bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Steroid Sparing Potential Study of DGLA Cream in Early Childhood Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the steroid sparing potential of DS107E to vehicle in patients
      with moderate to severe atopic dermatitis.

      DS107E or vehicle will be topically administered with a steroid twice a day for the first 7
      days. For the following 56 days DS107E or vehicle will be topically administered twice a day.

      This study will enrol approximately 40 paediatric patients.
    

Detailed description: 
      Patients will come to the clinic on 8 occasions: Screening, Baseline, Day 7, Day 21, Day 35,
      Day 49, Day 63 (End of Treatment) and Day 91 (Follow-up). The primary efficacy variables will
      be IGA (Investigator Global Assessment) and SCORAD (SCORing Atopic Dermatitis) .

      The secondary efficacy variables will be IGA, SCORAD, EASI (Eczema Area and Severity Index),
      IDQOL (Infant Dermatology Quality of Life), DFI (Dermatitis Family Impact), BSA, TEWL
      (Transepidermal Water Loss) and Time to Rescue Medication.
    

Intervention name(s): DS107E; Vehicle; Hydrocortisone Butyrate 0.1% Cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Steroid taken topically once a day
Intervention MeSH terms: Hydrocortisone; Hydrocortisone-17-butyrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Virtual Reality in Hazmat Training
Condition: No Disease or Condition is Being Studied; Evaluating a Brief Intervention; Does Virtual Reality Aid in Hazmat Training
Study type: Interventional

Summary: 
      Type of study: Two-group comparison.

      Main question it aims to answer:

      Does the use of virtual reality emergency scenarios provide a practical and effective tool to
      supplement traditional instructor-led training for first responder trainees?

      A. For the traditional hazmat response training group; Traditional training will be held in
      the classroom environment for 45 minutes in the form of a lecture, then the training session
      will be terminated.

      B. For VR hazmat response training group; After the traditional classroom session has ended,
      the participants will complete the additional VR training scenario, online content, and
      question-answer session. Once completed the session will be closed.
    


Intervention name(s): Classroom Training; Virtual Reality Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Active Comparator; Experimental
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An experimental and a pretest-posttest control group design method were applied in this regard.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks
Condition: Muscle Tone
Study type: Interventional

Summary: 
      This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of
      buttocks. The study is a prospective multi-center open-label two-arm study. The subjects will
      be enrolled and assigned into two study groups. The subjects will be enrolled and assigned
      into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be
      required to complete four (4) treatment visits and two follow-up visits.
    


Intervention name(s): BTL-899 Buttocks
Intervention type(s): Device
Intervention description(s): The treatment administration phase in both study groups will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the gluteal area.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.
Masking: None (Open Label)
Primary purpose: Treatment
Register Study of the Neoadjuvanten Treatment by Patients With Rectumcarcinoma
Condition: Feasibilitystudy
Study type: Observational [Patient Registry]

Summary: 
      goal of this study is to check the effecivity, feasibility and toxicity of the
      chemoradiotherapy and hyperthermia
    

Detailed description: 
      Radiation: 5x1,8Gy until 50,4 Gy Hyperthermia: 2x/week

      Chemotherapy:

      neoadjuvant= day 1-5 and day 29-33 5FU 1000mg/m2 adjuvant = 4 Cycles 5FU 500mg/m2 all 4 weeks
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with rectumcarcinoma stage UICC II+III
Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants
Condition: Infant, Premature
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      The antioxidant system of very low birth weight infants is immature. This immaturity is
      implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy.
      The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant.
      Photoprotection decreases the oxidant load infused with parenteral nutrition. In a
      preliminary study, photoprotection reduced the frequency of pulmonary bronchodysplasia,
      increased the quantity of enteral nutrition tolerated, and decreased the arterial blood
      pressure among very low birth weight infants. The aim of this study is to evaluate the impact
      of photoprotection on oxidant related diseases among very low birth weight infants. This
      study is a randomized multicenter trial. In the intervention group, photoprotection is
      applied until the infusion of parenteral nutrition with amber bags, tubing, and syringes. The
      quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24
      hours of infusion. The control group will receive parenteral nutrition with transparent bags
      and tubing. The outcomes are evaluated at 36 weeks, and 680 infants will be enrolled, with
      stratification among centers and gestational age.
    


Intervention name(s): photoprotected bags, tubing, syringes; standard tubing and bags
Intervention type(s): Device; Device
Intervention description(s): use of photoprotected parenteral nutrition device; Use of standard (transparent) parenteral nutrition device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Photoprotection,; Parenteral nutrition; Oxidant stress; Infant, Premature
Zonisamide for Weight Reduction in Obese Adults
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The primary aim of this study is to assess long-term weight loss efficacy of zonisamide
      relative to placebo in obese patients prescribed a dietary intervention.
    

Detailed description: 
      This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects
      are randomly assigned to one of the three treatment interventions at Duke University Medical
      Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes
      include changes in waist circumference, glycaemic and inflammatory markers, lipids, food
      craving, hunger and satiety, quality of life, blood pressure and heart rate.
    

Intervention name(s): Zonisamide
Intervention type(s): Drug
Intervention description(s): zonisamide 400 mg, 200 mg, or placebo
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity treatment; weight loss; antiobesity drugs; zonisamide
A Study of the Effects of Paroxetine on the Pharmacokinetics of Paliperidone ER
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of a CYP2D6 inhibitor, paroxetine, on
      the pharmacokinetics of a single dose of orally administered paliperidone ER and to evaluate
      the safety and tolerability of both treatments in healthy men
    

Detailed description: 
      This is a randomized, open-label, single-center, single-dose, 2 treatment, 2 way crossover
      study. It consists of 3 phases: a screening phase beginning within 21 days before the first
      study drug administration; an open label treatment phase consisting of 2 treatment periods
      (Period 1 and Period 2), during which patients will receive 2 single doses of 3 mg
      paliperidone ER; and end of study evaluations upon completion of all the study procedures in
      Period 2 or at early withdrawal. All volunteers will receive each of the following 2
      treatments in random order: Treatment A: 1 tablet of 3 mg paliperidone ER in the fasted
      state; Treatment B: one 20 mg paroxetine tablet once a day from Day 1 to Day 13 and 1 tablet
      of 3 mg paliperidone ER on Day 10 in the fasted state. Successive paliperidone ER
      administrations will be separated by a washout period of at least 14 days and no more than 28
      days. Paroxetine is a potent and selective CYP2D6 inhibitor. Inhibitors of CYP2D6 such as
      paroxetine have been reported to increase the plasma concentrations of antipsychotics such as
      perphenazine, clozapine, and risperidone. Because paliperidone ER and paroxetine could
      potentially be used in combination in schizophrenic patients, the potential for a drug-drug
      interaction between paroxetine and paliperidone ER needs to be explored.The safety and
      tolerability of the 3 mg tablet of paliperidone ER administered with and without paroxetine
      to healthy men will be monitored.

      Two single oral doses of paliperidone ER 3-mg; 20-mg paroxetine orally once a day for 13 days
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paliperidone ER; Antipsychotic drugs; Selective serotonin reuptake inhibitors; Mood disorders; Schizophrenia
Mediterranean Diet and Endothelial Function
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effect of Mediterranean diet and some of its specific components (olive oil,
      non fried fish and nuts) on endothelial function in overweight and obese patients
    

Detailed description: 
      Abdominal obesity is well known to increase the risk of cardiovascular disease (CVD), since
      it is commonly associated with hypertension, dyslipidemia, impaired fasting glucose, type 2
      diabetes, metabolic syndrome, insulin resistance, systemic inflammation and endothelium
      dysfunction.

      Abnormal endothelial function, expressed as lower vasodilatation through flow-mediated
      vasodilatation (FMD) of brachial artery in response to an increase in blood flow, is
      considered an index of subclinical atherosclerosis, and an early hallmark of cardiovascular
      disease, with a strong prognostic value for future cardiovascular events. Changes in diet,
      level of physical activity and behavior are well known key elements influence endothelial
      function. Recent studies seem to show that Mediterranean diet has beneficial role on
      cardiovascular risk. It could protect against the development of coronary heart disease also
      through a possible effect on body weight and obesity.

      At the best of our knowledge, the effect of Mediterranean diet on endothelial function in
      obese subjects has not been definitely established. Therefore, the aim of this study was to
      evaluate the impact of Mediterranean diet on anthropometric parameters (body weight, BMI and
      waist circumference), lipid profile [total cholesterol (TC), high density lipoprotein
      cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C)], triglycerides (TG),
      fasting glucose and endothelium function, evaluated by FMD, in a group of obese and
      overweight subjects. In particular, subjects were invited to follow a standard Mediterranean
      diet for a short (3 months) or a longer (18 months) period. The specific role of some
      components of Mediterranean diet (olive oil or non fried fish or nuts) was also investigated.
    

Intervention name(s): Mediterranean diet
Intervention type(s): Dietary Supplement
Intervention description(s): Patients underwent administration of Mediterranean diet and olive oil, or Mediterranean diet and not-fried fish, or Mediterranean diet and nuts.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mediterranean diet; FMD; obesity; cardiovascular risk.
Estradiol-Receptor Blockade in Older Men and Women
Condition: Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to
      estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that
      estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and
      insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic
      syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in
      prostatic cancer
    

Detailed description: 
      Systemic concentrations of Te, E2, GH, IGF-I and insulin growth factor binding protein 3
      (IGFBP-3) decline in healthy aging men and women. Relative sex-steroid deprivation
      accentuates GH and IGF-I depletion, since Te stimulates GH and IGF-I production in older men,
      hypogonadal males of all ages, and patients undergoing (genotypic female-to-male) gender
      reassignment. The estrogen-receptor antagonist, tamoxifen, blocks this effect of Te,
      suggesting involvement of E2 in GH's stimulation at least in young men. E2 alone stimulates
      GH secretion in young and older women. Because Te is converted to E2 by aromatization in the
      body, we postulate that E2 is the active moiety in both men and women. Moreover, we
      hypothesize that the decline of E2 in older men and women contributes to the fall in GH
      output. These basic concepts will be tested here.
    

Intervention name(s): Toremifene; Placebo; GHRH/Ghrelin combined Injection
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Toremifene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Trial of Caries Prevention Effect of Fissure Sealants
Condition: Caries Prevention; Fissure Sealant; Fluoride Concentration; Glass Ionomer Cement; Resin
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial was to compare caries prevention of a
      conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and
      fissures over a one year period in a high caries children group. Additionally the
      concentration of Fluoride in saliva was evaluated.
    


Intervention name(s): Fissure sealant application
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
    


Intervention name(s): DMB-3111; trastuzumab
Intervention type(s): Drug; Drug
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Bioequivalence; Biosimilarity; Similarity; Pharmacokinetics; Phase I; Trastuzumab; Healthy Male Volunteers; Single-dose; HER-2; Oncology
Accumbofrontal Tract Study in 2 Populations of Patients With Anorexia Nervosa and Obsessional Compulsive Disorder and Healthy Volunteer
Condition: Accumbo Frontal Tract
MeSH terms: Anorexia; Compulsive Personality Disorder; Anorexia Nervosa
Study type: Interventional

Summary: 
      Restrictive anorexia nervosa and TOCs are psychiatric diseases which shares a common
      pathophysiological substrate We hypothesize that anorexia patients and patients with OCD have
      structural and functional changes in the accumbofrontal tract. The main objective of this
      study will be to compare the structure and the connectivity of this tract in MRI with
      diffusion sequences (DTI tractography) and resting-state, in 3 distinct populations of
      anorexic patients, patients with OCD and healthy patients. The role of the accumbo-frontal
      tract in the cortico-striato-hypothalamo-cortical circuit seems to be established. DTI
      tractography will allow the measurement of functional anisotropy (FA), a parameter that
      evaluates the diffusion of water molecules along the white matter fibers, and therefore the
      potential alteration of the studied tract. Resting state sequences will allow to estimate the
      BOLD signal and the functionality of the tract.
    


Intervention name(s): Multimodal MRI with diffusion sequence for anorexia nervosa patient; Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient; Multimodal MRI with diffusion sequence for healthy volunteer
Intervention type(s): Radiation; Radiation; Radiation
Intervention description(s): Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast; Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast; Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals With Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The overall aim of the project is to determine whether or not exercise influences
      cardiovascular or nervous responses to meal ingestion in individuals with insulin resistance
      or type 2 diabetes.
    

Detailed description: 
      Participants will undergo a screening procedure, including telephone screening and physical
      examination, as well as determination of body composition and fitness. Participants will be
      asked to complete 5-10 days of supervised exercise training and will undergo testing to
      assess cardiovascular and metabolic responses to an oral glucose tolerance test, including
      muscle sympathetic nerve activity, blood flow, and circulating glucose and insulin
      concentrations at baseline and following training. In addition, day-to-day variations in
      blood glucose will also be monitored. The overall aim of the project is to determine whether
      or not acute exercise training influences postprandial metabolic, vascular or autonomic
      nervous system responses in individuals with insulin resistance or T2D.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): daily exercise: supervised treadmill walking or cycle ergometry use
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin Resistance; Type 2 Diabetes
(PEKK) Framework for Mandibular Implant-supported Complete Fixed Prostheses
Condition: Bone Loss; Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      This clinical study aims to evaluate the effect of using PEKK (Pekkton) framework in
      mandibular implant-supported complete fixed dental prostheses with All-on-four treatment
      concept on peri-implant tissues health
    

Detailed description: 
      The aim of this clinical study is to evaluate the effect of using PEKK (Pekkton) framework in
      mandibular implant-supported complete fixed dental prostheses with All-on-four treatment
      concept on peri-implant tissues health regarding the following parameters:

        -  Modified Plaque index

        -  Modified Gingival index

        -  Peri-implant probing pocket depth

      Radiographic evaluation (periapical x-ray):

      Marginal bone height changes
    

Intervention name(s): PEKK framework
Intervention type(s): Other
Intervention description(s): PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Obesity Awareness, Physical Activity Level and Sedentary Behavior in Obese Women
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      It is known that the incidence of obesity, which is a global health problem, is higher in
      women. The aim of this study is to examine the relationship of obesity awareness with
      physical activity level and sedentary behavior in obese women.
    

Detailed description: 
      Obese people are at risk for medical conditions that can lead to greater morbidity and
      mortality. It is known that the incidence of obesity, which is a global health problem, is
      higher in women. Lack of physical activity and sedentary behavior are well-known risk factors
      for obesity and the relationship between them has been supported by many studies. As a matter
      of fact, some studies have reported that public health programs should focus on increasing
      individuals' physical activity levels as well as reducing sitting time. While examining the
      sedentary behavior and physical activity levels of obese women, evaluating their obesity
      awareness status, can facilitate increasing their awareness of the disease, initiating and
      complying with treatment. The aim of this study is to examine the relationship of obesity
      awareness with physical activity level and sedentary behavior in obese women.
    

Intervention name(s): Survey evaluation
Intervention type(s): Other
Intervention description(s): Obesity awareness, physical activity, and sedentary time questionnaires will be applied to these cases.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study will consist of 70 obese women volunteers aged between 18-65 years.
      
Keywords: obesity; women; physical activity; sedantary