bioihbjkbjnl/mcl2 huggingface dataset:
Laparoscopic Versus Open Repair of Bilateral Primary Inguinal Hernia
Condition: Bilateral Inguinal Hernia; Postoperative Complications
MeSH terms: Hernia; Postoperative Complications; Hernia, Inguinal
Study type: Interventional

Summary: 
      Currently, there is a controversy regarding the best approach for simultaneous repair of
      bilateral inguinal hernia. The aim of this study was to compare the outcome of laparoscopic
      versus open repair of bilateral inguinal hernia
    

Detailed description: 
      This prospective randomized study included 120 consecutive patients with bilateral primary
      inguinal hernia treated at Alexandria university hospital in the period between June 2014 and
      February 2017. Patients were randomized by sealed envelopes into 3 groups, each includes 40
      patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2
      separate meshes, Group II treated by open preperitoneal mesh repair, while Group III treated
      by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time,
      postoperative complications, pain, hospital stay, return to normal activity and work, chronic
      groin pain, patient's satisfaction and 3 years recurrence rate.

      Statistical Analysis: Numerical data in both groups was expressed as mean

      ± standard deviation (SD) and compared using One-way analysis of variance while categorical
      data was expressed as percentages and compared using Chi-squared test. Logistic regression
      test was used to determine predictors of postoperative complications. Differences were
      considered significant at p <0.05.
    

Intervention name(s): Bilateral TAPP Repair; Open PP Repair; Bilateral Lichtenstein Repair
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers; Open pre-peritoneal repair using single mesh fixed by sutures; Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This prospective study included 120 consecutive patients with bilateral primary inguinal hernia managed by simultaneous bilateral repair. Patients were randomized by sealed opaque envelopes containing computer generated random numbers into 3 groups, each includes 40 patients. Group I treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes (Lap TAPP), Group II treated by open preperitoneal mesh repair with mesh fixation (Open PP), while Group III treated by standard bilateral Lichtenstein repair (LICHT group).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bilateral Inguinal Hernia; Laparoscopic versus open mesh repair; Operative outcomes; Recurrence
A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy Volunteers
Condition: Hypertension; Hypercholesterinemia
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the influence of BR1017-1 and BR1017-2 on pharmacokinetics and safety when
      administered separately or co-administered to healthy volunteers.
    

Detailed description: 
      A total of 32 subjects will be enrolled in one sequence group. The investigational products
      will be administered according to the treatment groups (F, AE, F+AE) assigned to one sequence
      group in Period 1, Period 2, and Period 3.
    

Intervention name(s): BR1017-1; BR1017-2
Intervention type(s): Drug; Drug
Intervention description(s): Administration to the F/F+AE group: BR1017-1 will be administered 1 tablet QD, five-day repeat dose; Administration to the AE group: BR1017-2 will be administered 1 tablet QD, 9-day repeat dose Administration to the F+AE group: BR1017-2 will be administered 1 tablet once QD, 5-day repeat dose.
Other intervention name(s): Fimasartan 60mg; Atorvastatin 40mg / Ezetimibe 10mg
Intervention MeSH terms: Atorvastatin; Ezetimibe
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers
Condition: Glycaemia; Insulinemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine and compare the glycaemic index values and response
      parameters of 6 food products between 3 laboratories.
    

Detailed description: 
      This study will be performed at 3 centers and 15 subjects will be recruited at each center.
    

Intervention name(s): Reference Glucose; Food Product A: Corn Flakes; Food Product B: Ginger Bread; Food Product C:Sandwiched Breakfast Biscuit; Food Product D: Crackers Nature; Food Product E: Breakfast Biscuit; Food Product F: White Bread
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Other intervention name(s): Glucose Standard (50g of Glucose); Corn Flakes; Ginger Bread; Sandwiched Breakfast Biscuit; Crackers Nature; Breakfast Biscuit; White Bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glycaemia; Insulinemia
Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis
Condition: Calcaneal Apophysitis; Sever's Disease
MeSH terms: Osteitis
Study type: Interventional

Summary: 
      The study was a parallel-group, randomized controlled trial with concealed allocation,
      blinding of investigators and assessors and intention-to-treat analysis. It examined the
      effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis.

      It was hypothesized that the primary outcome, pain relief, would be significantly improved
      with the custom-made orthosis compared to the heel lift.
    


Intervention name(s): Podoactiva cutom-made foot orthoses; Podoactiva heel lifts
Intervention type(s): Other; Other
Intervention description(s): Children had to use the orthotics daily during the intervention period; Children had to use the orthotics daily during the intervention period
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Use of Thermal Suits as Preventing Hypothermia During Surgery
Condition: Prostate Cancer
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 4

Summary: 
      Unintentional hypothermia of a patient is a common adverse effect during surgical procedures.
      The aim of this prospective, randomised, controlled study is to determine whether the use of
      thermal suit could prevent surgical patient from experiencing thermal loss than conventional
      measures.

      Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between
      the groups is clinically relevant.
    

Detailed description: 
      The aim of this study was to compare a thermal suit (T-Balance) and conventional warming
      methods to maintain a constant body temperature in patients undergoing robotic laparoscopic
      radical prostatectomy under general anesthesia.

      A sample size calculation was made using a power analysis. Patients were randomly allocated
      into two groups.

      Patients in the intervention group were put on the T-Balance 1 hour before anesthesia
      induction. Patients in the control group got conventional cotton clothes. Intra-operatively
      same warming methods were used in both groups. The measuring points of the temperature were
      esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back
      of the left foot.

      Anesthesia was induced via target-controlled infusion. All temperature data of the patients
      were collected and recorded electrically and continuously.
    

Intervention name(s): Thermal suit; Conventional clothing
Intervention type(s): Device; Other
Intervention description(s): Thermal suit; Conventional clothing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this research study is to test the feasibility, acceptability, and preliminary
      effectiveness of the use of a mobile pharmacist-led intervention that incorporates home BP
      monitoring and medication reminders with patients recruited from a primary care setting, as
      well as identify challenges and potential solutions to broader implementation of a mobile
      pharmacist-led home-based BP monitoring intervention in primary care clinics through key
      stakeholder interviews.
    


Intervention name(s): BP Track
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting
      conditions.
    


Intervention name(s): Cefprozil 500 mg Tablets (Sandoz GmbH); Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefprozil; Cephalosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic
Fiber Longer Term Study on Energy Intake
Condition: Healthy
Study type: Interventional

Summary: 
      Dietary fibre seems to have a relevant role in body weight management. In an acute study the
      investigators found that high viscous-high gelling pectin increased feelings of satiety. The
      objective of this study is to study the effects of 2 weeks of supplementation of high
      gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.

      The investigators do this by measuring the difference in ad libitum energy intake after 15
      days of pectin or 15 days of control supplements. The investigators will further measure
      differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and
      composition of microbiota.
    


Intervention name(s): LM pectin (10%); gelatin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 15 days 1 daily consumption of a drink with 10g pectin added; 15 days 1 daily consumption of a drink with 10g gelatin added
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dietary fiber; energy intake; satiety; physicochemical properties; men and women; Healthy adults
Comparison of the Efficacy and Tolerability of the Addition of AVANDIA to Submaximal Doses of Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a randomized, double-blind, double dummy, multicenter study to assess the safety,
      efficacy and tolerability of the addition of RSG (rosiglitazone) to sub-maximal MET
      (metformin) combination relative to maximal MET monotherapy in subjects with type 2 DM
      (diabetes mellitus). The total duration of the study was approximately 20 months. The study
      consisted of a two-week washout period, a four to seven-week MET titration period, and a
      24-week randomized treatment phase in which subjects, stratified by prior therapy, received
      either RSG + MET combination therapy or MET monotherapy.
    


Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 Diabetes; metformin; rosiglitazone
Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia
Condition: Postoperative Pain After Knee Arthroscopy
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were
      included in this study.
    

Detailed description: 
      Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to
      undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in
      this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and
      the postoperative sham block was performed with an ultrasound probe. The second group is the
      control group; patients in this group are administered a placebo capsule 1 hour before
      surgery and sham block was performed with an ultrasound probe.The third group is administered
      a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed.
      All patients will be received postoperative a tramadol i.v. patient control analgesia device.
      At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded
      from the patient control analgesia. NRS score, white fast track, satisfaction will be
      questioned.
    

Intervention name(s): pregabalin (lyrica); Placebo oral tablet; adductor canal block including bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): preoperative pregabalin and the postoperative sham block will perform.; The preoperative placebo oral tablet and the postoperative sham block will perform.; The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine
Intervention MeSH terms: Pregabalin; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: pregabalin; adductor canal block; postoperative pain
Safety, Tolerability, and Efficacy of 21 Days Dermal Application of MRX-6 on Mild to Moderate Contact Dermatitis
Condition: Allergic Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of
      Three Weeks of Daily Dermal Application of MRX-6 or steroid on the Treatment of Mild to
      Moderate Allergic Contact Dermatitis of the Hand and Forearm.

      Total number of patients: up to 80.
    


Intervention name(s): MRX-6; Steroid
Intervention type(s): Drug; Drug
Intervention description(s): b.i.d treatment for 21 days; b.i.d. 21 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Contact dermatitis; Eczema
Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
Condition: Refractory Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      One third of children with epilepsy have seizures that are medically intractable.
      Uncontrolled seizures pose a variety of risks to children, including higher rates of
      mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible
      option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins
      diet have been shown to be effective alternative treatments in children with refractory
      epilepsy. However, these need parents to be educated, and understand complex instructions of
      weighing foods and diet preparation. Therefore, children with parents with low levels of
      literacy and poor socioeconomic status have not been able to benefit from these therapies.
      Also, the paucity of trained dieticians and limited availability of labeled foods in
      resource-constraint settings has made these dietary therapies even more inaccessible.

      This study aimed to to develop a simple-to-administer variation of the modified Atkins diet
      for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of
      this simplified modified Atkins diet in children with refractory epilepsy in a randomized
      controlled open-label trial.
    


Intervention name(s): Simplified Modified Atkins Diet; Antiepileptic drugs alone
Intervention type(s): Other; Drug
Intervention description(s): Modified Atkins diet with the following modifications:
Pictorial representation of various food items and exchange lists will be provided.
Instead of weights, we will provide standardized measures
We will calculate the amount of carbohydrates of daily readily available foods in the standardized measures
We will formulate recipes and diets based on locally available and culturally acceptable foods.
We will develop a parent instruction manual.
We will also develop methods for parents with low levels of literacy to maintain seizure logs. This will be done by using bars and color codes.
We will develop methods for parents with low levels of literacy to measure and record urine ketones. This will be done by using color codes.; The anti-epileptic drugs will be continued alone for 3 months following which they will be offered Simplified Modified Atkins Diet
Intervention MeSH terms: Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory epilepsy; Dietary therapy; Non-Pharmacological therapy; Simplified Modified Atkins Diet
Ultrasound Parameters to Predict Difficult Airway
Condition: Difficult Intubation
Study type: Observational

Summary: 
      Ultrasound has become an essential tool for the daily work of any doctor, but in certain
      specialties such as Anaesthesiology, its use has greatly increased the safety offered to
      patients throughout the perioperative period, either to perform nerve blocks, for vascular
      access, intraoperative hemodynamic management or any other use that allows increasing quality
      of care.

      The management of the upper airway and the diagnosis of pathological conditions are essential
      skills for any doctor especially for Anaesthesiologist, ER physician, or Intensive Care
      physician. Because an inadequate airway management continues to be an important contributor
      to patient mortality and morbidity, any tool that can improve it should be considered as an
      addition to conventional clinical evaluation.

      Unfortunately, most of the clinical parameters that should allow us to assess a potential
      difficult airway, do not always lead us to an adequate prediction, that is why US(Ultrasound)
      is use as an emerging tool in many fields, is also gathering strength in this search for a
      definitive predictor parameter.

      Ultrasound has many obvious advantages (safe,fast, repeatable, portable, widely available and
      gives dynamic images in real time).

      Sonographic studies are operator-dependent and although the identification of basic
      structures could be acquired with only a few hours of training, but more complex studies
      require a learning curve of months or even years. The high frequency linear probe (5-14 MHz)
      is probably the most suitable for the airway because images are of superficial structures
      (within 0-5 cm below the skin surface).

      The growing academic interest in the use of US to look for predictors of difficult airway is
      centred mainly on measurements at the level of pretracheal tissues.

      But the greatest limitation of these studies is the disparity of the fat distribution that
      exists between different ethnic groups and and sexes, and the lack of standardization method
      in patient´s intubation conditions.

      So, the investigator propose to assess different ultrasound windows at the level of
      pretracheal tissues such as independent predictors of Difficult Airway.
    


Intervention name(s): Compare clinical test with ultrasound parameters
Intervention type(s): Diagnostic Test
Intervention description(s): Compare various clinical test with four ultrasound parameters to predict difficult intubation.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing scheduled surgery requiring orotracheal intubation.
      
Keywords: ultrasound; difficult airway; difficult intubation
A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage
Condition: Cerebral Palsy; Stroke
MeSH terms: Cerebral Palsy; Brain Injuries
Study type: Observational

Summary: 
      The primary goal of this study is to establish and evaluate an image-based biomarker for the
      impaired motor control and sensory information processing present in Cerebral palsy (CP) and
      stroke patients.
    

Detailed description: 
      Brain damage may lead to various motor deficits, which further influence the activities and
      participation. Cerebral palsy (CP) and cerebral vascular accident (CVA) are the common
      disorder for congenital and acquired brain damage, respectively. It would be ideal to
      characterize neural network in patients with brain damage that underlies their clinical
      behavior by identifying altered neural network associated with behavioral improvement.

      The investigators hypothesize that the level of motor control and impact of brain image will
      change with time in patients with brain damage. Under this hypothesis, the measures of motor
      control are correlated with neural changes reflected by imaged using structural MRI, resting
      state fcMRI, and active fMRI sequences. The aim of this study is to investigate the motor
      control and brain image in patients with brain damage evaluated by clinical measures and
      multimodel imaging studies such as structural MRI, resting state fcMRI, and active fMRI. The
      primary goal of this study is to establish and evaluate an image-based biomarker for the
      impaired motor control and sensory information processing present in CP and stroke patients.
      This study will be executed in 3 years: 1st phase: to establish the multimodal brain images
      and motor control in healthy subjects; 2nd phase: to establish the brain images and motor
      control in patients with stroke.; and 3rd phase: to establish the brain images and motor
      control in patients with CP. Additionally, the association between brain images and clinical
      changes involving movement and participation will be analyzed. The investigators will
      identify the predictors influencing final outcome and analyze. The differences in structural
      image, functional connectivity and brain activation between patients with brain damage and
      healthy controls can potentially be a bio-marker for prognosis. The investigators believe the
      results of this study will allow clinicians to understand the brain mechanisms underling
      motor control and early predict the outcome for patients with brain damage.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CP and CVA, and healthy children, and adults
      
Keywords: cerebral palsy; cerebral vascular accident; multi-modal brain techniques; MRI; motor control