bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Obesity, Abdominal
Study type: Interventional

Summary: 
      The investigators' general goal is to identify approaches to risk stratification and health
      promotion through lifestyle modification that are acceptable, effective and efficient for
      prevention of T2D in South Asian communities from diverse settings.
    

Detailed description: 
      The specific aims of the proposed iHealth-T2D study are:

        1. Determine whether intensive lifestyle modification vs usual care reduces risk of T2D
           (primary endpoint) amongst South Asians with i. central obesity; ii. prediabetes and
           iii. overall (with central obesity and / or obesity).

        2. Investigate secondary endpoints, including health gains in family members. Identify
           social, demographic and environmental factors influencing primary and secondary
           endpoints.

        3. Carry out a health economic analysis of lifestyle modifications vs usual care for
           prevention of T2D on the Indian subcontinent and Europe. Quantify the cost-effectiveness
           of screening by waist circumference vs HbA1c.
    

Intervention name(s): Intensive lifestyle modification
Intervention type(s): Behavioral
Intervention description(s): The intervention is delivered as 9 face-face and 13 telephone contact sessions over 12 months. Index cases are the focus for the intervention, but lifestyle modification encourages the whole family to adopt healthy living.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Validating Accelerometers to Study Physical Activity of Toddlers
Condition: Motor Activity
Study type: Observational

Summary: 
      One way to assess impacts of nutrition supplements to health is to measure physical activity.
      Physical activity can be measured with small devices called "accelerometers". Before they can
      be used, the devices need to be validated in the population in question. Objectives of this
      study are to test accelerometers in field conditions and validate their use in 16-18 months
      old Malawian toddlers. This study does not have a pre-set hypothesis.
    

Detailed description: 
      Accelerometers have not been validated in children under 2 years of age. In this study 50
      toddlers from Lungwena will be recruited. The participants will wear an ActiGraph GT3X+
      -accelerometer fitted on their waist with an elastic belt for 7 days. During the measuring,
      they will have two videotaped one-hour activity observations while wearing and additional
      accelerometer device fitted on their ankle. The output from the two devices will be compared
      to observed activity classified with CPAF-method.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy children
      
Keywords: Motor activity; Infant; Validation studies; Malawi; Sub-Saharan Africa
Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the
      treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The
      primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets
      (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.
    


Intervention name(s): Montelukast Oral Granules (OG); Montelukast Chewable Tablets (CT)
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 4 mg in one sachet; Montelukast 5 mg in one tablet
Intervention MeSH terms: Montelukast
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of an Omega-3 SPM Supplement on Quality of Life
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft
      gel supplement for four weeks will increase the quality of life in adults with chronic pain.
    

Detailed description: 
      One third of the America population is affected by chronic pain. The societal costs
      associated with chronic pain is up to $635 billion dollars annually. Prescribed pain
      medications may have negative side effects, or cause addictions. Having alternative
      treatments that can reduce inflammation and the side effects associated with chronic pain may
      improve the quality of life for millions.

      This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft
      gel supplement for four weeks will increase the quality of life in adults with chronic pain.
      SPM™ softgels are a dietary supplement intended to reduce pain and inflammation. Up to 40 men
      and women with chronic pain will be recruited. Outcome measures will be collected at
      baseline, 2 weeks, and 4 weeks with a primary endpoint of 4 weeks. The primary outcomes of
      this pilot study include questionnaires to assess quality of life. Exploratory outcomes
      assess safety and tolerability, changes in anxiety and depression as well as levels of pain,
      and blood markers associated with inflammation.
    

Intervention name(s): Omega-3 SPM™ softgel
Intervention type(s): Dietary Supplement
Intervention description(s): This four week, prospective, non-randomized, open-label study is assessing the impact on quality of life from taking an Omega-3 SPM™ softgel supplement in adults with pain symptoms at screening of 4 or higher on the PROMIS-43 Profile - Pain Intensity subscale.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the OptiMedica
      Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with
      cataracts. The safety and efficacy will be compared to the standard surgical procedure of
      continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.
    


Intervention name(s): FS Laser Surgery; CCC Surgery
Intervention type(s): Device; Procedure
Intervention description(s): The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.; Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery.
Other intervention name(s): OptiMedica Catalys™ Precision Laser System (Catalys System) = femtosecond laser; Alcon Infiniti System = U/S (ultrasound) phacoemulsification system; Alcon Infiniti System = U/S (ultrasound) phacoemulsification system.
Intervention MeSH terms: Dipivefrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cataract; Surgery, cataract extraction; Optical devices, laser
A Study to Detect Hyperkalemia Using Smartphone-enabled Electrocardiogram (EKG)
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Observational

Summary: 
      The purpose of this study is to validate the real-world performance of a previously developed
      Artificial Intelligence - Electrocardiogram (AI-ECG) algorithm for identification of
      hyperkalemia with a six-lead mobile-enhanced device .
    

Detailed description: 
      1. Ambulatory adult patients in the Emergency Department (ED) at increased risk for
           hyperkalemia (due to age ≥ 50 years, and one or more criteria including estimated
           Glomerular filtration rate (eGFR) (from serum creatinine) < 45 ml/minute and/or a
           history of serum potassium > 5.2 milliequivalents per liter (mEq/l) who present to the
           emergency department will be approached to consent for the rapid screening process.

        2. Those who consent will undergo 30 second 6 L ECG recording with a portable,
           mobile-enhanced device (AliveCor Kardia).

        3. This ECG data is subsequently evaluated by our artificial intelligence algorithm to
           detect hyperkalemia, and the estimated probability of hyperkalemia is recorded.

        4. The research team notifies supervising Emergency Department staff of patients whose
           probability of hyperkalemia is significantly elevated above the optimized cutoff point
           according to the AI-ECG algorithm.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients in the emergency department who meet the above inclusion criteria. Patients with
        the above inclusion criteria experience hyperkalemia more frequently than the general
        population at a prevalence near 10% compared to 2-4%, respectively.
      
Keywords: electrocardiogram (ECG); Artificial Intelligence (AI); neural network; hyperkalemia; Emergency Department (ED); Smartphone; AliveCor Kardia 6 L ECG device
Investigating Circadian Rhythms in Youth With Persistent Tic Disorders
Condition: Tourette's Disorder
MeSH terms: Tic Disorders; Tics; Tourette Syndrome
Study type: Interventional

Summary: 
      This study examines circadian rhythms and morningness-eveningness preference in youth with
      Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD); and assesses the effects
      of wearable short wavelength light therapy on circadian rhythms and tic symptoms.
    

Detailed description: 
      Many individuals with Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD)
      fail to significantly benefit from existing tic treatments. Case studies have shown morning
      exposure to light therapy, known to advance circadian phase is associated with modest to
      large tic reductions (Coles & Strauss, 2013; Niederhofer, 2003) suggesting the presence of
      circadian abnormalities (i.e., phase delay) in select individuals with PTDs. The present
      project assesses circadian phase and morningness-eveningness preference in youth with
      Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD), and examines whether
      morning use of wearable short wavelength light therapy is associated with shifts in circadian
      rhythms and reductions in tic severity.

      Study participation will take place over a three-week period. Clinician-rated tic interview
      and rating scales of morningness-eveningness preference, sleep, tic, and other symptoms will
      be completed during an initial screening assessment. Participants will then monitor sleep at
      home using an actigraph for one week and return for a baseline clinical assessment of tic
      severity and evening assessment of internal melatonin levels involving saliva sampling every
      30 minutes for 6.5 hours in a dimly lit room. Next, participants will complete an abbreviated
      course (i.e., two weeks) of morning light therapy using wearable short wavelength (i.e.,
      blue-green) light-emitting glasses while continuing to monitor sleep using the actigraph.
      Following this two-week period participants will return for a final assessment of tic
      severity and internal melatonin levels.
    

Intervention name(s): Wearable short wavelength light therapy
Intervention type(s): Other
Intervention description(s): Wearable short wavelength (i.e., blue-green) light-emitting glasses worn for two weeks
Other intervention name(s): Re-Timer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tourette Syndrome; Tourette's; Tics; Circadian; Sleep
Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)
Condition: Mild Persistent Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in
      the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative
      Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated
      after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an
      Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose
      response.
    


Intervention name(s): BDP/formoterol; BDP/formoterol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol); pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol); pressurised metered dose inhaler
Other intervention name(s): Foster; Foster
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Tibolone Endometrium Study (Study 32972)(P06470)
Condition: Postmenopausal Women
Study type: Interventional
Phase: Phase 3

Summary: 
      Tibolone has been registered for the treatment of climacteric symptoms and for the prevention
      of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial
      safety of tibolone in comparison with CE/MPA.
    


Intervention name(s): tibolone; Tibolone 2.5 mg; CE/MPA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral 1.25 mg tablet, once daily, for 2 years; oral 2.5 mg tablet, once daily, for 2 years; oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years
Other intervention name(s): Livial; Premarin; Provera
Intervention MeSH terms: Tibolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in
      patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone
      or as added treatment to risperidone).
    


Intervention name(s): Placebo; Lu AF11167
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex for Cognitive Improvement in Schizophrenia
Condition: Schizophrenia; Cognitive Dysfunction
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate different stimulation intensities and frequencies
      of transcranial direct and alternating current stimulation over the dorsolateral prefrontal
      cortex for cognitive improvement in schizophrenia.
    

Detailed description: 
      In this randomized, double-blind study, 50 patients diagnosed with schizophrenia are randomly
      assigned into two arms. The first group receives transcranial direct current stimulation
      (tDCS) at three intensities (2 mA, 3 mA, and sham) and the second group receives transcranial
      alternating current stimulation (tACS) at three different frequencies (8 Hz, 40 Hz, and sham)
      over the left dorsolateral prefrontal cortex for 20 min. There are at least 72 hours between
      stimulation sessions. The patients conduct three cognitive tasks from the CANTAB
      neuropsychological battery for schizophrenia during stimulation including a working memory
      task, a cognitive flexibility task, and an emotion recognition task. Mood stability is also
      evaluated before and after each stimulation session with the Positive and Negative Affect
      Scale (PANAS).
    

Intervention name(s): transcranial direct current stimulation (tDCS); transcranial alternating current stimulation (tACS)
Intervention type(s): Device; Device
Intervention description(s): In tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm).; In tACS, alternating electrical currents at the frequency of interest (8 Hz for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group and each group with crossover design
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: schizophrenia; tDCS; tACS; Cognition; dorsolateral prefrontal cortex
Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma
Condition: Squamous Cell Carcinomas of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Esophageal Neoplasms
Study type: Observational

Summary: 
      Patients with HNSCC represent a high-risk group for the development of SESCC. Thus,
      esophagogastrofibroscopy should be performed to detect possible synchronous esophageal
      carcinomas in these patients.

      Although only two patients with synchronous primary carcinomas were found among the patients
      with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced
      endoscopic methods should be recommended after detection of HNSCC to exclude secondary
      esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy
      and inexpensive option and can be done in most of gastroenterology offices.
    

Detailed description: 
      ABSTRACT Objective: To evaluate the use of flexible esophagoscopy and chromoendoscopy with
      Lugol's solution in the detection of early esophageal carcinomas (second primary carcinomas)
      in patients with squamous cell carcinoma of the head and neck (HNSCC).

      Methods: All patients with newly diagnosed HNSCC underwent office-based Lugol
      chromoendoscopy. After flexible esophagoscopy with white light, 3.0% Lugol iodine solution
      was sprayed over the entire esophageal mucosa. Areas with less-intense staining (LVLs) were
      evaluated and biopsies taken.
    

Intervention name(s): Esophagoscopy and chromoendoscopy
Intervention type(s): Procedure
Intervention description(s): Esophagoscopy - examination of the interior of the esophagus by means of an esophagoscope.
Chromoendoscopy - a method, which involves the topical application of stains or pigments to improve tissue localization, characterization, or diagnosis during endoscopy.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with newly diagnosed head and neck carcinoma
      
Keywords: head and neck carcinoma; chromoendoscopy; Lugol's solution; esophageal carcinoma; synchronous tumors; deglutition; deglutition disorders; Newly diagnosed HNSCC
The Burden of Access in Duchenne Muscular Dystrophy in the US
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      This study is being conducted to determine if DMD patients / families and healthcare
      providers experience burdens related to access, and if so, to identify them, and to determine
      life impacts to the patient, if any, of these burdens. Data from healthcare providers will be
      collected by an online survey and from patients/families by one on one telephone interview.
    

Detailed description: 
      Patient/Parent Portion

      In this non-interventional study, DMD patients / parents of DMD patients will be interviewed
      to gather qualitative input, in the patient's voice, regarding challenges associated with
      access to medications, services and medical equipment, and how these burdens impact quality
      of life.

      Healthcare Provider Portion

      In this non-interventional study, healthcare providers who see patients with DMD and who deal
      with insurance issues on behalf of DMD patients will participate in an online survey designed
      to determine the burden associated with access to medications, services and medical
      equipment.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        For Patient/Parent Interviews:

        Patients residing in the US who have been diagnosed with DMD who are age 18 years or older,
        or the parent / legal guardian of a person of any age who has been diagnosed with DMD

        For Healthcare Provider Survey:

        Healthcare providers (physicians, nurse practitioners, and physician assistants) currently
        involved in the care of patients with DMD