bioihbjkbjnl/mcl2 huggingface dataset:
B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135
      and Y specific memory B Cells, measured 1 month after a primary vaccination series of
      Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human
      complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age
    


Intervention name(s): MenACWY-CRM; DTaP-Hib-IPV; PCV; MMR; Hib
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.; IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.; IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.; IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.; IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.
Other intervention name(s): Combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine; Pediacel; Heptavalent Streptoccus pneumonia; Prevnar; Measles, mumps, and rubella vaccine; Priorix; Vaxem Hib
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease; Prevention; Vaccination
A Single Session of tDCS (Transcranial Direct Current Stimulation) Improves Endurance for 30 Minutes
Condition: Athlete; Healthy
Study type: Interventional

Summary: 
      Healthy recreational athletes will undergo a session of anodal tDCS (transcranial direct
      current stimulation) or sham tDCS.

      The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' strength
      before and after each session
    

Detailed description: 
      Healthy recreational athletes will be recruited through social media and advertisements.

      Each subject came to the Liege University Hospitals' isokinetic lab. Each session began with
      strapping the subjet into the isokinetic machine, making sure that all the settings were
      adapted to the subject. Then, each subject underwent a concentric and eccentric isokinetic
      test of their lower limbs (dominant or non-dominant side depending on their group). Subjects
      then received either anodal tDCS, of sham tDCS. Neither the evaluator or the subject knew
      which they were receiving. Immediately following tDCS, there was a another isokinetic test,
      and 30 minutes after the second test, a subjects underwent a third test.
    

Intervention name(s): TDCS
Intervention type(s): Device
Intervention description(s): 20 minutes, 2 electrodes (C3/FP2)
Other intervention name(s): Non invasive brain stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, triple-blind, sham-controlled, crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: tDCS; Athlete; Isokinetic; Strength; Endurance
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
Condition: Colitis, Ulcerative; Crohn Disease
MeSH terms: Crohn Disease; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the PK of vedolizumab following a single intravenous
      infusion in healthy adult Chinese participants.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
      treat people who have ulcerative colitis (UC) or Crohn's disease (CD). This study will look
      at the PK, safety, and tolerability of vedolizumab following a single intravenous infusion of
      vedolizumab IV in healthy adult Chinese participants.

      The study will enroll approximately 16 participants. All participants will be assigned to
      receive a single dose of vedolizumab IV 300 mg on Day 1.

      This single center trial will be conducted in China. The overall time to participate in this
      study is approximately 7 months. Participants will make multiple visits to the clinic, and
      will be contacted by telephone, 6 months after single dose of study drug for a follow-up
      safety survey assessment.
    

Intervention name(s): Vedolizumab
Intervention type(s): Drug
Intervention description(s): Vedolizumab intravenous infusion.
Intervention MeSH terms: Vedolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery
Condition: Valvular Heart Disease; Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Heart Valve Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine Isoflurane's dose-dependent effect on left
      ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging
      (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane
      concentrations would be analyzed by using intraoperative transesophageal echocardiography
      (TEE) in cardiac surgery patients.
    

Detailed description: 
      Isoflurane is widely used in cardiac surgery patients due to its beneficial effects, but many
      studies have shown that isoflurane reduces myocardial contractility in a dose-dependent
      manner, and compromises left ventricular (LV) function.

      Tissue Doppler imaging (TDI) of mitral annular velocity during the cardiac cycle has been
      introduced as a reliable method for analysis of systolic and diastolic LV long-axis function.
      Efficacy of systolic and diastolic TDI profiles, including systole (S'), early early
      relaxation (E')and atrial contraction (A') have been suggested to be useful in predicting the
      impact of isoflurane on LV systolic and diastolic function.

      The investigators hypothesized that isoflurane, even at a clinical dosage, would affects
      intraoperative LV systolic function in a dose-dependent manner and thus produce significant
      changes int the TDI profiles of systolic mitral annular velocity (S').

      So the investigators planned to study the changes in S' of lateral mitral annulus at the
      clinical isoflurane dosage during remifentanil based anesthesia for cardiac surgery.
    

Intervention name(s): Isoflurane 1.0 MAC; Isoflurane 1.5 MAC; Isoflurane 2.0 MAC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 min-inhalation of each concentration of isoflurane, 1.0 MAC; 10 min-inhalation of each concentration of isoflurane, 1.5 MAC; 10 min-inhalation of each concentration of isoflurane, 2.0 MAC
Intervention MeSH terms: Isoflurane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Isoflurane; mitral valve annular velocity; tissue Doppler imaging; Monitoring; echocardiography
Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC
Condition: NSCLC Stage IV; Brain Metastases; PD-1 Antibody
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, Open-Label, Multicenter, Prospective Clinical Study to Investigate the
      Efficacy and Safety of Tislelizumab Combined with Pemetrexed/ Carboplatin in Patients with
      Brain Metastases of Non-squamous Non-small Cell Lung Cancer. The primary end point is PFS,
      and secondary endpoint is ORR, OS, DoR and Neurocognitive impairment. during the study, the
      exploratory objectives including (1) PD-L1 expression, TMB, and other potential predictive
      biomarkers, correlated with response to treatment (2) Progression-free survival based on
      intracranial response (iPFS) according to RECIST 1.1 and RANO-BM
    


Intervention name(s): Tislelizumab, Carboplatin, Pemetrexed
Intervention type(s): Drug
Intervention description(s): Tislelizumab: 200mg administered intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin: AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles
Pemetrexed: 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle
Intervention MeSH terms: Carboplatin; Pemetrexed; Tislelizumab
Intervention model: Single Group Assignment
Intervention model description: Tislelizumab Combined with Pemetrexed/ Carboplatin
Masking: None (Open Label)
Primary purpose: Treatment
a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric
Condition: Complications of Surgical and Medical Care: General Terms
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational

Summary: 
      laparoscopic hernia sac high-ligation

        -  has a high recurrence rate laparoscopic hernia sac high-ligation and the lateral
           umbilicus ligament covering the hernia opening

        -  The investigators developed a method of laparoscopic hernia repair by applying a new
           concept in hernia repair. The hernia opening was tightened, and hernia opening region
           repaired with a lateral umbilicus ligament in a tension-free manner. This method
           combines the advantages of a secure repair achieved by the open method with the minimal
           invasiveness of the laparoscopic method. The investigators hypothesized that the lateral
           umbilicus ligament covering the internal hernia opening region after the laparoscopic
           purse-string knot would result in lower recurrence and the same operation relative
           complication.
    

Detailed description: 
      The primary outcome measure was the recurrence rate after surgery, and the secondary outcome
      measures included degree of postoperative pain, the amount of postoperative analgesia,
      procedural duration, number of days to recovery normal activity, surgical complications,
      cosmetic results, and patient satisfaction. The outcome was recorded at the outpatient visits
      10 days, 6 months, 1 year, 3 years and 5 years after the surgery. The cosmetic result was
      scored (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by the patients or
      parents, the attending nurse, and the surgeon (maximum points = 9). The patient satisfaction
      was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The
      long axis of the testes was measured.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The sample size was calculated such that a 4% difference (α = 0.05) in recurrence rate at 5
        years between the groups could be detected with a power of 0.9. This required a sample size
        of 510 patients. Considering an estimated drop-out rate of 10%, we aimed to enroll 600
        patients.
      
Keywords: Inguinal hernia; Lateral umbilicus ligament; Recurrence
Responses to Colloid Infusions
Condition: Laparoscopic Cholecystectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      In situations such as dehydration, illness and surgery, fluid 'drips' are given to patients
      to keep them hydrated. Different fluids stay in the circulation for different lengths of
      time. For example, some types of fluid remain in the circulation for a short time which means
      patients would need to be given more fluid to achieve the desired effects. Giving a lot of
      fluid to sick patients can in itself cause problems, for example, it can affect the way the
      bowels work and delay the patient's recovery from illness. In these situations the
      investigators use specialized fluids called colloids, that are designed to stay in the
      circulation for longer. This means a smaller amount of fluid needs to be used and less
      problems are likely to occur. There are two different types of colloids that are commonly
      used, but the investigators do not know which of them is better. The purpose of this study is
      to investigate which of the two different colloids (one is called Gelofusin and the other is
      called Voluven) works better in patients who undergo surgery. Knowing which of the two fluids
      works best in patients will help us improve the care of surgical patients. The investigators
      hypothesis is that the fluid that has the larger size of molecules as part of the solution
      will work better during surgery.
    

Detailed description: 
      To study the responses of patients to 1 litre infusions of Gelofusine (succinylated gelatine
      40g/L) and Voluven (6% hydroxyethyl starch in 0.9% saline) over 1 h intraoperatively. In
      particular, the extent and time course of the effects of the two infusions on haematocrit,
      serum albumin, serum biochemistry, plasma expanding capacity and the resultant urinary
      responses will be measured
    

Intervention name(s): Succinylated gelatine, 40g/L, (Gelofusine - B Braun)
Intervention type(s): Other
Intervention description(s): 1 litre infusion following induction of anaesthesia
Intervention MeSH terms: Polygeline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: The responses of patients to 1L infusions of Gelofusine (succinylated gelatine 40g/L) and Voluven (6% hydroxyethyl starch in 0.9% saline) intraoperatively.
Impact of Butyricicoccus Pullicaecorum in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      During this project the safety, tolerability and effect on gut microbiota of oral
      administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers
      by a placebo-controlled cross-over randomized study.
    

Detailed description: 
      Intervention periods were 4 weeks, with daily intake of 1 capsule. Wash-out periods were 3
      weeks.
    

Intervention name(s): Butyricicoccus pullicaecorum 25-3T; Maltodextrin
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): LMG 24109T; CCUG 55265T
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Metformin in Children With Motor Deficit
Condition: Spina Bifida; Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases; Spinal Dysraphism
Study type: Interventional

Summary: 
      Obesity with insulin resistance in the paediatric population provides an increasing
      challenge. Children with neurological or neuromuscular diseases are even more prone to
      obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease
      in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated
      with a decrease in physical fitness and a further increase in body fat. In this study we want
      to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese
      patients with neurological or neuromuscular diseases. Metformin is a well-established insulin
      sensitizer.
    


Intervention name(s): Metformin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): daily 850 mg; placebo
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: metformin, spina bifida, duchenne, insulin resistance
A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and
      efficacy with follitropin alfa injection applied by Pen device compared with the subject's
      previous experience with injectable gonadotropins in oligoanovulatory infertile women
      undergoing ovulation induction
    


Intervention name(s): Follitropin alfa injected by Pen device; Recombinant Human Choriogonadotropin (r-hCG)
Intervention type(s): Device; Device
Intervention description(s): Follitropin alfa will be injected subcutaneously by Pen device at a dose of 75 International Unit (IU) and 150 IU in subjects aged 18-34 and 35-40 years, respectively, for 5 days. Dose will be adjusted on stimulation Day 6 until ovulation triggering criteria will met.; Recombinant Human Choriogonadotropin (r-hCG) injection will be administered as a single dose of 250 microgram subcutaneously when at least 1 follicle, but not more than 3 follicles, reached a mean diameter greater than or equal to (>=)17 mm and estradiol levels are approximately 150 picogram per milliliter (pg/mL) per mature follicle.
Other intervention name(s): Gonal-f®; Ovidrel®; Choriogonadotropin alfa
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oligoanovulatory infertility; Follitropin alfa; Pen device; Gonal-f®; Recombinant Human Choriogonadotropin (r-hCG); Ovidrel®
Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Physical exercise programs are effective and safe for the improvement of the sleep efficiency
      in patients with Rheumatoid Arthritis.
    


Intervention name(s): Combined Training ( Strength + Aerobics)
Intervention type(s): Other
Intervention description(s): Strength training performed using workout devices and aerobic training performed using stationary bicycle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Sleep Disorders; Polysomnography; Sleep Stages; Physical Exercise
The Effect of USM-IAM-based Counselling
Condition: Diabetes Type 2 on Insulin
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      According to the most current local data, the rate of patient's adherence to insulin
      injections is very low. A recent cross sectional study in Klinik Pakar Perubatan (KPP)
      Hospital Universiti Sains Malaysia (HUSM) among 355 patients with Type 2 diabetes treated
      with insulin showed only 19% of patients adhered to their insulin regime with the mean
      fasting plasma glucose of 10mmol/L and mean HbA1C of 10.0%. This condition may lead to
      undesirable health consequences.

      Patients education has been showed to improved adherence. Among the 355 participants involved
      in the study, 82% of the patients have received consultation by diabetic educators yet their
      glycemic control were suboptimal. A new approaches using a module-based counseling that
      emphasized on adherence has been developed and the effectiveness of the counseling need to be
      evaluated.
    

Detailed description: 
      General objective: To determine the effect of USM-insulin adherence module (U-IAM)-based
      counseling on the insulin adherence, glycemic control and inflammatory markers in
      poorly-controlled type 2 diabetes mellitus patients on insulin therapy.

      Specific objective:

        1. To determine within group changes and between group differences of insulin adherence
           score (using IAQDM) between patients in intervention and control group at baseline, 3rd
           month and 6th month

        2. To determine within group changes and between group differences of FBS and HbA1c between
           patients in intervention and control group at baseline, 3rd month and 6th month.

        3. To determine within group changes and between group differences of HsCRP and VCAM-1
           between patients in intervention and control group at baseline, 3rd month and 6th month.

        4. To identify factors associated with nonadherence (before starting of intervention) among
           patients on insulin such as sociodemographic, SMBG and treatment factors.
    

Intervention name(s): The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
Intervention type(s): Other
Intervention description(s): To study the effect of counseling using USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in improving Insulin Adherence, Glycemic Control and Inflammation
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparing effect of counseling to insulin adherence, FBS, HbA1c, HsCRP and VCAM-1
Masking: None (Open Label)
Primary purpose: Other