bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in the
      healing of foot ulceration in diabetic patients.
    


Intervention name(s): Pedyphar Ointment; Panthenol
Intervention type(s): Drug; Drug
Intervention description(s): Ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic; Foot; Ulcer
Gastric Ultrasound
Condition: Surgery
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate gastric volume and contents as well as
      gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The
      hypothesis is that patients with stress, pain and opioid administration will have delayed
      gastric emptying and therefore a larger gastric fluid volume than those scheduled for
      elective surgery. The patients who have an appropriate NPO time will have a larger
      gallbladder size than the patients with shorter NPO time.
    


Intervention name(s): Point-of-Care Ultrasound
Intervention type(s): Device
Intervention description(s): Portable ultrasonography done at the bedside.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Body Dissatisfaction Among Islamic Veil Practicing (IVP), Non-Complete IVP, and Inconsiderate to IVP Women
Condition: Depression; Body Dissatisfaction; Obesity; Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Observational

Summary: 
      The aim of this research is to examine the social, psychological and Islamic veil practicing
      (IVP), non-complete IVP and Inconsiderate to IVP correlates of body mass index (BMI) status
      in a women population. It is hypothesized that women who are IVP would differ on depression,
      and social variables compared with their non-practicing peers.
    

Detailed description: 
      In this cross-sectional study, a population-based sample of 1774 female responded anonymously
      to an aerobic health club administered questionnaire. Body mass index was calculated from
      height and weight and categorized into four classes of underweight, normal, overweight, and
      obese. The questionnaire also included questions about social experiences, body
      dissatisfaction as Body Shape Questionnaire (BSQ), future goals and Islamic Veil Practicing
      (IVP). Persian version of Beck Depression Inventory (BDI-II Persian) and Rosenberg Self
      Esteem Scale was also distributed among six groups of women having IVP/regular exercise (RE),
      IVP/non-RE, Non-complete IVP/RE, Non-complete IVP/non-RE, Inconsiderate to IVP/RE, and
      Inconsiderate to IVP/non-RE. Correlations of BMI with social, psychological, future goals and
      IVP were explored
    

Keywords: Self Concept; Eating Disorder; Body Mass Index; Dressing; Islamic Veil
Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Training Executive, Attention and Motor Skills (TEAMS) is a new research program for
      preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use
      game-like activities and physical exercise to promote the growth of neural processes that
      underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as
      associated areas of difficulty (e.g., socialization, motor skills). These activities are
      implemented at home and in supervised playgroups at no cost to families and are coupled with
      extensive parental education about ADHD symptoms and associated impairments.
    


Intervention name(s): TEAMS (Training Attention Executive and Motor Skills)
Intervention type(s): Other
Intervention description(s): Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.
Other intervention name(s): Cognitive enhancement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Executive function; Preschool children; Treatment; Memory; Attention; Training; Cognitive enhancement
Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      NRG1 gene fusions are extremely rare across solid tumours (estimate 0.3-0.5%). However, it is
      felt to be an actionable and potentially major growth pathway for those tumours that harbour
      this gene rearrangement. Tumours that harbour NRG1 fusions are driven by HER3 overactivation.
      Seribantumab is a mono-clonal antibody against HER3, it binds HER3 and inhibits
      NRG1-dependent activation and HER2 dimerization.
    


Intervention name(s): Seribantumab
Intervention type(s): Drug
Intervention description(s): For the induction phase: Seribantumab 3,000 mg IV weekly for 12 weeks then Maintenance Phase: Seribantumab 3,000 mg IV infusion once every 2 weeks, initiating approximately 14 days after completion of induction phase. Dose or schedule may be adjusted at the discretion of the treating physician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lymphedema Prevention in Breast Cancer
Condition: BREAST CANCER; LYMPHEDEMA
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Interventional

Summary: 
      OBJECTIVE: To find out the effectiveness of early application of physical therapy in the
      prevention of lymphedema after breast surgery and lymphadenectomy.

      DESIGN: Randomized, controlled and single blinded clinical trial. Three years duration.
      Patients will be randomly assigned to one of these groups: Experimental group: Early physical
      therapy + training in means of prevention; Control group: just training in means of
      prevention. In both groups several physical therapy assessments will be undertaken: 1st
      before surgery; 2nd immediately after surgery; 3rd after completing intervention; 4th, 5th
      and 6th after 3, 6, 12 and 24 months.

      SUBJECTS: Women with breast cancer treated with breast surgery including lymphadenectomy in
      Principe de Asturias Hospital, provided that there is no contraindication for physical
      therapy, and after reading, understanding and freely signing an informed consent form.

      SAMPLE SIZE: A total of 116 subjects will be included in the study (58 subjects in each
      group), assuming a 15% of drop-outs and at least 20% reduction, with a statistical power of
      60%.

      DATA ANALYSIS: To find out the effectiveness of intervention we will compare the rate of
      lymphedema in both groups by means of a logistic regression analysis, in which the main
      factor is the intervention group. Other factors aimed to control the effect of the
      intervention will also be included. In order to compare the rate of appearance of lymphedema
      in both groups, a survival analysis will also be included.
    


Intervention name(s): Early Physical Therapy and Educational strategy
Intervention type(s): Other
Intervention description(s): Experimental group:
physical therapy including a manual lymph-drainage technique, progressive massage of the scar, and progressive active and action-assisted shoulder exercises started in conjunction with functional activities and proprioceptive neuromuscular facilitation without resistance and Educational strategy including instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors,etc.
Other: control group: only the educational strategy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lymphedema; Prevention; Breast cancer; Physical therapy
Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Preliminary scientific studies, in both animals and humans suggest that oral consumption
           of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity
           of osteoblasts responsible for bone formation while improving the bone mineral density
           and biomechanical resistance of long bones.

        -  The objective of this clinical research is to measure changes in biomarkers of bone
           turnover in postmenopausal healthy women, not osteoporotic, in response to consumption
           of hydrolyzed collagen for three months.

        -  For this, we propose to measure blood and urinary markers of formation and bone
           resorption before consumption, then 45 and 90 days after daily consumption of 10 g of
           hydrolyzed collagen.
    


Intervention name(s): hydrolyzed collagen; wheat protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10g/day at breakfast during 90 days; 10g/day at breakfast during 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Osteoporosis; Postmenopausal women; Functional food; Hydrolysed collagen; Bone metabolism; Bone marker of resorption; Bone marker of formation
Dairy Modulation of Oxidative and Inflammatory Stress in Overweight and Obese Subjects
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of this study is to determine the acute effects of a dairy supplement compared
      to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in
      the absence of any changes in adiposity.
    

Detailed description: 
      Obesity is associated with sub-clinical chronic oxidative and inflammatory stress, both of
      which are major contributors to obesity-associated co-morbidities. Calcitriol (1,
      25-(OH)2-D3) regulates adipocyte lipid metabolism, while dietary calcium inhibits obesity by
      suppression of calcitriol. We have recently shown calcitriol to increase oxidative stress and
      to stimulate the expression and release of inflammatory cytokines, while inhibiting the
      expression and release of anti-inflammatory cytokines. We have also shown that inhibition of
      calcitriol with high calcium diets decreases both adipose tissue and systemic oxidative and
      inflammatory stress in a mouse model of obesity. Moreover, dairy exerted a greater effect on
      both oxidative and inflammatory stress. These mice also exhibited significant reductions in
      adiposity, which could lead to confounding, as this reduction will independently reduce
      oxidative and inflammatory stress. However, the supporting cellular/mechanistic data indicate
      an effect which is independent of adiposity reduction. Consequently, we propose that low
      calcium diets exacerbate oxidative and inflammatory stress and that high dairy diets can
      attenuate both independently of changes in adiposity, thereby significantly reducing the risk
      of obesity-associated co-morbidities. Accordingly, the objective of this study is to
      determine the acute effects of a dairy-rich diet on oxidative and inflammatory stress in
      overweight and obese subjects in the absence of any changes in adiposity.

      Twenty subjects (10 obese and 10 overweight) will undergo a randomized crossover study of low
      dairy and high dairy eucaloric diets. Each dietary period will be four weeks, and the two
      dietary periods will be separated by a four-week washout period. Primary outcomes will be
      circulating indices of oxidative stress and of inflammation. Secondary outcomes include blood
      pressure, circulating glucose, insulin, lipids, calcium-regulatory hormones and body
      composition.
    

Intervention name(s): Milk; Soy
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Milk-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate adn 350 mg Ca. Three consumed each day.; Soy-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate and 30 mg Ca. Three consumed each day for 28 days,
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Inflammation; Oxidative stress
Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy
Condition: Kidney Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional

Summary: 
      This prospective, randomized study is aimed to assess the efficacy and safety of
      paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The
      investigators suppose that paravertebral block is not inferior in controlling the
      perioperative pain for percutaneous nephrolithotomy compared to epidural block.
    

Detailed description: 
      Background: Percutaneous nephrolithotomy (PCNL) is generally performed under general or
      neuraxial anesthesia. The investigators have reported three patients who were at high risk of
      both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with
      ultrasound guided paravertebral block. Then，The investigators performed ultrasound guided
      paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully.
      The investigators' impression is that paravertebral block is as effective as epidural
      anesthesia for surgical anesthesia of percutaneous nephrolithotomy.

      Objectives:To assess the efficacy and safety of paravertebral block compared to epidural
      anesthesia for surgical anesthesia of percutaneous nephrolithotomy.

      Methods: Fifty adult patients undergoing elective percutaneous nephrolithotomy will be
      randomized to receive ultrasound guided paravertebral block or epidural anesthesia. The
      primary outcome will be the pain score 12h postoperation. The secondary outcomes will
      include: time spent to perform block, dose of intraoperative opioids, rate of hypotension
      need for vasoconstrictors, muscle Power Grading of the lower legs at the end of the
      operation, anus exhaust time, opioid consumption postoperation, postoperative PONV score and
      the frequency of vomiting , hospitalization duration and patient satisfaction.

      Clinical Implications: Ultrasound guided paravertebral block could be an equally effective
      and safe alternative to epidural block for surgical anesthesia of percutaneous
      nephrolithotomy.
    

Intervention name(s): paravertebral block; epidural anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound guided two-segment paravertebral block; thoracic epidural anesthesia
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: paravertebral block; ultrasound; percutaneous nephrolithotomy; postoperative pain
Levobupivacaine vs Levobupivacaine + Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients
Condition: Post-tonsillectomy Analgesia; Levobupivacaine
MeSH terms: Laryngismus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Tonsillectomy is one of the most common surgical performed procedures in children.
      Adenotonsillectomy surgery in pediatrics is commonly managed as an ambulatory surgery. This
      may be attributed to the use of the electro-dissection surgical technique that decreases the
      incidence of immediate postoperative hemorrhage. However, the use of the electro-cautery
      technique increases postoperative inflammation. Postoperative throat pain is a very important
      and significant problem because it can lead to decreased oral intake and dehydration with
      subsequent serious complications of dehydration.
    

Detailed description: 
      The idea behind the use of local anesthetic agents in the peri-operative period is not only
      related to its ability to block peripheral nociceptor transmission after tissue damage but
      also in preventing sensitization of the central nervous system. Levobupivacaine is new,
      long-acting bupivacaine, amide-type local anesthetic and is thought to be less cardio and
      neurotoxic. However, few studies showed that local infiltration of levobupivacaine reduces
      the intensity of postoperative pain. Dexmedetomidine is a highly selective α2-adrenoceptor
      agonist recently introduced to anesthesia practice producing dose-dependent sedation,
      anxiolysis, and analgesia (involving spinal and supraspinal sites), without respiratory
      depression. Dexmedetomidine is being used off-label as an adjunctive agent in pediatric
      patients for sedation and analgesia; in the critical care unit, during non-invasive (
      Magnetic resonance imaging) and invasive procedures ( cardiac catheterization and endoscopy).
      It may also decrease opioid usage and anesthesia requirements as seen from adult data prevent
      emergence delirium and postanesthesia shivering.
    

Intervention name(s): Levobupivacaine hydrochloride; Levobupivacaine Hydrochloride + Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): levobupivacaine 0.25%; Levobupivacaine plus Dexmedetomidine
Other intervention name(s): levobupivacaine; levobupivacaine + precedex
Intervention MeSH terms: Dexmedetomidine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is open-labe randomized multicenter comparative Phase III study conducted in 7 medical
      facilities. The objective of the study is to assess the efficacy and safety of Favipiravir
      for parenteral administration compared with the Standard of care (SOC) in hospitalized
      patients with moderate COVID-19 pneumonia.
    

Detailed description: 
      Upon signing the informed consent form and screening, 217 eligible patients hospitalized with
      COVID-19 pneumonia were randomized at a 1:1 ratio to receive either Favipiravir intravenously
      by drip infusion for 2 hours 1600 mg twice a day (BID) on Day 1 followed by 800 mg BID on
      Days 2-14 (1600/800 mg), or SOC. The course of treatment by Favipiravir is 10 days.
    

Intervention name(s): Favipiravir; Favipiravir; Remdesivir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg, lyophilizate for preparation of concentrate for solution for infusion; 200 mg coated tablets; 100 mg, lyophilizate for preparation of concentrate for solution for infusion
Other intervention name(s): Areplivir
Intervention MeSH terms: Remdesivir; Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Areplivir; 2019-nCoV; Favipiravir; Pneumonia; Coronavirus Infections
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway
      anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway
      infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway
      Pa infection will be safe and well-tolerated, and will increase the time-to-need for
      antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and
      symptoms compared with placebo.
    


Intervention name(s): KB001-A; Placebo Comparator
Intervention type(s): Biological; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Pseudomonas aeruginosa (Pa); CF
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR)
      versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive
      Disorder (MDD).
    


Intervention name(s): Desvenlafaxine Succinate Sustained-Release; Desvenlafaxine Succinate Sustained-Release; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.; Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.; Subjects randomized to the Placebo treatment arm will receive placebo tablets
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Depression
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose
      combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin
      (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy
      participants in the fasted and fed states.
    


Intervention name(s): Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state); Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state); Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state); Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week; Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week; Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week; Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
Other intervention name(s): Onglyza™; Glucophage™; Onglyza™; Glucophage™
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)