bioihbjkbjnl/mcl2 huggingface dataset:
Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery
Condition: Dexmedetomidine; Fentanyl
MeSH terms: Hernia, Inguinal
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The perioperative management of pain following abdominal surgery can pose a challenge to
      anesthesia providers. Conventional practice has involved the use of opioids as well as
      neuraxial analgesic techniques. Unfortunately, these therapies are not without potential
      risks and side effects. These include nausea, vomiting, pruritus, urinary retention,
      constipation, respiratory depression, and sedation.
    

Detailed description: 
      As a result, the goal to reduce perioperative pain has taken on a multimodal approach.

      Multimodal or "balanced" analgesia uses a combination of opioid and nonopioid analgesics to
      improve pain control and minimize opioid-related side effects. These include the use of
      nonsteroidal anti-inflammatory drugs, local anesthetics, peripheral nerve blocks,
      gabapentinoids, and alpha2 adrenergic agonists. Any combination of these therapies can help
      reduce the surgical stress response and improve patient outcomes such as pain control,
      patient satisfaction, time to discharge, and return to daily activities.

      One method used in this multimodal approach is the transversus abdominis plane block. As
      first described by Rafi in 2001, this block provides analgesia to the anterolateral abdominal
      wall. In 2007, further studied this technique in patients undergoing large-bowel resection.
      He discovered a reduction in postoperative pain and morphine consumption in the first 24
      hours postoperatively, resulting in fewer opioid-mediated side effects. In this same year,
      Hebbard described the use of ultrasound guidance to provide real-time imaging of the muscle
      layers and needle placement to improve TAP block accuracy. In 2008, Hebbard. described the
      subcostal approach of TAP blocks, to target the nerves of the upper abdomen. Transversus
      abdominis plane blocks continue to be studied and developed as an effective method for
      providing analgesia for numerous types of abdominal surgeries.
    

Intervention name(s): Levobupivacaine; Dexmedetomidine Hydrochloride; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Levobupivacaine 5%; Levobupivacaine 5% + 1 µg/kg dexmedetomidine.; Levobupivacaine 5% + 1µg/kg fentanyl
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to determine if an investigational vaccine Gardasil
      (V501) with 4 components will provide an immune response and will be well tolerated in
      pre-adolescents and adolescents.
    


Intervention name(s): V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
Intervention type(s): Biological
Intervention description(s): qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
Other intervention name(s): V501; Gardasil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
Condition: Edentulism
Study type: Interventional
Phase: Phase 4

Summary: 
      Change in crestal bone level implants at 5% significance level.
    


Intervention name(s): Ankylos Implants; Biomet 3i Prevail Implants
Intervention type(s): Device; Device
Intervention description(s): ANKYLOS Implant System vs Certain PREVAIL Implant
Intervention MeSH terms: Cimetidine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: subjects with edentulous mandible
Ventilator Hyperinflation and Manual Rib Cage Compression
Condition: Pulmonary Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      This is a randomized crossover trial to evaluate the effects of thoracic compression applied
      alone or in association with hyperinflation maneuver with the ventilator. In addition, the
      mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.
    

Detailed description: 
      Ventilator hyperinflation is widely used in hypersecretive patients. It consists of
      increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions
      of the peripheral airways are mobilized into the central airways so that they can be removed
      by tracheal aspiration or cough. Thoracic compression consists of manually compressing the
      rib cage during expiration, in order to increase expiratory flow, mobilize and remove
      pulmonary secretions. A randomized crossover clinical trial was performed with 30 patients
      submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour
      interval. Patients were evaluated through compliance and resistance of the respiratory
      system.
    

Intervention name(s): Expiratory Rib Cage Compression; Compression + Ventilator Hyperinflation
Intervention type(s): Other; Other
Intervention description(s): Compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.; Mechanical ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. In Expiratory Rib Cage Compression associated with ventilator hyperinflation, thoracic compression maneuver was performed at the end of inspiration, at the exact moment of cycling.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ventilator Hyperinflation; Expiratory Rib Cage Compression; Physical Therapy; Mechanical Ventilation
Rehabilitation in Chronic Obstructive Pulmonary Disease Outpatients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      A retrospective analysis on a cohort of unselected COPD patients admitted to pulmonary
      rehabilitation (PR) performed in one rehabilitation centre has shown that the usual program
      is feasible and effective even in the presence of complex comorbidities, although some
      combined diseases might reduce the overall proportion of patients who respond to pre-defined
      outcomes criteria (Crisafulli E, et al. Thorax 2008;63:487-92).

      The aim of this prospective study is to describe the pattern of prevalence of the most
      frequently associated COPD-comorbidities and the clinical impact on rehabilitation outcomes,
      referred to 3 teaching and 1 private hospitals admitting for pulmonary rehabilitation
      purposes.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD outpatients eligible for pulmonary rehabilitation
      
Keywords: COPD (Chronic Obstructive Pulmonary Disease); outpatients; rehabilitation; comorbidities; patient-centered outcome
Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat
Condition: Drug Interaction Potentiation; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, fixed sequence, open-label study to evaluate the effect of multiple oral
      doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat 300 mg in healthy
      male and female subjects.
    

Detailed description: 
      This is a Phase 1, fixed sequence, open-label study in healthy adult subjects to evaluate the
      effect of multiple doses of rabeprazole on the pharmacokinetics of a single dose of
      vadadustat in healthy male and female subjects. Approximately twenty (20) subjects, with at
      least 30% female subjects, will be enrolled to ensure 18 evaluable subjects. Subjects will be
      on study for up to 66 days, including a 28-day screening period, 9-day clinic period, and a
      30-day follow- up period post last dose. Subjects who are confirmed eligible and receive at
      least one dose of study drug will be considered enrolled in the study. Blood samples for PK
      analysis will be collected at pre-defined time points throughout the study up to 48 hours
      post administration of vadadustat.
    

Intervention name(s): Vadadustat; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Vadadustat 300 mg; Oral Rabeprazole
Intervention MeSH terms: Rabeprazole
Intervention model: Single Group Assignment
Intervention model description: This is a single arm fixed sequence study. Subjects will be administered vadadustat on day 1, rabeprazole on days 2 to 5, and vadadustat and rabeprazole on day 6.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vadadustat; Rabeprazole; Pharmacokinetics
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with
      placebo as treatment for major depressive disorder (MDD) in adult females.
    


Intervention name(s): onabotulinumtoxinA; Normal Saline
Intervention type(s): Biological; Drug
Intervention description(s): OnabotulinumtoxinA injected into protocol-specified areas on Day 1.; Placebo (normal saline) injected into protocol-specified areas on Day 1.
Other intervention name(s): BOTOX®; botulinum toxin Type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Healthy Volunteer Study of PBI-4050
Condition: Fibrosis; Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the study drug PBI-4050 to determine the safety,
      tolerability and concentration profile in the blood when the drug is given to healthy
      volunteers as multiple doses and different dosing regimens over a period of 14 days.
    


Intervention name(s): PBI-4050/ Placebo; PBI-4050/ Placebo; PBI-4050/ Placebo; PBI-4050/ Placebo; PBI-4050/ Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants receive either 800mg PBI-4050 capsules or placebo, twice a day for 14 days; Participants receive either 1200mg PBI-4050 capsules or placebo, once a day for 14 days; Participants receive either 1000 mg PBI-4050 capsules or placebo, twice a day for 14 days; Participants receive either 1200 mg PBI-4050 capsules or placebo, twice a day for 14 days; Participants receive either 800 mg PBI-4050 capsules or placebo, three times a day for 14 days
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Cohorts will be dosed sequentially in an ascending fashion with approximately 14 days between starting dose at each dose level.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acute Kidney Injury in Children After Cardiopulmonary Bypass
Condition: Congenital Heart Disease in Children; Cardiopulmonary Bypass
MeSH terms: Acute Kidney Injury; Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Acute kidney injury (AKI) is a common complication in patients with congenital heart defects
      after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high
      and reaches 60%.

      The basic criteria for diagnosing and assessing the severity of kidney injury until recently
      were the level of serum creatinine and the amount of urine released. However, it should be
      noted that the level of serum creatinine, traditionally used to assess renal function, does
      not significantly increase until a decrease of more than 50% of the glomerular filtration
      rate, in addition, its level depends also on some extrarenal causes. Artificial blood
      circulation and hemodilution leads to the preservation of the level of creatinine at
      sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as
      the level of creatinine is a nonspecific criterion after cardiac surgery and depends on
      several factors.

      Currently, in the field of acute renal injury studies, progress has been made in the
      emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and
      insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute
      renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7
      increased In the first 24-48 before the diagnosis of IR-associated renal damage.

      Among pediatric patients with congenital heart defects, such studies are single and only
      present for the age group 3 and older, which also demonstrated the high specificity and
      prognostic significance of these biomarkers in the early diagnosis of acute renal damage.

      It should also be noted that, in spite of the high specificity of the markers described, it
      is also necessary to note their considerable cost.

      Thus, taking into account the above, it is planned to compare and identify the relationship
      of these indicators with such parameter as the index of renal vascular resistance, the
      increase of which in the pre- and postoperative period may serve as a sign of the beginning
      acute renal injury.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 1 month to 1 year with congenital heart disease, operated under conditions of
        cardiopulmonary bypass
      
Keywords: acute kidney injury, cardiosurgery
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus
      subjects receiving placebo.
    


Intervention name(s): DVS-233 SR
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Melancholia, Involutional; Depression, Involutional
Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a new
      oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female
      volunteers.
    

Detailed description: 
      The study was designed to compare the bioavailability of nifedipine new formulation specially
      designed to be used in pre-term labour management instead of anti-hypertensive therapy.
    

Intervention name(s): Nifedipine soft gelatine capsules; Nifedipine oral solution
Intervention type(s): Drug; Drug
Intervention description(s): 3 Adalat capsules of 10 mg each one; 6 mL of Nife Par solution
Other intervention name(s): Adalat; Nife-Par
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation
Condition: Skin Disorders
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to compare the tolerability of the application of a combination
      of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and
      cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional
      radiofrequency treatment using the Venus Viva versus standard of care.
    

Detailed description: 
      Randomized, open-label, multi-centre study to evaluate the tolerability of the application of
      a combination of a serum containing human bone marrow stem cell derived growth factor and
      cytokines (SCR Complex™) and a botanical lipid based occlusive (Bio Cel™) following facial
      fractional RF treatments using the Venus Viva™ SR system. Each subject will receive 2
      treatments separated by a 3-week interval. Subjects will complete a VAS and Tolerability
      Scale immediately following each treatment. Telephone follow-up calls by the site will ask
      the subject to respond to the Self-Report Adverse Event Questionnaire 24 and 72 hours after
      the first treatment and 24 hours after the second treatment. Subjects will complete a Home
      Tolerability Scale 24 and 72 hours after the first treatment and 24 hours after the second
      treatment. Subjects will return for the final FU visit and be asked to respond to the
      Self-Report Adverse Event Questionnaire and complete the Home Tolerability Scale for 72
      hours. The investigator will also evaluate the subject's improvement using the GAIS at this
      visit.
    

Intervention name(s): Topical combination therapy
Intervention type(s): Other
Other intervention name(s): SCR Complex; Bio Cel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resurfacing; ablation
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
Condition: Infant Term Birth
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effects of term infant formula containing high
      2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal
      (GI) Tolerance.
    

Detailed description: 
      This is a multicenter, open label, observation study; 500 formula fed infants are planned to
      be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait,
      Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12
      weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.
    

Intervention name(s): Standard Infant Formula
Intervention type(s): Other
Intervention description(s): Standard Infant Formula containing High Sn-2
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        500 healthy, full-term, formula fed infants
PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
Condition: Cesarean Section Complications; Cesarean Wound; Dehiscence; Cesarean Wound Disruption
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized controlled, parallel group, superiority, open-label, single-institution, Phase 3
      interventional clinical trial to evaluate clinical outcomes in obese gravidas undergoing
      elective cesarean delivery whose wounds were dressed with the PICO Negative Pressure Wound
      Therapy (NPWT) versus the standard dressing. We hypothesize that the PICO NPWT will reduce
      the incidence of surgical site occurrences and interventions and postoperative readmissions
      in obese women. The study will compare surgical site occurrences and surgical incision
      intervention incidence within 42 +/- 10 days post cesarean delivery in obese women who have
      the current standard-of-care dressing versus the PICO NPWT.
    


Intervention name(s): PICO Negative Pressure Wound Therapy; Standard Dressing
Intervention type(s): Device; Device
Intervention description(s): The PICO unit is a single patient use, battery-powered, disposable unit that can provide continuous 80 - 125 mmHg negative pressure over a 5 to 7-day therapy period.The dressing is applied to the wound and extra strips are placed over the outside edge to help hold the dressing in place. When the pump is turned on, air is pulled out of the dressing and excess fluid from the wound will start to enter the dressing.; The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing
Other intervention name(s): PICO Dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cesarean section; negative-pressure wound therapy; surgical wound dehiscence; hospital readmission; surgical site infection
THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death
Condition: Acute Ischaemic Stroke; Transient Ischaemic Attack
MeSH terms: Stroke; Ischemic Stroke; Ischemic Attack, Transient; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo
      (inactive tablet) and ASA in preventing new stroke events
    


Intervention name(s): Ticagrelor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor arm: Day 1, loading dose of ticagrelor followed by daily maintenance dose until Day 30.; Placebo arm: Day 1, loading dose of placebo followed by placebo daily maintenance dose until Day 30.
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute ischaemic stroke; Transient Ischaemic Attack (TIA); Stroke