bioihbjkbjnl/mcl2 huggingface dataset:
Eating Behavior in Adolescents
Condition: Overweight; Eating Behavior; Binge Eating
MeSH terms: Overweight; Bulimia
Study type: Observational

Summary: 
      This study will explore the eating habits of adolescents and determine if eating behavior is
      linked to genetics.

      Healthy adolescents between 13 and 17 years of age may be eligible for this study. Candidates
      come to the NIH Clinical Center at 8:00 AM to be screened with the following:

        -  Medical history and brief physical examination, including height, weight, and body fat
           measurements. Body fat is measured using a device called a Bod Pod. The adolescent sits
           inside the device for about 5 minutes and the machine determines body fat by measuring
           air movement. The adolescent must wear a tight-fitting swimsuit for this test.

        -  Urine test to look for sugar or protein in the urine and to test for pregnancy in
           females.

        -  Blood tests for routine chemistries and for gene studies related to eating behaviors.

        -  Questionnaires and interviews about the adolescent s general health and eating habits.

        -  Acclimatization to test meal conditions for the study. The adolescent is given a
           breakfast shake to drink.

      Participants come to the NIH Clinical Center at 10:30 AM for laboratory meal testing. At this
      visit, the adolescent does the following:

        -  Eats food from a buffet of everyday foods that most kids eat.

        -  Fills out questionnaires.

        -  Tastes and rates the flavor of a variety of snack foods.
    

Detailed description: 
      Little is known about the eating behaviors that place adolescents at heightened risk for
      overweight. In the proposed study, we aim to investigate the role that eating behaviors and
      genes may play in the development of overweight. Participants will be adolescent girls and
      boys from a racially/ethnically diverse sample of adolescents from the DC Metro community.
      Adolescent eating behavior will be observed during laboratory test meals. Adolescents will be
      provided with a large buffet of foods or a standard meal and instructed to eat until you are
      no longer hungry. Thirty minutes later, they will taste and rate a variety of highly
      palatable snack foods. Blood tests will be conducted to examine genes related to eating
      behavior. Assessments also will include affective states, degree of hunger, degree of
      fullness, body image satisfaction, disordered eating attitudes and behaviors, and measures of
      interpersonal interactions.
    

Time perspective: Prospective
Keywords: Adolescents; Eating Behavior; Eating in the Absence of Hunger; Disordered Eating; Food Intake; Macronutrient Composition; Obesity; Adolescent; Healthy Volunteer; HV
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China
Condition: Lung Neoplasms; Lung Cancer, Nonsmall Cell; Adenocarcinoma of Lung; Squamous Cell Lung Cancer
MeSH terms: Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      To evaluate the concordance of sensitizing mutations detected between paired plasma and
      tissue samples; the correlation between the clonal status of sensitizing mutations and
      targeted therapy response; and the prognostic impact of the relative abundance of sensitizing
      / resistance mutations.
    

Detailed description: 
      In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive
      biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry
      actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will
      receive TKI treatment according to guidelines. During the TKI treatment, every patients will
      take liquid biopsy assay to monitor the mutation status. The study will be ended when all the
      patients had a progressive disease (PD) in their targeted lesion.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        treatment naïve Stage IIIB or Stage IV NSCLC patients, adenocarcinoma or squamous cell
        carcinoma without smoking history
      
Biospecimen description: 
      whole blood (including plasma, white cells), tissue
    
Keywords: Next Generation Sequencing (NGS); Tyrosine Kinase Inhibitor (TKI); liquid biopsy; EGFR Gene mutation
Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o.
      administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality
      over a dosage range of 7.5 mg to 22.5 mg
    


Intervention name(s): Meloxicam - low dose; Meloxicam - medium dose; Meloxicam - high dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Observational

Summary: 
      This study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/
      DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in
      diabetic peripheral neuropathy.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Two groups of 25 subjects each will be studied: subjects with confirmed diabetic peripheral
        neuropathy (DPN) and age- and sex-matched healthy controls.
Acclimatization Mechanisms During Ascent to 7500m
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      The trial evaluates the role of ascent protocol on acute mountain sickness and
      cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of
      mountaineers ascend with different acclimatization time to the summit. The prevalence and
      severity of symptoms of acute mountain sickness are evaluated along with physiologic
      variables.
    


Intervention name(s): ascent protocol
Intervention type(s): Behavioral
Intervention description(s): ascent protocol for the two groups has different acclimatization time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: altitude illness; hypoxia
Effectiveness of Telehealth Program in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes education is of great importance in the effective management of diabetes. Studies
      have shown that patients given diabetes education have positive developments in their ability
      to manage the disease and their attitudes towards the disease. The aim of the study is to
      compare the education given to individuals with Type 2 diabetes via mobile phone and the
      education given to individuals via brochures with conventional methods.
    

Detailed description: 
      The use of telehealth technologies in the field of health is becoming more and more
      widespread. Telehealth has become one of the frequently used options in the follow-up process
      of chronic diseases such as diabetes, especially in recent years. Diabetes education is of
      great importance in the effective management of diabetes. Studies have shown that patients
      given diabetes education have positive developments in their ability to manage the disease
      and their attitudes towards the disease. The aim of the study is to compare the education
      given to individuals with Type 2 diabetes via mobile phone and the education given to
      individuals via brochures with conventional methods.
    

Intervention name(s): TE; CE
Intervention type(s): Other; Other
Intervention description(s): After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.; After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus
Oculogica Portable EyeBOX Study
Condition: Concussion, Brain; Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      The objective of this study is to assess the accuracy of a portable version of the EyeBOX
      device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of
      concussion. The utility of the portable assessment to aid in the monitoring of symptoms over
      time after an initial diagnosis of concussion will also be evaluated.
    


Intervention name(s): EyeBOX Model EBX-4 (Portable version)
Intervention type(s): Diagnostic Test
Intervention description(s): The portable EyeBOX takes less than 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high-speed camera continuously records gaze positions. The Portable EyeBOX software detects subtle changes in eye movements consistent with concussion and calculates a BOX score.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive subjects who meet all of the inclusion criteria and none of the exclusion
        criteria
Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile
      Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device.
      It will incorporate a modified method of cylinder sizing during implantation and a
      max-inflate technique after implantation.
    


Intervention name(s): Inflatable Penile Prosthesis
Intervention type(s): Device
Intervention description(s): Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction. The implant provides the participant with voluntary control over the erect and flaccid states of the penis.
Other intervention name(s): Titan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: penile length; IPP; Erectile dysfunction
18790 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor (SPF) efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987516)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different
      batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)
    

Detailed description: 
      This multicenter, double-blind, crossover, randomized clinical trial was designed to evaluate
      the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with
      T1DM. Patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon
      Batch B as their initial dose and the other as the second dose. To avoid bias in the
      evaluation of clinical assessments, the trial was conducted in a double-blinded manner.
    

Intervention name(s): dasiglucagon
Intervention type(s): Drug
Intervention description(s): Glucagon analogue
Other intervention name(s): ZP4207
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glucagon
Phase 1 Single Dose Study of ALXN1101 in Healthy Volunteers
Condition: Molybdenum Cofactor Deficiency (MoCD); Rare Autosomal Recessive Disorder; Deficiency of Activity of Molybdenum-dependent Enzymes (Sulfite Oxidase [SOX], Xanthine Dehydrogenase, and Aldehyde Oxidase)
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 single dose study of ALXN1101 in healthy volunteers.
    

Detailed description: 
      This is a first-in-human (FIH), randomized, blinded, placebo-controlled, single-dose,
      sequential-cohort, dose-escalation study to evaluate the safety, tolerability, and
      pharmacokinetics (PK) of a single dose of ALXN1101 in healthy adult subjects.
    

Intervention name(s): ALXN1101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level.; Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: molybdenum cofactor deficiency (MoCD); deficiency of activity of molybdenum-dependent enzymes
Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox)
Condition: Voice Disorders; Virtual Reality Therapy
MeSH terms: Voice Disorders
Study type: Interventional

Summary: 
      Scientific literature supports that teachers are at greater risk for voice disorders than the
      general population. In the classroom, the teacher's voice represents the main communication
      tool. Optimal voice use is indispensable to ensure effective teaching and preserve the
      teacher's vocal health.

      This project investigates how virtual reality (VR) facilitates the learning of effective
      vocal skills and their application in real-world contexts. Based on acoustic analyses and
      self-assessment scales, the investigators compare 100 future teachers randomly assigned in
      two groups. The experimental group (n=50) receives a voice training by VR simulations and
      voice information. The control group (n=50) only receives voice information.
    

Detailed description: 
      Experimental group participants receive direct method (three 1-hour sessions of voice
      training by virtual reality simulations over a course of 3 weeks) and indirect method (one
      1-hour session of information on voice function and voice hygiene). Control group
      participants receive indirect method (one 1-hour session of information on voice function and
      voice hygiene).
    

Intervention name(s): Direct Method; Indirect Method
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Learning effective vocal skills using speech therapy exercises and virtual reality simulations.; Information on voice function and voice hygiene.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Speech Therapy; Virtual Reality; Teacher's voice; Background Noise; School Teachers
A Study of the Efficacy and Safety of Supaglutide in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      the investigational drug Supaglutide proposed dosing once (or twice) weekly in Chinese
      healthy subjects.
    


Intervention name(s): Supaglutide injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC in the Supaglutide arms.; Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.
Other intervention name(s): Diabegone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of 100% Medical Grade Manuka Honey on Tympanic Membrane Reconstruction Healing.
Condition: Otitis Media, Suppurative; Tympanic Membrane Perforation
MeSH terms: Suppuration; Otitis Media, Suppurative; Otitis; Otitis Media; Tympanic Membrane Perforation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Throughout history, honey has been recognized for its healing properties. The use of honey
      for its medicinal properties dates back to 2200 BCE.

      The purpose of this clinical trial is to learn about the healing effects of 100% medical
      grade Manuka honey in participants with Chronic Suppurative Otitis Media of the mucosal type.

      The main question it aims to answer is: Can 100% Manuka honey given at the time of
      Tympanoplasty improve the re-epithelialization (healing process) of the tympanic membrane
      compared to controls?

      Participants in the intervention group will receive a wound dressing of 100% medical grade
      Manuka honey after reconstructive surgery of the tympanic membrane.

      Researchers will compare the intervention group to the control group to see healing process.
    

Detailed description: 
      The aim of the present study is to conduct a randomized clinical trial to compare the effect
      of 100% sterile Manuka honey on re-epithelialization of the tympanic membrane post
      Tympanoplasty compared to the control group. The investigation will involve 64 participants
      with Chronic Suppurative Otitis Media of the mucosal type, who will be randomly put into two
      groups (intervention or control), where the intervention group will receive a dressing of
      100% sterile Manuka honey during surgery. Results of this study will inform practitioners as
      to the potential benefits of 100% sterile Manuka honey on the re-epithelialization of the
      tympanic membrane.
    

Intervention name(s): Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey
Intervention type(s): Drug
Intervention description(s): After surgical reconstruction of the tympanic membrane by grafting, Manukamed - Manukapli 100% Sterile honey wound dressing is applied onto the gelfoam to close the area, followed by an antibiotic tampon.
Other intervention name(s): Manukamed - Manukapli 100% sterile honey wound dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Chronic Suppurative Otitis Media; Manuka Honey; Wound Healing; Re-epithelialization; Tympanoplasty; Tympanic Membrane
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate whether a novel dosage form of a prednisolone
      ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.
    

Detailed description: 
      Ulcerative colitis is a disease that causes inflammation of the large bowel, causing fever,
      diarrhoea, dehydration and other symptoms. Standard treatment for ulcerative colitis includes
      general medical treatments such as fluid and salt replacement and attention to diet.
      Anti-inflammatory medicines such as steroids (e.g. prednisolone) and aminosalicylates (e.g.
      mesalazine) are the main drug treatments.

      This study will investigate whether COLAL-PRED®, a novel dosage form of a prednisolone ester,
      is safe and effective in the treatment of ulcerative colitis, compared with the standard
      treatment (conventional prednisolone) and also to determine which dose which will work best
      for future patients.
    

Intervention name(s): COLAL-PRED®; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.; Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Other intervention name(s): Prednisolone sodium metasulfobenzoate.
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative colitis
Effects of Wearing Progressive Addition Lens on Working Distance and Refractive Status in Adult Computer Users
Condition: Video Game Play Using Handheld Computer
Study type: Interventional

Summary: 
      With the increasing reliance on tablet computers and smartphones in daily life, it is
      important to determine whether and how the prolonged usage of these handheld digital devices
      influences the working habits and refractive status. This study aimed to determine the
      effects of wearing conventional single-vision lenses vs. new progressive addition lenses on
      the working distance and refractive status while playing interactive video game in Chinese
      pre-presbyopic adult computer users.
    

Detailed description: 
      Chinese adult computer users were recruited from two age cohorts. They were prescribed, in
      random order, with conventional single-vision lenses and progressive addition lenses designed
      for handheld digital display devices (iPad). Basic ocular parameters were measured through a
      comprehensive eye examination at the baseline visit. Working distance and refractive shift
      were measured immediately after delivering the lenses and after one month of lens wear.
      Working distance were recorded with an automatic ultrasound sensor while the participants
      were playing a 30-minute video game. Refractive-error shift before and after playing the
      video game were measured with an open-field autorefractor in both eyes and averaged.
    

Intervention name(s): Spectacle lens
Intervention type(s): Device
Intervention description(s): Wearing a spectacle lens design with corrective prescription power while playing computer game using an iPad tablet computer. Two lens designs were prescribed for each participant: the conventional single-vision lens and a new progressive addition lens designed for handheld digital device. Primary outcome measures were performed immediately after each lens delivery and one-month of lens wear.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science