bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of single and multiple doses of VAK694
      in healthy volunteers and otherwise healthy volunteers with a history of allergies.
    


Intervention name(s): NVP-VAK694; NVP-VAK694
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Allergic rhinitis, anti-interleukin 4
Ambu®AuraGain™ Versus I-gel® in Obese Patients
Condition: Obese
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical
      i-gel® and Ambu®AuraGain™) in obese patients
    

Detailed description: 
      Since the incidence of a difficult intubation lies between 4.5% -7.5%, the search for
      alternative airway devices has been forced in the past.

      As an option, the laryngeal mask is suitable, which has been used as a universal airway with
      a high degree of safety in routine anesthesia.

      There are numbers of different laryngeal masks available which have the characteristic to
      insert an endotracheal tube through the ventilation lumen.

      The indications for these laryngeal masks can be extended due to continuous improvements in
      the laryngeal masks, these laryngeal masks can also be used in obese patients. Obese patients
      generally have a 4-fold increased risk of a difficult airway, and a BMI over 35 is a
      predictor of a difficult tracheal intubation.

      There are no studies comparing the Intersurgical i-gel® Laryngeal Mask and the Ambu®AuraGain
      ™ Laryngeal Mask in obese patients.
    

Intervention name(s): Ambu AuraGain; Intersurgical i-gel
Intervention type(s): Device; Device
Intervention description(s): Insert and intubation of an Ambu® AuraGain™ laryngeal mask; Insert and intubation of an Intersurgical i-gel®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obese; Laryngeal Mask Airway; Anaesthesia
Evaluation of Block Duration in Type 2 Diabetes Patients
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Diabete animal studies demonstrated a longer period recovery after local anesthetic injection
      (perineural administration). No clinical study demonstrated a prolonged nerve block duration
      in diabete type 2 patients after peripheral nerve block. The investigators hypothesized that
      block recovery is delayed in diabetic patients.
    

Detailed description: 
      For diabetic patients, peripheral nerve block is an interesting alternative to general
      anesthesia because it provides effective analgesia and may decrease haemodynamic
      complication. The fear of nerve injury after regional anaesthesia in diabetic patients is a
      concern that has neither been confirmed nor refuted by current literature. As a matter of
      fact, diabetic patients with neuropathy may be considered at increased risk because of the
      possibility for double crush syndrome when a chronic axon lesion related to diabetes is
      associated with an unexpected distal nerve injury related to regional anaesthesia.
    

Intervention name(s): ropivacaine
Intervention type(s): Drug
Intervention description(s): patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve
Other intervention name(s): naropin
Intervention MeSH terms: Ropivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: local anesthetic; sciatic; diabetes; block; duration
How Body Awareness Promotes Mental Health During Yoga and Physical Exercise
Condition: Negative Thoughts; Mild Depression; Stress
MeSH terms: Depression
Study type: Interventional

Summary: 
      The integrity of interoceptive networks is linked to resilience against depressive symptoms,
      whereas degradation of these networks is linked to apathy and deficits in emotion processing.
      The goal of this study is to compare two major styles of yoga and cardiovascular exercise
      through a 10-week training program to promote interoceptive awareness. The researchers
      hypothesize that improvement in affective symptomatology will be correlated with better
      interoceptive development. Changes in mood related symptoms and interoception will be
      assessed at baseline, week 12 and week 14, in a cohort of adults aged 18-55.
    

Detailed description: 
      A recent annual survey of U.S. college freshman has found consistently declining levels of
      emotional health over the past 25 years. Exposure to such stress can have profound
      longitudinal effects on well being, influencing risk for disease later in life. Physical
      exercise is linked to benefits across a variety of physical and psychological domains. While
      the affective and physiological consequences of exercise are well-documented, how they work
      to improve subjective well-being is unclear. It has been suggested that exercise promotes
      well-being by increasing interoception. The integrity of interoceptive networks is linked to
      resilience against depressive symptoms, whereas degradation of these networks is linked to
      apathy and deficits in emotion processing. The goal of this study is to compare two major
      styles of yoga and cardiovascular exercise through a 10-week training program to promote
      interoceptive awareness. The researchers hypothesize that improvement in affective
      symptomatology will be correlated with better interoceptive development. Changes in mood
      related symptoms and interoception will be assessed at baseline, week 12 and week 14, in a
      cohort of adults aged 18-55.
    

Intervention name(s): Gentle Yoga Intervention; Rigorous Yoga Intervention; Physical Exercise Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 10-week exercise program structured around gentle yoga practice.; 10-week exercise program structured around rigorous yoga practice.; 10-week exercise program structured around cardiovascular exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
PRESERVE-MITRAL Post-Market Registry
Condition: Mitral Valve Disease
Study type: Observational

Summary: 
      The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral
      repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended
      use up to 12 months from the day of procedure
    

Detailed description: 
      There is limited local evidence on mitral repair products in South Asia and a prospective
      post market registry will provide real world data on clinical outcomes.

      Patients suffering from mitral valve disease and indicated for a mitral valve repair
      procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in
      accordance with the product label indications (instructions for use), contraindications, and
      warnings will be considered for study participation.

      PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market
      registry

      The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral
      repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended
      use up to 12 months from the day of procedure
    

Intervention name(s): Profile 3D™ and CG Future® annuloplasty system
Intervention type(s): Device
Intervention description(s): Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from mitral valve disease and indicated for a mitral valve repair
        procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care,
        in accordance with the product label indications (instructions for use), contraindications,
        and warnings
CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional

Summary: 
      The investigators hypothesized that migraine without patients with many genetic loci
      associated with migraine (high genetic load) would be more sensitive and get provoked more
      migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few
      genetic loci associated with migraine (low genetic load).
    

Detailed description: 
      Migraine is a very prevalent neurological disorder with a strong genetic factor. The common
      forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics
      research is crucial for a deeper understanding of migraine mechanisms. Recently, 12 genetic
      loci have been identified to be associated with migraine with (MA) and without aura (MA) in
      four large genome-wide association studies (GWAS). The functional consequences of these
      genetic loci in humans are yet unknown.

      Calcitonin gene-related peptide (CGRP) is a neuropeptide which plays a crucial role in the
      pathophysiology of migraine and is present in migraine relevant structures. CGRP can induce
      migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway and
      CGRP antagonism is efficient in the treatment of migraine attacks. Also, a recent study has
      showed that intracellular accumulation of cAMP is crucial for the induction of migraine
      attacks. However, CGRP does not cause migraine attacks in familial hemiplegic migraine (FHM),
      an autosomal dominant subtype of MA.

      The phenotype of the migraine inducing effects of CGRP might therefore be linked to some of
      the 12 genetic susceptibility loci that have been identified. One of the genetic loci
      (rs13208321) is located in a gene (FHL5) that is associated with the regulation of
      cAMP-responsive elements.
    

Intervention name(s): CGRP
Intervention type(s): Drug
Intervention description(s): Calcitonin-gene-related-peptide (CGRP)
Other intervention name(s): calcitonin-gene-related peptide
Intervention MeSH terms: Calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
Condition: GVHD; Adult Acute Myeloid Leukemia; Adult Acute Lymphoid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to
      standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe
      chronic GVHD-free survival.
    

Detailed description: 
      This study is randomized, prospective, double-blind, placebo-controlled, phase 3 study
      evaluating the prevention of moderate to severe chronic GVHD in patients undergoing bone
      marrow or peripheral blood stem cell transplantation from matched, unrelated donors for acute
      leukemia and myelodysplastic syndrome during the first year after transplant.

      Patients meeting all the inclusion and none of the exclusion criteria will be randomized
      (1:1). All patients will receive premedication and study drug 3 days prior to
      transplantation.
    

Intervention name(s): US-ATG-F; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation; 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Other intervention name(s): Anti-human-T-lymphocyte Immune Globulin, Rabbit
Intervention MeSH terms: Immunoglobulins; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: adult acute myeloid leukemia; adult acute lymphoid leukemia; adult myelodysplastic syndrome; allogenic stem cell transplantation; unrelated donor; GVHD; US-ATG-F (Anti-human-T-lymphocyte Immune Globulin, Rabbit)
H-Senses Project - Self Care Mediated by the Senses
Condition: Stress
Study type: Interventional

Summary: 
      Randomized clinical trial about self-care mediated by the senses in female health
      professionals and their influence on stress, self-esteem, mood states, life satisfaction and
      levels of salivary cortisol.
    

Detailed description: 
      The work environment of health professionals is commonly considered stressful, given that
      they need to deal with difficult situations that include pain, risk of death, the decisions
      that need to be fast and accurate, and conflicts generated in interpersonal relationships.
      There is an ongoing discussion that the investigators need to care for those who care,
      however, there are few interventions studied and validated to effectively reduce the stress
      of these professionals that resonate in states of well-being. There is little room for
      discussion of this topic during the workday, as well as to learn techniques and measures for
      effective stress management. This study aims to explore the relationship between well-being,
      self-esteem and stress of women health professionals, and compare three self-care
      interventions mediated by the senses.
    

Intervention name(s): one-sensory self care (Todo Dia®); multisensory self care (Todo Dia®); bi-sensory self care (Todo Dia®)
Intervention type(s): Other; Other; Other
Intervention description(s): daily use of odorless body moisturizer (Todo Dia® - Natura); daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) + audiovisual stimulus; daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
Condition: Neoplasms; Breast Neoplasms; Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main purpose of this study is to determine if AZD8931 can improve the efficacy of
      standard chemotherapy for the treatment of advanced breast cancer. This study will be
      conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be
      safely administered with paclitaxel chemotherapy. The second part (phase II) will determine
      the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast
      cancer.
    


Intervention name(s): AZD8931; Paclitaxel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet Oral bid; IV once weekly for 3 weeks followed by a week off (repeated cycles); Oral bid (twice daily)
Other intervention name(s): Taxol
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cancer; Tumour; Breast cancer; Metastatic; Secondary
A Study of Single and Repeat Dose Administration of UBX0101 in Patients With Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess safety, tolerability and clinical effects of single and repeat dose
      intra-articular administration of UBX0101 in patients with moderate to severe painful knee
      osteoarthritis (OA).
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study conducted as two parallel
      cohorts to assess the safety, tolerability, and clinical effects of single dose (SD) and
      repeat dose (RD) intra-articular (IA) administration of UBX0101 in patients with symptomatic
      knee osteoarthritis (OA).

      Approximately 36 patients will be randomly assigned to either Cohort 1 (SD) or Cohort 2 (RD)
      (18 patients per treatment cohort) and further randomized in a 2:1 ratio to UBX0101 and
      placebo in each cohort.

      The primary objective of the study is to evaluate the safety and tolerability of SD and RD IA
      administration of UBX0101 over 24 weeks.
    

Intervention name(s): UBX0101; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Investigational drug intra-articular (IA) injection; Placebo intra-articular (IA) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Painful Osteoarthritis; Osteoarthritis, Knee; Senescence
Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy
Condition: Anesthesia
Study type: Interventional

Summary: 
      Dacryocystorhinostomy aims to create a channel between the lacrimal sac and nasal mucosa to
      relieve nasolacrimal duct occlusion. General anesthesia is still preferred by many surgeons
      to secure the airway and control blood pressure.
    

Detailed description: 
      Bleeding even minor can obscure the surgical field. This can extend the operative time &
      increase the failure rate. The hemostatic effect of desmopressin on the quality of the
      surgical field was investigated in patients undergoing endoscopic sinus surgery and revealed
      that desmopressin could reduce intraoperative bleeding.
    

Intervention name(s): Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray; Epinephrine topical 1:100,000 Nasal Packs
Intervention type(s): Drug; Drug
Intervention description(s): The patient will receive two puffs of desmopressin acetate 10 µg/puff in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct (20 μg totally) 60 minutes before surgery.; The patient will receive topical 1:100,000 epinephrine in the side of the nasal cavity ipsilateral to the obstructed lacrimal gland via 3 soaked packs placed in the middle meatus for 5 minutes immediately before the start of surgery.
Other intervention name(s): Minirin 10 μg/0.1 ml per spray; Adrenaline 1 mg / 1ml
Intervention MeSH terms: Deamino Arginine Vasopressin; Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Desmopressin; Dacryocystorhinostomy
Multi-component Interventions to Increase HPV Vaccination in a Network of Pediatric Clinics
Condition: Human Papillomavirus (HPV)
Study type: Interventional

Summary: 
      The purpose of the study is to determine the comparative effectiveness of a provider-only
      intervention and a parent plus provider intervention to increase initiation of HPV
      vaccination among male and female patients ages 11-17 in a large pediatric clinic network in
      the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in
      clinics randomized to the parent plus provider intervention compared with clinics randomized
      to the provider-only intervention.
    


Intervention name(s): Provider assessment and feedback; Provider reminders; Provider education; Patient reminders; Parent education
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Tailored immunization reports highlighting adolescent vaccination rates at the individual, clinic and network levels are distributed by clinic champions every quarter. Reports track vaccination rates over time and allow physicians to compare their rates to the national goal.; An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.; Provider education is being delivered through a comprehensive online continuing education activity that is tailored specifically to physicians, nurses, and clinical staff at TCP practices. It focuses on HPV vaccination best practices and communicating with parents about the HPV vaccine.; Patient reminders are delivered through MyChart, the clinics' online personal health record system, to inform patients (parents) that they are due or overdue for HPV vaccination.; The parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Assess the Clinical Efficacy of the Specialized Enteral Tube Nutrition Composition Nutrison Advanced Cubison as a Part of Complex Pressure Ulcers (PU) Therapy
Condition: Pressure Ulcer ( Stage 2-3)
MeSH terms: Pressure Ulcer; Ulcer
Study type: Observational

Summary: 
      A large number of studies are devoted to studying the effect of patient nutrition on the
      occurrence and treatment of pressure ulcers. Several studies, including the US National
      Long-term Treatment of Pressure Ulcers Study, have shown that weight loss and malnutrition
      were associated with a higher risk of pressure ulcers.

      One of the successful products specially created for the treatment of pressure ulcers and
      taking into account the results of research is the high-protein, energy-rich, ready-to-use
      enteral tube feeding food product Nutrison Advanced Cubison. It is a complete enteral
      nutritional supplement with an innovative nutrient composition for patients with chronic
      wounds, including pressure ulcers, or at increased risk of developing them.

      Taking into account the available data, it seems expedient to continue studying the unique
      combination of nutrients that make up the study food product Nutrison Advanced Cubison in
      order to develop the most effective nutritional protocols for patients at risk for the
      treatment and prevention of pressure ulcers.
    


Intervention name(s): Nutrison Advanced Cubison
Intervention type(s): Dietary Supplement
Intervention description(s): (20% protein energy 100 kcal, 5.5 g protein, 0.85 g arginine, 38 mg of vitamin C and 2 mg of zinc) in a volume not exceeding 1.5 liters / day and, if necessary, to replenish nutritional needs based on the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g of protein / kg body weight / day according to the recommendations for nutritional support
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 patients hospitalized with strokes or traumatic brain injury, who are on tube feeding
        and with the presence of pressure ulcers of 2-3 stages identified at baseline or during
        hospital stay
      
Keywords: Stroke; Traumatic Brain Injury