bioihbjkbjnl/mcl2 huggingface dataset:
Reducing Aggression in Children and Adolescent on an Inpatient Unit
Condition: Anger; Aggression
MeSH terms: Aggression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether Anger Control Therapy (ACT) with Regulate
      and Gain Emotional-Control (RAGE-Control) is a feasible behavioral therapy to provide on a
      pediatric inpatient psychiatric unit.
    

Detailed description: 
      Aggression and disruptive behavior are the most common reasons for child and adolescent
      inpatient psychiatric hospitalization. Aggressive children and adolescents who merit
      admission to inpatient psychiatric hospitals for treatment typically display dramatic
      problems with self-regulation that interfere with global adaptive functioning. The goal of
      this study is to teach self-regulation techniques by combining Cognitive Behavioral Therapy
      with a biofeedback video game in effort to motivate patients to learn and practice these
      coping skills, which will translate to decreased feelings of anger and aggression while
      hospitalized.
    

Intervention name(s): ACT with RAGE-Control
Intervention type(s): Behavioral
Intervention description(s): This is an open trial of ACT with RAGE-Control which is a behavioral intervention. The therapy involves five psychotherapy sessions taking place over five consecutive days.
Other intervention name(s): Cognitive Behavioral Therapy (CBT)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anger; Aggression; CBT; Videogame; biofeedback
Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5
      mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a
      washout period of 14 days
    

Detailed description: 
      The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence
      Study with a washout period of 14 days. During each session, the subjects will be
      administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc
      Tablet 5mg) under fasting and FED conditions.
    

Intervention name(s): LANDI-Amlodipine Besylate Tablet 5mg; Norvasc Tablets 5mg
Intervention type(s): Drug; Drug
Intervention description(s): LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.; Norvasc Tablet 5mg will be used as a comparator drug for the BE study.
Other intervention name(s): Amlodipine Tablet 5mg; Amlodipine Tablet 5mg
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rizatriptan for Episodic Dizziness in Vestibular Migraine
Condition: Vestibular Migraine; Migrainous Vertigo
MeSH terms: Vertigo; Migraine Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Suffering from dizzy spells and migraine headaches?

      Vestibular Migraine (VM), a newly recognized type of migraine that causes bouts of dizziness.

      University of California, Los Angeles (UCLA) and The Mayo Clinic is seeking people with VM to
      participate in a research study. The purpose of this study is to look at the natural history
      of VM and learn more about common symptoms. Investigators also want to learn the effects,
      both positive and negative, of the commonly used migraine drug, rizatriptan, when it is used
      for spells of dizziness in people with VM.

      Patients may be eligible to participate if:

        -  Patients are between the ages of 18 & 65

        -  Patients have a history of vestibular migraine

        -  Patients are able to maintain a vestibular symptom diary

      The study includes 3 visits with compensation. All participants must complete questionnaires
      on dizziness, headache symptoms, general health and well-being, mental health, and a
      questionnaire on patient's satisfaction with study medication.
    

Detailed description: 
      The primary Specific Aim is to conduct the first successful controlled study of a treatment
      for Vestibular Migraine. The investigators hypothesize that rizatriptan will be superior to a
      look alike inactive capsule for:

      1a. Reducing the severity and duration of vertigo attacks in patients with Vestibular
      Migraine,

      1b. Reducing the severity of symptoms commonly associated with vertigo attacks in patients
      with Vestibular Migraine (e.g., nausea, vomiting, motion sensitivity, gait disturbance,
      headache, light and sound sensitivity), and

      1c. Improving treatment satisfaction and health-related quality of life in patients with
      Vestibular Migraine, and that

      1d. Rizatriptan will be well tolerated by patients with Vestibular Migraine.
    

Intervention name(s): Rizatriptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.; During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.
Other intervention name(s): Maxalt; Sugar Pill
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers
Condition: Hyperhomocysteinemia
MeSH terms: Hyperhomocysteinemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A methyl-group acceptor such as guanidinoacetic acid (GAA) could induce hyperhomocysteinemia
      with the effects of GAA expected to be dose-dependent. Due to the fact that
      hyperhomocysteinemia is thought to be an independent risk factor for cardiovascular and
      neurodegenerative diseases, different dietary agents were used in the past for the treatment
      of elevated total plasma homocysteine (T-HCy), e. g. betaine, choline (betaine precursor) or
      folic acid. In the context of GAA loading the question arises whether intake of betaine,
      choline (betaine precursor) or folic acid during GAA loading could affect plasma T-HCy in
      healthy humans. Forty healthy physically active men and women aged 20 to 30 years will take
      part in this GAA-controlled, double-blind and parallel-group intervention study. Subjects
      will be allocated to four randomly assigned trials, with treatment lasting for 8 weeks and
      washout period of 28 days. The 4 test treatment-groups will include TEST1 (GAA only), TEST2
      (GAA, choline, B6, B12 and folic acid), TEST3 (GAA, betaine, B6, B12 and folic acid) and
      TEST4 (GAA, B6, B12 and folic acid). Plasma T-HCy will be the primary outcome measure
      assessed every second week throughout the study. Plasma B-vitamins and blood and urine
      metabolites (GAA, creatine, methionine, arginine) will be secondary outcome measures along
      with adverse-effects indicators assessed every second week throughout the study. Selected
      body composition indicators will be obtained at 0, 2, 8 and 12 weeks throughout the study to
      monitor the effects of experimental treatments on body hydration and protein synthesis. This
      research will test the hypothesis that a combination of GAA with homocysteine lowering
      nutrients attenuates the elevation of T-hcy, and will further display the size-effect of each
      additive used.
    


Intervention name(s): TEST 1; TEST 2; TEST 3; TEST 4
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2.4 g/day of guanidinoacetic acid; 2.4 g/day of guanidinoacetic acid + 3.0 g/day of choline dihydrogencitrate + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid; 2.4 g/day of guanidinoacetic acid + 1.6 g/day of betaine HCl + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid; 2.4 g/day of guanidinoacetic acid + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Remethylation; Human Subjects; Clinical Trial; B-vitamin; Creatine
A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the pharmacodynamic (PD) effects of
      clopidogrel, prasugrel, and ticagrelor when administered after a single subcutaneous (s.c.)
      dose of ACT-246475 in healthy male and female subjects
    


Intervention name(s): ACT-246475; Clopidogrel; Prasugrel; Placebo; Ticagrelor
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection; Tablet for oral administration (300 or 600 mg); Tablet for oral administration (60 mg); Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution; Tablet for oral administration (180 mg)
Intervention MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Role of Wound Irrigation After Appendectomy
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      Surgical site infection is a common problem after open appendectomy. Irrigation of the
      surgical wound by topical antibiotics has been devised as a measure to reduce the incidence
      of wound infection. The present trial aims to assess the efficacy of layer-by-layer wound
      irrigation with gentamicin-saline solution in prevention of superficial surgical site
      infection after open appendectomy for acute uncomplicated appendicitis.
    


Intervention name(s): Irrigation
Intervention type(s): Procedure
Intervention description(s): upon closure of the peritoneum gentamicin-saline solution (160 mg of gentamicin in 400 ml of normal saline 0.9%) will be used for irrigation of every layer of the wound before its closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to
      control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4,
      6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and
      rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed
      with administration of the booster dose. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, September 2007.
    

Detailed description: 
      The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of
      age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood
      samples taken. Half of the subjects of each group will have a blood sample taken just prior
      to the administration of the third dose of the primary vaccination and the other half of the
      subjects of each group will have a blood sample taken at one month after the third vaccine
      dose of the primary vaccination phase. In addition, all subjects of all groups will have a
      blood sample taken before and 42 days after administration of the booster dose.
    

Intervention name(s): MenHibrix (Hib-MenCY-TT); Infanrix® Penta; Prevenar®; ActHIB®; Meningitec®; M-M-R®II; Varivax®; PedvaxHIB®
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B); One intramuscular dose at 2, 4 and 6 months of age; One intramuscular dose at 2, 4 and 6 months of age; One intramuscular dose at 2, 4 and 6 months of age; One intramuscular dose at 2, 4 and 6 months of age; One subcutaneous dose at 12-15 months of age; One subcutaneous dose at 12 to 15 months of age; One intramuscular dose at 12 to 15 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Invasive Hib & N. meningitidis diseases
Impact of Parent's Presence in Neonatology
Condition: Newborn; Vitality
Study type: Observational

Summary: 
      Every year 75000 new-born babies are hospitalized in neonatology yard in France with about
      60000 born prematurely.

      Studies showed that parents presence is good for the baby development , decrease the stress
      due to hospitalization.It's also efficient for the attachment between the baby and parents.

      Although the team try to settle a good atmosphere to establish this link and let parents take
      their position,it seems that the time taken to stay with the baby is less moreover the night.

      The aim of the study is to evaluate the time of presence to find tools to increase this time
      in the neonatotology yard
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        every newborn baby hospitalized in neonatology yard
Reference Curve on Bone Mineral Density in Young Adult: French Multicenter Study
Condition: Bone Mineral Density; Grip Strength; Physical Performance
Study type: Interventional

Summary: 
      In men, the hope of lower life, the absence of equivalent of menopause and the existence of a
      higher peak bone mass are three factors that explain the lower incidence of osteoporosis in
      men. Epidemiological data indicate a prevalence of 15% among men aged over 50 years (Szulc et
      al. 2000). According to global analyzes, the number of fractures of the upper end of the
      femur in humans will increase from 400 000 to 800 000 per year between 2000 and 2025 (Kanis
      et al. 2004). Furthermore the mortality due to major osteoporotic fractures when they occur
      in humans than that seen in women (Johnell and al.2001).The main goal of this study is to
      establish reference curves in elderly male volunteers from 20 to 30 years through the
      assessment of bone mineral density of the spine, hip, and the measurement of body composition
      (fat mass, lean mass). This study will allow us to establish the mean and standard deviation
      of the value of the young adults of the same sex, which will eventually be applied in the
      calculation of the "T-score" for older people.
    


Intervention name(s): Bone densitometry measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Bone Densitometry and measurement of body composition
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The purpose of this study is to compare the recovery rates of moderately malnourished
      Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified
      spread or a commercially produced ready-to-use therapy food.
    


Intervention name(s): Soy/peanut fortified spread; Milk fortified corn/soy blend; Supplementary Plumpy®
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 75kcal/kg/day; 75 kcal/kg/day; 75 kcal/kg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Malnutrition; Supplemental Food; CSB++; Supplementary Plumpy
EFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKET
Condition: Dental Implant Stability
Study type: Interventional

Summary: 
      Aim of the study was to evaluate the effect of low-level laser therapy (LLLT) (660nm laser
      diode 0.5W) on implant stability and crestal bone loss in implants inserted in freshly
      extracted sockets augmented by Collaplug in the jumping gap.
    


Intervention name(s): Collaplug with low level laser; Collaplug
Intervention type(s): Other; Other
Intervention description(s): Immediate implant placement with applying a collaplug material in the jumping gap followed by low level laser application using Siro laser (660 nm, avg. power density: 0.5-WATT) circular spot diameter and area: 0.71 cm/0.4cm2) applied in six points in contact mode with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before bone perforation and after suturing.; Implant of suitable diameter and height was placed in the fresh extracted socket immediately after extraction and the jumping gap was augmented by the collaplug followed by healing abutment placement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalency Study of Terbinafine Tablets Under Fed Conditions
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine
      tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed
      conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover
      design.
    


Intervention name(s): Terbinafine
Intervention type(s): Drug
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters
Condition: Cerebral Oxygenation
Study type: Observational

Summary: 
      The aim of the study is to compare the values of cerebral tissue oxygenation measured
      simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinically stable, spontaneously breathing newborns will be included in the study. Enrolled
        patients will be divided into two groups: 15 term (≥37 weeks GA) and 15 preterm (32-37
        weeks GA) newborns. NIRS measurements will be performed on the 1st and 3rd day of life.
      
Keywords: cerebral oxygenation; NIRS; tissue oximeters; near infrared spectroscopy; newborn
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Condition: Acute Myeloblastic Leukemia; Lymphoblastic Leukemia; Myelodysplasia; Chronic Myeloid Leukemia; Myelofibrosis; Lympho-proliferative Diseases
MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Lymphoproliferative Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare Reduced Intensity Conditioning protocols containing
      either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from
      voluntary unrelated donors.
    

Detailed description: 
      The reduction of intensity of conditioning is currently indicated for patients who cannot
      undergo standard myelo-ablation due to their age, comorbidities or type of pathology.
      Furthermore, the rationale to use RIC regimens is based on the observation that the infusion
      of alloreactive donor lymphocytes may yield to a graft versus tumour effect. However, in this
      kind of regimens the morbidity and TRM due to GvHD are still a concern and in vivo
      T-depletion is a necessary treatment. Both monoclonal (Alemtuzumab) and polyclonal
      T-depletion protocols carry risks and benefits. Benefits being a better prophylaxis for GvHD,
      and risks being an higher incidence of post-transplantation infections and relapse. At the
      moment, it is not clear which type of regimen, monoclonal or polyclonal, is better for the
      treatment.
    

Intervention name(s): Alentuzumab; Globulina antilinfocitaria
Intervention type(s): Drug; Drug
Intervention description(s): Alentuzumab; Globulina antilinfocitaria
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Academic Self-regulation, Parenting Dimensions and Academic Procrastination
Condition: Self-regulation; Parenting; Procrastination
Study type: Observational

Summary: 
      the method was the correlational way. The statistical population of the was all of the boy
      students of the second-period elementary school in Garmeh city (Iran). the sample size was
      278. The age of participants was in the range of 9 to13 years old.
    


Intervention name(s): descriptive method
Intervention type(s): Other
Intervention description(s): After obtaining relevant permissions from the university and organization of education and selecting participants, the study was explained for students and their satisfaction obtained. Then questionnaires were given to participants. To observe ethical considerations, questionnaires were anonymous and has been confided that the participants' responses was maintained in the study and is not given anyone
Other intervention name(s): correlation
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        male students in age range of 9 to 13 years old in Garmeh city(Iran)
AcuGraph and Digestive Symptoms
Condition: Digestive Disorders; Irritable Bowel Syndrome; Constipation; Diarrhea
MeSH terms: Irritable Bowel Syndrome; Digestive System Diseases; Constipation; Diarrhea
Study type: Observational

Summary: 
      This research is designed to study the reliability of the results of an AcuGraph in college
      students and faculty members with reported digestive symptoms
    

Detailed description: 
      The specific aim of the study is to test the reliability of the AcuGraph in subjects with
      irritable bowel syndrome (IBS). The hypothesis is that the AcuGraph will be a reliable method
      to identify disorders in subjects.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Logan students currently enrolled