bioihbjkbjnl/mcl2 huggingface dataset:
A Controlled Study of Solriamfetol for ADHD in Adults
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with
      diagnosis of Attention Deficit Hyperactivity Disorder.
    

Detailed description: 
      Subjects will be between 18 and 65 years old, have at least 5 current symptoms of inattentive
      or impulsive-hyperactive traits, and childhood onset of ADHD symptoms, defined as two
      symptoms of inattentive or of impulsive/hyperactive traits by the age of 12. Subjects will
      also have a score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS).

      The investigators will exclude individuals who are contraindicated by current FDA label
      recommendations, which elaborates appropriate use of solriamfetol for individuals with sleep
      apnea and narcolepsy.

      This will be a a six week, double blind, dose-optimization study. After giving informed
      consent to participate, participants will undergo a comprehensive assessment including a
      psychiatric assessment reviewing eligibility.
    

Intervention name(s): Solriamfetol 75 MG; Solriamfetol 150 MG; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Daily oral consumption; Daily oral consumption; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: attention deficit hyperactivity disorder; clinical trial; solriamfetol
A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To demonstrate therapeutic equivalence and safety of adapalene gel 0.1% (Taro Pharmaceuticals
      U.S.A., Inc.) and Differin® Gel (Adapalene Gel 0.1%, Galderma) in the treatment of acne
      vulgaris.
    

Detailed description: 
      A multi-center, double-blind, randomized, placebo controlled, parallel-group study, Adapalene
      Gel 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and to Differin® Gel (Adapalene 0.1%, Galderma)
      and both active treatments to a placebo control in the treatment of acne vulgaris
    

Intervention name(s): Adapalene Gel 0.1%; Placebo Control; Differin® Gel (Adapalene 0.1%, Galderma)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.; The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.; The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Other intervention name(s): Test Product; Vehicle; Reference Product
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Double-Blind Comparison Between Mitiglinide and Nateglinide in Type 2 Diabetic Patients
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to
      Nateglinide for the treatment of type 2 diabetes.
    


Intervention name(s): Mitiglinide
Intervention type(s): Drug
Intervention description(s): 10mg tablet, 10mg TID
Other intervention name(s): Glufast
Intervention MeSH terms: Mitiglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; rapid and short acting insulin secretagogue; α-glucosidase inhibitor; HbA1C; insulin
Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction
Condition: Intra-abdominal and Intrapelvic Surgery
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon.
      Most patients will receive general anesthesia during surgery. Two groups of general
      anesthetics are used for this purpose. We hypothesize that the incidence of POCD is not
      different in patients received intravenous anesthetics only or sevoflurane (a volatile
      anesthetic-based general anesthesia) for their major intra-abdominal surgery.
    

Detailed description: 
      Patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly
      assigned into two groups: 1) sevoflurane-based general anesthesia group, and 2)
      propofol-based general anesthesia group. Each group will need 221 patients to detect 1/3 of
      decrease or increase in the rate of POCD of one group compared with another group at about
      one week after surgery, assuming the overall rate of POCD at this time is about 40% at this
      time. Considering about 10% loss to follow-up, we will have 250 patients in each group. In
      addition, investigators will need 184 subjects in the control group. The data of these
      control subjects will be used to normalize the data of the two studied groups to diagnose
      POCD. The subjects in control groups will also be elderly but without the exposure to
      anesthesia and surgery.
    

Intervention name(s): Sevoflurane; propofol; remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Remifentanil; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard
      of care therapy in participants with moderate to severe active systemic lupus erythematosus
      (SLE).
    


Intervention name(s): GDC-0853; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.; Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.
Other intervention name(s): RO7010939
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Naloxone Pharmacokinetics
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or
      intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been
      used successfully for this purpose as reported in clinical observational studies and a
      randomized controlled trial. Most of the published clinical studies concerning IN
      administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer
      device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using
      these kits is not available in the published literature. This study is designed to determine
      the PK of naloxone following one and two IN administrations using the improvised kits
      compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg
      administered IM using the Evzio autoinjector.
    


Intervention name(s): Naloxone; Mucosal atomization device and syringe; Narcan; Intramuscular Auto Injector
Intervention type(s): Drug; Device; Device; Device
Intervention description(s): Comparing pharmacokinetics of naloxone; Injection; Nasal Spray; Intramuscular injection
Other intervention name(s): Evzio
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.
Masking: None (Open Label)
Primary purpose: Treatment
Prebiotic Effects of Isomalto-oligosaccharide
Condition: Microbiota
Study type: Interventional

Summary: 
      The primary purpose of this study is to evaluate the effect of an IMO nutritional supplement
      on gut microbiome, gut health, and body weight. Two formulations of the supplement will be
      evaluated; thus, there will be three study arms: Supplement A, Supplement B, and placebo.
      Stool samples will be analyzed for bacterial DNA. The gut bacterial DNA, body weight, and gut
      health data will be compared across supplement and placebo groups.

      Primary Aim 1: To evaluate the effect of the IMO supplement on gut bacterial abundance,
      diversity, and gene function across intervention and placebo groups, and across two doses of
      the intervention.

      Secondary Aim 1: To evaluate the effect of the IMO supplement on gut health across
      intervention and placebo groups, and across two doses of the intervention.

      Secondary Aim 2: To evaluate the effect of the IMO supplement on body weight across
      intervention and placebo groups, and across two doses of the intervention.

      60 subjects, randomized to three arms (20 each: Supplement formula A, Supplement formula B or
      placebo) will take a daily dose of Supplement A, Supplement B, or placebo for 8 weeks. The
      supplement is a light syrup liquid. Ingredients that are in the supplement are:
      isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Ingredients that
      are in the placebo are: high maltose corn syrup (Satin Sweet™), water, and mannitol. Dose
      will be 500 mg during the first 4 weeks and then 1000 mg for second 4 weeks. Subjects will be
      instructed to take 500 mg/day of the supplement or placebo the first four weeks and 1000
      mg/day of the supplement or placebo for the second four weeks. Subjects will be blinded as to
      whether they are receiving placebo or supplement. After screening and once enrolled, subject
      involvement includes visits to George Mason University, being weighed, dropping off stool
      samples, and completing a survey on gut health. Stool samples will be analyzed for bacterial
      DNA. The gut bacterial DNA, weight, and gut health data will be compared across supplement
      and placebo groups.
    


Intervention name(s): Isomalto-oligosaccharide
Intervention type(s): Dietary Supplement
Intervention description(s): Isomalto-oligosaccharide (IMO) is a non-digestible type of oligosaccharide commonly used as a low-calorie sweetener mixed with a variety of other food and beverage products for the purpose of sweetening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Microbiota; Body weight; Digestive system
Preoperative Assessment of Difficult Laryngoscopy Using Different Videolaryngoscopes
Condition: Assessment; Difficult Airway Intubation; Preoperative
Study type: Interventional

Summary: 
      preoperative assessment of difficult airways are the subject of debate. Now, measuring the
      thyromental distance or evaluating the mallampati score, mandible protrusion or body mass
      index still not 100% specifically say anything. We compare 4 different video laryngoscopes
      for preoperative assessment of difficult laryngoscopy.
    

Detailed description: 
      preoperative assessment of difficult airways are the subject of debate. Now, measuring the
      thyromental distance or evaluating the mallampati score, mandible protrusion or body mass
      index still not 100% specifically say anything. all patients were pre oxygenated with 100%
      oxygen with nasal canulla during the whole procedure. We administered 0.07 mgr/kg
      remifentanil for minimum 3 minutes and continue this infusion during the procedure. The
      patients airway topicalized by 10% lidocaine spray. We enroll 20 patients undergoing elective
      surgery.

      We compare 4 different video laryngoscopes for preoperative assessment of difficult
      laryngoscopy in the same patient. We evaluate the patient and the instructors satisfaction
      with the visual analogy scale and the visualization time. Demographic vary,ables and the
      airway characteristics of patients. We assess the cormack lehane view of these
      videolaryngoscopes with or without cricoid pressure. and the occurrence of gag reflex as
      well.
    

Intervention name(s): airtraq; mcgrath mac x-blade; storz c-mac; storz d-blade
Intervention type(s): Device; Device; Device; Device
Intervention description(s): airtraq videolaryngoscope; mcgarth mac videolaryngoscope; storz c-mac videolaryngoscope; storz d-blade video laryngoscope
Other intervention name(s): videolaryngoscope; videolaryngoscope; videolaryngoscope; videolaryngoscope
Intervention MeSH terms: Pyrithione zinc
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: We used these 4 video laryngoscopes ( c-mac, d-blade, macgrath mac x-blade and airtraq) on the same patient.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: airtraq; c-mac; d-blade; mcgarth mac x-blade; prediction; difficult airway
Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized,
      controlled, parallel study design.
    

Detailed description: 
      Patients who have moderate to severe tinnitus, at least one year post diagnosis, may enroll.
      All patients will be implanted and randomized to one of two groups:

        -  a group receiving VNS paired with tones and;

        -  a group that receives VNS and tones, but with different settings.

      After device use training, therapy is delivered at home by the patient for 6 weeks. Patients
      have eight baseline audiometric assessments along with two questionnaire assessments, an
      assessment after recovery before treatment starts, and tinnitus assessments every two weeks
      during therapy through the 6 week randomized portion of the study. After the randomized
      portion, all patients receive VNS paired with tones. Patients will continue to return for
      quarterly visits and tinnitus assessments through the first year after implant, regardless of
      their therapy status. Interested patients can continue to receive longer-term treatment after
      the first year. A goal of up to 30 patients enrolled and implanted across four sites is
      planned for this study.
    

Intervention name(s): VNS Treatment; VNS Control
Intervention type(s): Device; Device
Intervention description(s): VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.; This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.
Other intervention name(s): VNS paired with tones; Serenity System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tinnitus; Medical Device; Randomized; Vagus Nerve Stimulation
Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Condition: Clostridium Difficile Associated Disease
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability,
      and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one
      of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.
    


Intervention name(s): Clostridium difficile Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL intramuscular injection; 0.5 mL intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in
      patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose,
      glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this
      improvement is due to an improvement in insulin sensitivity and insulin secretion. The
      purpose of this study is to evaluate the effect of the administration of Momordica Charantia
      on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.
    

Detailed description: 
      A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients
      with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes
      Association. Patients are assigned to two different arms: one group receives Momordica
      Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or
      placebo, under the same scheme of treatment.

      An oral glucose tolerance test is performed before and after the intervention. Matsuda index,
      Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and
      insulin secretion.

      Other clinical and laboratory parameters that are evaluated include: Body weight, body mass
      index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C,
      creatinine, lipid profile and liver transaminases.
    

Intervention name(s): Momordica charantia; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Momordica Charantia: 2000 mg per day for three months; Placebo: 2000 mg per day for three months
Other intervention name(s): Bitter gourd, karela, balsam-pear; Calcined magnesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Momordica Charantia; Insulin secretion; Insulin sensitivity
Oxytocin's Effect on Socioemotional Aging
Condition: Aging
Study type: Interventional

Summary: 
      This study will investigate the extent to which intranasal oxytocin affects changes in social
      decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the
      body and the brain and has been shown to be relevant for many behaviors, particularly in
      social situations. Research on the effects of oxytocin in aging is very scarce; therefore,
      the purpose of this research project is to determine the effects of oxytocin on
      socioemotional aging.
    

Detailed description: 
      In order to demonstrate oxytocin as a causal mechanism in socioemotional aging, the
      investigators propose to temporarily elevate oxytocin levels and then measure activity in the
      brain while participants engage in socially relevant tasks. Participants in this study will
      be randomly assigned (much like flipping a coin) to receive either a single administration of
      oxytocin or a placebo (a substance that looks like the oxytocin but does not have any active
      drug). Neither participants nor the investigator will know to which condition each
      participant is assigned. Prior to being enrolled into the study a screening to determine
      eligibility will be conducted. Once the screening visit is completed and it has been
      determined that subjects can be randomized into the study, an appointment will be scheduled
      for the full study visit.

      The purpose of the screening is to determine whether the individual is eligible for
      participation in the study and will consist of a series of questions about demographics and
      health history, two saliva samples, two short tasks, blood test, and brief meeting with a
      licensed clinician to ensure that it is safe for the individual to take part in the magnetic
      resonance imaging (MRI) and drug administration.

      The study visit will comprise two collections of saliva for laboratory tests prior to and
      following the oxytocin administration in order to measure levels of the hormone in the body
      at baseline and after the spray. Saliva samples will also allow for an examination of how
      oxytocin-related genes may impact cognition and behavior during study tasks. Participants
      will work on various social tasks while in the MRI scanner, and response accuracy, response
      time, and brain activity will be recorded. After the scan, participants will complete a
      series of brief questionnaires on paper and on the computer.
    

Intervention name(s): Oxytocin spray; Placebo spray
Intervention type(s): Drug; Drug
Intervention description(s): single dose of 24 IU oxytocin, self-administered intranasally (IN); single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxytocin; socioemotional functioning; trust; amygdala; aging
Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of a fixed-dose, single-capsule
      budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both
      delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was
      Randomized, double-blind, multicenter, phase III, parallel clinical trial.
    

Detailed description: 
      the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during
      which all of the patients received budesonide twice a day, they were randomized into one of
      the treatment groups for 12 weeks, twice a day.

      The primary outcome measures were FEV1, FVC and morning PEF. We performed an
      intention-to-treat analysis of the data.
    

Intervention name(s): Fixed combination of budesonide and formoterol; Budesonide
Intervention type(s): Drug; Drug
Intervention description(s): Delivered dry powder inhaler for 12 weeks.; Delivered dry powder inhaler for 12 weeks.
Other intervention name(s): Group 1 (experimental): Budesonide and formoterol; Group 2 (comparator): Budesonide
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Budesonide; Adrenergic beta-2 receptor agonists.