bioihbjkbjnl/mcl2 huggingface dataset:
Effect of T-scan Occlusal Analysis and Adjustment vs Articulating
Condition: Occlusion
Study type: Interventional

Summary: 
      The aim of this study is to compare two different methods for occlusal analysis of implant -
      supported prosthesis (T-scan and conventional method with articulating papers) regarding the
      stresses transmitted to the implants.
    

Detailed description: 
      Four implants will be inserted, two implants in canine regions and two implants in lower
      second premolar regions.

      After 3 months, two identical overdentures will be constructed for the patient on implants.

      The occlusion of each one of the two identical prostheses will be adjusted intraorally but
      according to different occlusal analysis:

        -  Group (A) : occlusal adjustments for the overdenture will be done according to
           articulating paper analysis.

        -  Group (B) :- occlusal adjustments for the overdenture will be done according to T-scan
           analysis.

      The two prostheses will be retained on dummy implants on acrylic cast and will be loaded
      under chewing simulator.

      The strain developed around the dummy implants will be measured. The data will be recorded
      manually then will be transferred into digital form. The obtained data will be recorded,
      tabulated and statistically analyzed using the appropriate tests for comparison within each
      group.
    

Intervention name(s): T-scan; articulating paper
Intervention type(s): Device; Other
Intervention description(s): occlusal analysis T-scan; articulating paper occlusal analysis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: t-scan; occlusal analysis; implant supported prosthesis
Effects of Monosodium Glutamate on Energy Balance and Eating Behavior
Condition: Obesity; Weight Gain; Food Preferences
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately
      prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and
      fat regain following a period of moderate, yet clinically significant weight loss.
    

Detailed description: 
      The proposed study enables us to assess the long term effects of consuming MSG on body weight
      regain following weight loss.
    

Intervention name(s): Broth; Broth
Intervention type(s): Other; Other
Intervention description(s): 200 mL of sodium chloride containing broth, consumed three times per day; 200 mL of MSG containing broth consumed three times per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Obesity; Food preferences; Eating Behavior
NovellusDx Tissue Collection Protocol
Condition: Patients That Have Been Diagnosed With Colorectal Cancer; Patients Eligible for Tumor Biopsy
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      NovellusDx is developing a diagnostic platform for the personalized cancer therapy based on
      patient derived tumor tissue. The assay is able to sense activating mutations by monitoring
      their effect on a chip-based device.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients that have been diagnosed with cancer and are eligible for tumor biopsy will be
        enrolled.
      
Biospecimen description: 
      pathology samples of tissue
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
Condition: Diphtheria; Hepatitis B; Haemophilus Influenzae Type b; Whole Cell Pertussis; Tetanus
MeSH terms: Hepatitis A; Hepatitis B; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to demonstrate consistent results in 3 production lots of
      Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a
      single injection, with respect to immunogenicity, safety and reactogenicity.
      Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine
      (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark
      vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.
    

Detailed description: 
      Randomized study with five groups to receive one of the following vaccination regimens after
      a birth dose of hepatitis B vaccine: One of the 3 lots of GSK Biologicals' Hib-MenAC mixed
      with GSK Biologicals' Tritanrix™-HBV (3 different groups) GSK Biologicals'
      Tritanrix™-HBV/Hiberix™ GSK Biologicals' Tritanrix™-HBV/Hiberix™ +Meningitec™
    

Intervention name(s): DTPw-HBV/Hib-MenAC conjugate vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Phase III Study of 5LGr to Treat Tic Disorder
Condition: Tic Disorder; Tourette Syndrome; Chronic Tic Disorder
MeSH terms: Tourette Syndrome; Tics; Tic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric
      patients with tic disorders.
    

Detailed description: 
      5LGr is a kind of traditional Chinese medicine(TCM) which under the direction of TCM
      theory.The aim of this study is prove the effective and safety of 5LGr in children and
      adolescence of Tic syndrome sub-population with specific TCM syndrome differentiation, when
      compared with tiapride and placebo.
    

Intervention name(s): 5LGr; tiapride; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosage form:Granule Strength:5 gram/sack Dosage:1 sack for patients less than 12 yrs 1.5 sacks for patients 13-18 yrs. Frequency: three times per day. Duration: 8 weeks.; dosage form: tablet Strength:100 mg Dosage: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks.
Total duration:8 weeks.; mimetic granule: same with 5LGr mimetic tablet: same with tiapride
Other intervention name(s): Wuling Granule; Tiapridel, Tiapridax; Blank tablet
Intervention MeSH terms: Tiapride Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tic disorder; pediatric
Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
Condition: Facial Wrinkles - Rough Texture - Hyperpigmentation
MeSH terms: Hyperpigmentation
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this work was to assess the efficacy of irradiated amniotic collagen matrix in
      comparison with platelet rich plasma in facial rejuvenation.The present study included 20
      patients with facial wrinkles divided into 2 groups using split face technique: Group (A)
      subjected to microneedling with amnion gel on the right side of the face . Group (B)
      subjected to microneedling with PRP on the other side of the face.According to a skin
      analysis camera (antera camera), there was statistically significant improvement after
      treatment and between both groups as regard to the roughness(texture) and melanin appeared by
      Antera camera in which group (A) showed better improvement than group (B). Also, skin
      biopsies showed improvement in both sides after treatment in which the epidermis was thicker,
      collagen bundles were broader and thicker than before treatment also elastic fibers were
      longer, evenly arranged and thicker than before treatment. The patients were followed up over
      a period of 3 months after the last session with no complications or changes were occurred
      and the results of sessions were maintained.
    


Intervention name(s): Amnion collagen; Platelet-rich plasma
Intervention type(s): Biological; Biological
Intervention description(s): A collagen extract sourced from the human amniotic membrane; Autologous preparation of PRP
Other intervention name(s): PRP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
NET in Iranian Women Suffering From Post Traumatic Stress Symptoms
Condition: Mental Disorders; Domestic Violence
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an
      effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD)
      and depression and for the improvement of daily functioning in Iranian women who have
      experienced intimate partner violence (IPV). In addition, the study seeks to investigate
      whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within
      their marriage.
    


Intervention name(s): Narrative Exposure Therapy; Treatment-as-usual
Intervention type(s): Behavioral; Other
Intervention description(s): Narrative Exposure Therapy (NET) is a treatment approach that was developed by a research group of the University of Konstanz (Schauer, Neuner, & Elbert, 2005, 2011). In NET, the patient repeatedly talks about the most arousing traumatic events in detail while re-experiencing the emotions associated with this event. In the process, the patient constructs a narration of his life, focusing on the detailed report of the traumatic experiences.; Treatment-as-usual was defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive counseling.
Regarding supportive counselling, the sessions included:
Life skill education CBT techniques ACT techniques Finding resources to stop violence Discussing marital and sexual conflicts with the presence of husbands Working on their children problems Improvement of communication skills
Other intervention name(s): NET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post Traumatic Stress Disorder; Depression; Intimate Partner violence; Narrative Exposure Therapy
Virtual Reality Application in Chemotherapy
Condition: Chemotherapy Training
Study type: Interventional

Summary: 
      The present study wants to design a training program for chemotherapy with using VR. Then the
      investigators design a protocol to compare the training effects in the VR program and ISO
      document.
    

Detailed description: 
      As technology advances, mobile devices have gradually turned into wearable devices.
      Furthermore, virtual reality (VR), augmented reality (AR), and mixed reality (MR) are being
      increasingly applied in medical fields such as medical education and training, surgical
      simulation, neurological rehabilitation, psychotherapy, and telemedicine. Research results
      demonstrate the ability of VR, AR, and MR to ameliorate the inconveniences that are often
      associated with traditional medical care, reduce incidents of medical malpractice caused by
      unskilled operations, and reduce the cost of medical education and training. What is more,
      the application of these technologies has enhanced the effectiveness of medical education and
      training, raised the level of diagnosis and treatment, improved the doctor-patient
      relationship, and boosted the efficiency of medical execution. The present study wants to
      design a training program for chemotherapy with using VR. Then the investigators design a
      protocol to compare the training effects in VR program and ISO document.
    

Intervention name(s): VR training program
Intervention type(s): Behavioral
Intervention description(s): Use VR software to make a training education program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention: VR training; control group: ISO document
Masking: None (Open Label)
Primary purpose: Other
Keywords: virtual reality; chemotherapy
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Haemophilus Influenzae Type b
MeSH terms: Influenza, Human; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants
      and toddlers when given at 2,3,4 and 12-18 months of age.

      Primary Objectives:

        -  To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both
           are co-administered with Prevenar®.

        -  To describe the post-dose 3 pertussis antibody responses.

      Secondary Objectives:

        -  To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both
           are co-administered with Prevenar®.

        -  To describe the safety after each vaccination following co-administration with
           Prevenar®.
    


Intervention name(s): PEDIACEL® and Prevenar®; Infanrix®-IPV+Hib and Prevenar®
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL each, IM (opposite thigh); 0.5 mL each, IM (opposite thigh)
Other intervention name(s): PEDIACEL®: DT5aP-IPV-Hib 5-component Pertussis vaccine; Prevenar®: Pneumococcal saccharide conj. vaccine, adsorbed; Infanrix®-IPV+Hib: DTap, IPV and adsorbed conjugated Hib; Prevenar®: Pneumococcal saccharide conj vaccine, adsorbed.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Haemophilus influenzae type b; Pneumococcal infections
Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open label, single dose, randomized, 2 way (2 period) crossover study
      in healthy adult subjects at a single study center.
    

Detailed description: 
      This study will be an open label, single dose, randomized, 2 way (2 period) crossover study
      in healthy adult subjects at a single study center. Screening evaluations will occur from Day
      28 to Day 2 and subjects will be confined to the clinical research unit (CRU) from Day 1 to
      Day 2 for each treatment period. The treatment periods will be separated by at least a 7 day
      washout period. Subjects meeting the study enrollment criteria will be randomly assigned to 1
      of 2 sequences (AB or BA) on Day 1 of Treatment Period 1 and will receive either the
      reference product (A) or the treatment product (B) once during the study
    

Intervention name(s): Cortenema; Hydrocortisone Acetate
Intervention type(s): Drug; Drug
Intervention description(s): Hydrocortisone Administered as a Liquid Enema; Hydrocortisone Acetate Administered as a Suppository with the Sephure® Rectal Suppository Applicator
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioavailability
Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of the test formulation
      of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg
      tablets (GlaxoSmithKline), under fasted conditions in healthy male and female adult subjects.
    

Detailed description: 
      A randomized, single dose, two way crossover study was conducted with up to 32 healthy, male
      and female adult subjects to compare two Zidovudine 300 mg tablet formulations under fasting
      conditions.

      In each period one x 300 mg tablet was administered to fasting subjects. Subjects received
      the test product in one study period and the reference product in the other period. The order
      of the treatment administration was as per the dosing randomization schedule. Each dose was
      separated by at least a 7 day interval.

      A total of thirty two (32) subjects (23 males and 9 females) were enrolled for the study, of
      which only twenty eight (28) subjects completed the clinical portion of the study.
    

Intervention name(s): Zidovudine tablets 300 mg
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence
Lung Function and Inflammatory Markers in Cement Dust Exposed Workers: A Cross-shifts Study
Condition: Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Observational

Summary: 
      The aim of the study is to examine possible changes in lung function, nitric oxide levels and
      systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).
    

Detailed description: 
      OBJECTIVE:

      Cement dust is suspected to be one of the main factors causing increased mortality among
      workers not only in the cement production industry, but also in the construction industry
      worldwide. Our aim is to examine possible changes in lung function, nitric oxide levels and
      systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).

      METHODS:

      All employees from Norwegian cement plants, are invited to participate. The workers will
      perform spirometry, single-breath determination of carbon monoxide uptake, blood samples
      before and after a working shift of 6-8 hours, and again after 24 hours. Information on
      respiratory symptoms, allergy and former respiratory disease as well as exposure information
      will be given on a self-reported questionnaire. Changes in lung function indices, nitric
      oxide levels and serum inflammatory markers will be calculated. Nitric oxide will only be
      measured in non-smokers. We will compare cement dust exposed workers with low-level or
      non-exposed workers (controls).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All employees of two Norwegian cement production plants are invited to participate.
      
Biospecimen description: 
      Whole blood serum
    
Keywords: Cement dust exposure; Cross-shift study; Lung function indices; Exhaled nitric oxide; Serum inflammatory markers
Home Bicycle Exercise and Aerobic Capacity
Condition: Metabolic Cardiovascular Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program.
      All participators underwent an indoor bicycle exercise for twelve weeks. In addition to
      demographic data and biochemical tests were determined after an overnight fasting. Extension
      of muscle strength was detected in the dominant lower extremity.
    

Detailed description: 
      This prospective open-labeled study was conducted in Taichung Veterans General Hospital. The
      adult participants with metabolic syndrome and/or type 2 diabetes were enrolled. MetS. The
      procedures were fully explained to all subjects before the cardiopulmonary exercise test. ll
      enrolled subjects received a scheduled twelve-week program for exercise-training program. A
      commercially available bicycle with an indoor bicycle trainer are used as the home exercise
      training modality. All medications were not allowed to be changed during the study.
    

Intervention name(s): bicycle exercise
Intervention type(s): Behavioral
Intervention description(s): All enrolled subjects received a scheduled twelve-week exercise program. A commercially available bicycle (Giant CS800, Taichung, Taiwan) with an indoor bicycle stand (Giant Cyclotron Mag, Taichung, Taiwan) was used as the home exercise training modality.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Diabetes; Muscle strength; Aerobic exercise; Bicycle; Brain-derived neurotrophic factor
A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
Condition: Healthy Volunteers; Drug Users
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center study will be a single-dose, randomized, double-blind, placebo- and
      active-controlled crossover study with a single inpatient treatment visit. The abuse
      potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of
      placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant
      users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient
      Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety
      Follow-up visit (Visit 4).
    

Detailed description: 
      Subjects will be randomized to 1 of 10 treatment sequences according to a two 5 x 5 William
      squares design. To maintain blinding, subjects will be required to ingest eight capsules with
      approximately 240 mL water on each study drug administration day.

      Serial pharmacodynamic (PD) evaluations will be conducted up to 24 hours after each study
      drug administration. Pharmacokinetic (PK) samples will be obtained to confirm exposure to
      EB-1020. Safety monitoring will include recording of adverse events (AEs), regular
      assessments of vital signs measurements, 12-lead electrocardiogram (ECG) findings, and
      continuous telemetry monitoring for at least 3 hours after study drug administration.
    

Intervention name(s): EB-1020 400 mg; EB-1020 800 mg; lisdexamfetamine 150 mg; d-amphetamine 40 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 4 x EB-1020 100-mg capsules, and 4 matching placebo capsules; 8 x EB-1020 100-mg capsules; 3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules; 4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules; 8 x matching placebo capsules
Intervention MeSH terms: Amphetamine; Lisdexamfetamine Dimesylate; Dextroamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: abuse liability; recreational drug user; stimulant; d-amphetamine; ADHD