.
    

Intervention name(s): Weight loss through diet and exercise; Rosiglitazone insulin sensitizing agent
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV; Body composition; Weight reduction; Insulin resistance/sensitivity; Exercise; Diet; Visceral adiposity
Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this two-part study is to assess the efficacy, safety and tolerability of
      multiple intra-articular (i.a.) injections of LNA043, in regenerating the articular surface
      in patients with cartilage lesions of the knee (Part A) and knee osteoarthritis (Part B).
    

Detailed description: 
      There was a 30 day screening period for both Part A and Part B. In Part A, participants were
      randomized to 3:1 ratio and received an injection of LNA043 (20 mg in 3 ml) or matching
      placebo (3 ml) on Days 1, 8,15 and 22 and were monitored in clinic for 3 hours after each
      injection followed by telephone calls 48 hours after injection. Participants returned to the
      clinic on Days 50, 106, 190 and 365 for follow up visits. MRIs, safety assessments and
      pharmacokinetics were assessed at selected clinic visits.

      In Part B, this study aimed at further evaluating the cartilage anabolic activity of LNA043
      in a more severe knee OA population, and to explore the safety and efficacy of a higher dose.

      In Part B, participants were randomized to LNA043 20 mg, LNA043 40 mg or matching placebo
      according in a 1:1:1 ratio. Injections were given in clinic on Days 1, 29, 57 and 85 and
      participants were monitored in clinic for 3 hours after each injection followed by telephone
      calls 48 hours after injection. Participants returned to the clinic on Days 113,197 and 365
      (end of study) for follow up visits. MRIs, safety assessments and pharmacokinetics were
      assessed at selected clinic visits.
    

Intervention name(s): LNA043; Placebo
Intervention type(s): Biological; Other
Intervention description(s): LNA043 intra-articular injection; Placebo intra-articular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 142 participants were randomized, but only 141 received treatment. One participant in Part B was discontinued due to poor veins that were not adequate for blood samples.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Articular cartilage; partial thickness cartilage lesion; knee cartilage; regeneration; osteoarthritis; adult
A Prospective, Randomized, Clinical Study on the Effects of CPP-ACP-paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding.
Condition: White Spot Lesion; Orthodontic Appliance Complication
Study type: Interventional

Summary: 
      The goal of this randomized clinical trial is to compare the influence of casein
      phosphopeptide amorphous calcium phosphate (CPP-ACP), CPP-ACP in combination with fluoride
      (CPP-ACPF), high fluoride concentration, and conventional fluoride toothpaste on the color
      and size of white spot lesions (WSLs) in orthodontic patients following bracket removal.
    


Intervention name(s): CPP-ACP paste; CPP-ACPF paste; 1.25% fluoride gel; Conventional
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Daily application of CPP-ACP (Casein phosphopeptide amorphous calcium phosphate) paste (Tooth Mousse®) in addition to twice daily use of conventional toothpaste.; Daily application of CPP-ACPF (Casein phosphopeptide amorphous calcium phosphate in combination with fluoridepaste) (MI Paste Plus®) in addition to twice daily use of conventional toothpaste.; Weekly application of 1.25% fluoride gel (Elmex Medical Gel®) in addition to twice daily use of conventional toothpaste.; Twice daily use of conventional toothpaste.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: orthodontics; orthodontic brackets; dental caries; decalcification; caseins; fluorides
Impact of Exercises and Chair Massage on Musculoskeletal Pain of Young Musicians
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

Summary: 
      The study is tested the idea of two forms of musculoskeletal pain prophylaxis (chair massage
      and an original set of exercises) among musicians.

      The hypothesis of the study was that massage and exercises could be helpful for musicians to
      avoid pain conected with playing musical instrument.
    


Intervention name(s): chair massage; the exercise program
Intervention type(s): Other; Other
Intervention description(s): Chair massage was performed useing only traditional methods of Swedish massage were used, consisting of stroking (smooth, continuous movements to relax and calm the sympathetic nervous system), kneading (consisting of wringing, squeezing muscles, compressing pressure points for the relaxation of soft tissues, i.e. muscles, tendons, fascia), stretching combined with swaying and passive movements of the upper limbs (to mobilize the joints of the upper limbs) and final stroking combined with slapping and shaking percussion, vibration.; The original set of exercises was developed based on the knowledge and clinical experience of the authors of the study and based on EBP (Evidence Based Practice). The program consisted of 14 strengthening and stretching exercises involving the muscles of the trunk and limbs whose main goal was to mobilize the joints and strengthen the weakened muscles and relax overloaded muscle groups.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: musculoskeletal pain; playing related musculoskeletal disorders; physiotherapy
Effects of Tolperisone on Measures of Drowsiness and Cognitive Function
Condition: Healthy
MeSH terms: Sleepiness
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, 4-Period, Crossover Study to characterize the effects of tolperisone 200 mg and
      400 mg (supratherapeutic dose) three times a day (TID) over 3 days of dosing on measures of
      simulated driving performance, cognitive function and drowsiness and compared to placebo and
      cyclobenzaprine (single-day, residual effect, multiple-day).
    


Intervention name(s): Tolperisone Hydrochloride; Cyclobenzaprine Hydrochloride 10 MG; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Study Drug; Active Comparator; Placebo Comparator
Other intervention name(s): Tolperisone
Intervention MeSH terms: Cyclobenzaprine; Tolperisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effect of montelukast compared to placebo in children during the
      spring allergic rhinitis season.
    


Intervention name(s): montelukast sodium; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years; one placebo chewable tablet daily at bed time for 2 weeks
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vaccine Against Escherichia Coli Infection
Condition: E.Coli Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Escherichia coli Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I multi-center placebo controlled study is conducted in healthy women with a
      history of recurrent urinary tract infections (UTI) aged between 18 and 70 years.
    

Detailed description: 
      GlycoVaxyn is a Swiss company that has developed a multivalent bioconjugate vaccine for the
      prevention of E.coli-infections. Cystitis is the most common UTI, however kidney infections
      or bacteremia are possible. The E. coli bacterium is responsible for 85 % of all UTIs.

      The objectives of this trial are to assess the safety and ability to elicit an immune
      response of the candidate vaccine as well as the effectiveness of the vaccine in the
      reduction in UTIs .
    

Intervention name(s): E.coli bioconjugate vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, intramuscular injection (0.5 mL); Single dose, intramuscular injection (0.5 mL)
Other intervention name(s): EcoXyn-4V
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Bioconjugate vaccine; Urinary tract infections
Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students
Condition: Hepatitis B; Immune Response; Seroprevalence
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      At present, children less than 15 y of age have been regarded as a key group for hepatitis B
      immunization in China. However, there is not yet special immunization strategy for population
      above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and
      immune response to HB vaccine among Chinese college students to uncover the need on universal
      mass vaccination or booster immunization only for students with HBV vaccination history
      against hepatitis B in Chinese college students to inform decision making.
    


Intervention name(s): HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU
Condition: Hyperglycemia; Normoglycemia; Myokine
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Normal glucose uptake and metabolism in skeletal muscles are essential to keep blood glucose
      within normal range and hence, insulin resistance (possibly mediated by inflammatory
      processes) in skeletal muscle is a major pathogenic factor in type 2 diabetes. Physical
      activity seems to be of essential importance in the prevention and treatment of type 2
      diabetes. Myokines are proteins secreted from skeletal muscle that can execute important
      biological functions locally in the muscle (paracrine) or in other organs like the brain,
      heart and pancreas (endocrine). Evidence suggest that several interleukines and other
      cytokines are secreted by skeletal muscles. In the present project, the investigators will
      explore the relation between secreted myokines from muscle cells, insulin resistance and
      glucose metabolism before and after 12 weeks of exercise intervention. Subjects with normal
      as well as impaired glucose metabolism will be included in the study.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): 12 weeks of exercise; 4 times pr week
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Myokine; Insulin sensitivity; Exercise; Skeletal muscle
Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264
Condition: Urticaria
MeSH terms: Urticaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This First Time in Human (FTIH) study, which will be performed in three parts, is designed to
      investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after
      single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding
      placebo within the same subject, in healthy adult subjects (Part A), subjects with cold
      urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The
      study will also measure short term effects of GSK2646264 on the number and size of weals in
      subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.
    


Intervention name(s): GSK2646264 0.5% topical cream; GSK2646264 1% topical cream; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK2646264 0.5% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars; GSK2646264 1% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars; Placebo topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars
Intervention MeSH terms: GSK2646264
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Urticaria; SYK Inhibitor
Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment
Condition: Subchorionic Hematoma in the First Trimester Pregnancy; Miscarriage
MeSH terms: Abortion, Spontaneous; Hematoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to compare the therapeutic efficacy of lipoic acid versus
      progesterone by vaginal administration on subchorionic hematoma resorption in women at the
      first trimester of pregnancy with threatened miscarriage.
    


Intervention name(s): Lipoic acid; Progesterone
Intervention type(s): Device; Drug
Intervention description(s): Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day); Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)
Intervention MeSH terms: Thioctic Acid; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Abutment Type Following Oral Implants in Terms of the Surrounding Bone Height
Condition: Missing Teeth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional

Summary: 
      Compare two different types of abutments (molded abutments and computer-designed 3D printed
      abutments) in terms of the amount of bone loss, and depth of periodontal pockets around the
      implant during different periods.
    

Detailed description: 
      In the past few years, the number of research conducted on the designs of abutments and
      materials has increased. Often, the restoration is done over the implant using standard
      abutments that the implant company prefabricated, but due to the problems facing the dentist
      from the occurrence of bone absorption, an increase in the depth of the pocket after
      restoration, other types of abutment design methods have been introduced as needed (molded
      abutment made by lost wax technique and computer-designed abutment made using a 3D laser
      printer), those customised abutments were made special for each patient depending on their
      conditions.
    

Intervention name(s): Molded abutment; 3D printed abutment
Intervention type(s): Other; Other
Intervention description(s): The waxed plastic abutment will dismantle, wedged, and poured using a Ni-Cr mixture then it will be trimmed to make it ready to make the permanent restoration over it.
The prostheses will be cemented above the abutment using dual-cure resin cement then the final restoration (crown and abutment) will be fixed using a screw-retained manner.; A marker or Scan body appropriate for the type of implant will be placed on the laboratory implant substitute, a digital scan of the marker will be done in the lab, and the scanned image will be transferred to a computer design software where the prosthesis is designed, In the printing phase, the final prosthesis will be manufactured using a stepwise metal powder supply and a laser fusion process. Making the abutment ready to make the permanent restoration over it. The prostheses will be cemented above the abutment using dual-cure resin cement then the final restoration (crown and abutment) will be fixed using a screw-retained manner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental implant; 3D printed abutment; molded abutment