bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Part 1 of the study will assess the enhancement of task-related brain activation (BOLD
      response) in key brain areas in schizophrenia during the performance of working memory,
      episodic memory and visual activation tasks as measured by functional magnetic resonance
      imaging (fMRI) in people with schizophrenia. Part 2 of the study will assess the safety and
      tolerability of multiple doses of AQW051 in people with schizophrenia.
    


Intervention name(s): AQW051; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Manic depression; anxiety
The Effect of Individualized Exercise Guidance on Pregnancy Outcome
Condition: Pregnancy Outcome; Gestational Weight Gain; Mediation; Macrosomia, Fetal
MeSH terms: Fetal Macrosomia; Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      A single center, randomized controlled trial was conducted to investigate whether
      individualized exercise guidance was more effective in improving pregnancy outcomes in normal
      pregnant women. What's more, the trial was also conducted to find out whether there is a
      mediating effect between prenatal exercise and pregnancy outcomes.
    

Detailed description: 
      Fetal macrosomia refers to newborns with a birth weight more than 4000 grams, which poses
      varying degrees of risks to the health of both mother and infant and also affects the health
      outcomes of future generations. Research has found that exercise can effectively reduce the
      incidence of macrosomia and prevent gestational diabetes mellitus, pregnancy-induced
      hypertension, and excessive weight gain during pregnancy. However, every pregnant woman's
      individual situation and exercise habits are different, and personalized guidance based on
      their own circumstances is necessary during pregnancy exercise. The use of intelligent
      devices for supervision and management is also essential. To explore the impact of
      personalized exercise guidance during pregnancy on macrosomia, as well as the mediating
      effect of weight gain during pregnancy on exercise and macrosomia, we conducted a prospective
      randomized controlled clinical trial. The study included pregnant women who were over 20
      years old, married, singleton, in the mid-term of pregnancy, and had no contraindications for
      exercise during pregnancy. They were randomly divided into an individualized exercise
      guidance group and standard clinic prenatal care group. Both groups received routine prenatal
      care and did not have any special dietary recommendations. The pregnant women in the
      individualized exercise guidance group received regular exercise guidance from a professional
      teacher and were supervised and managed through a WeChat group. The main outcome indicators
      were the incidence of macrosomia and the total weight gain during pregnancy.
    

Intervention name(s): Individualized exercise guidance
Intervention type(s): Behavioral
Intervention description(s): Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effectiveness and Underlying Mechanisms of Applied Relaxation as Indicated Preventive Intervention
Condition: Anxiety Disorders; Depressive Disorder; Stress Disorder
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      As mental disorders constitute a core health care challenge of the 21th century, increased
      research efforts on preventive interventions are indispensable. In the field of clinical
      psychology, indicated preventive interventions targeted to those with initial symptomatology
      appear particularly promising. Applied relaxation (AR) is a well-established intervention
      technique proven to effectively reduce tension/distress, anxiety and depressive symptoms in
      the context of treatment of a wide variety of manifest mental disorders as well as somatic
      illnesses. However, it has not been studied so far whether AR as indicated preventive
      intervention in subjects with initial symptomatology but no full-threshold mental disorder
      yet is capable to prevent a further symptom escalation. This randomized controlled trial in
      subjects with elevated tension/distress, anxiety or depressive symptomatology aims to
      investigate whether an AR intervention (10 sessions à 60 min) can (a) effectively reduce
      present psychopathological symptoms as well as (b) prevent a further symptom progression to
      full-threshold DSM-5 mental disorders. Putative mediators (physiological, emotional,
      cognitive and behavioral changes including heart rate and heart rate variability, hair and
      salivary cortisol secretion, affectivity, self-efficacy, internal locus of control and
      cognitive / behavioral coping) and moderators (sex, age, symptom severity at baseline and
      homework adherence during the intervention course) of the intervention/preventive efficacy
      will be additionally studied. Predictor and outcome measures will be assessed both
      conventionally (via personal interview, questionnaires and physiological measures during the
      respective main assessment) and with ecological momentary assessments (EMA, applied via smart
      phone over a 1-week interval following the respective main assessment) in everyday life.
    


Intervention name(s): Applied Relaxation
Intervention type(s): Behavioral
Intervention description(s): 10 training sessions (90 min. each) in Applied Relaxation (group format)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of HIIT Integrated in PE Classes, on Physical Condition, Physical Activity and Motivation for Exercise
Condition: Adolescents
Study type: Interventional

Summary: 
      Levels of activity and physical condition among adolescents are low, increasing the risk of
      chronic diseases. The most recent literature suggests that physical activity and physical
      condition are correlated with improved biopsychosocial variables of the young. The School
      and, concretely, the Physical Education classes are privileged spaces, promoters of positive
      changes for the rest of the life. HIIT is an efficient alternative to the invested time
      compared to aerobic training, being a powerful stimulus in improving cardiorespiratory
      performance, muscles oxidative capacity and sensitivity to insulin. This study intends to
      verify the effectiveness and feasibility in the implementation of HIIT in High-School
      Physical Education classes. The activity levels and physical condition of the adolescents
      will be evaluated and identified, before and after 16 weeks of implementation of the training
      program, as well as their effects on the motivation for the practice.
    


Intervention name(s): High-Intensity Interval Training
Intervention type(s): Other
Intervention description(s): The program will be applied in the first 10-15 minutes of each PE class, twice a week, including a brief warm-up, ranged from 14 to 20 intervals, adopting a 2:1 work to rest ratio (ie, 30-s work, followed by 30-s rest)
A cut-point of >=90% of maximal heart rate was used as our criterion for satisfactory compliance to high-intensity exercise
In order to estimate effort, fatigue and training load, a subjective effort scale will be used throughout each session. The heart rate will be monitored throughout the session in real time through Bluetooth technology.
Actigraph accelerometers (wGT3X-BT), randomly distributed by the students in each session, will be used to characterize the intensity of the sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIIT; Adolescents; Physical Exercise; Health; Motivation
The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients
Condition: Carcinoma Surgery; Parenteral Nutrition; Post-Operative Hospital Stay
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil
      emulsion on outcome in post-operative cancer patients.
    

Detailed description: 
      As an essential component of parenteral nutrition, fat emulsion has been used more than 30
      years. It provides energy and essential fatty acids. Commercial fatty emulsion products
      mostly come from soy bean. The omega 6 fatty acids make up with the major fatty acids of this
      fat emulsion, and lack of omega 3 fatty acids generally. The imbalance of these two types of
      fatty acids may impact with negative clinical outcomes.

      There are lots of omega 3 fatty acids makes up with fish oil emulsion, especially with
      eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA).Few clinical studies found its
      clinical efficacy in recently years. A commercial product of omega 3 fat emulsion by
      Fresenius-Kabi was registered in Europe at 1998. There is no any clinical trial in Asia to
      elaborate the efficacy of omega 3 fat emulsion, as well the lack of large scale clinical
      trial in the world.

      Currently study is the first large scale, randomized, double blind and multi-center clinical
      trial to elaborate the impact of fish oil fat emulsion in Asia and Europe.
    

Intervention name(s): Omega-3 fish oil emulsion (Omegaven ); long-chain triglyceride
Intervention type(s): Drug; Drug
Intervention description(s): Patients of the treatment group received 0.2 g fish oil (10% Omegaven, Fresenius Kabi, Bad Homburg, Germany) and 1.0 g soy bean oil per kg BW per day; the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)
Other intervention name(s): Omegaven; Intralipid
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Impact of Omega 3 fatty acid on outcome; Omega-3 fatty acid; Carcinoma surgery; Digestive System; Parenteral Nutrition; Fat Emulsions, Intravenous; Clinical outcome; SIRS; Infectious complication; Postoperative hospital stay; Cost of postoperative period; Post-operative nutritional cost & total treatment cost
Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study
      was conducted to assess the immunogenicity and safety of a single dose of Meningococcal
      Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when
      administered alone and in combination with other pediatric vaccines in healthy toddlers in
      South Korea, Thailand, the Russian Federation, and Mexico.

      Primary Objective:

        -  To describe the immunogenicity profile of MenACYW Conjugate vaccine administered alone
           or concomitantly with licensed pediatric vaccine(s) (measles-mumps-rubella vaccine [MMR]
           + Varicella, diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and
           Haemophilus influenzae type-b Conjugate vaccine [DTaP-IPV-HB-Hib], or pneumococcal
           Conjugate vaccine [PCV13]).

      Secondary Objective:

        -  To describe the immunogenicity profile of licensed pediatric vaccine(s) (MMR +
           Varicella, DTaP-IPV-HB-Hib, or PCV13) when administered alone or concomitantly with
           MenACYW Conjugate vaccine.
    

Detailed description: 
      Healthy, meningococcal-vaccine naïve toddlers aged 12 to 23 months were randomized either to
      a single dose of MenACYW Conjugate vaccine alone or in combination with other pediatric
      vaccines in healthy toddlers in South Korea and Thailand (MMR + varicella vaccine), the
      Russian Federation (PCV13), and Mexico (DTaP-IPV-HB-Hib). Immunogenicity (pre- and 30 days
      post-vaccination) and safety was assessed.
    

Intervention name(s): MenACYW conjugate vaccine; MMR; Varicella; DTaP-IPV-HB-Hib; PCV13
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular; Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous; Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous; Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular; Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; MenACYW Conjugate vaccine
Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1
      clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in
      combination with DWP14012 in healthy subjects
    


Intervention name(s): DWP14012; DWC202202; DWC202203
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Potassium-competitive acid blocker; Clopidogrel Bisulfate; Proton pump inhibitor
Intervention MeSH terms: Fexuprazan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Various Modalities Water Immersion on Veins
Condition: Hydrotherapy
Study type: Interventional

Summary: 
      Objectives In this study the investigators examined the changes in common femoral vein (CFV)
      and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold
      water immersion (CWI) and contrast water therapy (CWT).

      Design Ten professional handball players visited the laboratory on three occasions. At each
      visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air
      (baseline) and then 16-minutes lower limbs TNI (~35°C), CWI (~12°C) or CWT (2:2minutes (~12°C
      to ~35°C) ratio), selected randomly.

      Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the
      end of 16 min immersion.
    


Intervention name(s): immersion
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: femoral vein; saphenous vein; hydrostatic pressure; temperature; recovery
Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial
Condition: Dental Diseases
MeSH terms: Stomatognathic Diseases
Study type: Interventional

Summary: 
      Bulk Fill" (RBF) composite resins (RC) has been on the market, with the main advantage of
      being applied in a single layer, faster and easier than a conventional RC. Repair of RC
      restorations is a validated treatment option in dentistry, which has been shown to increase
      the longevity of restorations by minimizing tooth damage such as complete replacement.
      Currently there are no clinical studies that support the actual performance of RBF repair
    

Detailed description: 
      Main objective: Compare the clinical performance with FDI of repairs proximal RC restorations
      between a conventional resin and a RBF in a period of 24 months. Hypothesis: There is not
      different clinical performance of proximal RC repairs done with RBF when compared to
      conventional RC repairs. Material and method: 80 volunteer patients will be randomly
      recruited to attend the clinic of the Faculty of Dentistry of the University of Chile who
      have two proximal RC restorations with indication of repair according to the FDI system (n
      per group = 80). Each patient must accept and sign an informed consent. The repairs will be
      randomly divided into two groups on the same patient. Control Group: Conventional RC repair
      (Z350 XT). Experimental Group: RBF (Tetric Evoceram Bulk Fill) Repair. For the restorative
      technique, a three-step adhesive with acid-etched enamel-dentin will be used. It will be
      evaluated at 2 weeks (Baseline), at 6, 12, 18, 24 months by two blind and calibrated
      evaluators (Cohen Kappa> 0.8). The data will be analyzed with the SSPS 21.0 software and the
      Friedman, Wilcoxon and Mann Whitney tests will be applied with a significance level of 95%.
    

Intervention name(s): Repair resin composite proximal
Intervention type(s): Procedure
Intervention description(s): Repair proximal composite resin restoration, removing the defective material and then restoring it with another composite resin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Composite Dental Resin
Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel
      plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer
    

Detailed description: 
      Prognosis of the advanced, recurrent, or persistent cervical cancer, which is not amenable to
      curative treatment with surgery and/or radiation therapy, still remains poor. Recently,
      cisplatin plus paclitaxel for palliative chemotherapy were reported to improve the response
      rate and progression-free interval compared to cisplatin alone and has been shown as a new
      appropriate regimen. However, more effective and/or less toxic combinations are needed.
      Carboplatin as a single agent has less response rate but less overall toxicity than
      cisplatin. Particularly, because less nephrotoxicity does not require hydration and less
      neurotoxicity enables 3hrs administration of paclitaxel in the combination, out patient
      therapy becomes possible and patients' quality of life must improve. Therefore, we planned to
      evaluate the benefits of less toxicity of the chemotherapy containing paclitaxel and
      carboplatin, which could reduce the hospitalised days, in comparison with the standard
      chemotherapy containing paclitaxel and cisplatin. This clinical trial is targeted on the
      patients in Japan with incurable cervical cancer diagnosed by means of image.
    

Intervention name(s): chemotherapy: Paclitaxel/Cisplatin; chemotherapy: Paclitaxel/Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Drug: chemotherapy: Paclitaxel/Cisplatin; Drug: chemotherapy: Paclitaxel/Carboplatin
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical cancer; palliative chemotherapy; recurrent; persistent; stageⅣb; cisplatin; carboplatin; paclitaxel
Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head
Condition: Femur Head Necrosis
MeSH terms: Osteonecrosis; Legg-Calve-Perthes Disease; Femur Head Necrosis; Necrosis
Study type: Interventional

Summary: 
      In this study, the aim is to identify the modifications responsible for aseptic osteonecrosis
      of the femoral head and its structural evolution by the association of the micro scanner
      analysis and Raman spectrometry performed on the femoral heads removed during hip
      replacements. The study of femoral heads will allow the analysis of bone tissue at two
      different scales, both correlated with the biomechanical properties of the bone. Also, the
      association with preliminary MRI analysis will provide pathogenic explanations correlated to
      these modifications.
    


Intervention name(s): femoral head removal
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: aseptic osteonecrosis; femoral head; micro scanner; Raman spectrometry; MRI
Pomegranate Juice and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic
      syndrome.
    

Detailed description: 
      The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic
      syndrome in shabestar.
    

Intervention name(s): pomegranate juice; placebo
Intervention type(s): Other; Other
Intervention description(s): Randomized clinical trial or RCT; Randomized clinical trial or RCT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy
Condition: Anxiety; Postoperative Pain; Bleeding
MeSH terms: Pain, Postoperative
Study type: Observational [Patient Registry]

Summary: 
      Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The
      purpose of this run is to use the association between this use during surgery and the
      attrition of post-operative pain and discomfort. In the research, laboratory and monitoring
      results will be obtained before, during and after the operation. Postoperative patient
      complaints will be evaluated at the postoperative service visit. This study is decided on a
      completely voluntary basis.
    


Intervention name(s): Fentanyl; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.; In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.
Other intervention name(s): Talinat; Precedex
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or
        adenoidectomy operation will be included
      
Keywords: Dexmedetomidine; tonsillectomy; adenoidectomy; postoperative anxiety