bioihbjkbjnl/mcl2 huggingface dataset:
Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
Condition: Asthmatic
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is aimed to assess the dose proportional total systemic exposure (when the
      administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its
      lung bioavailability (when the administration is with the activated charcoal) after single
      inhalation of CHF 1535 NEXThaler DPI at two dose strengths.

      At the same time, the study will assess if the lung deposition and the total systemic
      exposure to Formoterol is affected by increasing doses of BDP.
    


Intervention name(s): NEXThaler 100/6 mcg DPI; Flixotide Accuhaler 500 mcg; NEXThaler 200/6 mcg DPI; NEXThaler placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Active comparator; Placebo comparator
Other intervention name(s): Fixed combination of BDP plus formoterol fumarate; Fluticasone Propionate; Fixed combination of BDP plus formoterol fumarate
Intervention MeSH terms: Fluticasone; Xhance; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patients; Adult
Effect of Auditory Stimulation on Spike Waves in Sleep
Condition: Epilepsy; Sleep
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Background: Close relationship exists between sleep slow wave (SSW) and the generation of
      spike wave in NREM-sleep. SSW are cortically generated oscillations alternating between
      excitatory depolarization ("Up-phase" of the SSW) and inhibitory hyperpolarization
      ("Down-phase" of the SSW). It has been shown experimentally that with increasing synchrony of
      slow neuronal oscillations SSW turn into spike waves. Acoustic pulses applied in
      correspondence to the SSW "Up-phase" enhance the amplitude of the subsequent SSW. Conversely,
      tones delivered at the SSW "Downphase" have a disruptive effect on the following SSW.

      Participants: Patients with epilepsy and spike waves in NREM-sleep.

      Objective: Modification of spike wave frequency, amplitude and spreading during NREM sleep by
      acoustic pulses applied at the "Up-" or "Down-phase" of SSW.
    


Intervention name(s): Acoustic pulses
Intervention type(s): Device
Intervention description(s): Acoustic pulses applied during NREM sleep slow waves "Up-phase" or "Down-phase". The acoustic stimulus will be delivered by speakers with a volume of about 50 dB.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Benign epilepsy with centro-temporal spikes; Continuous spike waves in slow wave sleep; Electroencephalography; Sleep, slow wave
Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations
Condition: Cocaine Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam)
      in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9
      healthy male and female (not of childbearing potential) volunteers. The study will evaluate
      the bioavailability and food effect of a new formulation of EMB-001 relative to the original
      formulation of EMB 001.

      During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each
      of 3 treatment sequences
    


Intervention name(s): Original formulation EMB-001; New formulation EMB-001
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose (720 mg metyrapone/24 mg oxazepam); Single oral dose (720 mg metyrapone/24 mg oxazepam)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3-period, 3-sequence crossover evaluating 3 treatments
Treatment-1: new formulation under fed conditions
Treatment-2: new formulation under fasted conditions
Treatment-3: original formulation under fed conditions
Masking: None (Open Label)
Primary purpose: Other
Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA
      approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.
    


Intervention name(s): Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Placebo nasal spray
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate; 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate; Placebo nasal spray
Other intervention name(s): Perrigo Product; Reference Listed Drug Product
Intervention MeSH terms: Fluticasone; Xhance; Azelastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the
      blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given
      as an oral suspension under fasted conditions as well as a tablet formulation under fasted
      and fed conditions, in male healthy subjects.

      Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral
      suspension under fasted conditions as well as a tablet formulation under fasted and fed
      conditions, will be assessed.

      Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an
      oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be
      separated by a wash-out period of at least 6 days.
    


Intervention name(s): 500 mg GLPG1837 as oral suspension; 500 mg GLPG1837 as oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 500 mg GLPG1837 administered as oral suspension; A single dose of 500 mg GLPG1837 administered as oral tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Local Anaesthetic Effects of Transcutaneous Amitriptyline
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on
      the skin of human volunteers, considering the differential effects on mechanic and thermic
      sensitivity, the local and general tolerance, and the systemic absorption of the drug. The
      solution used for dilution of amitriptyline is the only one known to allow transcutaneous
      absorption of the drug [1]. Considering that the peripheral sensitive fibre is a possible
      site of action of tricyclic antidepressants for relieving neuropathic pain [2,3], this is a
      first step study before further assessment of the therapeutic effects of transcutaneous
      amitriptyline.
    

Detailed description: 
      Sixteen male healthy volunteers are enrolled for this study. They receive in a randomised
      order on six regions of dorsal skin (after previous targetting by ink marks) the six
      following treatments : lidocaïne-prilocaïne anaesthetic cream (EMLA (R)), normal saline,
      amityptiline hydrochloride diluted in solution of water (%), isopropanol (%) , glycerol (%),
      titrated with sodium hydroxide for pH=8.5, at four different concentrations (0,25, 50 and 100
      mM). The person in charge of local application does not participate to further examination.
      Immediately after one hour of application, the volunteer is examined, and then every 2 hours
      during 8 hours, and 24 hours after the end if application. Every trial includes, for every
      treated area, (a) measurement of sensitive and nociceptive threshold to Von Frey hair
      application, (b) assessment of sensation induced by cold and heat after Rolltemp TM
      application, (c) measurement of sensitive threshold to cold, then sensitive and nociceptive
      thresholds to heat with Thermotest TM, (d) clinical evaluation of tolerance to the treatment,
      (e) blood sampling for measuring amitriptylinemia (HPLC). The possible residual anaesthetic
      effects of the treatment are assessed one and three weeks after the application, by
      measurement of sensitive and nociceptive threshold to Von Frey hair application. The
      statistical analysis will use two-way ANOVA, considering the following factors : treatment,
      time, order, subject, subject/order.
    

Intervention name(s): Amitriptyline
Intervention type(s): Drug
Intervention MeSH terms: Amitriptyline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Tricyclic antidepressants; Neuropathic pain; Local anaesthesia; Transcutaneous
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
Condition: Partial Onset Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and
      one 12 mg tablet of perampanel in healthy subjects.
    

Detailed description: 
      A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group
      of 28 subjects.
    

Intervention name(s): perampanel; perampanel
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 6 tablets 2 mg orally; Single dose of 1 tablet 12 mg orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy
Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
Condition: Whipple Procedure
Study type: Interventional

Summary: 
      The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple
      procedure were studied by compiling demographic details of the patients, common presenting
      symptoms, various indications for Whipple's procedure, the cofactors which affect the
      procedures outcome and morbidity and mortality of the patients.
    

Detailed description: 
      This study was performed by collecting data through predesigned questionnaire about patients
      undergoing Whipple's procedure from operation theatres and medical record section. Those
      patients, whose tumor was unresectable and undergone palliative surgical procedures were
      excluded from the study.
    

Intervention name(s): Whipple Procedure
Intervention type(s): Procedure
Intervention description(s): Patients underwent Whipple procedure for pancreatic tumors. The procedure commenced with rooftop incision. then layers of abdomen dissected to reach the peritoneum. Then Duodenum dissected out along with pancreas and common bile duct. After rescetion of these structures the anatomy of the tract restored with three anastomosis namely pancreaticojejunostomy, gastrojejunostomy and choledochojejunostomy/hepaticojejunostomy.
Intervention model: Single Group Assignment
Intervention model description: Patients undergoing Whipple procedure due to pancreatic tumor were included in the study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Whipple procedure, pancreatic carcinoma, biliary stenting,
The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy
Condition: Achilles Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Tendoactive, eccentric training, or the
      combination or both could be effective in the treatment of Achilles tendinopathy.
    


Intervention name(s): Tendoactive; Eccentric training
Intervention type(s): Drug; Behavioral
Intervention description(s): Food supplement containing mucopolysaccharides, type I collagen and vitamin C; Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Achilles tendinopathy; Tendoactive; Eccentric training
Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid
Condition: Keloid Scar
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a split-scar study with a target sample size of 20. There are two interventions:
      fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and fractional
      erbium:YAG-assisted drug delivery of triamcinolone acetonide. Patients will undergo
      treatments in a series of 4 treatments at approximately 4 week ± 1 week intervals.
      Investigators will monitor for safety and continued benefit after the end of the
      interventional treatment.
    


Intervention name(s): Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil; Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments); Split-scar fractional ablative erbium laser-assisted delivery of 10 mg/mL of triamcinolone acetonide solution to the other half of the scar (4 treatments)
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Fluorouracil; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the
      safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and
      efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time
      of dose administration. Approximately 100 subjects will be enrolled. Subjects will be
      followed for approximately 1 year after dose administration.
    

Detailed description: 
      Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract
      infection (LRTI) among infants and young children, resulting in annual epidemics in Japan.
      Children with congenital or acquired immunodeficiencies, transplant recipients, and those
      receiving immunosuppressive therapy are at increased risk for severe RSV-associated LRTI with
      prolonged viral shedding and higher viral loads, resulting in prolonged hospitalizations,
      admissions to the intensive care unit (ICU), and the need for mechanical ventilation.
      Palivizumab (Synagis®) is the only approved agent for RSV prophylaxis, and its half-life
      (t1/2) is approximately 1 month, infants and young children need to receive monthly
      intramuscular doses of palivizumab throughout the RSV season to maintain protection. This
      constitutes a significant burden on healthcare providers as well as the infants/children and
      their families.

      Nirsevimab may provide a cost-effective opportunity to protect all infants from RSV disease
      based on an improvement in potency and the extended t1/2 that is expected to support
      once-per-RSV-season dosing.
    

Intervention name(s): Nirsevimab
Intervention type(s): Drug
Intervention description(s): Single fixed IM dose of nirsevimab 50 mg if body weight < 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg
Other intervention name(s): Nirsevimab (MEDI8897)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: LRTI by RSV infection
Comparison of QoR-15 in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine
Condition: Neuromuscular Blockade Reversal Agent; Sugammadex; Neostigmine; Quality of Recovery; Laparoscopic Cholecystectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The quality of recovery in patients who were reversed neuromuscular blockade by using
      Sumamadex and Neostigmine in laparoscopic cholecystectomy was compared through the
      QoR(Quality of Recovery)-15 questionnaire.
    

Detailed description: 
      Quality of Recovery questionnaire includes five details (Emotional status, Physical comfort,
      Physiological support, Physical independece, Pain), and is a proven method of reliability,
      consistency and validity for evaluating recovery from surgery and anesthesia.

      After laparoscopic cholecystectomy, patients experience various discomforts such as pain,
      nausea, vomiting, and placebo due to general anesthesia.

      Neostigmine has side effects such as crampy abdominal pain, nausea and vomiting. In addition,
      residual neuromuscular blockade was higher in neostigmine compared with sugammadex.

      Although sugammadex expected to improve patient's recovery, it is still controversial that
      sugammadex contributes to clinically meaningfull difference compared with neostigmine.

      Therefore, the aim of our study is comparison of quality of recovery through QoR-15
      questionnaire in patients who were reversed neuromuscular blockade by using sugammadex and
      neostigmine in laparoscopic cholecystectomy.
    

Intervention name(s): Sugammadex; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg); with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg)
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Effect of Speed,Agility and Quickness Training on Technical Skills in Football Players
Condition: Physical Fitness
Study type: Interventional

Summary: 
      The study is designed to determine the effectiveness of Speed, Agility and Quickness training
      on technical skills in football players
    

Detailed description: 
      Football is a fast-paced, dynamic sport that requires expert movements. The goal of the game
      is to outscore your opponent in terms of goals scored. Players must perform a variety of
      expert movements, both with and without the ball, to achieve this goal. 'The learned ability
      to bring about predetermined results with utmost assurance, frequently with the least
      investment of time or energy or both,' according to an initial definition of talent. 'The
      constant output of goal-oriented movements, which are taught and unique to the job,'
      according to a more modern definition of competence. It is critical for players to have the
      fundamental motor abilities, such as running, agility, and acceleration, in order to learn
      and execute soccer skills effectively. Fundamental motor skills are seen as essential
      precursors or related factors to technical skills and therefore excellence in
      soccer.Furthermore, through a variety of soccer-specific activities, the SAQ training system
      consolidates speed, agility, and quickness. All exercises are carried out with appropriate
      biomechanical movement structures, resulting in significant energy and time savings. Aside
      from major abilities, power performance necessitates optimal joint mobility, dynamic balance,
      an appropriate locomotors system, and energy generation, among other things.
    

Intervention name(s): SAQ training
Intervention type(s): Other
Intervention description(s): interventions listed above were applied on the players which will improve running mechanics and impove speed power and agility in football players
Other intervention name(s): High knee with mini hurdles; depth jumps; 30 yard sprint; Agility rings hops; Overhead ball drop
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups with randomization Assignment: High knee with mini hurdles, agility ring hops, 30 yard sprint, depth jumps, overhead ball drop
Masking: Single (Participant)
Primary purpose: Other
Keywords: Football, Technical skills, speed, agility, quickness
A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to estimate the proportion of participants fulfilling criteria
      for symptomatic remission following a transition to 12 months treatment with flexible-dose
      paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia
      previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at
      least 4 months.
    

Detailed description: 
      This is an international, multicenter (study conducted at multiple sites) study designed to
      estimate remission rates and assess treatment response, tolerability, and patterns of use of
      Paliperidone Palmitate 3-Month Formulation (PP3M) in a diverse population of participants
      with schizophrenia. The study will consist of a screening phase (Day -7 to Day 1), a 52-week,
      open-label, flexible-dose PP3M treatment phase and a follow up safety assessment 3 months (
      +/-14 days ) after the month 12 visit or early discontinuation. Participants' Safety will be
      monitored throughout the study.
    

Intervention name(s): Paliperidone palmitate 3 month formulation (PP3M)
Intervention type(s): Drug
Intervention description(s): Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq) up to 525 mg eq based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq.
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; R092670; Paliperidone Palmitate