bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to determine the effect of raltegravir on pravastatin
      pharmacokinetics and vice versa by intrasubject comparison.
    

Detailed description: 
      Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and
      pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both
      agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug
      interaction.

      Because co-administration will be indicated in many HIV-infected patients, it is essential to
      investigate this potential interaction.
    

Intervention name(s): Pravastatin; Raltegravir; Pravastatin and raltegravir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg tablet; QD; 4 days; 400mg tablet; BD 4 days; pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days
Other intervention name(s): Selektine; Isentress; Selektine and Isentress
Intervention MeSH terms: Raltegravir Potassium; Pravastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interaction; statins; pharmacokinetics
Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions
Condition: Cognitive Change; Child Development
Study type: Interventional

Summary: 
      The use of board games in classrooms has been increasing in recent years. Education and
      psychology professionals have found in the board game a way to train some key cognitive
      processes for good academic development: executive functions. Recent research has obtained
      promising results using modern board games as a neuroeducational intervention in children and
      old people (Benzing et al., 2018; Estrada-Plana et al., 2019; Estrada-Plana et al., 2020;
      Vita-Barrull et al., 2022). However, there is still little evidence of its cognitive and
      academic benefits in typically developing school-age children. Given that it is a methodology
      that, due to its dynamism and flexibility, could be adapted to different developmental
      levels, it has been proposed to study the possible effects on executive functions and
      academic skills of a classroom intervention based on board games with school children from
      rural areas of Spain (6-12 years). An experimental group will carry out the game program
      Conectar Jugando, which will be guided by the teachers themselves, through stable game groups
      of 3-4 students. On the other hand, a control group will develop the classes in a habitual
      way without the inclusion of board games and will be compensated at the end of the
      evaluations. The students of each center will be randomly assigned to the experimental group
      and the control group.
    

Detailed description: 
      The hypotheses of the study are:

      i) the experimental group will show a significantly higher improvement than the control group
      in the neuropsychological tasks that assess executive functions after completing the Conectar
      Jugando program; ii) the experimental group will show a significantly higher improvement than
      the control group in the academic content tasks after the intervention; iii) the experimental
      group will show a significantly higher improvement than the control group in the results of
      the evaluations carried out by their families regarding behaviors related to executive
      functions.

      All hypotheses will be controlled for age, estimated IQ and socioeconomic level, as well as
      previous experience in board games and other cognitive activities.
    

Intervention name(s): Conectar Jugando Game Program
Intervention type(s): Behavioral
Intervention description(s): Modern Board and Card Games as Cognitive Training in Rural Elementary Classrooms
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: executive function; modern board games; cognitive training; school-age children; rural school
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell
      administration in treatment of ischemic damages of cardiovascular system with control group,
      who will be treated by the administration of placebo during the sham procedure.
    

Detailed description: 
      It is planned to enroll 105 patients into AMI trial with randomization into active
      (CardioCell) therapy and sham procedure/placebo administration with 2:1 ratio.

      Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded
      fashion, labelled CardioCell to determine the early uptake and retention of IMP in the target
      ischemic tissues.

      The primary research question of this project is to check if the administration of CardioCell
      could improve the clinical outcomes in patients with AMI. There are several secondary
      questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to
      administered, if the investigated treatment is safe and way of CardioCell administration, if
      it is possible to define any selected subgroup in which the treatment results are
      significantly different than in whole group.
    

Intervention name(s): Cardiac Drug; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the AMI trial will receive one dose of IMP during the index procedure. The IMP administration will be performed by dedicated catheter into infarct related artery.
Active IMP consist of 30 000 000 of Wharton's jelly mesenchymal stem cells (WJMSCs) in each IMP dose prepared for patients randomized into active treatment group.; Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner.
Control group will receive the same amount of fluid used for WJMSCs preparation, without cells.
Other intervention name(s): CardioCell administration; Placebo administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The AMI trial will enroll 105 patients with randomization into active vs. sham therapy with 2:1 ratio.
Additional 5-10 subjects meeting inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early uptake and retention of IMP in the target ischemic tissues.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Effects of Nopal in Healthy Humans
Condition: Healthy
Study type: Interventional

Summary: 
      The overall goal is to increase the knowledge that can be used for the development of food
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices
      for people. More specifically the purpose of this study is to evaluate effects on metabolic
      test markers of Nopal (Opuntia) in healthy humans.
    

Detailed description: 
      The study include three visits at the research unit. At two of the visits the test subjects
      consume nopal in different doses. At one visit the subjects will consume a reference product.
      The intervention products are consumed at breakfast (at 8.00) and metabolic effects are
      investigated 3 hours postprandially. Consumption of the intervention products is separated by
      a one week washout period.
    

Intervention name(s): Nopal food product 1; Nopal food product 2; control
Intervention type(s): Other; Other; Other
Intervention description(s): Dried Nopal incorporated in a food product; Dried Nopal incorporated in a food product; Food Product without nopal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Relationships Between Sleep Spindle and Cognitive Process in Healthy Adults
Condition: Sleep
Study type: Interventional

Summary: 
      Meta-analyses demonstrate that sleep spindles, characterizing NREM sleep, may be a
      physiological index of high-level cognitive processes. The aim of the study is to determine
      if sleep spindles can predict interindividual variation in attention and cognitive
      performance. Relationship between attention and cognitive performance and sleep spindles
      characteristics (density, frequency and amplitude) recording during 1 night in 80 healthy
      subject (aged between 18-75y), will be calculated.
    

Detailed description: 
      It is currently well demonstrated that sleep promotes brain plasticity and therefore is
      directly involved in cognitive processes such as memory, language, reasoning, learning,
      intelligence, problem solving…. Sleep deprivation affects most cognitive processes. More
      specifically, it is the sleep microstructure and in particular the sleep spindles that are
      specifically linked to memory, learning and cognitive abilities. Sleep spindles are
      grapho-elements that characterize NREM sleep. They exhibit high inter-individual stability
      and variability, depend on the genetic heritage and correlate with anatomical properties of
      the brain. Sleep spindles can therefore be considered as an electrophysiological
      "finger-print" as one of the most heritable traits of humans. Studies support the notion that
      sleep spindles are electrophysiological markers of high-level cognitive abilities. It remains
      to be seen whether the sleep spindles can predict interindividual variations in attention and
      executive functions.
    

Intervention name(s): study intervention
Intervention type(s): Other
Intervention description(s): The sleep structure of healthy volunteers will be recorded (9 Electroencephalograms (EEG), 2 Electrooculograms (EOG), 2 Electromyograms (EMG) and 2 Electrocardiograms (ECG)) during 1 night. The characteristics of the spindle (density, frequency and amplitude) will be automatically analyzed from purified EEG during Non Rapid Eye Movement sleep (NREM).
Volunteers will completed a neuropsychological evaluation that will evaluate Sustained attention (simple reaction time test), Vigilance (TAP Vigilance), Sustained and selective attention (CPT II), Inhibition (Stroop test), Mental flexibility (TAP flexibility) , Executive operation (Tower of London), Short-term memory (Wechsler code test).
Driving performance will be analyzed as part of a complex scenario involving attentional and high-level functions on a driving simulator.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sleep spindles; cognitive processes
A Study of How the Body Breaks Down and Eliminates LY2623091
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has
      been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally
      occurring radioactive form of the element, carbon. This study will increase understanding
      about how the drug appears in the blood, urine, and stool after it is administered to healthy
      participants. Information about any side effects that may occur will also be collected. This
      study will last up to 22 days for each participant, not including screening. Screening is
      required within 28 days prior to enrollment
    


Intervention name(s): LY2623091
Intervention type(s): Drug
Intervention description(s): Administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
Condition: Squamous Cell Carcinoma of Oropharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to try to reduce radiation side effects that happen with the
      standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy
      are standard treatment for people with squamous cell carcinoma of the oropharynx.

      The study will look at giving a slightly smaller dose of radiation (de-intensification) to
      see if regularly expected late toxicities (two years after receiving treatment) can be
      reduced. This study will also try to see if the smaller dose of radiation is equally
      effective at treating the cancer and to see if it improves quality of life. Along with this
      radiation treatment plan some participants in this study will have surgery on their tumor and
      or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy
      will be up to the participant's doctor.

      Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is
      required for this study. Some studies have suggested that HPV-related cancer is biologically
      and clinically different as compared to non-HPV-related cancer. Some studies have found that
      patients with HPV-related oropharynx cancer have a better response to treatment. This test
      will help researchers learn more about HPV-related cancer.
    


Intervention name(s): IMRT; Cisplatin; Carboplatin
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks); Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.; Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
Intervention MeSH terms: Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Squamous Cell Carcinoma; Oropharynx
Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and
      abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a
      cohort of healthy women
    

Detailed description: 
      This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC
      80 μg injected subcutaneously into the periumbilical region of the abdomen, and
      abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and
      to make a similar evaluation in a cohort of healthy women.
    

Intervention name(s): abaloparatide-sMTS; abaloparatide-SC
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen
Other intervention name(s): BA058; abaloparatide-sMTS; BA058; abaloparatide-SC
Intervention MeSH terms: Abaloparatide; Parathyroid Hormone-Related Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In each of 2 study periods, subjects received receive either a transdermal patch containing 300 μg abaloparatide for 5 minutes or an injection of abaloparatide SC 80 μg.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoporosis; transdermal delivery; solid microstructured transdermal system; abaloparatide; TYMLOS®; abaloparatide-SC; abaloparatide-sMTS; PK
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
Condition: Impetigo
MeSH terms: Impetigo
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to show non inferiority in terms of safety and efficacy of
      topical administration BID (Twice daily) of Mupirocin Gel 20 mg/g compared to topical
      administration of Mupirocin Ointment 20 mg/g TID (three times daily) (Bactroban) in the
      treatment of impetigo in paediatric population.
    


Intervention name(s): Mupirocin gel; Mupirocin ointment; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical administration of Mupirocin gel 20 mg/g BID for 7 days; Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days; Topical administration of Placebo (ointment) TID during 7 days
Other intervention name(s): Bactroban
Intervention MeSH terms: Mupirocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impetigo; Mupirocin; Mupirocin gel; Mupirocin ointment; Impetigo in children
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given
      weekly in patients with advanced or recurrent breast cancer
    


Intervention name(s): Paclitaxel
Intervention type(s): Drug
Intervention description(s): Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Other intervention name(s): Taxol; BMS-181339
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Qualitative Study of Delays in Hospital Admission in Patient With Acute Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Observational

Summary: 
      To identify the circumstance during decision making processes to seek medical help in
      patients with symptoms of acute ischemic stroke.
    


Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        20 patients admitted to hospital due to acute ischemic stroke and were delayed to receive
        thrombolytic therapy. Family or caregivers who had involved in the process of decision
        making were also invited to the interview.
      
Keywords: Qualitative study; stroke; 20 patients, Family or caregivers; acute ischemic stroke; delayed to receive thrombolytic therapy.
Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery
Condition: To Control Pain After Third Molar Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare analgesic effects of preoperative administration of paracetamol 500 milligram plus
      codeine 30 milligram in single-tablet and effervescent formulation to ibuprofen 400
      milligram, and placebo in the management of moderate to severe postoperative pain after
      mandibular third molar surgery.
    

Detailed description: 
      Materials and methods: One hundred twenty healthy outpatients aged 15 to 29 years undergoing
      surgical removal of one bony impacted mandibular third molar were enrolled in this,
      single-center, prospective, randomized, triple-blind parallel-group, placebo-controlled,
      clinical trial. Study participants were randomly assigned to three treatment arms. According
      to the concealed allocation, each patient 30 minutes before surgery received paracetamol 500
      mg plus codeine 30 mg (group A), ibuprofen 400 mg (group B) or placebo (group C). Rescue
      therapy allowed in the postoperative period was paracetamol 500 mg plus codeine 30 mg in
      groups A and C and ibuprofen 400 mg in group B. Patients recorded on Numerical Rating
      Scale-11 (NRS-11) the pain intensity, total number of postoperative-supplement medications
      and time of the first intake, until 12-hours after surgery and over extra two days
    

Intervention name(s): paracetamol 500 mg plus codeine 30 mg preoperative administration; ibuprofen 400 mg preoperative administration; Placebo oral tablet preoperative administration
Intervention type(s): Drug; Drug; Drug
Intervention description(s): each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg; each patient 30 minutes before surgery received ibuprofen 400 mg; each patient 30 minutes before surgery received placebo
Other intervention name(s): GROUP A; GROUP B; GROUP C
Intervention MeSH terms: Acetaminophen; Ibuprofen; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a single-center, 2-stage, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: postsurgical dental pain
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in
      advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and
      some biomarkers is also to be evaluated.
    

Detailed description: 
      Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as
      (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving
      high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in
      squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC
      of lung.
    

Intervention name(s): Albumin paclitaxel plus carboplatin; Gemcitabine plus carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive carboplatin AUC=5 q3w and nab-p 135 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.; Patients receive carboplatin AUC=5 q3w and gemcitabine 1250 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.
Other intervention name(s): Abraxane(Albumin-bound paclitaxel,nab-P); Gemzar(Gemcitabine)
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: squamous cell carcinoma of lung; Albumin bound paclitaxel; chemotherapy