bioihbjkbjnl/mcl2 huggingface dataset:
An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in
      Patients with Major Depressive Disorder (MDD)
    


Intervention name(s): Radafaxine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GW353162,; Major depressive disorder,; flexible
Naïve HIV POC Monotherapy Trial
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the trial is:

      • to evaluate the change from baseline in plasma viral load with placebo and one of up to 4
      dose regimens of RDEA806.

      The secondary objectives are:

      Efficacy

        -  to describe the nadir of the plasma viral load

        -  to describe the DAVG

        -  to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log,
           or reach an undetectable viral load

        -  to assess the plasma viral load decay rate

        -  to evaluate immunologic changes (as measured by CD4 and CD8 cells)

        -  to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics

        -  to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of
           RDEA806 Safety

        -  to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy
    


Intervention name(s): RDEA806 400 mg; Placebo; RDEA806 1000 mg; RDEA806 600 mg; RDEA806 800 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; treatment naïve
Oral Administration of Peptides; Absorption From Gastrointestinal Tract
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Context: Oral formulations of GLP-1 and PYY3-36, two satiety peptides, were studied. An oral
      delivery system would be preferable in many of the possible therapeutic indications of these
      peptides.

      Objectives: Our objective was to establish the pharmacological profile of increasing oral
      doses of GLP-1 and PYY3-36 in healthy volunteers. In addition, the pharmacological effects of
      GLP-1 were investigated.

      Setting: Single center escalating dose study with oral applications. Subjects and Methods: In
      the first part, GLP-1 was given orally to 6 male subjects; the treatment consisted of one of
      the following oral doses of either GLP-1 (0.5, 1.0, 2.0 and 4.0 mg) or placebo. In the second
      part, PYY3-36 was given orally to another 6 healthy male subjects; the treatment consisted of
      one of the following oral doses of either PYY3-36 (0.25, 0.5, 1.0, 2.0 and 4.0 mg) or
      placebo.
    

Detailed description: 
      The study was conducted as a phase I, open, placebo-controlled, dose-escalating study. In
      part I, six treatments, separated by at least 7 days, were performed in 6 male subjects;
      treatments consisted of one oral dose of GLP-1(7-36 amide) (0.5, 1.0, 2.0, and 4 mg) or
      placebo; the last treatment was an intravenous infusion of GLP-1 given for 45 min (0.4
      pmol/kg per min infused for 45 min). The treatments were identical in design except for the
      oral dose of GLP-1. In part II, six oral treatments, separated by at least 7 days, were given
      in an additional 6 male subjects; treatments consisted of one oral dose of PYY3-36 (0.25,
      0.5, 1.0, 2.0, and 4 mg) or placebo; an intravenous infusion of PYY3-36 could not be given as
      no GMP conform PYY3-36 was available for use in humans. Blood was drawn in regular intervals
      in EDTA tubes containing aprotinin (500 kIU/ml blood) and a DPP-IV inhibitor for hormone
      determinations: -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300 min.
    

Intervention name(s): Increasing doses of GLP-1; PYY3-36
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kinetics of GLP-1 and PYY3-36; increasing oral doses
Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics
Condition: PreDiabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare efficacy and safety of metformin versus apple
      cider vinegar in prediabetics . The main question[s] it aims to answer are:

        -  Efficacy of metformin versus apple cider vinegar in prediabetics

        -  Safety of metformin versus apple cider vinegar in prediabetics

      Researchers will compare group of prediabetics taking metformin with group of prediabetics
      taking apple cider vinegar to see if there is difference in safety and efficacy..
    


Intervention name(s): Metformin Hydrochloride (HCL); Apple cider vinegar
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics; Apple cider vinegar aimed at improving glycemic indices in Prediabetics
Intervention MeSH terms: Metformin; Acetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, open label, prospective, clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prediabetes; Metformin HCl; Apple cider vinegar
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the
      treatment of children with symptomatic HIV disease who have had to discontinue zidovudine
      (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.

      The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The
      benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for
      approximately 12 to 18 months, at which time most patients have progressive deterioration.
      Recently published literature has described a reduced sensitivity of HIV isolated from
      patients after prolonged AZT treatment. Although the clinical significance of this is
      unclear, it makes the development of new antiretroviral drugs important.
    

Detailed description: 
      The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The
      benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for
      approximately 12 to 18 months, at which time most patients have progressive deterioration.
      Recently published literature has described a reduced sensitivity of HIV isolated from
      patients after prolonged AZT treatment. Although the clinical significance of this is
      unclear, it makes the development of new antiretroviral drugs important.

      Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy
      receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension.
      Patients are seen for clinical and laboratory evaluations at scheduled times during the
      study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics
      studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an
      additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.
    

Intervention name(s): Didanosine
Intervention type(s): Drug
Intervention MeSH terms: Didanosine
Primary purpose: Treatment
Keywords: Didanosine; Drug Evaluation; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine
Hypercapnia and Gas Exchange Under the Avalanche Snow Model (HyperAvaSM)
Condition: Accident Caused by Snow Avalanche
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      The aim of the study is to investigate respiratory parameters of a person in the simulated
      avalanche snow and consequent use of the measured data for development of a
      mathematical-physical model of breathing during increasing hypercapnia in the avalanche.
    

Detailed description: 
      The study is a part of a university research project aimed at studying physiological
      conditions and development of breathing parameters of a person breathing in the simulated
      avalanche snow. Presence of an air pocket and its size play an important role in survival of
      victims buried in the avalanche snow. Even small air pockets facilitate breathing, yet they
      do not provide a significant amount of fresh air for breathing. The investigators hypothesize
      that the size of the air pocket significantly affects the airflow resistance and work of
      breathing. The aim of the study is to investigate the effect of the air pocket volume on gas
      exchange and work of breathing in subjects breathing into the simulated avalanche snow and to
      test, whether it is possible to breathe with zero air pocket.
    

Intervention name(s): Breathing in the simulated avalanche snow.; air pocket
Intervention type(s): Other; Device
Intervention description(s): Breathing in the simulated avalanche snow with zero air pocket and one-liter air pocket.; Zero air pocket or one-liter air pocket in the snow.
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      The aim of this study is to determine the correlation of neck circumference with difficult
      mask ventilation and laryngoscopy in morbidly obese patients.
    

Detailed description: 
      Patients' Mallampati score, upper lip bite test, neck mobility, teeth abnormalities were
      evaluated preoperatively. Mouth opening, sternomental and thyromental distances, neck
      circumference, thoracic circumference, breast circumference , belly circumference and hip
      circumference were measured preoperatively.

      After anesthesia induciton with propofol and rocuronium, patients' mask ventilation
      difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2-
      Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4-
      Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.

      Laringoscopy was performed with MacIntosh laryngoscop and Cormack Lehane (CL) score was
      evaluated. CL score III and IV were defined as difficult laryngoscopy.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with body mass index (BMI) > = 40, applied for elective surgery.
      
Keywords: morbid obesity; neck circumference; difficult mask ventilation; difficult laryngoscopy
Resistance Training With Milk Supplementation in Adolescents
Condition: Body Composition; Cardiovascular Risk Factors
Study type: Interventional

Summary: 
      The investigators primary objective is to evaluate the effect of a 6 month (3 days/wk)
      supervised, progressive RT program with increased daily milk intake in untrained adolescents
      on measures of body composition and cardiovascular risk factors. The investigators
      hypothesize that milk supplementation will produce significantly greater favorable changes in
      all body composition measures compared with RT + carbohydrate and control.
    

Detailed description: 
      We will recruit 150 healthy, adolescent middle school boys and girls (grades 7 through 9),
      BMI > 50th percentile < 98th percentile, who will participate in 6 months of supervised
      resistance training (3 days/wk) and will be randomized to one of 3 groups: RT + milk, RT +
      isocaloric carbohydrate, RT only (control). Both physical activity and diet outside the study
      protocol will be carefully monitored. Measurements will be completed at baseline 3 months and
      upon completion of the training protocol at 6 months.
    

Intervention name(s): Resistance Training with Milk Supplementation in Adolescents
Intervention type(s): Other
Intervention description(s): On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day.
On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Resistance training; Body Composition; Cardiovascular Risk factors; Dairy
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study seeks to determine if a specialized multidisciplinary diabetes team (SMDT)
      approach that incorporates the use of the chronic care model can be an effective method for
      improving glycemic control in Hispanic adults with uncontrolled type 2 diabetes residing in
      the Rio Grande Valley. The study will expand the current model of care used and focus on the
      multidimensional aspects that consist of physical, nutritional, educational and psychological
      needs of this underserved Hispanic population residing in the Rio Grande Valley.
    


Intervention name(s): Specialized multidisciplinary diabetes team (SMDT) approach; Traditional model of care
Intervention type(s): Other; Other
Intervention description(s): The implementation of the pilot study will consist of a specialized multidisciplinary diabetes team care (SMDT) that includes endocrinologists, a nurse practitioner, dieticians, pharmacists and a licensed professional counselors (LPCs) to collaborate and coordinate care. Subjects in the pilot study will follow a multidisciplinary team approach process with the following team members: pharmacist, LPC, and dietician.
There will be 3 individualized visits: 1 visit with the counselor (LPC), 1 visit with the Pharmacist, and 1 visit with the Dietician.
In addition, a follow up phone call post visit, that can range from 5 to 30 minutes, will be scheduled from each of the team members during the study. Also, throughout the pilot study participant's blood glucose readings will be monitored weekly via a transmittable wireless patient transmission monitor.; Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multidisciplinary Team; Hispanic adults
Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
Condition: Cannabis Abuse; Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Cannabis use is a significant public health concern that disproportionately affect youth.
      Although promising psychosocial interventions are being developed, most youth do not benefit
      from these interventions alone. Given the clinical demand for effective treatments, the
      National Institute on Drug Abuse (NIDA) identified the critical need for data on the
      tolerability and potential efficacy of medications in adolescents. The purpose of this
      two-year study is to test if and how topiramate, a medication under intense study for
      treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the
      investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years
      old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for
      the 6-week period using handheld electronic diaries and complete assessments of reactivity to
      cannabis-related cues.
    


Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topiramate (200 mg daily); Placebo (daily)
Other intervention name(s): Topamax
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Accuracy of Digital Models Using Open-access Software Programs
Condition: Accuracy of Digital Dental Model
Study type: Observational

Summary: 
      Background: Despite the clear drive toward digital model transformation, there are
      limitations to some paid software necessary for digital model production. The aim of the
      study is to compare the accuracy of open-access software against paid software regarding the
      segmentation process to produce a digital model. Four groups of software programs will be
      assessed regarding their accuracy in the segmentation process to produce a digital dental
      model. The reference models will be scanned by a desktop scanner and will be set as the gold
      standard. The same models will be scanned by the same CBCT machine. The obtained DICOM data
      will be converted into STL files by four different software programs.
    


Intervention name(s): Bluesky software; 3D slicer software; OnDemand software; Mimics software
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Bluesky software.; Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by 3D slicer software.; Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by OnDemand software.; Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Mimics software.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who are young adults attending the Periodontology, Oral Medicine, Diagnosis and
        Oral Radiology Department, Faculty of Dentistry, Alexandria University.
Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women
Condition: Obesity
MeSH terms: Hyperlipidemias; Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether gut microbiota modulation by probiotic and
      symbiotic contribute with weight loss and improvement of metabolic parameters in women with
      obesity.
    

Detailed description: 
      We will evaluate the effects of probiotic and symbiotic on weigh loss, blood glucose, lipid
      profile, metabolomic profile, and gut microbiota composition variables in women with obesity.
    

Intervention name(s): Probiotic; Symbiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin; Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide; Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
Other intervention name(s): Bifidobacterium lactis; Bifidobacterium lactis and fructooligosaccharide; Gelatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Probiotic; Symbiotic; Weight loss; Gut microbiota; Bifidobacterium lactis; Fructooligosaccharide; Blood sugar; Lipemia; Metabolome
A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
Condition: Healthy Subjects; Pharmacokinetics of Isavuconazole; Pharmacokinetics of Plasma Mycophenolic Acid (MPA); Pharmacokinetics of Plasma Phenolic Glucuronide of MPA (MPAG)
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety
      and tolerability of isavuconazole will be assessed alone and in combination with MMF.
    


Intervention name(s): isavuconazole; Mycophenolate mofetil
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL4815; CellCept, MMF
Intervention MeSH terms: Mycophenolic Acid; Isavuconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: isavuconazole; mycophenolate mofetil (MMF); BAL8557; BAL4815; healthy volunteers; Mycophenolic acid (MPA); Phenolic glucuronide of MPA (MPAG); CellCept