bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
Condition: Meningitis; Meningococcemia
MeSH terms: Diphtheria; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to evaluate the antibody response to a Menactra® booster dose in
      participants who previously received one dose of Menactra® or Menomune® as adolescents 3
      years earlier in Study MTA02.

      Primary Objective:

      To evaluate the antibody responses to a booster dose of a tetravalent meningococcal
      diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received
      Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of
      Menactra® in naive adolescents.
    

Detailed description: 
      All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the
      response, the magnitude and the avidity of the antibody produced.
    

Intervention name(s): Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Menactra®; Mneactra®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcemia; Neisseria meningitidis
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and bioequivalence of
      amlodipine besylate formulations under fasting conditions.
    

Detailed description: 
      This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of
      Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy
      volunteers with a washout period of 14 days.
    

Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention description(s): Amlodipine Tablets, 10 mg
Other intervention name(s): Norvasc 10 mg tablets of Pfizer, Inc.,
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Amlodipine Besylate
Quantum Natural Family Planning Pilot
Condition: Fertility Disorders
Study type: Interventional

Summary: 
      •The Pilot study will involve current Marquette Method users who own and use a ClearBlue
      Fertility monitor and who will be asked to simultaneously use the Mira monitor for the sake
      of comparing the two devices to monitor the menstrual cycle.
    

Detailed description: 
      -  The Mira fertility monitoring system (www.miracare.com) is a new home-use hormone
           tracking device with the ability to quantitatively measure reproductive hormones in the
           urine but is also synced to a smart phone App that provides a graphic representation of
           the hormonal levels throughout a menstrual cycle.

        -  The Mira monitor will be compared to the ClearBlue Fertility Monitor for its ease of
           use, satisfaction, and accuracy.

        -  The Mira hormonal monitor and App system has not been tested for its use in Natural
           Family Planning (NFP).

        -  The Pilot study will involve current Marquette Method users who own and use a ClearBlue
           Fertility monitor and who will be asked to simultaneously use the Mira monitor for the
           sake of comparing the two devices.

        -  Female participants invited to participate will need to meet the following criteria:

        -  Age 18 to 42 years

        -  Menstrual cycle ranging between 21-42 days

        -  At least 3 cycles after cessation of breastfeeding

        -  Not currently on medications that affect ovulation and 3 months prior

        -  Not currently pregnant or breastfeeding

        -  No known fertility problems

        -  Not planning on achieving pregnancy during the 3 menstrual cycles of the study
    

Intervention name(s): Mira monitor comparison to ClearBlue monitor
Intervention type(s): Device
Intervention description(s): Testing first morning urine with hormone test sticks at home
Intervention model: Single Group Assignment
Intervention model description: Prospective cohort analysis of three menstrual cycles of hormone data, comparing two fertility monitors that analyze urine hormones. Satisfaction and ease of use will be assessed using surveys. Individual data will be anonymized.
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Costoclavicular and Paracoracoid Approaches to Infraclavicular Brachial Plexus Blocks
Condition: Anesthesia
Study type: Interventional

Summary: 
      Infraclavicular block has taken its place in the literature as a proven technique in the
      anesthetic management of upper extremity surgeries. Compared to general anesthesia; The
      prominent advantages of regional anesthesia are that it provides longer perioperative pain
      control, reduces the incidence of postoperative nausea and vomiting, reduces opioid
      consumption and reduces the cost of hospitalization. The widespread use of ultrasonography
      (USG) in the last two decades has facilitated the application of the method and allowed the
      investigation of different injection methods.

      Regional blocks are planned according to the surgery to be performed. For anesthesia of arm,
      forearm and hand operations; brachial plexus can be blocked in the axillary, infraclavicular,
      supraclavicular or interscalene region. The infraclavicular technique, on the other hand, is
      roughly divided into three types: costoclavicular lateral, costoclavicular medial and
      paracoracoid (Lateral sagittal). The image obtained by placing the ultrasonography probe in
      the relevant anatomical region serves as a guide for the orientation of the peripheral block
      needle and performing the intervention by observing the vascular structures in the existing
      region provides a great advantage in terms of patient safety.

      In this study, we aimed to examine 3 different infraclavicular block methods; lateral
      costoclavicular, medial costoclavicular and lateral sagittal (Paracoracoid) approach, in
      terms of ease of application and motor/sensory block efficiency. Our hypothesis is that the
      sensory block will begin in a shorter time with costoclavicular methods compared to the
      lateral sagittal method. We are also planning to compare performance difficulties (needle
      maneuver numbers, subjective block exertion, block performance time etc.) for each type of
      intervention.
    


Intervention name(s): Infraclavicular brachial plexus block
Intervention type(s): Procedure
Intervention description(s): Named after the anatomical site; patients will be applied infraclavicular brachial plexus block with costoclavicular lateral, costoclavicular medial or lateral sagittal approach.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Prospective, Interventional
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury (SCI) (Kids STEP Study)
Condition: Spinal Cord Injury (SCI)
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The Kids STEP Study aims to

        1. Determine if walking can be restored in children with incomplete SCI and little to no
           leg movement

        2. Identify the neural pathways that permit recovery of walking
    

Detailed description: 
      Locomotor training (LT) is an activity-based therapy to promote plasticity and recovery of
      walking. It is based on animal studies investigating walking recovery after spinal cord
      injury and the nervous system's control of walking. Normal walking is achieved through the
      interaction of multiple levels of the neural axis (cortex, brain stem, spinal cord). However,
      a basic rhythmic walking pattern is generated by central pattern generators (CPGs) located
      within the spinal cord. Investigations of central pattern generators indicate that sensory
      input specific to the task of walking can enhance the firing of these spinal neuronal
      centers. Thus, LT is an intensive walking program designed to provide sensory input to the
      spinal cord so that the neural output from the spinal CPGs can be maximized. In addition, LT
      uses a treadmill and a harness to provide partial body weight support enabling persons with
      injury to repetitively practice walking in a safe, enabling environment.

      Children enrolled in the study (after medical clearance and consent to participate) will
      undergo extensive testing and complete 12 weeks of locomotor training. Testing will examine
      the child's neurologic and functional status. Tests to examine functional status include:
      ASIA evaluation of sensory and motor function, gait analysis, comprehensive strength tests,
      and assessment of skills such as cycling, stepping, and kicking. Tests to examine the child's
      neurologic injury include: MRI, Transcranial Magnetic Stimulation (TMS), and reflex testing.
      Locomotor training will be conducted daily (5 days/ week) for a total of 60 sessions over 12
      weeks. During training children will work closely with therapists, researcher, and trainers
      to practice walking skills on the treadmill and over-ground.
    

Intervention name(s): Locomotor Training
Intervention type(s): Behavioral
Intervention description(s): Task-specific practice of walking with assistance from trainers using body weight support and treadmill followed by training over ground, 5x/week, approximately 1.5 hours/day
Other intervention name(s): body weight supported treadmill training; activity-based therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: walking; walking recovery; physical therapy; locomotor training; body weight support; neuroplasticity; step; treadmill; treadmill training; locomotion
Comparative Effectiveness of Intubating Devices in the Morbidly Obese
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective, randomized study will compare the effectiveness of 4 different airway
      intubating devices which are most commonly used.

      The four different devices are as follows: McGrath video laryngoscope, GlideScope video
      laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.
    

Detailed description: 
      Hypothesis: the use of a video laryngoscope will improve the glottic view compared to direct
      laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to
      achieve successful tracheal intubation in patients undergoing bariatric surgery. (Weight loss
      surgery). The three types of video laryngoscopy devices include; the Verethon GlideScope, LMA
      McGrath and Karl-Storz Video-Mac.
    

Intervention name(s): McGrath; GlideScope; Direct Macintosh Laryngoscopy; Video-Mac
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Intubation with the McGrath device; Intubation with the GlideScope device; Intubation with Direct Macintosh Laryngoscope; Intubation with the Video-Mac device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Direct Laryngoscopy; Video-Mac; GlideScope; McGrath; Laryngoscopy; Bariatrics; Glottic view; Airway intubating devices; Tracheal intubation
Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall hypothesis of this proposal is that nutrient sensing in the foregut regulates
      metabolic hormone secretion and nutrient metabolism via enteric neural signals, and these
      mechanisms might be defective in obesity.
    

Detailed description: 
      The study proposes two specific aims Aim 1 will determine if blocking enteric neuronal
      signaling will alter: a) circulating levels of nutrient substrates and secretion of hormones
      that regulate nutrient metabolism; and b) glucose and fatty acid absorption, production, and
      utilization.

      Obese (BMI = 30-50 kg/m2) subjects will be studied. The topical anesthetic benzocaine will be
      infused into the duodenum prior to infusion of glucose and oleic acid into the duodenum.
      Duodenal infusions with a naso-intestinal feeding tube will circumvent the confounding
      effects of gastric emptying on the metabolic responses to a meal. Substrates (glucose, free
      fatty acids), and lipoproteins) and hormones will be measured by standard biochemical and
      immunological methods. Aim 2 will determine if enteric neural signals regulate appetite. The
      studies will be carried out in both lean and obese humans and the procedure will be performed
      as described above. In addition, the subjects will be asked to use a visual analog scale to
      estimate their level of appetite before, during and after enteral infusions.
    

Intervention name(s): benzocaine; placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.5% benzocaine solution in saline/hydrochloric acid administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes); Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
Other intervention name(s): ethyl 4-aminobenzoate; NaCl, sodium chloride
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Normal Body Weight
Effects of Warm Water on GI System in Laparoscopic Cholecystectomy Patients
Condition: Laparoscopic Cholecystectomy; Abdominal Distention
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Objective: The study was carried out to determine the effect of drinking warm water on GIS
      functions in patients who underwent laparoscopic cholecystectomy surgery.
    

Detailed description: 
      Method: The research was completed in Kahramanmaraş Necip Fazıl City Hospital with 100
      patients, 50 of whom were in the Study Group (WG) and 50 were in the Control Group (KG). The
      patients in CG were given warm water to drink at the 2nd hour after surgery. On the other
      hand, patients in KG were allowed to drink warm water after bowel sounds started and gas was
      produced. Patients in both groups were 2,4,8,12 after surgery. hours were evaluated in terms
      of GIS functions. Statistical analysis was done in SPSS 22.0 for Windows package program. A
      p<0.05 value was accepted for statistical significance.
    

Intervention name(s): Drinking Warm Water Intervention
Intervention type(s): Other
Intervention description(s): Patients in the Warm Water Group (WG) received a warm water drinking intervention post-laparoscopic cholecystectomy. Before intake, the bed head was elevated to 45°C, and gagging and swallowing reflexes were assessed using an Abeslang to touch the oropharynx. Nausea indicated a positive reflex. Two patients with negative reflexes were excluded from WG. To maintain water temperature, individual insulated cups with thermal features were used, preventing infection transmission. Water was boiled in a clinic kettle, cooled to 37-38°C, and given to patients to drink within 15 minutes. Swallowing ability was monitored after the first sip; successful swallowing allowed the patient to continue. Patients were observed for 15 minutes with an aspirator on standby for aspiration risks. No complications occurred during the water drinking process in WG.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This single-center randomized controlled study, conducted between January 15 and May 15, 2022, comprised 100 patients equally divided into the Water Group (WG) and Control Group (CG). Patients in the WG were allowed to take warm water orally during the 2nd postoperative hour without waiting for the onset of bowel sounds or flatus while those in the CG were not. GI functions were evaluated at 2, 4, 8, and 12 postoperative hours and the findings were recorded.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Laparoscopic Cholecystectomy; Bowel Movements
Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
Condition: Generalized Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional

Summary: 
      Generalized aggressive periodontitis (GAgP) is a distinct type of periodontal disease
      characterized by rapid loss of attachment and alveolar bone occuring in young individuals.
      Photodynamic therapy (PDT) was introduced in periodontology as an adjunctive approach to
      non-surgical periodontal treatment (NPT) in periodontitis patients. In this trial, it was
      aimed that to evaluate the clinical and microbiological effects of adjunctive PDT to NPT in
      patients with GAgP. In this prospective controlled clinical study, 24 systemically healthy,
      non-smoking subjects with GAgP were enrolled. Subjects were randomly assigned to a control
      group (n=12) treated with NPT only or to a test group (n=12) treated with NPT and PDT. Plaque
      index, sulcus bleeding index (SBI), pocket depth (PD), relative attachment level, gingival
      recession, mobility were recorded at baseline and on day 63. Microbiological samples were
      obtained fom the sites with PD ≥5 mm at the same time points and evaluated for
      Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia,
      Tannerella forsythia and Treponema denticola using micro-IDent test.
    


Intervention name(s): Ultrasonic; Hand Instruments; LED Source
Intervention type(s): Device; Device; Device
Intervention description(s): Cavitron® BOBCAT® Pro, Dentsply International, USA; Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA; LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease
Condition: Critical Limb Ischemia; Buerger's Disease
MeSH terms: Chronic Limb-Threatening Ischemia; Thromboangiitis Obliterans; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy
      of different doses of Stempeucel in critical limb ischemia patients.
    


Intervention name(s): Allogeneic Mesenchymal Stem Cells; Allogeneic Mesenchymal Stem Cells
Intervention type(s): Biological; Biological
Intervention description(s): Single intramuscular administration of low dose of stem cells; Single intramuscular administration of intermediate dose of stem cells
Other intervention name(s): Stempeucel - CLI; Stempeucel - CLI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Critical limb ischemia; Buerger's disease; Critical limb ischemia due to Buerger's disease
Oxytocin Administration During Cesarean Section
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the
      uterine wall. This definition does not include removal of the fetus from the abdominal cavity
      in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the
      Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow
      intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin
      has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin
      infusion at caesarean section is in maintaining uterine contractility throughout the surgical
      procedure and immediate postpartum period, when most primary haemorrhage occurs
    


Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): intravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients
Condition: Advanced Cancer
Study type: Interventional

Summary: 
      Adolescents and young adults who are living with cancer are not benefiting from the same
      age-appropriate physical and psychosocial care, as are children and older adults. As a
      result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a
      lack of age-appropriate care may be responsible for a deceased quality of life. Studies have
      also shown that physical activity is able to reduce many of the negative side-effects linked
      to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical
      activity that is both safe and manageable for cancer patients is yoga. The purpose of this
      study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha
      yoga program (available on DVD) in the adolescent and young adult non-curative cancer
      population. This study will also examine the ability of yoga to reduce cancer related side
      effects.
    


Intervention name(s): Hatha Yoga
Intervention type(s): Behavioral
Intervention description(s): This is a 7-week home/hospice-based instructive Hatha yoga program (available on DVD) for adolescent and young adults diagnosed with a non-curative cancer. Participants will be asked to complete a minimum of one, 75-minute yoga session per week. The DVD package includes four discs that increase in difficulty over the course of the 7-week program. The DVD focuses on postures and breathing exercises. Participants will be asked to keep track of the number and duration of yoga sessions completed over the 7-week period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer; Adolescent and Young Adult; Exercise; Physical Activity; Quality of Life; End-of-Life; Palliative; Terminal; Yoga; Alternative Therapies; Fitness; Fatigue
A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the
      treatment of pain after endoscopic surgery of the lower abdominal.
    


Intervention name(s): SHR0410 Injection; Placebo; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SHR0410 Injection; Placebo for SHR0410 Injection; Morphine
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SHR0410 injection compared with placebo and morphine
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment