bioihbjkbjnl/mcl2 huggingface dataset:
Respiratory Muscle Strength in Volleyball Players Suffered From COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      In literature, there is no data evaluating respiratory functions in volleyball players during
      Covid-19 pandemic. The aim of this study is to evaluate and compared pulmonary functions,
      respiratory muscle strength, body compositions and performance situations perceptions in
      female volleyball players with Covid-19 and non-Covid-19.
    


Intervention name(s): Respiratory functions
Intervention type(s): Other
Intervention description(s): Respiratory muscle strength, pulmonary functions and body composition were evaluated in volleyball players
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female volleyball players
      
Keywords: respiratory muscles; pulmonary functions
Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway
Condition: Laryngeal Masks
Study type: Interventional

Summary: 
      Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask
      Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.
    

Detailed description: 
      The study aims to compare the two devices with respect to:

      Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure
      Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed
      attempt. Haemodynamic variation Incidence of adverse events like failed insertion,
      aspiration-regurgitation, hypoxia (SpO2< 90%), bronchospasm, airway obstruction, gastric
      insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of
      the airway device and trauma to tongue, lip, teeth, or gums.
    

Intervention name(s): ProSeal Laryngeal Mask Airway; AmbuAuraGain Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): ProSeal Laryngeal Mask Airway was used as the supraglottic device; AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized single blinded parallel group controlled study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Exercise is Medicine: a Pilot Study
Condition: Hypertension; Diabetes Mellitus
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Background: Regular exercise is beneficial to patients with hypertension and/or diabetes
      mellitus. However, most patients cannot maintain exercise habit. The investigators had
      developed a program called the "exercise is medicine"(EIM), combining motivational technique,
      information technology use and teaching exercise techniques. Before using this intervention
      in a main randomized controlled trial, the investigators would like to test its feasibility
      and acceptability. It is hypothesized that this program is feasible and acceptable to
      patients.

      Method: 40 patients with HT and/or DM will be recruited to attend the EIM intervention.
      Primary outcomes will be the rate of recruitment and rate of retention. Other clinical
      outcomes will be obtained before and immediately after the 12-week program.
    


Intervention name(s): EIM exercise classes and intervention
Intervention type(s): Behavioral
Intervention description(s): This is a complex intervention. On recruitment, they will be seen by a nurse and counselled using motivational technique. They will then undergo a 12-week class. The exercise levels will be regularly feedback to the patients by use of mobile devices and trackers. Peer support is formed during the 12-week class. Resources to continue exercise will be provided to patients. Regular monitoring of physical improvement will be feedback to patients to encourage continued exercise.
Intervention model: Single Group Assignment
Intervention model description: patients will go to different classes: (i) Hypertension basic exercise class (ii) Hypertension advanced exercise class (iii) diabetes basic exercise class (iv) diabetes advanced exercise class; if the patient has normal BMI AND reported some regular exercise, they will be prescribed the advanced level class. There is no control group for this pilot study
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of different modes of (S) ketamine administration in healthy
      participants.
    


Intervention name(s): (S)-ketamine Oral Thin Film; (S)-ketamine IV Infusion; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): (S)-ketamine OTF sublingual formulation at a dose of 7 mg, 14 mg, and 28 mg will be administered in sequential cohorts.; (S)-ketamine IV solution will be infused at a dose of less than or equal to 14mg.; Participants will receive matching placebo.
Other intervention name(s): JNJ-54135419; Ketanest
Intervention MeSH terms: Ketamine; Esketamine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Salivary Bacterial Associations to Short Term Discontinuation of Self-performed Oral Hygiene
Condition: Mouth Diseases
MeSH terms: Mouth Diseases
Study type: Interventional

Summary: 
      The purpose of the present investigation is to record and compare bacterial compositions in
      supragingival plaque samples and saliva samples in subjects discontinuing regular oral
      hygiene for 10 days. The hypothesis is that the composition of the salivary microbiota might
      reflect local bacterial alterations in relation to discontinuation of oral hygiene.
    

Detailed description: 
      35 orally healthy individuals will be enrolled in this study, in which they will discontinue
      regular oral hygiene procedures for a period of 10 days. Clinical registrations and
      collection of microbiological samples (supragingival and saliva) will be performed at
      baseline and 4, 7 and 10 days after discontinuation of regular oral hygiene, and will be
      repeated 14 days after regular oral hygiene has been resumed.
    

Intervention name(s): Oral hygiene discontinuation group
Intervention type(s): Procedure
Intervention description(s): Discontinuation of regular oral hygiene for 10 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: biofilm; saliva; bacteria; oral hygiene
A Study of LY2623091 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The first purpose of this study is to evaluate the effect of itraconazole (and possibly
      diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get
      rid of it.

      The second purpose of the study is to evaluate the effect of LY2623091 on the amount of
      simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get
      rid of it.

      The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and
      diltiazem or tadalafil will be evaluated.

      There will be three groups of participants in this study. Results from Groups 1 and 2 will be
      analyzed during the study to determine whether to enroll participants in Group 3 or 4. The
      study is expected to last up to 40 days from the first dose to follow-up (inclusive).
      Screening may occur up to 28 days prior to enrollment.
    


Intervention name(s): LY2623091; Itraconazole; Simvastatin; Tadalafil; Diltiazem
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Itraconazole; Diltiazem; Tadalafil; Simvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
Condition: Malaria; Malaria Vaccines
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a
      candidate malaria vaccine GSK 257049 for the routine immunization of infants and children
      living in malaria endemic areas. The vaccine would offer protection against malaria disease
      due to the parasite Plasmodium falciparum. The vaccine would also provide protection against
      infection with hepatitis B virus (HBV).

      In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a
      new variant RTS,S/AS02D (0.5 mL dose) has been developed.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      This is a phase 2b trial designed to evaluate the safety and immunogenicity of RTS,S/AS02D
      when co-administered with a multivalent DTPw/Hib (Aventis Pasteur's TETRActHib vaccine).
      Infants randomized to the control group will receive a licensed hepatitis B vaccine,
      Engerix-B in place of RTS,S/AS02D.

      Data pertaining to RTS,S/AS02D or Engerix-B will be collected in a double blinded manner;
      data relating to TETRActHib will be collected in an open fashion.

      Oral polio vaccine (OPV) will be administered at birth, 8, 12, 16 weeks in co-administration
      with other vaccines and will not be administered as part of this protocol. Antibody titers to
      OPV will not be assessed as part of this protocol.
    

Intervention name(s): RTS,S/AS02D; Engerix-B®; TETRActHib™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3-dose intramuscular injection in the thigh; 3-dose intramuscular injection in the thigh.; 3-dose intramuscular injection in the thigh.
Other intervention name(s): GSK 257146; RTS; S/AS02D; DTPw/Hib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coccidiosis; Parasitic Diseases; Malaria, Falciparum; Malaria
A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label study to evaluate the drug-drug interaction potential of a
      strong CYP3A4 inhibitor (itraconazole) and a pan-CYP inducer (rifampin) on APX001 in two
      parallel groups of healthy subjects.
    


Intervention name(s): APX001; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cohort 1 Day 1: APX001 500 mg IV BID over a 3-hour infusion; Day 18: APX001 500 mg IV BID over a 3-hour infusion. Cohort 2 Day 1: APX001 1000 mg IV BID over a 3-hour infusion; Day 24: APX001 1000 mg IV BID over a 3-hour infusion.; Cohort 1 Days 15-30: itraconazole 200 mg oral solution QD.; Cohort 2 Days 15-33: rifampin 600 mg oral QD.
Other intervention name(s): Fosmanogepix; Sporanox; Rifampicin
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Brain Activation During Different Motor Patterns in Healthy Adults
Condition: Neurosciences
Study type: Observational

Summary: 
      This study aims to investigate the brain activation during different motor patterns,
      including motor execution (ME), motor imagery (MI), action observation (AO) and mirror visual
      feedback (MVF). In addition, the relations between brain activation and motor performance
      will also be explored. This study includes two parts, which are upper limb and lower limb
      part. While executing all the tasks, brain activation in primary motor cortex(M1), premotor
      cortex(PMC), and supplementary motor cortex(SMA) will be monitored by functional
      near-infrared spectroscopy. One-way ANOVA with repeated measure will be used to detect the
      differences of brain activation level between each mode. Pearson correlation coefficient will
      be used to determine the relations of brain activation and motor performance.
    

Detailed description: 
      In upper limb part, subjects will be instructed to execute functional reaching task in ME,
      MI, AO, and MVF mode. During ME mode, motor performance including maximum speed, maximum
      acceleration, and jerk will be collected simultaneously. In the lower limb part, subjects
      will be instructed to walking over ground in ME, MI, and AO mode. During ME mode, the
      temporal and spatial gait parameters, including speed, stride time, cadence, and stride
      length will be collected.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population in this study are heathly adults.
      
Keywords: brain activation; near infrared spectroscopy; motor imagery; action observation; mirror visual feedback
A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that
      gets into the blood stream and how long it takes the body to get rid of lebrikizumab
      (LY3650150) when given using either a pre-filled autoinjector (AI) or a pre-filled syringe
      with needle safety device (PFS-NSD). The safety and tolerability of lebrikizumab will also be
      evaluated. The study will last up to 102 days.
    


Intervention name(s): Lebrikizumab
Intervention type(s): Drug
Intervention description(s): Administered SC.
Other intervention name(s): LY3650150
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion
Condition: Compliance, Patient; Treatment Adherence
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      To compare the effect of two control intervals (once every 4th week or once every 6th week)
      on the wear time of a Twin Block removable appliance.
    

Detailed description: 
      If the patient fulfill the inclusion criteria, they will be asked to participate in the
      study. After being informed about the study and the planned treatment, participants and their
      guardians will give their written consent to participate in the study.

      Therafter they will be consecutively randomized into one of two groups with different control
      intervals, Group 1 (every 4th week) and Group 2 (every 6th week). They will recieve a
      clinical and radiological examination and then start treatment with a Twin Block appliance.

      The Twin Block appliance will be fitted with a digital timer module to measure the wear time
      of the appliance objectively.
    

Intervention name(s): Twin block
Intervention type(s): Device
Intervention description(s): Twin Block orthodontic appliance for treating patients with Angle class II molar relationship and a large horizontal overjet, often in combination with an incomplete lip closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthodontic; Removable; Compliance; Adherence; Twin Block
A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in
      healthy male volunteers to study the absorption, distribution, metabolism and elimination of
      ertugliflozin.
    


Intervention name(s): Ertugliflozin
Intervention type(s): Drug
Intervention description(s): Ertugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of [14C]ertugliflozin
Intervention MeSH terms: Ertugliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Absorption; Distribution; Metabolism; and Excretion; Mass Balance; Metabolic Profile; Radiolabel Study
TP0502-B-Pharmaco-Scintigraphic-Study
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, single-site trial to evaluate the drug release, using
      scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9]
      subjects will be evaluated. The subjects will receive one [1] radio-labelled tablet after a
      high fat and a rich in calories breakfast.
    


Intervention name(s): TP05
Intervention type(s): Drug
Intervention description(s): One radio-labelled tablet given to subject after a high fat and a rich in calories breakfast
Other intervention name(s): Mesalazine
Intervention MeSH terms: Mesalamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway
      inflammation with topical steroids improves the twitchiness of the airways
      (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces
      symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related
      deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves
      quality of life. While there is evidence that combined treatment of the nose and the lungs
      with topical steroids improves symptoms and underlying inflammation, it is unclear whether
      such control can be achieved using a smaller dose of inhaled steroid in combination with
      nasal steroid. It is therefore the intention of this study to evaluate if combination steroid
      therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis
      using sensitive markers of airway inflammation.
    


Intervention name(s): Fluticasone Evohaler pMDI; Placebo; Fluticasone Evohaler; Placebo intranasal spray; fluticasone propionate (Flixonase®)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg); 1 puff of inhaled Placebo twice a day; One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg); placebo intranasal spray 2 squirts each nostril once a day; intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Allergic rhinitis; fluticasone; methacholine
Kidney Function After Pneumoperitoneum and Analgesia
Condition: Laparoscopic Cholecystectomy
Study type: Observational

Summary: 
      double blind study of kidney function of two groups of adult patients submitted to
      laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac
    

Detailed description: 
      Background: The laparoscopic cholecystectomy (LC) reduces surgical trauma and hospital stay
      but requires effective and safe postoperative analgesia. This prospective and double blind
      study aimed to study the effects of tramadol analgesia associated to dipyrone or ketorolac in
      the kidney function of patients submitted to LC, using creatinine (Cr), cystatin C, and
      enzymuria evaluations.

      Methods: In the pre- and postoperative (PO) periods, estimated glomerular filtration rates
      (GFR), obtained from two formulas dependants of blood Cr and one from blood cystatin C
      values, and tubular enzymuria - alkaline phosphatase (AP), γ-glutamyltransferase (γ-GT) -
      were determined in patients who underwent LC and analgesia with tramadol and dipyrone (G1,
      n=63) or tramadol and ketorolac (G2, n=63). In the recovery room (RR), pain and need of
      rescue analgesia with morphine were evaluated.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol plus
        ketorolac or dypirone
      
Keywords: kidney function tests; anti-inflammatory agents, non-steroidal; laparoscopic cholecystectomy; adult