bioihbjkbjnl/mcl2 huggingface dataset:
Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study is conducted to assess potential effectiveness and feasibility of a comprehensive
      digital intervention for people with poorly-controlled Type 2 Diabetes Mellitus (T2DM), to
      explore the intervention effects of a combined online and offline management for people with
      T2DM and ultimately to improve the accessibility of lifestyle intervention among participants
      with T2DM.
    

Detailed description: 
      The study is a single-arm, non-randomized clinical trial conducted to assess potential
      effectiveness and feasibility of a comprehensive digital intervention for people with
      poorly-controlled T2DM, to explore the 16 weeks intervention effects of a combined online and
      offline management for people with T2DM and ultimately to improve the accessibility of
      lifestyle intervention among participants with T2DM.

      Primary objective is to study the proportion of participants with decrease in Hba1c by 0.6%
      by providing digital based lifestyle modifications. Secondary objectives include to 1)
      estimate the change in Hba1c, body mass index (BMI) and improvement in lipid profile
      components at week 16 compared with baseline readings; 2) to evaluate of the use of the
      Ramadan Risk Score (IDF-DAR Risk Stratification Scoring Tool); 3) to evaluate the rate of
      fasting and diabetes complications (hyperglycaemia / hypoglycaemia) amongst Muslims with T2DM
      during Ramadan.
    

Intervention name(s): 16 weeks digital intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will be enrolled into a 16-week program which consist of an online and offline support from health coaches and dietitian. Participants will be given diet and exercise recommendations and lesson plans on a weekly basis by the health coaches, and supported by the dietitian.
Participants will be required to log in their blood sugar levels, weight and steps daily using connected device, including glucometer, smart band and body fat weighing scale provided into the daily report card. They will also be required to manually record their meals and exercise daily in the daily report card provided upon enrollment into study. Reviews of log will be done on a weekly/biweekly interval by the health coaches.
Other intervention name(s): lifestyle intervention
Intervention model: Single Group Assignment
Intervention model description: This study is a single-arm, non-randomized clinical trial, which will collect participant's baseline data, apply relevant assessment scales, collect data using a comprehensive digital intervention in 16 weeks to evaluate the improvement of relevant markers post intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: digital intervention
Effect of Laser Application in Pain Management Following the Use of Orthodontic Elastomeric Separators
Condition: Orthodontic Treatment
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain
      management in people commencing orthodontic treatment. The study design is a randomized
      controlled trial.

      Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly,
      and the other side will be treated by a placebo procedure. Pain assessment will be measured
      using Visual Analog Scales (VAS).

      The hypothesis of this study is that laser irradiation decreases the amount of pain following
      the insertion of orthodontic separators.
    

Detailed description: 
      Here we have two groups:

      The first group will undergo one dose of irradiation which is going to be applied on one side
      of the mouth whereas the opposing side will serve as a control side (placebo).

      The second group will undergo two doses of irradiation which is going to be applied on one
      side of the mouth whereas the opposing side will serve as a control side (placebo).
    

Intervention name(s): Laser Irradiation One dose; Laser Irradiation Two doses
Intervention type(s): Radiation; Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low level laser therapy; Elastomeric separator; Placebo; Visual analog scale; Laser irradiation
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
Condition: Age-related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      This study was a retrospective cohort study of patients to assess the early insights into
      real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to
      describe their patient characteristics and clinical outcomes. The study was conducted using
      the Komodo Healthcare Map.
    

Detailed description: 
      Komodo Healthcare Map claims data from 08-Oct-2016 to the date of most recent data from
      patients with wet AMD who initiated brolucizumab were analyzed in this study.

        -  Identification period of the index date (index period): The patients fulfilling the
           selection criteria were identified during the period from 08-Oct-2019 to 30-Apr-2020.

        -  Index date: Defined as the date of the earliest brolucizumab injection during the index
           period.

        -  Study Period: The period from 08-Oct-2016 to the most recent data extraction date
           (05-Jun-2020).

           o Note since 05-Jun-2020 was the date data was pulled, claims data from recent months
           (e.g. May) may be incomplete (relative to the final DB state) as well.

        -  Pre-index period: The period 36 months prior to the index date

           o Note: Data within 36 months prior to the index date will be used to assess baseline
           characteristics.

        -  Post-index period: The period of 180 days after the index date
    

Intervention name(s): Brolucizumab
Intervention type(s): Drug
Intervention description(s): Participants received brolucizumab injection during the index period
Other intervention name(s): BEOVU®
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with wet AMD who initiated brolucizumab were analyzed in this study.
      
Keywords: Brolucizumab,; intravitreal injection,; neovascular age-related macular degeneration
A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin
Condition: Peripheral Nueropathy Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial to compare the pharmacokinetic characteristics of
      YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release
      formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and
      secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.
    


Intervention name(s): YHD1119; Lyrica
Intervention type(s): Drug; Drug
Intervention description(s): 2 by 2; 2 by 2
Other intervention name(s): Pregabalin 300mg; Pregabalin 150mg
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the safe and effective dose range of
      boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic
      hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy
      with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin
      provides an additional benefit when combined with PEG-Intron plus boceprevir.
    


Intervention name(s): Boceprevir (BOC); PegIntron (PEG); Ribavirin (RBV)
Intervention type(s): Drug; Biological; Drug
Intervention description(s): 100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID; 1.5 mcg/kg weekly subcutaneously; 200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight [weight-based dosing {WBD}])
Other intervention name(s): SCH 503034
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PEG-Intron; Ribavirin; Protease Inhibitor
Efficacy of a Microalgae Extract PhaeoSOL Combined With Natural Stimulant on Cognitive Function and Gaming Performance of Video Gamers
Condition: Cognitive Function; Video Gamers
Study type: Interventional

Summary: 
      Considering the important growing development of gaming in the world, this research area has
      developed considerably over the last few years. Even if it seems to be well admitted that
      video gamers showed better cognitive functions (e.g. visual selective attention, cognitive
      flexibility, task switching) parameters compared to non video gamers there is a constant
      concern for optimizing performance as for all other kind of athletes. However to our
      knowledge, only one randomized controlled trial have investigated the potential benefits of
      dietary supplementation on cognitive function and performance in video gamers. The use of
      microalgea as molecule of interest sources is a recent promising approach also to meet
      societal challenge as the maintain of biodiversity/landscape.

      Thus, the purpose of this study is to examine whether acute (single-dose) and chronic (1
      month) supplementation of Microphyt's phaeosol ingredients (BrainPhyt) ingested with or
      without a natural stimulant, would affect cognitive function and gaming performance in
      experienced video gamers.
    


Intervention name(s): Phaeosol low dose; Phaeosol high dose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 Phaeosol softgel of 440mg/day and 1 placebo softgel of 500mg/day (look like softgel of Phaeosol product) + 1 capsule of 440mg/day of natural stimulant Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively).; 2 Phaeosol softgels of 440mg/day + 1 capsule of 440mg/day of natural stimulant. Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively).; 2 placebo softgels of 440mg/day (look like softgel of Phaeosol product) + 1 capsule of 500mg/day containing Microcellulose (look like capsule of natural stimulant). Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Fucoxanthin; Microalgae; Gaming performance; E-sports; Cognitive performance; Energy
The Swedish Two-County Trial of Mammography Screening
Condition: Breast Neoplasm Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Population-based randomized controlled trial carried out in two Swedish counties, Dalarna and
      Ostergotland to find out the impact of early detection on mortality from breast cancer.
    

Detailed description: 
      The Swedish Two-county study is a randomized controlled trial of invitation to mammography
      screening. The trial took place in Kopparberg (W), now called Dalarna, and Ostergotland
      counties in Sweden. The trial randomized 77,080 women aged 40-74 years to invitation to
      screening (active study population, ASP) and 55,985 women to no invitation to screening
      (passive study population, PSP). The trial started in 1977 in W-county and in 1978 in
      E-county. Women in age 40-49 years were invited to single-view mammography screening on
      average every 24 months, and women aged 50-74 years on average every 33 months. Approximately
      seven years after randomization a significant 31% decrease in breast cancer mortality was
      observed in the ASP group, whereupon the PSP was invited to screening once and the screening
      phase of the trial ended. The mortality data have been reported every two years during the
      follow-up period and published in peer-reviewed medical journals. The investigators have
      follow-up data to the Dec 31 2015. The 29-year follow-up data has been published in 2012 in
      Radiology. Publication of the long-term data reflects the fact that deaths avoided by early
      detection include some that would have occurred a considerable time later than the screening.
    

Intervention name(s): Imaging
Intervention type(s): Diagnostic Test
Other intervention name(s): Screening mammography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430
Condition: Filovirus Infections; Ebola Virus Infection
MeSH terms: Infections; Communicable Diseases; Hemorrhagic Fever, Ebola; Filoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and
      pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection
      in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2
      subjects will receive BCX4430 for 7 days.
    

Detailed description: 
      Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics of single,
      ascending doses of BCX4430 versus placebo in healthy subjects. Up to 6 ascending dose cohorts
      will be enrolled in a sequential manner. Eight subjects will be treated with a single dose of
      study drug per dose cohort: 6 subjects per cohort will receive BCX4430, and 2 subjects per
      cohort will receive matching placebo.

      Part 2 of the study will be initiated following review of all available data from Part 1 by
      an independent Safety Monitoring Committee

      Part 2 of the study will evaluate the safety, tolerability, and pharmacokinetics of 7 days of
      daily dosing with BCX4430 versus placebo in healthy subjects. Up to 4 ascending dose cohorts
      will be treated in a sequential manner. Ten subjects will be treated with study drug per dose
      cohort (8 subjects will receive BCX4430 and 2 subjects will receive placebo per cohort). The
      planned doses and dosing regimens for each of the Part 2 cohorts will be determined based
      upon data collected during Part 1.
    

Intervention name(s): BCX4430; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Galidesivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers; Ebola virus; Filovirus
Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium
Condition: Asthma; Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is a biomarker-based pilot study of the safety of Cockroach Subcutaneous
      Immunotherapy in Cockroach-sensitive Adults (SCITCO) who have a history of perennial allergic
      rhinitis, asthma, or both.
    

Detailed description: 
      Scientific evidence has shown that, over the past two decades, the combination of cockroach
      allergy and cockroach exposure is one of the most important factors contributing to the
      dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a
      major goal of the Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of
      cockroach immunotherapy in inner city asthma.
    

Intervention name(s): German cockroach (Blattella germanica) allergenic extract
Intervention type(s): Biological
Intervention description(s): Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cockroach; Immunotherapy; Subcutaneous immunotherapy; Inner city asthma
Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety of combining Sorafenib and
      chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.
    

Detailed description: 
      Patients who have AIPC and are progressing despite systemic chemotherapy will be offered
      participation in this study. Patients who relapse or progress shortly (within 12 weeks) after
      discontinuation of chemotherapy with either docetaxel/prednisone or mitoxantrone/prednisone
      will also be offered participation in this trial. Enrolled patients will receive sorafenib as
      per protocol define dose. Sorafenib will be administered in combination with the last
      chemotherapy utilized. If there is no disease progression after 6 cycles, chemotherapy will
      be stopped and Sorafenib may continue until disease progression.
    

Intervention name(s): Sorafenib
Intervention type(s): Drug
Intervention description(s): 400mg twice daily
Other intervention name(s): Nexavar
Intervention MeSH terms: Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AIPC
Yogic Breathing and IBS
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Adults with irritable bowel syndrome (IBS) are being randomized to a yogic breathing or
      control condition. Participants randomized to the yogic breathing group will be asked to
      complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and
      control group participants will be asked to maintain their current activities. Participants
      in this group will be given access to the yogic breathing video at the end of the 4-week
      control period. IBS symptoms and autonomic and vascular function will be assessed at baseline
      and at the end of week 4 in both groups.
    


Intervention name(s): Yogic breathing intervention
Intervention type(s): Behavioral
Intervention description(s): Yogic breathing will be completed while following a video provided by the investigative team. Breathing practices consist of slow, deep, relaxation breathing and are led by a certified yoga instructor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Post-Bariatric Weight Regain Behavioral Intervention
Condition: Obesity
Study type: Interventional

Summary: 
      This project aims to evaluate a newly developed Internet-delivered (via e-learning modules)
      acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight
      regain after bariatric surgery. Specifically, the investigators aim to assess ABTi's efficacy
      on stopping and/or reversing weight by comparing it to a wait-list control (WLC) condition.
      The investigators also aim to evaluate its effect on targeted weight control behaviors and
      acceptance-based skills. Finally, the investigators will examine the relationship between
      weight outcomes and changes in process variables through exploratory analyses. Treatment
      outcomes (i.e., weight, maladaptive behaviors, physical activity, acceptance-based skills)
      will be measured at assessments pre-, mid-, and post-treatment, as well as at 3 months after
      treatment has ended.

      Primary Aims.

        1. To test the hypothesis that participants randomly assigned to ABTi will display greater
           weight loss from pre- to post-treatment than those assigned to WLC.

        2. To test the hypothesis those receiving ABTi, compared to WLC, will display decreased
           maladaptive eating behaviors (i.e., loss of control episodes, grazing, emotional eating,
           disinhibition), increased physical activity, and greater improvements in
           acceptance-based skills (i.e., mindfulness, defusion, food-related acceptance).

      Exploratory Aim.

      (1) To assess if changes in acceptance-based skills, maladaptive eating behaviors, and
      physical activity are associated with pre- to post-treatment weight outcomes.
    


Intervention name(s): Acceptance Based Behavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): This intervention focuses on acceptance-based strategies with an emphasis on willingness to experience less pleasurable internal experiences (e.g., pleasure from eating calorically-dense foods) and aversive internal experiences (e.g., hunger, food cravings). Strategies to increase this willingness will be taught, including defusion (i.e., getting psychological distance from internal experiences to allow oneself to act independently of them). Mindful decision-making, as it relates to eating and exercise, will also be emphasized. Clarification and commitment to core values is another key component, as living life in accordance with one's values (e.g., health) makes willingness to make difficult choices worthwhile. Standard behavioral techniques for weight loss (i.e., self-monitoring, stimulus control, psychoeducation) will also be included.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic
      patients to better understand the skin penetration of topically applied BCT194.
    


Intervention name(s): BCT194
Intervention type(s): Drug
Intervention description(s): Topically applied BCT194 cream (0.5%)
Intervention model: Single Group Assignment
Keywords: Psoriasis; Stable plaque psoriasis; lesions; TNF-alpha; BCT194