bioihbjkbjnl/mcl2 huggingface dataset:
Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure
      (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate
      the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and
      ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and
      peribulbar anesthesia.
    

Detailed description: 
      In this prospective randomized and double blind clinical study, involving 80 patients with
      ages from 30 to 86 years old, ASA I and II, both genders. The patients were randomly divided
      into 4 groups of 20 patients, and then were administered in control sub-Tenon's group 5 mL of
      2% lidocaine with 1 mL of 0.9% sodium chloride solution; in sub-Tenon's group clonidine, 5 mL
      of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride
      solution. In the peribulbar anesthesia, the control group with 6 mL of 2% lidocaine and 1 mL
      of 0.9% sodium chloride solution, and peribulbar group clonidine, 6 mL of 2% lidocaine
      associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. Were
      evaluated the systemic hemodynamic variables; IOP and OPA measurements according the dynamic
      contour tonometer (DCT) and calculation of OPP, prior to the blockade (M0), and one (M1),
      five (5) and ten minutes (M10) after the injection of the anesthetic solutions. Complications
      related to the sub-Tenon's and peribulbar anesthesia were recorded.
    

Intervention name(s): Clonidine
Intervention type(s): Drug
Intervention description(s): Clonidine 1 µg/kg plus 2% lidocaine
Other intervention name(s): Atensine
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clonidine; Sub-Tenon's and Peribulbar block; IOP; OPP; OPA
Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
Condition: Gynecomastia
MeSH terms: Gynecomastia
Study type: Interventional

Summary: 
      This is a prospective, multi-center, single-blinded, randomized study of up to 10 study
      subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an
      adjunct procedure on one side. The study was conducted at a single investigational center in
      the United States.
    

Detailed description: 
      This is a prospective, multi-center, single-blinded, randomized study of up to 10 study
      subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an
      adjunct procedure on one side. The study was conducted at a single investigational center in
      the United States.

      At baseline, the grade of gynecomastia was recorded by side, male chest measurements will be
      taken, and pre-surgery photographs taken in the frontal, lateral, and oblique views.

      The gynecomastia surgery and Renuvion APR System use were as per investigator's standard
      clinical practice. During the procedure, fat transfer and treatment of the lateral chest
      and/or axilla was not allowed. The Renuvion APR System was used on one side only. The
      Renuvion treated side was randomized and the patient was blinded as to which side of the
      chest received Renuvion. Procedure data and adverse events were captured. Endermology was not
      allowed post-procedure. Post-procedure compression was used for 2-3 weeks with a standard
      compression vest for all subjects.

      Follow-up images, grade of gynecomastia, and male chest measurements were taken at
      D30/D90/D180.

      All images were assessed for correct identification of Renuvion-treated side by blinded
      Independent Photographic Reviewers (IPR) following the D180 visit.

      Following study participation, the subject was offered an optional balancing treatment to the
      side not previously treated with Renuvion.
    

Intervention name(s): Renuvion APR System; Gynecomastia Correction Surgery
Intervention type(s): Device; Procedure
Intervention description(s): The Renuvion APR Handpiece (K191542) is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The Renuvion APR Handpiece is compatible with the Electrosurgical Generators BVX-200H/P (K170188), and APYX-JS3/RS3 (K192867) owned by Apyx Medical that are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures.; Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Renuvion; Helium Plasma
Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors
Condition: Liver Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Observational

Summary: 
      The PI will study metabolism during liver regeneration in living liver donors
    

Detailed description: 
      Samples of blood and urine will be collected from study participants at defined timepoints.
      The samples will be evaluated to study the metabolism of the regenerating liver after a
      portion of the liver has been donated from a living donor.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be comprised of living liver donors.
      
Biospecimen description: 
      Each subject will provide samples of urine and blood at specific timepoints as outlined in
      the protocol
    
Keywords: Living liver donor
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Airway management in anesthesia is critical to guarantee appropriate treatment of possible
      respiratory complications and successful operative practice. LMA® is an alternative to
      tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using
      muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a
      superior manner in airway management in radical modified mastectomy on breast cancer than the
      tracheal tube, and the LMA® might produce less influence on patients' circulatory
      homeostasis, and easier to be placed before operation.
    


Intervention name(s): LMA®; Endotracheal tube
Intervention type(s): Device; Device
Intervention description(s): LMA® is placed after anesthesia induction and removed after the operation; Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Intubation, intratracheal; Homeostasis; Mastectomy, modified radical; Breast Neoplasms
Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation
Condition: Stroke; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor
      impairment after stroke. It is based on the hypothesis that after stroke, the brain's
      utilization of glucose, it's primary source of energy, is disrupted. The MAD is a
      low-carbohydrate diet that has can switch the body's metabolism from using glucose to using
      products of fat metabolism, so-called ketones. Ketones may act as an alternative energy
      substrate for the brain. Ketones also have several neuroprotective effects after stroke.
    


Intervention name(s): Modified Atkins Diet; Control diet
Intervention type(s): Other; Other
Intervention description(s): A high fat, high protein, low- carbohydrate diet; The control diet is a diet determined by the attending physician caring for the patient and may consist of either a low sodium diet, a low sodium/ low cholesterol diet, a regular diet or a diabetic diet.
Other intervention name(s): Low sodium diet; low sodium/ low cholesterol diet; regular diet; diabetic diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; ketones; ketogenic diet; impairment; disability
A Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?
Condition: Renal Failure; Renal Transplantation; Living Donors
MeSH terms: Renal Insufficiency; Hypertension
Study type: Interventional

Summary: 
      Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for
      donation according to official guidelines. An assessment of salt sensitivity, 11 beta HSD
      activity, 24 hour blood pressure, urine collection and physical exam will be performed prior
      nephrectomy and 14, 52, 156, 208 days post-nephrectomy.
    

Detailed description: 
      Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for
      donation. The assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure,
      urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208
      days post-nephrectomy.
    

Intervention name(s): Low and high salt diets
Intervention type(s): Dietary Supplement
Intervention description(s): High salt diet: 150mmol/d Low salt diet: 30mmol/d
Other intervention name(s): NaCl
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets
Condition: Healthy
Study type: Interventional

Summary: 
      The study was an open-label, randomized, single-dose, two-period, two-sequence, two-day
      crossover study, conducted to find out whether the dapagliflozin 10 mg film-coated tablet
      produced by PT Dexa Medica (test drug) was bioequivalent to the reference drug (Forxiga® 10
      mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca
      Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia), under
      fasting condition with a five days wash-out period, involving 24 healthy adult male and
      female subjects.
    

Detailed description: 
      The study was an open-label, randomized, single-dose, two-period, two-sequence, two-day
      crossover study, conducted to find out whether the dapagliflozin 10 mg film-coated tablet
      produced by PT Dexa Medica (test drug) was bioequivalent to the reference drug (Forxiga® 10
      mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca
      Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia), under
      fasting condition with a five days wash-out period, involving 24 healthy adult male and
      female subjects. The participating subjects had an overnight fast and in the next morning
      were given orally either one film-coated tablet of the test drug or one film-coated tablet of
      the reference drug with a total 240 mL of a 20% glucose solution in water. Following drug
      administration, 60 mL of 20% glucose solution was administered at every 15 minutes for up to
      4 hours after dosing as maintenance to prevent hypoglycemic symptoms. Blood samples were
      drawn before taking the drug (control) and at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50,1.75, 2.00,
      3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 36.00 and 48.00 hours after drug administration. The
      blood samples were analyzed to investigate the pharmacokinetics parameters of the single dose
      administration of dapagliflozin. The plasma concentrations of dapagliflozin were determined
      by using a validated ultra-performance liquid chromatography with tandem mass spectroscopy
      detection (UPLC-MS/MS).
    

Intervention name(s): Dapagliflozin 10 mg film-coated tablet; Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of the test drug was given orally (swallowed with 240 mL of 20% glucose solution in water), after an overnight fast.; One tablet of the reference drug was given orally (swallowed with 240 mL of 20% glucose solution in water), after an overnight fast.
Other intervention name(s): Test; Reference
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a bioequivalence study.
Masking: None (Open Label)
Primary purpose: Other
Cognitive Behavioural Group Therapy for Perinatal Anxiety
Condition: Perinatal Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study evaluated the effectiveness of a 6-week, group-based, cognitive behavioural
      therapy (CGBT) program for women with anxiety disorders (with or without comorbid depressive
      symptoms) during pregnancy or early postpartum. The CBGT program was evaluated compared to a
      6-week waitlist condition.
    

Detailed description: 
      Anxiety disorders affect up to 15% of women in the perinatal period (i.e., pregnancy,
      postpartum) and are a serious mental health concern. Anxiety disorders often coexist with
      depression and result in high distress and an impaired ability for new mothers to take care
      of themselves and their babies. In spite of the high prevalence of anxiety disorders during
      pregnancy and postpartum, research and clinical attention in this area is lacking and no
      empirically supported psychological treatments exist. Further, since many pregnant or
      postpartum women are unable or choose not to take medication for their mental health
      symptoms, establishing an effective non-pharmacological alternative is imperative.
      Cognitive-behavioural therapy is a well established psychological treatment for anxiety and
      mood disorders, with moderate to large effect sizes (Cohen's d = 0.5-1.3). The investigators
      developed a novel group-based cognitive-behavioural treatment program (CBGT) for perinatal
      women with anxiety disorders. In an initial, single-sample pilot study (Green et al., 2015),
      a significant reduction in symptoms of anxiety and depression was found from pre to
      post-treatment, along with reported high levels of treatment satisfaction. The purpose of the
      current study is to evaluate the effectiveness of this treatment using a larger sample and a
      randomized controlled trial (RCT).
    

Intervention name(s): Cognitive Behavioural Therapy for Perinatal Anxiety
Intervention type(s): Other
Intervention description(s): The treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-blind, randomized controlled trial was conducted to evaluate the effectiveness of a new group-based cognitive-behavioural therapy (CBGT) for women with anxiety during pregnancy or in the early postpartum.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive-behavioural therapy (CBT)
Effect of Avocado Honey (Apis Mellifera) on Anthropometric and Biochemical Parameters in Healthy Subjects: A Pilot Study
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Thirteen healthy subjects (5 males; 8 females) ages 25-50 years, with BMI (body mass index):
      <25 kg/m2 completed the study. The participants were selected randomly, either the control
      group (n= 7) or honey group (n= 6). Subjects of honey group consumed 25 g of honey each day
      for 4 weeks.
    

Detailed description: 
      18 healthy participants (body mass index [BMI] <25 kg/m2) between 25-50 years of age were
      recruited, of which 13 subjects (male [n=5]) and female [n=8]) completed the study. The
      participants were allocated randomly either control group (n= 7) or honey group (n= 6).
      Subjects of honey group consumed 25 g of honey each day for 4 weeks. Participants of both
      groups did not undergo a special diet regimen, drug therapy, or change in their lifestyle,
      such as physical exercise, during the period of study. A 3- day food record including two
      weekdays and one weekend day was used to assess the habitual food intake of the participants
      prior to initiation of the trial and repeated each week of intervention. Also, dietary intake
      was calculated using the database Food Processor® (Version. 10.3.0.), including nutritional
      information of Mexican foods when they weren't on the list.
    

Intervention name(s): The consumption of avocado honey was analyzed
Intervention type(s): Dietary Supplement
Intervention description(s): The subjects of honey group consumed 25 g of honey each day for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: avocado honey; anthropometric parameters; biochemical parameters; natural sweetener
The Effect of Somatosensory Cue on Postural Stability in Blinded Persons
Condition: Visual Impairment
MeSH terms: Vision Disorders; Vision, Low
Study type: Observational

Summary: 
      Blind Adults that willing to participate in the study will be tested with well-established
      measuring techniques of Balance control using force plate in the movement and Rehabilitation
      Laboratory at Ben-Gurion University. An automated algorithm will be used to extract
      standardized stabilogram-diffusion parameters from each of the COP data sets collected during
      quiet standing. These parameters include diffusion coefficients, critical displacement,
      critical time and scaling exponents for both lateral and anterior-posterior sway directions
      (Collins & De Luca, 1993). the subjects will be tested in 3 task conditions (eyes
      blindfolded, eyes blindfolded holding stick, eyes blindfolded holding a dog). Participants
      will be required to stand on the platform 10 times for 30 s For each trial, they will be
      instructed to sway as little as possible.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        30 blind persons and 30 control
NBP in Adult Patients With Acute Ischemic Stroke (AIS)
Condition: AIS
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, add-on to
      standard of care study of NBP softgel capsules for the treatment of mild to moderate AIS in
      adults.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, add-on to standard-of-care study with
      a primary objective to assess the safety of NBP treatment in patients with mild to moderate
      acute ischemic stroke. The secondary objectives include determination of pharmacokinetic (PK)
      profile and exploratory evaluation for the efficacy of NBP treatment in stroke patients.

      All randomized subjects will also receive standard supportive medical care for treatment of
      AIS throughout the study. The overall duration of the study will be approximately 90 days,
      including 30 days of treatment and an additional 60 days for follow up assessments. Subjects
      will be hospitalized long enough to receive the first four doses of study drug. After
      discharge from the hospital, subjects will continue to take study treatment daily through Day
      30 and have scheduled assessments completed.

      To maintain the blind, all subjects will take 4 softgel capsules BID, which will contain
      either 100 mg NBP or matching placebo. The first dose must be taken within 12 hours of the
      onset of the AIS defined as the last known normal.
    

Intervention name(s): NBP Softgel Capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.; Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing
Other intervention name(s): NBP; NBP Placebo Softgel Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multicenter; Randomized; Double-Blind; Placebo-Controlled; Add-On to Standard-of-Care; Safety; Efficacy
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
Condition: Asthma
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      In people who develop asthma after the age of 12 and who are also overweigh, there can be an
      increased burden of asthma symptoms, more flare-ups, and poorly-controlled asthma when
      compared to normal weight asthmatics. Certain factors are more abundant in the blood of
      individuals who are obese. One such factor is derived from the metabolism of an amino acid
      found in your diet, which is known as L-arginine (Amino acids are most commonly known as the
      building blocks of proteins, the same as the proteins found in food). This factor is called
      asymmetric dimethylarginine or ADMA. The balance of L-arginine to ADMA may be important to
      the health of subjects with asthma. The balance between L-arginine and ADMA plays an
      important role in producing nitric oxide (NO) in the airways. NO is normally produced in the
      lung and plays a major role in maintaining airways open and functioning normally. Our
      research has shown that in subjects with asthma who are overweight and developed asthma later
      in life, the combination of low L-arginine and high ADMA, may lead to lower NO levels. We are
      asking participants in this study to take L-citrulline, which is converted to L-arginine by
      your body, as a supplement for a period of one week. We anticipate that L-citrulline will
      restore NO levels in the airways, by increasing the ratio of L-arginine to ADMA
    


Intervention name(s): L-citrulline
Intervention type(s): Dietary Supplement
Intervention description(s): Patients will take 3-gr of L-citrulline/day for 7 days
Other intervention name(s): L-citrulline 3 gr efervescent powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: L-citrulline; ADMA; Asthma; Obesity