bioihbjkbjnl/mcl2 huggingface dataset:
Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators
      will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate
      or severe attack receiving immunomodulatory therapy or not. Patients will be randomly
      assigned to one of the two groups.
    

Detailed description: 
      This is a multicenter, randomized, double blind clinical trial to test whether oral
      methylprednisolone (MP) is not inferior to intravenous methylprednisolone for the treatment
      of multiple sclerosis (MS) relapse in terms of clinical and radiological efficacy.

      Patients will be randomly assigned to one of the following two groups.

      Group A: methylprednisolone 1.000 mg/day intravenous administered during three days + placebo
      of methylprednisolone orally administered

      Group B: methylprednisolone 1.250 mg/day orally administered during three days + placebo of
      methylprednisolone intravenously administered.

      Clinical visits will be conducted at 7, 28 and 90 days after treatment starting.
    

Intervention name(s): methylprednisolone; methylprednisolone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): methylprednisolone 1.000 mg/day intravenous administration during three days; methylprednisolone 1.250 mg/day orally administered during three days; Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)
Other intervention name(s): Group A; Group B; Group A; Group B
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; relapse; methylprednisolone
Cognitive Behavioral Factors and Central Sensitization in Chronic Shoulder Pain
Condition: Chronic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Observational

Summary: 
      The objective of this study is to examine the relationship between symptoms of central
      sensitization (CS) and important cognitive behavioral and psychosocial factors in patients
      with chronic shoulder pain.
    

Detailed description: 
      Participants, both male and female, with chronic shoulder pain for at least 3 months will be
      included in the study. They will complete several questionnaires and a functional test.
      Spearman's correlation will be used to analyze associations between symptoms of CS and pain
      behavior, functioning, pain, pain catastrophizing, kinesiophobia, and illness perceptions.

      Additionally, a between-group analysis will be performed to compare patients with and without
      clinically relevant symptoms of CS.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 64 participants suffering from chronic unilateral shoulder pain will be
        recruited from an orthopedic clinic and a chronic pain clinic. Chronic pain will be defined
        as pain lasting for 3 or more months. Pain intensity will be at least 3 on a 0-10 numerical
        pain rating scale on most days of the last 3 months. Shoulder pain conditions will include
        non-specific shoulder pain, subacromial pain sydrome, rotator cuff tendinopathy,
        instabillity without trauma, SLAP lession, adhesive capsulitis, acromioclavicular pathology
        and/or shoulder osteoarthritis. Diagnosis will be carried out by a clinician and the
        criteria will be controlled in a short interview.
      
Keywords: CSI; kinesiophobia; Central Nervous System Sensitization; Catastrophizing; Illness Behavior
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Metabolic Syndrome; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting
      on such increasing populations like metabolic syndrome patients with Vytorin® in korea.
      Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian
      population with metabolic syndrome.
    


Intervention name(s): simvastatin (+) ezetimibe; Comparator: atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks; atorvastatin 10 mg; tablet, once daily, 8 Weeks
Other intervention name(s): MK0653A; Vytorin®; Lipitor®
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic Disorder
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week
      study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets)
      taken daily at bedtime for the treatment of fibromyalgia.
    


Intervention name(s): TNX-102 SL; Placebo SL Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
Other intervention name(s): Low dose cyclobenzaprine sublingual tablets; Placebo sublingual tablets
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Sleep; Fibromyalgia; FM
Efficacy and Safety of Profile HaloTM Mixed Fractional Laser on Treating of Facial and Neck Photoaging.
Condition: Photoaging
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      1. Fractional laser has become an important laser modality in management of a number of
           skin conditions and photoaging. Fractional photothermolysis is the fractional emission
           of light into microscopic treatment zones, creating small columns of injury to the skin
           in a pixilated fashion. Epidermal and dermal disruptions occur in these focal zones of
           thermal injury, stimulating dermal collagen production and elastic tissue formation.
           Fractional laser has been used successfully to treat photodamage and overall dyschromia
           in the Caucasian population. However, there is not much improvement in Asian population.

        2. Photoaging refers to the skin caused by intense and chronic exposure to sunlight. The
           visible effects of photoaging are fine wrinkles, mottling, pigmentation and roughness of
           the skin. These changes are usually associated with chronologic aging. However,
           photoaging is not a good indicator of chronologic age. It just makes a person look older
           than his or her chronologic age. Skin ageing may be divided into two processes:
           intrinsic ageing and extrinsic ageing (or photoageing). Both are accompanied by changes
           in the morphological and biomechanical properties of skin.

        3. Profile HaloTM dual-wavelength fusion fractional laser is the first hand tool in the
           world that integrates ablative and non-ablative fractional lasers. It includes a
           non-ablative fractional laser with a wavelength of 1470nm and an ablative fractional
           laser with a wavelength of 2940nm. A day after treatment, new epithelial tissue began to
           appear, and the necrotic epidermis formed microepidermal necrotic debris (MENDs). MENDs
           were surrounded by keratin 2-7 days after treatment, and collagen sequence in MTZs was
           changed 7 days later. The 2940 ablative fractional laser can be added with 20-100 micron
           lattice stripping, ensuring safety while enabling MENDs to be peeled off 2 days earlier
           and reducing the risk of side effects. This makes the laser safe and effective compared
           with the single fractional laser and reduces the downtime.
    


Intervention name(s): Profile HaloTM Mixed Fractional Laser
Intervention type(s): Radiation
Intervention description(s): Profile HaloTM fractional laser is the world's first hand tool with nonablative and ablative fractional laser. It includes a nonablative fractional laser with a wavelength of 1470 nm and an ablative fractional laser with a wavelength of 2940 nm. It has a good therapeutic effect on skin aging.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fractional Laser; Photoaging; Treatment; Halo
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single and multiple doses of MBX 2109 in healthy volunteers.

      This study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a
      subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109
      taken as a SC injection just under the skin. Each participant will enroll in only one part.
    


Intervention name(s): MBX 2109 (Part A); MBX 2109 (Part B); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg; Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg; Single SC dose or repeated SC doses of placebo.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
An Efficacy and Safety Study of Tacrolimus Ointment in Pediatric Participants With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in
      treating the signs and symptoms of moderate (medium level of seriousness) to severe (very
      serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic
      [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease
      with a genetic predisposition [latent susceptibility to disease at the genetic level]) in
      pediatric participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention) study in pediatric
      (2-12 years) participants with moderate to severe atopic dermatitis. Participants will be
      treated with 0.03 percent concentration of tacrolimus ointment which will be applied twice
      daily for 4 weeks or until 1 week after the affected areas defined for treatment at baseline
      are completely cleared, whichever is first. The study visits will consist of 6 visits:
      pre-study (optional), Baseline, Weeks 1, 2, 3 and 4. The ointment should be applied at least
      2 hours before or at least 30 minutes after bathing, showering, shaving, use of sauna, or
      heavy exercise (i.e. causes sweating). On study visit days, the ointment should be applied at
      least 2 hours before the visit. Efficacy evaluation will be done at all subsequent study
      visits in participants receiving study drug for at least 3 consecutive days (minimum of 5
      applications) while the participants who will receive at least 1 application of the study
      drug, will be evaluated for safety. Primary efficacy evaluation will be based on the
      Physician's Global Evaluation of Clinical Response (PhGECR). Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): Tacrolimus ointment, 0.03 percent twice a day for pediatric population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dermatitis, Atopic; Tacrolimus
Parental Affect in Dental Procedures
Condition: Behavior; Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Background: To evaluate the effect of the anxiety of a parent accompanying a child on the
      child's anxiety during treatment.

      Methods: Parents of 160 patients (4-8 years old) were divided into two groups anxious and
      non-anxious. Each groups had separated two randomized subgroups that with/without parents
      accompanied their children. At the first visit, participating children were examined while
      the behavior of the child during the examination was evaluated by a single pediatric dentist
      according to their heart rates measured by a portable pulse oximeter and the data were
      recorded (objective data).Forty-two children with a score of 1 and 4 on the Frankel Scale
      were excluded. After the parents were divided into two groups, anxious and non-anxious, the
      groups were equally divided randomly and the parents accompanied their children during the
      treatment.

      Patients were recalled after one week for the treatment visit. Both groups were evaluated
      using the basic behavior technique. Compomer fillings were performed on children with
      infiltration anesthesia. The children's heart rates were measured by a portable pulse
      oximeter during treatment. Finally, the children were asked to express how they felt about
      the treatment by pointing out one of the faces on the Wong-Baker Faces Scale (subjective
      data). The children also rated the experience on the Frankel scale administered by the same
      operator.
    


Intervention name(s): parent accompanying the child during treatment
Intervention type(s): Behavioral
Intervention description(s): After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Behaviour; Dental anxiety; Parental presence
Perinatal Opioid Use
Condition: Opioid Use; Pregnancy
Study type: Observational

Summary: 
      To compare maternal and newborn outcomes among pregnant women with OUD receiving care via
      telemedicine versus in-person.
    

Detailed description: 
      Participants: Pregnant women with OUD.

      Intervention: Participants were seen weekly for four weeks, every two weeks for four weeks
      and monthly thereafter and provided relapse-prevention therapy and buprenorphine.

      Design: A cohort derived from a prospectively collected database including 98 women receiving
      perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed
      until 6-8 weeks postpartum from September, 2017 to December, 2018. Logistic regression with
      propensity score adjustment was applied to reduce group selection bias and control for
      potentially confounding variables.

      Setting: Four outpatient obstetric practices in the southeast.
    

Intervention name(s): In-Person Perinatal OUD Treatment; Perinatal OUD Treatment via Telemedicine
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine as part of standard of care.; Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine as part of standard of care..
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort derived from a prospectively collected database including 94 women receiving
        perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed
        until 6-8 weeks postpartum from September, 2017 to December, 2018.
      
Keywords: pregnancy; prescription opioids
Effects of Arabinoxylan-Oligosaccharides Compared to Other Prebiotics in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the effects of arabinoxylan-oligosaccharides (AXOS)
      on the colonic metabolism and microbial composition, and to compare these effects with the
      reference prebiotic fructo-oligosaccharide enriched inulin.
    


Intervention name(s): FOS-IN; AXOS
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): prebiotic fructo-oligosaccharide enriched inulin
intake period: 2 weeks, 1.25 or 2.50g every morning and evening; arabinoxylan-oligosaccharides (AXOS)
intake period: 2 weeks, 1.25 or 2.50g every morning and evening
Other intervention name(s): Synergy1, Orafti, Tienen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: gastrointestinal effects; prebiotic
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): Sunscreen Sport Spray (BAY987519); Untreated Skin
Intervention type(s): Drug; Other
Intervention description(s): 50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB#Y51-002); This site is patched without treatment as irradiated control.
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control
Condition: Ovulation Suppression
MeSH terms: Vision Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the adequacy of ovulation suppression, cycle control, and safety of three
      transdermal contraceptive delivery systems (TCDSs).
    

Detailed description: 
      The primary objective was to evaluate the adequacy of ovulation suppression, cycle control,
      and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different
      doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3
      consecutive cycles of administration of each treatment.
    

Intervention name(s): levonorgestrel and ethinyl estradiol
Intervention type(s): Drug
Intervention description(s): pregnancy prevention
Other intervention name(s): contraception; hormonal contraception; transdermal
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception; pregnancy prevention
Motivational Enhancement for Spanish Speaking Individuals - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare a three-session Spanish version of Motivational
      Enhancement Therapy (MET) to standard treatment to see how well MET engages and retains
      Spanish-speaking clients in outpatient substance abuse treatment.
    


Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: behavioral intervention
Diet-Induced Variability in Appetite (DIVA)
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The aim of this study is to test the hypothesis that dietary weight loss (WL) through
      alternate day fasting (ADF) will enhance appetite control, health markers and wellbeing
      following WL compared to standard daily calorie restriction (CR).
    

Detailed description: 
      This is a proof of concept randomized controlled trial in which overweight/obese females will
      be randomised to a dietary weight loss intervention (ADF or CR) to achieve ≥5% WL.
      Behavioural measures of appetite control including ad libitum intake after a fixed meal, body
      composition, resting metabolic rate, measured physical activity and daily energy expenditure,
      sleep quality, hedonic food reward and eating behaviour traits will be assessed before,
      during and after the WL intervention in those who reach the target weight loss within 12
      weeks. After weight loss phase, participants will be given standard healthy eating and
      physical activity advice for weight maintenance and body weight will be followed up after
      weight loss at 12 months.
    

Intervention name(s): Alternate Day Fasting; Continuous dietary restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.; 25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science