bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
Condition: Prevention of Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, immunogenicity and induction of immune
      memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate
      Vaccine administered to healthy infants.
    


Intervention name(s): MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation); MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation); MenACWY PS (MenACWY-CRM, polysaccharide vaccine); HBV (Hepatitis B vaccine); Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197); MMR (Measles, Mumps and Rubella vaccine); DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine); Menjugate (Men C conjugated vaccine)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.; MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.; MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.; Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.; Prevnar was administered IM in the anterolateral area of the left thigh.; MMR at 12 month of age, administered in the left arm.; DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.; Menjugate was injected IM in the anterolateral area of the right thigh.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Exercise Interventions on Problematic Mobile Phone Use: a Multi-arm Randomized Controlled Trial
Condition: Exercise Intervention; Tai Chi Chuan; Intestinal Flora; Randomized Clinical Trial
Study type: Observational

Summary: 
      Problematic mobile phone use (PMPU) has been described as a growing public health issue. This
      randomized controlled trial aimed to determine if aerobic exercise or Tai Chi Chuan as
      compared to the wait-list control group decreased PMPU-related symptoms; and to analyze the
      composition of the intestinal flora in the three study groups to explore the correlation
      between PMPU scores and flora species. A consecutive sample of 90 college students with PMPU
      was randomized to the aerobic exercise group (AE group, n = 30), the Tai Chi Chuan group (TCC
      group, n = 30), or the wait-list control group (WLC group, n = 30). The primary outcome was
      addiction symptoms, i.e., the PMPU score as assessed by the Smartphone Addiction Scale-Short
      Version (SAS-SV). Secondary outcomes were the emotion-related symptoms (depression, anxiety,
      self-esteem and self-efficacy), and physical-related symptoms (sleep quality,
      physical-fatigue and mental-fatigue). Intervention effects were analyzed via generalized
      estimated equation analysis (GEE).
    


Intervention name(s): aerobic exercise or Tai Chi Chuan interventions
Intervention type(s): Behavioral
Intervention description(s): 8-week aerobic exercise (AE group), 8-week Tai Chi Chuan training (TCC group)
Other intervention name(s): aerobic exercise; Tai Chi Chuan
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Participants were recruited between February 2022 and March 2022. Participants from Anhui
        Medical University were recruited through promotion in academic departments and student
        societies as well as advertisements in social media (We-chat and QQ). The coordinator
        subsequently contacted potential participants via We-chat to provide them with information
        regarding the study; and determine their interest and eligibility.
      
Keywords: Problematic Mobile Phone Use; Exercise Intervention; Aerobic Exercise; Tai Chi Chuan; intestinal flora
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes
Condition: Diabetes; Metabolic Syndrome; Insulin Resistance
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      Growth hormone is well known to cause changes in glucose regulation. People with Laron
      syndrome are born without the growth hormone receptor and are protected from diabetes. Mice
      who are engineered without the growth hormone receptor are similarly protected from diabetes.
      Conversely, people who have excessive amounts of growth hormone, such as patients with
      acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment
      with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the
      growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been
      explored as a possibility for the treatment of type 2 diabetes or insulin resistance in
      people without acromegaly. In this study, the investigators hope to study the metabolic
      effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is
      expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum
      free fatty acids.
    


Intervention name(s): pegvisomant
Intervention type(s): Drug
Intervention description(s): Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Other intervention name(s): Somavert
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth hormone antagonism
A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I study is to assess the mass balance recovery after a single oral dose of
      [14C]-AK0529 in healthy male subjects.
    

Detailed description: 
      This is a single centre, single-dose, non-randomised, open label study. The primary
      objectives of this study are to assess the mass balance recovery and provide biosamples for
      metabolite profiling and structural identification after a single oral dose of [14C]-AK0529
      in healthy male subjects. 7 subjects will be recruited to receive a single oral
      administration of a solution containing 300 mg AK0529. The total duration of the study will
      be approximately 6 weeks.
    

Intervention name(s): AK0529
Intervention type(s): Drug
Intervention description(s): A solution containing 300 mg radiolabelled AK0529.
Intervention MeSH terms: Ziresovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain Reduction After Cholecystectomy
Condition: Cholecystolithiasis; Postoperative Pain
MeSH terms: Cholecystolithiasis; Cholelithiasis; Gallstones; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the effect of combined intracutaneous infiltration and intraperitoneal
      instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic
      cholecystectomy on abdominal pain up to 24 hours after surgery.
    

Detailed description: 
      The primary endpoint of this study was postoperative abdominal pain as measured by a visual
      analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a
      score from 0 to 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the
      surgical procedure the primary investigator visited the patient to obtain the VAS scores.
    

Intervention name(s): Levobupivacaine
Intervention type(s): Drug
Intervention description(s): 0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally
Other intervention name(s): Chirocaine (brand name); NDA 20-997
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gallstone; gallbladder; cholecystectomy; laparoscopic; pain
Study of Glycemic Control on Liver Transplantation Outcomes
Condition: Evidence of Liver Transplantation; Hyperglycemia; Rejection
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Many but not all studies have shown improvement in morbidity and mortality with intensive
      glycemic management postoperatively. In this study, the investigators propose to determine
      whether improved glycemic control using intensive insulin treatment immediately
      postoperatively will improve outcomes in patients undergoing liver transplant using a
      prospective, controlled, randomized, parallel-group study design targeting two different
      glucose levels, 140 and 180 mg/dL.
    

Detailed description: 
      Many studies have shown improvement in morbidity and mortality with intensive glycemic
      management postoperatively. However, some recent studies have not been able to reproduce
      these benefits and have raised the issue of adverse consequences of hypoglycemia associated
      with intensive therapy. Our own data show an association of increased graft rejection
      proportional to postoperative glucose levels in patients who have undergone a liver
      transplant. Preliminary data suggest that this may improved by better glycemic control using
      the Glucose Management Service here at Northwestern.

      In this study, we propose to determine whether improved glycemic control using intensive
      insulin treatment immediately postoperatively will improve outcomes in patients undergoing
      liver transplant using a prospective, controlled, randomized, parallel-group study design
      targeting two different glucose levels, 140 and 180 mg/dL. Postoperative glucose management
      with insulin will be supervised by the Glucose Management Service as is routine, with the
      only research aspect being the two different glucose targets and the outcome analysis with
      liver transplant rejection as the primary outcome and infections and hypoglycemia being the
      principle secondary outcomes.
    

Intervention name(s): Insulin
Intervention type(s): Drug
Intervention description(s): Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
Other intervention name(s): glargine insulin; aspart insulin; Lantus insulin; Novolog insulin; Detemir insulin; Levemir insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver; transplantation; Glucose; Hyperglycemia; Insulin; Rejection; Hypoglycemia
Parent Preferences and Family Engagement in a Conduct Problems Prevention Program
Condition: Conduct Problems
Study type: Interventional

Summary: 
      The purpose of this study is to gain a better understanding of family preferences for and
      engagement in services.
    

Detailed description: 
      The overarching goal of this pilot project is to elucidate factors that influence families'
      engagement in indicated prevention/early intervention programming for youth conduct problems.
      We will explore factors previously shown to influence engagement, including parent
      motivational cognitions, family context variables, and preferences for intervention type.
      Study aims are organized around a randomized preference trial with a parallel hybrid design
      structure (see Abikoff, 2001). Families with youth ages 5-12, referred to community mental
      health clinics in Michigan, will be invited to participate in a prevention study. Families
      who chose to participate were assigned at random to preference (i.e. choice) or no preference
      (i.e. no choice) conditions. Those randomly assigned to the preference condition were allowed
      to choose between four intervention options: clinic-based services-as-usual (youth
      intervention); individual, home-based Oregon Parent Management Training (PMTO; Patterson,
      2005), individual, clinic-based PMTO, and in-person group-based PMTO (Parenting Through
      Change; Forgatch & DeGarmo, 1999). Families in the no-choice condition were randomly assigned
      to one of the same four conditions.
    

Intervention name(s): PMTO-PTC Group clinic-based; PMTO Individual home-based; PMTO Individual clinic-based; Services as Usual
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Other intervention name(s): PMTO-Parenting Through Change - Group; Oregon Parenting Management Training - Individual @ home; Oregon Parent Management Training - Individual @ clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
Condition: Pharmacokinetics Study in de Novo Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic
      properties compared to Prograf® in de novo renal transplant patients and whether the
      comparable exposure resulted in similar renal function.
    

Detailed description: 
      In Phase II of this study there was a high patient drop-out rate and an associated long
      recruitment timespan. Eighty-one patients were recruited to Phase I and only 45 of the
      required 54 patients were available for PK analysis. To complete Phase II, 245 (in addition
      to 81) patients were to be required to achieve calculated sample size. Therefore the protocol
      was amended to stop recruitment and analyze Phase I patient data of CERL080ADE27 (PK-Phase
      I). Patients that were still ongoing were scheduled for an end of study (EOS) visit. During
      this visit patients were informed by the investigator about the end of study and advised
      about further treatment course.
    

Intervention name(s): Prograf; Tacrolimus Hexal
Intervention type(s): Drug; Drug
Intervention description(s): Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.; Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,
1 mg and 1.5 mg.
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics Study; Tacroliums; GFR; kidney; transplant rejection; allograft rejection; xenograft rejection; host vs graft disease; renal transplant
This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study in adults with schizophrenia. The study tests whether a medicine called BI
      425809 together with brain training improves mental abilities.

      Participants take study medication once a day for 12 weeks. At the start of the study, the
      participants are put into 2 groups. It is decided by chance who gets into which group. One
      group gets BI 425809 tablets every day. The other group gets placebo tablets every day.
      Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study,
      all participants do brain training using a computer.

      The doctors regularly test mental abilities of the participants. The results of the mental
      ability tests are compared between the groups. The doctors also check the general health of
      the patients.
    


Intervention name(s): BI 425809; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; Tablet
Other intervention name(s): iclepertin
Intervention MeSH terms: BI 425809
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine
      for ultrasound guided thoracic paravertebral block in thoracotomy
    

Detailed description: 
      paravertebral block is commonly used in the treatment for acute and chronic pain.The duration
      of paravertebral block could theoretically be prolonged with neurolytic agents.
      Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of
      prolonging duration of sensory and motor block on nerve blocks.
    

Intervention name(s): bupivacaine; dexmedetomidin; serum physiologic
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 21 ml 0.5 %bupivacaine is applied paravertebral space; 1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied paravertebral space; 21 ml serum physiologic is applied paravertebral space
Other intervention name(s): marcaine; precedex
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Urdu Version of Kujala Questionnaire: A Reliability and Validity Study
Condition: Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Observational

Summary: 
      The aim of this research is to interpret and make Kujala Questionnaire adaptable culturally
      into Urdu to investigate its validity and reliability in Pakistani population among anterior
      knee pain or patello femoral knee pain. Also check its correlation with 36-Item Short Form
      Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee
      Documentation Committee Subjective Knee Evaluation Form.
    

Detailed description: 
      The original English version of Kujala Questionnaire will be translated and culturally
      adapted as per previous recommendation. In patients with anterior knee pain or patella
      femoral knee pain, Kujala Questionnaire-Urdu will be distributed among hundred participants
      choose a convenience sampling technique based on pre-defined inclusion and exclusion
      criteria. To test reliability of inter/intra observer of ultimate final Urdu Version of
      Kujala, 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000
      International Knee Documentation Committee Subjective Knee Evaluation Form will be filled
      from patients on the equivalent day, by 2 different bystanders, and for inter observer
      valuation, with an interval of 30 minutes between the first and second application. Third
      assessment will be carried out after 7 days of the Observer -1 (re-testing), for
      intra-observer assessment. Data will be entered and analyzed Cronbach alpha value.
      Test-retest reliability will be assessed using an intraclass correlation coefficient. Urdu
      Version of Kujala was evaluated for content validity, construct validity, criterion validity
      and responsiveness.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pakistani population with patello femoral pain syndrome and anterior knee pain.
      
Keywords: Kujala Questionnaire; patello femoral pain syndrome; anterior knee pain; validity; functional limitations; reliability
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of SPD465 compared to
      placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also
      look at how SPD465 affects the participants sleep and how they perceive their quality of
      life.
    


Intervention name(s): Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Intervention type(s): Drug
Intervention MeSH terms: Amphetamine; Dextroamphetamine; Adderall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS)
      have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been
      shown to effectively reduce the incidence of PLMs in patients with RLS. The current study
      aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal
      BP elevations associated with PLMs in patients with RLS.
    


Intervention name(s): Rotigotine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.; Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rotigotine; Neupro; RLS; Cardiovascular Risk; Nocturnal Blood Pressure