bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and
      dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly
      in Bacille Calmette-Guerin (BCG) primed infants.
    

Detailed description: 
      This is a Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity
      and dose-range finding study in HIV-uninfected, HIV-unexposed, BCG-primed infants. The study
      vaccine AERAS-404 or placebo will be administered without concomitant EPI vaccines (Cohorts 1
      to 5, N = 159 subjects) and with concomitant EPI vaccines (Cohort 6, N = 70 subjects). Study
      vaccine or placebo will be administered as a single dose (injection) at Study Day 0 ( ≥168 to
      ≤ 196 days of age, Cohorts 1 and 2), a 2-dose schedule at Study Day 0 (≥ 168 to ≤ 189 days of
      age) and Study Day 28 (Cohorts 3A and 3B) or a 3-dose schedule at Study Day 0 (≥ 84 to ≤ 98
      days of age), Study Day 42 and Study Day 98 (Cohorts 4 and 5). Subjects in Cohort 6 will
      receive the study vaccine or placebo at Study Day 0 (≥ 64 to ≤ 83 days of age), Study Day 28
      (≥ 91 to ≤ 105 days of age), and Study Day 210 (≥ 273 to ≤ 287 days of age). A cohort will
      enroll once safety in the previous cohort has been established. AERAS-404 is an
      investigational vaccine manufactured by Sanofi Pasteur (SP) and Statens Serum Institute
      (SSI).
    

Intervention name(s): AERAS-404; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): AERAS-404 has two components: the H4 antigen and the IC31 adjuvant. The reconstitution of the vaccine components, H4 antigen (manufactured at SP) and IC31 adjuvant (supplied by SSI), will take place at the clinical research site (CRS) prior to injection.; Tris buffered saline (10mM Tris, pH 7.4, 150nm sodium chloride).
Other intervention name(s): H4; Tris buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: BCG Vaccinated; HIV Negative
Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
Condition: Hypertension; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The study hypothesis: Valsartan as an angiotensin II receptor blocker treatment has
      beneficial effects on both midwall mechanics and myocardial functions in hypertensive
      patients with Left ventricular hypertrophy.
    


Intervention name(s): valsartan
Intervention type(s): Drug
Intervention description(s): 80/160 mg dosage of valsartan or 160+12,5 mg valsartan+hydrochlorothiazide combination, once a day, for six months
Other intervention name(s): Diovan 80 mg; Diovan 160 mg; Co-diovan 160/12,5 mg
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; left ventricular hypertrophy; angiotensin receptor blocker; midwall mechanics; tissue Doppler imaging; Hypertension with left ventricular hypertrophy
Series Studies of Bipolar Disorder-Valproate add-on Memantine
Condition: Bipolar Disorders
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      All participants should fulfill the following criteria: aged between 18 and 65 years old, and
      of domestic Han descendants. Participants will be randomly assigned to either the (1)
      pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on
      memantine) plus Cognitive Behavior Group Therapy (CBGT) group; (3) valproate add-on placebo
      plus CBGT group, or (4) valproate add-on placebo only group. A total of 240-320 individuals
      (60-80 participants per group) will be recruited for this study. For each CBGT group,
      12-weekly sessions are scheduled according to patients' preference. The investigators will
      attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on
      neuro-protective drugs, pharmacotherapy with CBGT, mood stabilizer with CBGT, and the use of
      only traditional mood stabilizers in the treatment of BP II. Comparisons will be made for
      each type of treatment and possible mechanisms will be examined regarding the pharmacotherapy
      and CBGT for bipolar disorder patients.
    


Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg per day of memantine
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain
Condition: Varicocele; Postoperative Pain
MeSH terms: Varicocele; Pain, Postoperative
Study type: Interventional

Summary: 
      Aim of this study is to examine the effects of subcutaneously applied local anesthetics at
      trocar site in combination with intraoperative intraperitoneal analgesia on duration and
      character of pain in pediatric patients undergoing laparoscopic varicocelectomy.
    


Intervention name(s): 2% Lidocaine; 0.5% levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 6 mL of 2% lidocaine injected at the trocar insertion site.; 6 mL of 0.5% levobupivacaine injected at the trocar insertion site.
Intervention MeSH terms: Lidocaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A First-In-Human Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD,
      first-in-human study in subjects with mild to severe AD receiving si-544. The study consists
      of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and
      will be randomized within each cohort to treatment with si-544 or placebo. Initially, 2
      sentinel subjects will be treated (randomized to placebo or si-544) in each cohort.
    


Intervention name(s): si-544; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection in the abdomen; Subcutaneous injection in the abdomen
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study consists of 2 parts, a single ascending dose (SAD) part, and a multiple ascending dose (MAD) part.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Eczema; Neurodermatitis
The Effect of Nicotine Delivery Rate on Reinforcement
Condition: Nicotine
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project
      addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence
      threshold among youth and adults and impact of nicotine reduction on tobacco product use
      behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and
      relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is
      necessary for accurately assessing dose-response and threshold effects. The estimated
      threshold for reinforcement will establish a benchmark for evaluating the addictive potential
      of ECs and other inhaled nicotine products.
    

Detailed description: 
      A placebo-controlled study that will recruit male and female nicotine dependent smokers/EC
      users (n=18) to complete four separate experimental sessions. Each session will include one
      randomly assigned infusion that will be either saline or a single dose of nicotine (1 mg per
      70 kg body weight) delivered at three different infusion rates, rapid, moderate or slow
      (0.24, 0.048 or 0.024 mcg per kg body weight per second). A total infusion duration of 10 min
      will be maintained during each session by adding saline infusions of variable duration after
      nicotine delivery. This will be achieved by two separate infusion pumps, one for saline and
      one for nicotine. For example, the rapid 0.24 mcg/kg/s condition will include a 1 min
      infusion of nicotine followed by a 9 min infusion of saline. The subjects will be blinded to
      the infusion pump procedures. The rapid delivery rate, which we have used in our prior
      studies, induces positive subjective drug effects and suppresses symptoms of nicotine
      withdrawal. The moderate delivery rate,0.048 mcg/kg/s, approximates the rate of nicotine
      intake encountered while smoking a typical cigarette over 5 min (4). The slowest nicotine
      delivery rate, 0.024mcg/kg/s, was chosen to approximate the rate of nicotine intake
      encountered while using a newer EC (5).
    

Intervention name(s): Nicotine saline 0.00mcg/kg/s; Nicotine 0.24 mcg/kg/s; Nicotine 0.048 mcg/kg/s; Nicotine 0.024 mcg/kg/s
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): saline 0.00mcg/kg/s; nicotine 0.24 mcg/kg/s; nicotine 0.048 mcg/kg/s; nicotine 0.024 mcg/kg/s
Other intervention name(s): nicotine infusion; nicotine infusion; nicotine infusion; nicotine infusion
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The effects of different IV nicotine delivery rates of (saline), 0.24, 0.048 and 0.024 mcg/kg/s), as a within-subject factor, on peak change in the intensity of subjective effects as measured by the DEQ, will be used as a measured of a reinforcing threshold.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: nicotine, smoking
The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength
Condition: Post-traumatic; Arthrosis; Osteoarthritis Thumb
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The aim of the study is to measure the position of the metacarpophalangeal joint of the thumb
      during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the
      optimal position of metacarpophalangeal joint arthrodesis.
    

Detailed description: 
      The aim of the study is to measure the position of the metacarpophalangeal (MCP) joint of the
      thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine
      the optimal position of metacarpophalangeal joint arthrodesis.

      The force will be measured in three positions (key-pinch, tripod-pinch and opposition-pinch).
      Also measured is the degree of flexion of the MCP joint of the thumb. The mobility of the MCP
      joint of the thumb in maximum flexion and extension will also be measured. A total of about
      300 healthy volunteers will be examined, with no history of trauma or disease to tendons or
      joints of the thumbs and between the ages of 18 and 40. The sponsor of this study is
      Professor Nadine Hollevoet. Master students of medicine from the faculty of medicine and
      health sciences will be part of the research team.
    

Intervention name(s): measurement of range of motion and strength
Intervention type(s): Other
Intervention description(s): measurement of range of motion (goniometer) and strength (dynamometer) of the metacarpophalangeal joint of the thumb
Intervention model: Single Group Assignment
Intervention model description: measurement of the joint mobility and the force of the thumb
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh
Condition: Incisional Hernia
MeSH terms: Hernia; Incisional Hernia
Study type: Interventional
Phase: Phase 1

Summary: 
      The intraperitoneal repair has been proven safe for the repair of incisional hernia and is
      accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the
      repair of incisional hernia. However no studies have convincingly proven that this approach
      is better than the on-lay repair.

      The authors believe that the intraperitoneal repair performs better than the on-lay repair
      for incisional hernia.
    


Intervention name(s): Implant of a prosthetic mesh
Intervention type(s): Device
Intervention description(s): A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Incisional hernia; Intraperitoneal mesh repair; On-lay repair; Prosthetic mesh; First repair (no recurrent hernia will be included); Recurrence; Complications
The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet
Condition: Healthy; Focus: Effect of Processing on Energy Value of Almonds
Study type: Interventional

Summary: 
      The objective of this study is to measure the effect of processing (roasting, slicing, or
      grinding) on the energy value of almonds in the human diet and study molecular mechanisms
      that may help explain the beneficial health effects of almonds.
    

Detailed description: 
      The metabolizable energy values, or Atwater general factors, for protein, fat, and
      carbohydrate are commonly used to calculate the metabolizable energy of a diet. Atwater
      factors are based on average values of mixed diets and are not exact; thus, using these
      values could introduce an error in the calculated metabolizable energy of a particular food
      due to differences in chemical structure and availability. Studies have demonstrated that
      Atwater general factors overestimate the energy derived from protein and fat, as well as the
      measured metabolizable energy of mixed diets, particularly those that are high in dietary
      fiber. Studies are lacking, however, that examine how different processing methods affect the
      metabolizable energy of a food due to differences in chemical structure and availability.
    

Intervention name(s): Control; Whole Almonds; Roasted Whole Almonds; Diced Almonds; Almond Butter
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Controlled diet for 3 weeks with 0 servings/day of almonds.; Controlled diet for 3 weeks with 1.5 servings/day of whole, natural almonds.; Controlled diet for 3 weeks with 1.5 servings/day of roasted whole almonds.; Controlled diet for 3 weeks with 1.5 servings/day of diced almonds.; Controlled diet for 3 weeks with 1.5 servings/day of almond butter.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Stress Levels and Mental Well-Being Among Students During e-Learning
Condition: Anxiety; Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      Introducing restrictions on human contact has been effective in preventing the uncontrolled
      spread of COVID-19, however, it appears to have negatively impacted mental health.
      Psychological problems in different age groups occur with different intensity and duration of
      the pandemic. This study was aimed to assess the impact of introducing distance learning
      (e-Learning) on the stress levels and mental well-being among Polish, Slovak and Lithuanian
      Students.
    

Detailed description: 
      The COVID-19 pandemic has had the effect of accelerating changes in educational processes
      around the world. It resulted in a rapid conversion from face-to-face to online classes. This
      has disrupted the regular pattern of education and standard practices that have been followed
      for many years. It is a big organizational challenge for the academics but most importantly
      for the students. Remote learning has resulted in long-term social isolation and limitations
      in interaction with peers. It has also been noted that about 30% of students have symptoms of
      depression and increased levels of perceived stress, which during the COVID-19 pandemic
      affects about 50% of young people. Many factors have an impact on this condition, besides the
      epidemic situation, the social mood and the numerous restrictions, the prolonged time spent
      online and the reduced level of physical activity have an additional negative impact on their
      mental health. Due to the dynamic situation of the pandemic, there is a lack of current
      studies on the mental state of young people especially in the context of ongoing e-learning.
      Therefore, it was decided to investigate what is the prevalence of depressive disorders and
      the level of perceived stress during the ongoing remote learning in the group of students of
      8 European Universities among Poland, Slovakia and Lithuania.
    

Intervention name(s): Stress Levels and Mental Well-Being assessment
Intervention type(s): Diagnostic Test
Intervention description(s): At the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Students participating in active learning
      
Keywords: depression; anxiety; COVID-19; e-Learning
Effect of Preoperative Psychological Intervention on the Degree of Cooperation During Tracheal Catheter Extubation in Patients
Condition: Nurse's Role
Study type: Interventional

Summary: 
      The patients in the experimental group received the relevant knowledge education in the
      recovery period 30 minutes before anesthesia. The operation time, anesthesia time,
      cooperation degree score, total cooperation rate and patient satisfaction were observed and
      recorded. Results: there was no significant difference in operation time and anesthesia time
      between the experimental group and the control group (P < 0.05). The percentage of patients
      in the experimental group was 20.12% and 70.89% respectively, while that in the control group
      was 40.32% and 20.73% respectively (P < 0.05). The total cooperation rate was 95.00% in the
      experimental group and 77.00% in the control group. There was significant difference between
      the two groups (P < 0.05). The satisfaction of patients in the experimental group was 95%.
      65% of the patients in the control group were satisfied (P < 0.05). Conclusion: preoperative
      psychological intervention for patients with general anesthesia and endotracheal intubation
      can significantly reduce the restlessness and uncooperative phenomenon during extubation, and
      improve the cooperation rate and satisfaction of patients.
    


Intervention name(s): preoperative psychological intervention
Intervention type(s): Other
Intervention description(s): including closing the relationship between nurse and patient , knowledge education,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment of Non-falciparum Malaria
Condition: Acute Non-falciparum Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Patients with non-falciparum infection will be given artemether-lumefantrine for three days
      and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on
      immunology will be performed.
    


Intervention name(s): artemether-lumefantrine
Intervention type(s): Drug
Intervention description(s): Standard artemether-lumefantrine treatment
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Educational Program and Schoolchildren's Energy Expenditure
Condition: Physical Activity
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the impact of a classroom teachers' educational
      intervention on 1st and 2nd grades children's physical activity level and energy expenditure
      during physical education classes in elementary public schools, in São Paulo, Brazil.
    

Detailed description: 
      This study is a School-based Randomized Controlled Trial. Three-step cluster sampling was
      used for subject selection. In the first step, 8 schools in the Vila Mariana district - São
      Paulo were selected and assigned randomly to physical activity intervention (3 schools) or
      control condition (5 schools). In the second step, all 48 classes from the 1st and 2nd grades
      were selected. In the third step, 352 children were randomly selected compose the
      observational group. In both groups, questionnaire data and SOFIT's observation were
      collected two times: "pre" (immediately before the intervention), and "post" (immediately
      after the intervention), with a six weeks interval between them. No educational intervention
      was taken place in the control schools while the project was running. Afterwards control
      schools received training.
    

Intervention name(s): Educational Intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention was applied to classroom teachers by the multidisciplinary team of the RRIDA Project. Training lasted six weeks, 12 hours devoted to physical activity and 18 hours to nutritional content. Modules of educational activities to classroom teachers were to be replicated at PE classes to children from 1st and 2nd grades of three exposed schools. The physical activity module was based on a theoretical approach of physical activity benefits and risks for health, children's physical fitness and activity patterns, physical education and change behavior models.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Energy Expenditure; Physical Education; Children; Randomized Controlled Trial