bioihbjkbjnl/mcl2 huggingface dataset:
the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma
Condition: Glaucoma; Intraocular Pressure
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      -  Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma
           management and is very easy to learn and easy to perform.

        -  Recent advances in laser technology; the role of TSCPC is being expanded because it has
           benefits of noninvasive glaucoma procedure.

        -  The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation)
           are three energy delivery techniques.

        -  The present study would report on the outcome (efficacy and safety) of the
           slow-coagulation versus the titration method in treatment of refractory glaucoma with
           dark iris.

        -  The results would provide reliable evidences to supplement clinical judgment when making
           a decision in favor of each treatment method for glaucoma patients.
    

Detailed description: 
      -  Several protocols afford delivery of the "optimum" dose of laser energy per session
           necessary to achieve a long-term effective ocular hypotensive response balancing risks
           related to a high energy treatment and risks related to retreatment due to suboptimum
           dose delivery.

        -  There are two main approaches to delivering laser energy, the pops-titration method and
           the fixed energy method that are the fixed-high and low-energy (the Gaasterland's
           slow-coagulation technique).

        -  Of particular interest is which laser energy delivery method (slow-coagulation versus
           pops-titration) affords the optimal dose of photocoagulation necessary to achieve an
           effective long-term intraocular pressure (IOP) reduction while minimizing the risk of
           adverse events related to overtreatment and retreatments especially in refractory
           glaucomatous eyes with dark iris color.
    

Intervention name(s): The pops-titration group; The slow-coagulation group
Intervention type(s): Procedure; Procedure
Intervention description(s): The energy delivery is started at a low level and is increased in intervals till an audible pop is heard, following which the power is reduced downward until the pops are no longer audible, then the treatment is completed at these parameters; The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Refractory glaucoma; Transcleral cyclophotocoagulation (TSCPC); Dark iris; Pops-titration; Slow-coagulation; Neovascular glaucoma
Fasting and Exercise-induced Changes in Human Skeletal Muscle
Condition: Skeletal Muscle Energetics
Study type: Interventional

Summary: 
      This study examines the impact of increasing energetic stress during an 8-hour fast on
      metabolic pathways in human skeletal muscle. Specifically, participants will undergo two
      8-hour fasting sessions in a randomized crossover fashion, with the addition of low-intensity
      arm exercise in one of the sessions. Changes in metabolic pathways will be examined in
      resting (leg) muscle before, during, and after the fast.
    


Intervention name(s): FAST+EX; FAST
Intervention type(s): Other; Other
Intervention description(s): Participants will perform 2-hours of low-intensity arm exercise (8 x 15 min bouts of arm ergometer exercise separated by 10 min of rest) during an 8-hour fast.; Participants will complete an 8-hour fast.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases
Condition: Tonsillitis; Tonsillar Hypertrophy; Immune System Diseases
MeSH terms: Tonsillitis; Immune System Diseases; Hypertrophy
Study type: Observational

Summary: 
      Tonsillar tissue is a significant organ for the performing of immune systems in children. The
      Endoplasmic Reticulum (ER), is an organelle needed for the care of a stable function of the
      cells. The purpose of the study was to explore the correlation among ER stress and tonsillar
      tissue disorders and to explain the structure of diseases related to the immune system.
    

Detailed description: 
      A prospective study was conducted on 46 children aged who underwent tonsillectomy for chronic
      tonsillitis or tonsil hypertrophy. Tonsil tissues were evaluated in terms of ER stress
      markers and apoptosis markers by Real-time PCR and Western blot methods.
    

Intervention name(s): Tonsillectomy surgery
Intervention type(s): Procedure
Intervention description(s): The tonsillectomy procedure was performed under general anesthesia using the classical dissection method. Extracted tonsil tissue samples were sent to the medical genetics department in tubes to investigate the ER stress and apoptosis.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent tonsillectomy surgery aged between 2 and 16 years and who were
        clinically diagnosed with chronic tonsillitis and tonsil hypertrophy by the ENT clinician.
      
Biospecimen description: 
      Tonsillar tissues were gathered in groups in accordance with their size and analyzed in
      regards to Endoplasmic Reticulum stress and apoptosis markers by Real-Time PCR and Western
      Blotting method.
    
Keywords: Endoplasmic Reticulum; Apoptosis; İmmune system
Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects
Condition: Weight Loss
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the effect on weight loss in a group of subjects
      suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75
      Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
    

Detailed description: 
      The primary objective of the study is to evaluate the effect on weight loss in a group of
      subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with
      weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.

      The secondary objectives of the study are:

        -  to evaluate the effect of supplementation on blood triglyceride levels

        -  to evaluate the effect of supplementation on blood levels of Total Cholesterol (CT),
           LDL, and HDL

        -  to evaluate the effect of supplementation on glucose, insulin, insulin resistance
           assessed by calculating the Homeostatic metabolic assessment (HOMA)

        -  to evaluate the effect of supplementation on liver enzymes (transaminases) and renal
           function (creatinine)

        -  to evaluate the effect of supplementation on BMI (Body Mass Index)

        -  to evaluate the effect of supplementation on the abdominal circumference

        -  to evaluate the effect of supplementation on body composition evaluated by dual X-ray
           densitometer (DXA)

        -  to evaluate the effect of supplementation on the serum levels of reactive oxygen species

        -  to evaluate the effect of supplementation on serum antioxidant capacity
    

Intervention name(s): Polyglucosamine L112; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Polyglucosamine; Ascorbic Acid; Tartaric Acid; Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide
Other intervention name(s): Formoline L112
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Polyglucosamine; Formoline L112; Medical Device
Snacking, Satiety &Weight: A Randomized, Controlled Trial
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Proposed is a parallel-design randomized controlled trial to compare the effects of consuming
      two types of snacks on a daily basis for a 12-week period on health outcomes, diet quality,
      and self-reported satiety in a group of overweight adults. The types of snacks to be studied
      are KIND snack bars with almonds and typical American snack foods).
    

Detailed description: 
      Snacking has been implicated in the obesity epidemic, but judicious snacking can help control
      appetite and calorie intake and add nutrient-dense foods to the diet. The investigators
      hypothesize that snacking on nutrient-dense, highly satiating snack foods (i.e. KIND snacks
      with almonds) as compared to snacking on nutrient-dilute, energy-dense foods (i.e.,
      conventional snack foods) will contribute to satiety, weight loss, and health improvements.
      The investigators further hypothesize that the benefits of healthful snacking are enhanced
      when portion is clearly defined and controlled by packaging. Finally, the investigators
      hypothesize that these effects will be seen even when study participants are given clear
      guidance about the calorie content of snack items, and how to make room for those calories in
      their diets.

      Hypotheses:

        1. Snacking on nutrient-dense, highly satiating snack foods (i.e. KIND snacks with almonds)
           as compared to snacking on nutrient-dilute, energy-dense foods (i.e., conventional snack
           foods) will contribute to satiety, weight loss, and health improvements.

        2. The benefits of healthful snacking are enhanced when portion size is clearly defined and
           controlled by packaging.

        3. These effects will be seen even when study participants are given clear guidance about
           the calorie content of snack items, and how to make room for those calories in their
           diets.
    

Intervention name(s): KIND Bars; Typical American Snack
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of KIND Bars for 12 weeks; Consumption of typical American snacks for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; snacks; satiety; hunger
PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer
Condition: Advanced and Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is an open, multi-center, phase Ic clinical study on the pharmacokinetics and drug
      interactions of utidelone injection combined with capecitabine in patients with recurrent and
      metastatic breast cancer.

      The purpose of this trial is:

        1. To evaluate the pharmacokinetic characteristics of continuous intravenous administration
           of utidelone.

        2. To evaluate the drug interaction of utidelone and capecitabine.
    


Intervention name(s): Utidelone Injection; capecitabine; Utidelone
Intervention type(s): Drug; Drug
Intervention description(s): 8 patients will be assigned to utidelone plus capecitabine arm receiving utidelone plus capecitabine. Utidelone injection 30mg/m2/day, intravenously administered once a day for 5 consecutive days; capecitabine tablets, 1000mg/m2, orally, 2 times a day for 14 consecutive days. 21 days is a cycle; 8 patients will be assigned to utidelone arm and receive utidelone injection 30 mg/m2/day intravenously, once a day for 5 consecutive days in a 21-day cycle.
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in
      combination with rabies vaccine compared with human rabies immune globulin (HRIG) in
      combination with rabies vaccine in healthy children and adolescents.
    


Intervention name(s): CL184; HRIG
Intervention type(s): Biological; Biological
Intervention description(s): CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28; HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rabies post-exposure prophylaxis; Monoclonal antibody
Nalox-Comm: Naloxone Communication Training for Pharmacists
Condition: Naloxone
Study type: Interventional

Summary: 
      This is a pilot Randomized Controlled Trial (RCT) in which 120 pharmacists will be randomized
      to an experimental or control group and data on naloxone dispensing and secondary outcomes
      will be collected over the course of the RCT.
    

Detailed description: 
      This is a prospective pilot RCT that will evaluate the impact of naloxone communication
      training (Nalox-Comm) on 120 pharmacists' naloxone dispensing behaviors (primary outcome).
      Data will be collected at baseline, immediately after training is completed, and at 3-month
      follow up. Data sources include pharmacy records (for naloxone dispensing), simulated patient
      observations (to rate quality of communication), and survey data (for self-reports of
      knowledge and self-efficacy).
    

Intervention name(s): Nalox-comm Training Module; Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The online communication module will be 30-60 minutes. Content will include: 1) using non-judgmental language, 2) how to raise the topic of overdose (OD) and naloxone with patients in a non-threatening manner; 3) videos modeling how to initiate the conversation with patients and caregivers; 4) considerations in how to communicate differently with patients versus caregivers; and 5) addressing pharmacists' perceived barriers to naloxone counseling. Pharmacists can receive continuing education credit (0.1 CEU) for completing the course.; A 55 minute long online module with videos, didactic content, and quizzes that covers the following topics: risk factors for overdose (OD), how to respond to OD, how naloxone works, types of naloxone, how to administer naloxone, medico-legal issues, how to bill for naloxone, and strategies to address overdose. Pharmacists can receive continuing education credit (0.125 CEUs) for completing the course.
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: community pharmacy; communication
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral
      administration of Gemigliptin and Food effect in healthy Chinese subjects.
    


Intervention name(s): Gemigliptin 25mg; Gemigliptin 50mg; Gemigliptin 100mg; Gemiglptin 50mg multiple dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Gemigliptin 50mg 1/2T; Gemigliptin 50mg 1T; Gemigliptin 50mg 2T; Gemigliptin 50mg 1T * 10days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls
Condition: Chronic Kidney Disease stage4
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      In this study the effect of an acute acid load on the intrarenal renin angiotensin-system is
      evaluated in patients with chronic kidney disease and healthy controls
    

Detailed description: 
      Metabolic acidosis is one of the metabolic complications of chronic kidney disease (CKD).
      Correction of metabolic acidosis in CKD has been shown to prevent further loss of kidney
      function over time. Currently, a clinical trial (the BIC-study, MEC-2013-332) is conducted in
      which patients with CKD and metabolic acidosis receive sodium bicarbonate, sodium chloride,
      or no treatment (time control) to address the hypothesis that the beneficial effects of
      acidosis correction are mediated through inhibition of the intrarenal renin-angiotensin
      system (RAS). It is unknown, however, if and how acute changes in acid-base status affect the
      intrarenal RAS during CKD. In the present study it is hypothesized that an acute acid load
      increases the activity of the intrarenal RAS, and that this response is exaggerated in
      patients with CKD compared with healthy controls.
    

Intervention name(s): Urinary acidification test
Intervention type(s): Diagnostic Test
Intervention description(s): Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
Condition: COPD; Sedation; Dexmedetomidine
Study type: Interventional
Phase: Phase 4

Summary: 
      A variety of medications have been used to treat the anxiety, discomfort, and fear associated
      with continuous and sudden episodic breathlessness in patients with advanced respiratory
      disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed
      for this distressing symptom. Clinicians are concerned about the adverse effects of opioids,
      especially respiratory depression, so they frequently prescribe benzodiazepines. Recent
      studies have shown that benzodiazepine use is associated with increased adverse respiratory
      outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).

      Dexmedetomidine may be an alternative to current drug therapies for breathlessness.
      Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without
      respiratory depression or cognitive dysfunction. The drug can be administered intranasally to
      induce light to moderate sedation of several hours duration.

      The objective of the proposed research, a pilot study, is to assess the dose dependent safety
      and efficacy of intranasal dexmedetomidine in clinically stable patients with severe COPD.
      This will be accomplished in a staffed acute care setting with routine vital signs monitoring
      and pulse oximetry. Patients will be assessed objectively and subjectively for their level of
      sedation by validated sedation scales.

      This pilot study is an initial investigation of a drug with favorable pharmacologic
      properties in this patient population with distressing and difficult to treat symptoms. The
      pilot study may provide evidence that a larger trial is needed to confirm the study results,
      or evidence that additional study in symptomatic patients and treatment comparison trials
      should be pursued.
    


Intervention name(s): Intranasal dexemdetomidine (IN-DEX)
Intervention type(s): Drug
Other intervention name(s): precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management
Condition: Endotracheal Intubation
Study type: Interventional

Summary: 
      Endotracheal intubation is usually required to allow unrestricted surgical approach. The
      Macintosh laryngoscope is the standard method. However in certain situations as difficult
      airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic
      intubation is the gold standard in this scenario, however sometimes it is not possible due to
      failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,
      Barcelona, Spain) has been designed specifically for the airway management. However, despite
      its use in clinical practice, there are no comparative studies regarding direct laryngoscopy
    


Intervention name(s): orotracheal intubation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of a Pandemic Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The World Health Organisation has warned that an influenza pandemic is inevitable. The avian
      influenza H5N1 virus strain is the leading candidate to cause the next avian influenza
      pandemic. This study will test the safety and immunogenicity of a H5N1 pandemic influenza
      vaccine in healthy adults.
    


Intervention name(s): Pandemic influenza vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Pandemic; Influenza; Prevention; Vaccine; Prevention of Pandemic Influenza