bioihbjkbjnl/mcl2 huggingface dataset:
A Postural Study Comparing Sitting on the Floor Versus Sitting in a Chair While Playing Video Games.
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      To determine if sitting in a chair or sitting on the floor lends itself to better posture
      while playing video games.
    

Detailed description: 
      Upon completion of the parental consent form, each test subject will be instructed to flip a
      two-sided coin to determine the sitting position of the test subject. If the flip reveals a
      "heads", the child will be instructed to sit in a chair; chairs will be appropriately sized
      to allow the child to rest his/her feet on the ground. If the flip reveals a "tails", the
      child will be instructed to sit on a small carpet piece that measures 2-feet by 2-feet. Each
      test subject will be taken to their gaming station which will sit approximately 8 feet away
      from a 55-inch flat screen television that will be on a 30-inch table and handed a wireless
      controller. Two gaming stations will be available with one featuring the game Lego Batman and
      the other featuring Lego Indiana Jones with both gaming stations testing simultaneously. The
      test subjects will be told they can play for 5 minutes with a Physical Therapist at each
      station to monitor and record the test subjects' positioning.
    

Intervention name(s): Time to fatigue
Intervention type(s): Other
Intervention description(s): 5 minutes while playing video games
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Posture analysis; Video gaming; Forward Head Position; Rounded Shoulder Position; Spine Posture
Pharmacotherapy for Schizophrenic Drug Users - 6
Condition: Cocaine-Related Disorders; Substance-Related Disorders; Shcizophrenia
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate maintenance neuroleptics for Schizophrenic patients
      who are cocaine abusers.
    


Intervention name(s): Amantadine
Intervention type(s): Behavioral
Intervention MeSH terms: Amantadine
Primary purpose: Treatment
Keywords: anti psychotic agents
A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.
    


Intervention name(s): PF-04427429; PF-04427429
Intervention type(s): Biological; Biological
Intervention description(s): Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30; Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety; tolerability; pharmacokinetics; pharmacodynamics; chronic pain
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
Condition: Latent Autoimmune Diabetes in Adult (LADA)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Latent Autoimmune Diabetes in Adults
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in
      Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune
      Diabetes in Adult (LADA).
    


Intervention name(s): rhGAD65 formulated in Alhydrogel® (Diamyd®)
Intervention type(s): Drug
Intervention description(s): 20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
Intervention MeSH terms: Aluminum Hydroxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; LADA; Latent Autoimmune Diabetes in Adult; Autoimmunity; HbA1c; C-peptide
Effect of 100% Orange Juice on Food Intake and Glycemic Response in Adults
Condition: Healthy; Adult; Glycemic Response; Appetite
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of 100% orange juice on short-term food
      intake (FI), satiety, post-prandial glycemia and mood in healthy adults. We hypothesize that
      the consumption of 100% orange juice in the pre-meal environment will improve satiety signals
      and mood, and suppress FI through its effect on post-prandial glycemia.
    

Detailed description: 
      A randomized within-subjects repeated measures design will be employed. Study visits will
      take place in the morning, separated one-week apart. At each session, participants will
      consume one of three treatments: 1) 100% orange juice; 2) orange flavoured drink; or 3)
      water. Glycemic response will be measured for 60 minutes (baseline (0 minutes), 15 minutes,
      30 minutes, 45 minutes and 60 minutes) post-treatment via finger prick. Blood glucose
      measures will also be provided over 24 hours via a Dexcom G6 continuous glucose monitoring
      (CGM) device. Subjective appetite, emotions and mood will be measured for 90 minutes min
      (baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes and 90 minutes)
      post-treatment. At 60 minutes, participants will consume an ad libitum pizza lunch to
      evaluate food intake. After lunch, participants will be sent home with a rest-of-the-day food
      intake sheet to record their snacks, meals, and beverages, as well as a physical activity log
      to record their physical activity for the rest of the day following test session completion.
    

Intervention name(s): Orange juice; Orange flavoured drink; Water
Intervention type(s): Other; Other; Other
Intervention description(s): Matched for volume (240 mL/ 8 oz) of other test beverages. 100% orange juice.; Matched for volume (240 mL/ 8 oz) of other test beverages. Orange flavoured drink; Matched for volume (240 mL/ 8 oz) of other test beverages. Water control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Food intake; Appetite; Blood glucose; Glycemic response; Orange juice; Adults
Study on the Antiaging Effect of Chinese Herb Drink
Condition: Gynecological Disorders
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      The purpose of the current study was to check the physiological improvement of SWT on liver
      and skin and also the antioxidation in healthy adults.
    

Detailed description: 
      Background: Si-Wu-Tang (SWT) is a well-known traditional Chinese medicine (TCM) and widely
      used for treating various gynecological disorders. The purpose of the current study was to
      check the physiological improvement of SWT on liver and skin and also the antioxidation in
      healthy adults.

      Methods: Sixty healthy voluntary subjects were recruited and assigned into two groups, who
      drank 125 mL of placebo (n=30) or SWT (n=30) for 6 continuous days per month during the
      following 6 months and vice versa with one month of washout period in between. During the
      initial, 3rd, 6th, 10th, and 13th months anthropometric measurements were performed as well
      as fasting blood samples were drawn for various biochemical assays. Abdominal ultrasonic and
      skin examination were performed at the initial, 6th and 13th months.
    

Intervention name(s): Si-Wu-Tang (SWT); placebo
Intervention type(s): Other; Other
Intervention description(s): The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.; The purpose of the current study was to check the physiological improvement of placebo on liver and skin and also the antioxidation in healthy adults.
Other intervention name(s): Si-Wu-Tang (SWT) is a Traditional Chinese Medicine formula
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Si Wu Tang; antioxidation; anthropometric measurements; liver; skin
18F-FAPI PET Imaging in Pancreatic Adenocarcinoma
Condition: 18F-FAPI; 18F-FDG; Pancreas Adenocarcinoma; Diagnosis; Staging
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare
      the results with those obtained using 18F-FDG PET/CT.
    

Detailed description: 
      Accurate diagnosis and staging are crucial for selecting treatment for patients with
      pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are
      often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein
      inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in
      evaluation of PDAC, and compared the findings with those obtained using
      (18F)-fluorodeoxyglucose (18F-FDG).
    

Intervention name(s): 18F-FAPI; 18F-FDG
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection of one dosage of 18F-FAPI.; Intravenous injection of one dosage of 18F-FDG.
Other intervention name(s): (18)F-FAPI; (18)F-FDG
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of Prototype for Simulation for Environmental Exposure Education (SE3)
Condition: Effect of Game in Increasing Environmental Health Literacy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this clinical trial is to test a prototype of a new educational game about
      environmental health literacy with middle school age youth. The main questions it aims to
      answer are:

        -  Does playing the game increase knowledge about environmental health?

        -  Does playing the game improve environmental health literacy?

        -  Does playing the game increase interest and confidence in science?

      Participants will be asked to:

        -  Take a survey at the beginning of the study

        -  Play the game for a minimum of 50 minutes

        -  Take a survey at the end of the study
    

Detailed description: 
      The proposed project will establish the technical merit and feasibility of producing and
      using a serious game to improve environmental health literacy among young people. A small
      evaluation is being conducted to assess the impact of the prototype game on environmental
      health knowledge, literacy, ability to understand mitigation, and impact on science interest
      and confidence.

      Participants will be youth ages 11-13 who are currently in middle school. Participants are
      being recruited by the projects education advisor (CA) and youth community board members
      (MI).

      Investigators will conduct an evaluation with 45 middle school age participants from
      communities disproportionately impacted by environmental risk. The goal is to test the
      usability and playability of the prototype and assess the games impact on outcomes. The
      participant will complete a short online pre-test assessment (environmental health
      knowledge), participate in either a 50 play session or a week long play period logging a
      minimum of 50 minutes. At the end of the play period the participant will complete a short
      post-test with similar questions to the pre-test plus additional questions about their usage,
      satisfaction with, and enjoyment of the game. During independent game use, the app will
      collect metrics on usage, player performance, and conditional knowledge including the ability
      to apply concepts in context. Participants will each receive a $100 gift card.
    

Intervention name(s): SE3 Game
Intervention type(s): Other
Intervention description(s): A prototype online game designed to increase environmental health literacy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: environmental health; game; air quality; STEM; health literacy
Kegel Exercise Pregnant Training mHealth App
Condition: Pregnancy Related; Urinary Incontinence
MeSH terms: Urinary Incontinence
Study type: Interventional

Summary: 
      This pilot feasibility study protocol is to assess the feasibility in the future definitive
      trial that is the Kegel Exercise Pregnancy Training app (KEPT-app) trial. The aim of this
      study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to
      evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility
      of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve
      PFMT skills of pregnant women.
    

Detailed description: 
      The aim of this pilot feasibility study as follows: (1) to evaluate the recruitment
      capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to
      determine the implementation feasibility of using KEPT-app, and (4) to determine the
      preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.
    

Intervention name(s): Kegel Exercise Pregnancy Training - app
Intervention type(s): Device
Intervention description(s): KEPT-app is designed to educate pregnant women on PFMT via the step-by-step training with the capability element to improve their confidence and skills (beginner, intermediate and advance skills). Pregnant women are encouraged to continue adopt the PFMT throughout pregnancy until postpartum period.
The details of the mHealth app content was developed based on the need assessment gathered from the cross-sectional study (Jaffar et al., 2020). It was conducted to identify the need of PFMT by looking at the prevalence of the UI among pregnant women and to understand their knowledge, attitude, and practices towards PFMT.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will use a single-blind, single-centre, parallel, randomized controlled trial (RCT) design which will incorporate individualised treatment flexibility, as in a real-world setting, and provide a realistic estimation in future KEPT-app RCT study (Sidik et al., 2021).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilot study; Feasibility study; Acceptability; mHealth app; Pelvic Floor Muscle Training
Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Condition: Bullous Pemphigoid
MeSH terms: Pemphigoid, Bullous
Study type: Interventional
Phase: Phase 2

Summary: 
      Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically
      affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with
      widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations
      and remissions, which may be accompanied by significant morbidity.

      BP usually requires on average a 1-year duration of treatment. Superpotent topical
      corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical
      corticosteroids are often considered as poorly convenient, requiring the assistance of
      patients' relatives or a nurse to apply the topical treatment on a long period of time.

      Overall, whereas BP lesions can be adequately and rapidly controlled with either topical
      corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side
      effects due to cumulative doses of corticosteroids over months.

      Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory
      cascade associated with BP represent future alternatives to classical immunosuppressant drugs
      for maintenance therapy.
    

Detailed description: 
      The aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks
      with superpotent topical corticosteroids in patients with bullous pemphigoid
    

Intervention name(s): Ustekinumab
Intervention type(s): Drug
Intervention description(s): Ustekinumab (90 mg subcutaneously at weeks 0, 4, 16), in association with topical superpotent corticosteroid (10-30 g per day during the first 4 weeks, then every other day during 4 weeks).
Intervention MeSH terms: Ustekinumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bullous pemphigoid; ustekinumab; superpotent topical corticosteroids; efficacy; safety
Methadone Maintenance for Prisoners
Condition: Heroin Addiction
MeSH terms: Heroin Dependence
Study type: Interventional
Phase: Phase 3

Summary: 
      This five-year study examines the benefits of methadone maintenance treatment initiated in
      prison and continued in the community to male offenders who were previously, but not
      currently, heroin-dependent. It is anticipated that such prisoners will have more favorable
      outcomes in the year following release with regard to drug abuse, crime, and HIV risk
      behavior than either prisoners who receive counseling only or begin initiation of methadone
      maintenance in the community
    

Detailed description: 
      Most prisoners with histories of pre-incarceration heroin addiction do not receive treatment
      while incarcerated or upon release. Effective treatment for such prisoners is urgently needed
      because rapid relapse typically follows release. Relapse is associated with increased risk
      for HIV, overdose death, criminal activity, and reincarceration. Other than three studies of
      methadone maintenance with short-term jail inmates, the only study of longer-term inmates who
      were previously, but not currently, heroin-dependent was the investigator's pilot study with
      pre-release inmates. Based on that pilot study, which found that initiating maintenance
      treatment is feasible and facilitates post-release treatment entry, the present study
      provides a more rigorous examination of this unique treatment approach.
    

Intervention name(s): Counseling Only; Counseling + Transfer; Counseling + Methadone
Intervention type(s): Other; Drug; Drug
Intervention description(s): Counseling only in prison, with passive referral to drug abuse treatment upon release; Counseling only in prison, with opportunity to enter methadone maintenance upon release; Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of buprenorphine and its
      metabolites in the presence and absence of ketoconazole.
    

Detailed description: 
      To assess the pharmacokinetics of buprenorphine and its metabolites (nor-buprenorphine,
      buprenorphine 3 glucuronide and nor-buprenorphine glucuronide) in the presence and absence of
      ketoconazole.

      Safety evaluation of BTDS and ketoconazole in healthy subjects.
    

Intervention name(s): Buprenorphine transdermal patch; Ketoconazole tablet; Placebo to match ketoconazole tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.; Ketoconazole 200 mg tablets taken orally twice daily.; Placebo to match ketoconazole 200 mg tablets taken orally twice daily.
Other intervention name(s): Butrans™
Intervention MeSH terms: Ketoconazole; Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy subjects; Opioid; Transdermal
A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after
      dosing a combination of the study medications.
    


Intervention name(s): Fluticasone Propionate; Formoterol Fumarate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fluticasone; Formoterol; PK Study; Pharmacokinetics
Gingival Wetness and Gingival Crevicular Fluid Volume in Patients With Dry Mouth
Condition: Xerostomia; Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Xerostomia
Study type: Observational

Summary: 
      The investigators questioned whether patients with dry mouth complaints display any reduction
      in residual saliva coating the gingiva and other selected mucosal surfaces. We further
      intended to test the hypothesis that Gingival Crevicular Fluid volume in patients with dry
      mouth could be different from that of control subjects. Correlations between gingival/mucosal
      wetness; and unstimulated whole salivary flow rate or minor salivary gland secretion rates
      and the correlations between clinical periodontal status and salivary measures were also
      attempted.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The data for this study were taken from 28 subjects at the Department of Periodontology,
        Hacettepe University from 2004 to 2007. The study group consisted of 14 patients with dry
        mouth complaints. All of them had the diagnosis of Sjögren's syndrome and ten of them were
        on therapy for sicca symptoms.

        Fourteen randomly selected age-matched systemically healthy females were also included as a
        control group
      
Keywords: Saliva; Sjögren's Syndrome; GCF; Oral Mucosal Wetness