bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Topical Anesthesia on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery.
Condition: Coronary Artery Disease; Valvular Heart Disease; Arrhythmia; Myocardial Disease
MeSH terms: Coronary Artery Disease; Heart Diseases; Heart Valve Diseases; Cardiomyopathies
Study type: Interventional

Summary: 
      The aim of the induction is to decrease stress response of endotracheal intubation. It is
      also important to keep hemodynamics stable during and after the induction period. Previous
      studies have shown that topical anesthesia can provide excellent superior supraglottic and
      subglottic local anesthetic effects and can significantly reduce the dosage of intravenous
      anesthetics. Therefore, it is significant to explore whether the combination of topical
      anesthesia and intravenous anesthetics could decrease the stress response of endotracheal
      intubation and keep hemodynamics stable during and after the induction period.
    

Detailed description: 
      The routine anesthesia induction strategy for cardiac surgery is to decrease stress response
      during endotracheal intubation by using large doses of opioids. However, high doses of
      opioids often leads to persistent and recurrent hypotension in patients from the anesthesia
      induction period to the beginning of the surgery. Patients scheduled to accept cardiac
      surgery often have severe concomitant disease. Hemodynamic fluctuation might lead to
      disastrous events. Anesthesia induction for such patients should not only provide adequate
      depth of anesthesia to decrease the stress response of endotracheal intubation, but also make
      hemodynamics stable after tracheal intubation.
    

Intervention name(s): The combined topical anesthesia induction group
Intervention type(s): Procedure
Intervention description(s): The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia，3-5ml 2% lidocaine would be used for supraglottic anesthesia, and 3ml 1% tetracaine would be used for subglottic anesthesia.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Topical anesthesia; Cardiac surgery; Hemodynamics; Induction period
DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using
      Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in
      antibiotic-treated children with complicated acute otitis media or beta-hemolytic
      streptococcal pharyngo-tonsillitis.
    


Intervention name(s): Bacillus clausii
Intervention type(s): Drug
Intervention description(s): 2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent
      therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60
      Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a
      previous non-randomized bicentric phase II trial, primary combination chemotherapy with
      lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et
      al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of
      CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the
      projected phase III trial confirms the phase II data, CCNU/TMZ combination would be
      significantly better than TMZ monotherapy and would thus be the new standard treatment for
      newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the
      potential to profoundly change the standard therapy of this most aggressive brain tumor.
      Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a
      benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months;
      Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the
      trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly
      diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6
      courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6
      weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming
      that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ)
      to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients
      have to be accrued. Patients will be accrued over 24 months and each patient will be followed
      for at least 24 months adding up to a total minimal duration of the time from first patient
      in until the end of the follow-up time of 48 months. The primary endpoint is overall
      survival; secondary endpoints include progression-free survival, response rate, acute and
      late toxicity, and quality of life.
    


Intervention name(s): Temozolomide and lomustine; Temozolomide
Intervention type(s): Drug; Drug
Other intervention name(s): Temodal, Temomedac, CeCeNu; Temodal, Temomedac
Intervention MeSH terms: Temozolomide; Lomustine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MGMT promotor status; overall survival
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet
      eligibility criteria will be randomized to receive pregabalin vs matching placebo while
      simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment
      of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and
      benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam,
      will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use).
      The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to
      discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated
      groups. Hypothesis is that a greater proportion of subjects will be successful in
      discontinuing and remaining free from benzodiazepines who were treated with pregabalin as
      compared to subjects treated with placebo.
    


Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg twice daily. Subjects successful in discontinuation of alprazolam while treated with pregabalin will continue to be maintained on pregabalin for 6 weeks and assessed weekly for ability to remain in the study.; GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Three Experimental Toothpastes to Remove Plaque
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The Dose response of three experimental toothpastes (test product 1, test product 2 and test
      product 3) to remove plaque after a single brushing, compared to a positive control and
      negative control dentifrice will be evaluated.
    

Detailed description: 
      This will be a single centre, controlled, examiner blind, five treatment, five period,
      crossover design study in healthy participants. This study will evaluate the dose response of
      three experimental toothpastes (test product 1, test product 2 and test product 3) to remove
      plaque after a single brushing, compared to a positive control and negative control
      dentifrice. Plaque removal efficacy will be measured by Turesky modification of Quigley Hein
      Plaque Index (TPI).
    

Intervention name(s): 20% w/w sodium bicarbonate; 35% w/w sodium bicarbonate; 50% w/w sodium bicarbonate; 67% w/w sodium bicarbonate; 0% w/w sodium bicarbonate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dentifrice containing 20% w/w sodium bicarbonate.; Dentifrice containing 35% w/w sodium bicarbonate.; Dentifrice containing 20% w/w sodium bicarbonate.; Dentifrice containing 67% w/w sodium bicarbonate.; Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Measuring the Neurological Benefits of Intermittent Hypoxia Therapy With MRI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Hypoxia
Study type: Interventional

Summary: 
      This study uses Magnetic Resonance Imaging to image the brain and spinal cord before and
      after an Intermittent Hypoxia intervention. Acquiring these scans in patients with chronic
      cervical spinal cord injury and uninjured controls will enable characterization of changes in
      neurovascular physiology caused by this promising new therapy.
    

Detailed description: 
      Acute intermittent hypoxia (AIH) is an emerging, safe technique for facilitating neural
      plasticity in individuals with chronic spinal cord injury (SCI), demonstrating significant
      transient improvements in respiratory function, plantar flexion, locomotor function, and hand
      dexterity and strength. Although these studies observe some degree of success eliciting
      plasticity, we lack a framework for systematic optimization of the AIH protocol for
      individual patients.

      Better understanding of what physiological mechanisms drive AIH-induced neural plasticity in
      humans will directly inform the development of AIH as an effective treatment option in
      chronic SCI. This study applies magnetic resonance imaging (MRI) to test how AIH influences
      vascular and neural properties of the brain and spinal cord.

      Individuals with SCI and uninjured participants will be recruited to undergo two MRI scan
      sessions on one day. In between these scan sessions, participants will undergo a single
      30-minute session of AIH. In each scan session, functional MRI will assess AIH-induced
      changes in neural activation patterns during motor tasks (unilateral isometric hand grasping
      tasks) and vascular reactivity to breath hold tasks (transient hypocapnia to induce
      vasodilation). Additional structural scans will be acquired to aid in image analysis.
    

Intervention name(s): Acute Intermittent Hypoxia
Intervention type(s): Other
Intervention description(s): Participants will wear a non-rebreathing face mask and alternate between breathing 9% O2 gas mixture for up to 1 minute, or until the target SpO2 of 85 percent is reached, and normal room air (21 percent O2) until 2 minutes are complete. This cycle will be repeated 15 times, resulting in a 30-minute protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Spinal Cord Injury; Acute Intermittent Hypoxia; Magnetic Resonance Imaging
A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute mountain sickness is a common ailment in people venturing over 2500 m altitude.
      Pilgrims to high altitudes are at an added risk since they are unaware and they gain height
      faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of
      acute mountain sickness. There are no randomized controlled trials that have studied
      protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies
      regarding this matter.

      This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus
      placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent
      that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will
      be randomly assigned for 3 days and participants will be assessed at 3 stations.

      This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be
      the first RCT done in this issue.

      The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent
      to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the
      incidence and severity of acute mountain sickness.
    


Intervention name(s): Acetazolamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 125 mg twice daily until 4380 meters altitude; Twice daily
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Acute mountain sickness; Rapid ascent; High altitude headache; Mountain Medicine Society Nepal
Improving HPV Vaccination Rates Among Rural and Native American Adolescents
Condition: HPV Vaccinations
Study type: Interventional

Summary: 
      This study will develop and implement a multi-level intervention aimed at improving human
      papillomavirus (HPV) vaccination rates at an Indian rural health clinic.
    

Detailed description: 
      The focus of this study is to develop, implement, and evaluate a human papillomavirus (HPV)
      vaccination program aimed at accelerating vaccine uptake among rural and Native American
      adolescents ages 11-17. HPV vaccination coverage with at least one dose remains
      disproportionately lower among rural adolescent compared to adolescents residing in urban
      areas and the rate of series completion is lower among Native American adolescent girls
      compared to non-Hispanic White adolescent girls.
    

Intervention name(s): HPV vaccination training and education
Intervention type(s): Behavioral
Intervention description(s): 1) Training of providers and clinic staff on the importance of providing a strong HPV vaccination program and 2) HPV vaccination education for parents and the community.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects
Condition: Cat Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with
      allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived
      peptide desensitising vaccine, currently being developed for the treatment of cat allergy.
      This study will investigate the efficacy of 4 treatment regimens of Cat-PAD in cat allergic
      subjects following challenge to cat allergen in an environmental exposure chamber (EEC).
    

Detailed description: 
      This study is designed as a multicentre, randomised, double-blind, placebo-controlled study
      of 4 treatment regimens in up to 120 cat allergic subjects. A total of 24 subjects will be
      randomised into each treatment group. Each subject will undergo screening up to 4 weeks
      before treatment. Baseline challenge will consist of exposure to cat allergen for 3 hours in
      an EEC on 4 visits on successive days a week before the first administration of Cat-PAD or
      placebo. Treatment will be administered as intradermal injections into the flexor surface of
      alternate forearms. There are 5 treatment regimens involving administration of Cat-PAD or
      placebo. Post-treatment challenge (PTC) will consist of exposure to cat allergen for 3 hours
      in an EEC on 4 visits on successive days 18 weeks after the first administration of study
      medication.
    

Intervention name(s): Cat-PAD; Cat-PAD; Cat-PAD; Cat-PAD; Cat-PAD
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Cat-PAD dose 2X 4 administrations 2 weeks apart; Cat-PAD dose 1X 4 administrations 2 weeks apart; Cat-PAD dose 1X 4 administrations 4 weeks apart; Cat-PAD dose 1X 8 administrations 2 weeks apart; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cat allergy; Immunotherapy; Cat-PAD; Environmental Exposure Chamber
Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief
Condition: Pain
Study type: Interventional

Summary: 
      A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of
      cannulation when compared to vapocoolant spray.
    

Detailed description: 
      Needle pain is the most common and the most feared source of childhood pain, resulting in
      needle phobia for 10% of adults. Current pain relief options include numbing creams,
      vapocoolant spray, or injected lidocaine. 17 million pediatric IV access procedures are done
      yearly with no pain intervention. An inexpensive, immediately acting form of needle pain
      control could reduce needle phobia in the long term if demonstrated to be effective for
      needle pain.

      This study will evaluate pain self report and parent report using the Faces Pain Scale
      revised, and video-coded OSBD-R scores for patients undergoing emergency department venous
      access or cannulation procedures. Demographic information, pre-procedural anxiety, and
      success data from the attempts at placement will be included.
    

Intervention name(s): Buzzy; vapocoolant
Intervention type(s): Device; Other
Intervention description(s): "Buzzy" is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front.; venipuncture with vapocoolant spray offered
Other intervention name(s): BuzzyR; PainEase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pediatric; venipuncture; pain; vibration; vapocoolant
Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to compare and determine the the efficacy of minimal stimulation
      and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic
      Ovary Syndrome(PCOS).
    

Detailed description: 
      All patients received 100 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5
      days starting from day 3 of spontaneous or induced menstruation. In group A (minimal
      stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland,
      75 IU/vial) were given IM on cycle day 9. A total of 3 cycles was offered to each group.
    

Intervention name(s): clomiphene citrate +highly purified uFSH; clomiphene citrate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; clomiphene citrate; minimal stimulation; infertility treatment
Vaginal Transluminal Endoscopic Sacrocolpopexy
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This study aims to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal
      hysterectomy, focusing on perioperative and early postoperative results. The impact of
      V-NOTES sacrocolpopexy on patients' quality of life is investigated using validated
      assessment tools. Additionally, operative time, complications, pain scores were assessed.
    

Detailed description: 
      Patients who presented to the obstetrics and gynecology outpatient clinic with complaints
      related to pelvic organ prolapse, had stage III or IV prolapse according to POP-Q
      classification, were between 45 and 79 years old, had no contraindications for
      pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal NOTES
      and gave written informed consent were included in the study. Demographic data, age, medical
      and surgical history, body mass index (BMI), operation time, preoperative and postoperative
      haemoglobin levels, perioperative complications and length of hospital stay were collected.
      Pelvic organ prolapse quantification (POP-Q) scores were evaluated before and 1 month after
      surgery. Quality of life was evaluated before and 1 month after surgery with the
      Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress
      Inventory (PFDI-20).
    

Intervention name(s): V NOTES Sacrocolpopexy
Intervention type(s): Procedure
Intervention description(s): The procedure involved a single-port laparoscopic surgery through the vaginal route, aiming to restore pelvic floor function by suspending the vagina to the anterior longitudinal ligament. The surgical approach differs from conventional methods, as these procedures are conducted through abdominal or vaginal routes without the aid of laparoscopic cameras, However, in our approach, we uniquely combine the widely acknowledged gold standard sacrocolpopexy procedure using vaginal route with laparoscopic camera assistance. No experimental drugs or devices were employed; only the surgical approach was modified.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment