bioihbjkbjnl/mcl2 huggingface dataset:
DNA Methylation and 1-C Metabolism Nutrient Intake
Condition: DNA Methylation
Study type: Observational

Summary: 
      The present study used a sub-sample of the Melbourne Collaborative Cohort Study (MCCS) (Milne
      RL et al, Int J Epidemiol, 2017), who had valid data on dietary intakes (121-item food
      frequency questionnaire) and valid measures of DNA methylation using the HumanMethylation
      Infinium 450K Beadchip assay, or using LINE-1, Alu and Sat2 assays.

      The investigators studied the association between nutrients involved in one-carbon metabolism
      and DNA methylation in peripheral blood.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population is a sub-sample of the Melbourne Collaborative Cohort Study (MCCS), with
        non-random sampling based on selection into of six case-control studies nested within the
        MCCS. The MCCS is a prospective cohort study of 41,513 people (17,044 men and 24,469 women)
        recruited between 1990 and 1994. The age range at recruitment was 27-80 (99.3% being aged
        40-69). Southern European migrants to Australia were over-sampled to extend the range of
        exposures, including dietary patterns.

        Participants in this sub-study had valid dietary intake data and valid measures of DNA
        methylation.
Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
Condition: Total Knee Arthroplasty (Replacement)
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients
      undergoing total knee replacement
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy, tolerability, safety, and
      pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty
    

Intervention name(s): 4975, 15 and 5 mg; Placebo Comparator; 4975 - 5 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Direct instillation into the surgical site; Direct instillation into the surgical site; Direct instillation into the surgical site
Other intervention name(s): Adlea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: TKA; Total knee arthroplasty; Total knee replacement; Knee surgery
Study To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending
      dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety,
      tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean
      subjects.
    


Intervention name(s): C1K 150mg; C1K 300mg; Placebo with the same volume of C1K 300mg; C1K 600mg; Placebo with the same volume of C1K 600mg; C1K 900mg; Placebo with the same volume of C1K 900mg; C1K 1200mg; Placebo with the same volume of C1K 1200mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneously administrate C1K 150mg at Day 1, Day 8, Day 15; Subcutaneously administrate C1K 300mg at Day 1, Day 8, Day 15; Subcutaneously administrate placebo with the same volume of C1K 300mg at Day 1, Day 8, Day 15; Subcutaneously administrate C1K 600mg at Day 1, Day 8, Day 15; Subcutaneously administrate placebo with the same volume of C1K 600mg at Day 1, Day 8, Day 15; Subcutaneously administrate C1K 900mg at Day 1, Day 8, Day 15; Subcutaneously administrate placebo with the same volume of C1K 900mg at Day 1, Day 8, Day 15; Subcutaneously administrate C1K 1200mg at Day 1, Day 8, Day 15; Subcutaneously administrate placebo with the same volume of C1K 1200mg at Day 1, Day 8, Day 15
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Study of Cinepazide Maleate Injection in the Treatment of Acute Ischemic Stroke
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel controlled,
      post marketing confirmatory clinical trial in Chinese patients with acute ischemic stroke.
      Objective to evaluate the efficacy and safety of cinepazide maleate injection compared with
      placebo in the treatment of patients with acute ischemic stroke.
    

Detailed description: 
      The target population of this study is patients with acute ischemic stroke within 48 hours.
      All potential participants must provide informed consent, and those who provide informed
      consent will enter the screening (- 48 ~ 0h), and the screening qualification will be
      evaluated according to the inclusion criteria. The eligible subjects will enter the treatment
      period (day 1-14) and will be randomly assigned to the experimental group (cinepazide maleate
      injection group) or the control group (placebo group).

      During the treatment period, all subjects will receive cinepazide maleate injection or
      placebo by intravenous drip at the rate of 100ml / h, once a day for 14 consecutive days.
      During the treatment, all subjects need to receive basic treatment: citicoline sodium
      injection 0.5g, dissolved in 5% glucose injection or normal saline 250ml, intravenous drip
      slowly, once a day, continuous administration for 10 days. According to the Chinese
      guidelines for the diagnosis and treatment of acute ischemic stroke (2014), the patients were
      given antihypertensive, hypoglycemic, lipid-lowering, anticoagulant or mannitol. All subjects
      were not allowed to receive interventional therapy, thrombolysis (such as rtPA and
      urokinase), defibrillator, any platelet inhibitor except aspirin and clopidogrel, other
      cerebrovascular dilators (such as cinnarizine, flunarizine, nicardipine and nimodipine),
      other neuroprotective agents (except citicoline) during the whole trial period After the end
      of the treatment period (the 14th day), the subjects will enter the follow-up period (the
      15th-90th day).

      During the follow-up period, subjects need to be followed up twice (30th day) ± 2 days, 90th
      day ± 3 days).
    

Intervention name(s): Cinepazide Maleate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The experimental group: guipiprazitel maleate injection (klingo): 320mg (4), dissolved in 500ml of normal saline, and injected in a medium vein at a rate of 100ml/h, once a day, and administered for 14 days.; Placebo: 4 pieces, dissolved in normal saline 500ml, intravenous drip, the speed is 100ml / h, once a day, continuous administration for 14 days
Intervention MeSH terms: Cinepazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acupressure in Hyperemesis Gravidarum
Condition: Hyperemesis Gravidarum
MeSH terms: Hyperemesis Gravidarum
Study type: Interventional

Summary: 
      To examine the degree of nausea, vomiting between the acupressure and control group in women
      with hyperemesis gravidarum
    

Detailed description: 
      A prospective RCT conducted at Department of Obst and Gynae, UKMMC. All pregnant women with a
      normal intrauterine pregnancy of ≤ 16 week gestation with hyperemesis gravidarum will be
      assessed by the medical officer/ specialist/ consultant in charge. Explanation regarding the
      research study will be given for patients who fulfill the inclusion and exclusion criteria.
      Patients who have understood the research study and consented will be recruited as subjects
      for the study.
    

Intervention name(s): Acupressure band; Standard treatment hospital protocol
Intervention type(s): Device; Other
Intervention description(s): acupressure band apply to P6 (nei guan) point which located three fingers below the skin wrinkles of the anterior wrist.
Acupressure band wear 3 times daily before breakfast, lunch and dinner for at least 10 minutes; Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Urdu Version of COPENHAGEN Neck Functional Disability Scale: Reliability and Validity Study
Condition: Disability Physical
Study type: Observational

Summary: 
      -  The objective of the research is to do translation and to culturally familiarize the
           COPENHAGEN Neck Functional Disability Scale into the Urdu language.

        -  To investigate if the COPENHAGEN Neck Functional Disability Scale is reliable and
           validate in the Pakistani population with Chronic Neck pain.

        -  To check the correlation with Neck Disability Index, Neck Pain and Disability Scale.
    

Detailed description: 
      The English version of the COPENHAGEN Neck Functional Disability Scale will be translated
      into Urdu and culturally adapted, as per a previous recommendation. The COPENHAGEN Neck
      Functional Disability Scale will be given to participants who have consented, and would be
      chosen based on convenience sampling and inclusion and exclusion criteria. The inter-observer
      and intra-observer reliability of the COPENHAGEN Neck Functional Disability Scale, Neck Pain
      and Disability Scale , and Neck Disability Index will be evaluated in this study. On the same
      day, the questionnaire will be filled out created two times. An Inter - observer assessment
      will be done with 2 hour break between distributions of questionnaires. The initial observer
      then will gather a third assessment over one-week period. For data entry and analysis,
      Statistical Package of Social Sciences Version 23 will be utilized. Internal consistency will
      be checked using the Cronbach alpha value, and test retest reliability will be assessed using
      the Intra-class coefficient.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pakistani population with Chronic Neck pain will be part of the study.
      
Keywords: COPENHAGEN Neck Functional Disability Scale; Urdu Version; Reliability; Validity; Neck Disability
Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the immunologic and overall safety associated with
      long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less
      than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products
      other than Alphanate and who have no history of developing either antibody inhibitors to
      Factor VIII or nonspecific inhibitors of coagulation.
    

Detailed description: 
      This is a Phase IV, non-randomized, multicenter study of at least 50 evaluable subjects
      diagnosed with severe hemophilia A. Enrolled subjects will be treated at home and with
      in-clinic therapy exclusively with Alphanate as their sole source of Factor VIII concentrate
      for prophylaxis and treatment of all bleeding episodes and surgical procedures. Subjects will
      be treated for at least 2 years and a minimum of 50 exposure days, or if 50 exposure days are
      not reached, for a maximum of 30 months and in accordance with the subject's usual pre-study
      treatment regimen. Subjects will continue treatment as above or until they develop inhibitors
      to Factor VIII at a titer greater than or equal to 5 Bethesda units (BU/ml); Factor VIII
      becomes ineffective at providing hemostasis, or the subject exhibits severe or serious
      adverse events that prevent completion of the study.
    

Intervention name(s): Alphanate SD/HT
Intervention type(s): Drug
Intervention description(s): Plasma-derived preparation of Factor VIII
Other intervention name(s): Anti-hemophilic (human) coagulation factor VIII
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia A; Plasma-derived treatment; Factor VIII; Inhibitor
Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The Norwegian Directorate of Health recently published the Norwegian food-based dietary
      guidelines (NFBDG) in 2011. The target for the NFBDG is the general population, and the main
      aims of these guidelines are to promote public health and prevent chronic degenerative
      diseases. Reaching the healthy population is crucial as only small proportion of the general
      population comply to the current public dietary advice in Norway. Thus, the objective of this
      study is to investigate whether a multi-faceted dietary intervention could increase
      compliance to the NFBDG and affect biomarkers of chronic degenerative diseases in a healthy
      population.
    

Detailed description: 
      The study was conducted as part of a master level course in Clinical Nutrition at the
      University of Oslo. Thus, the main objective of the study was to teach the master students
      about planning, conducting and analysing data from a clinical trial. The students themselves
      are subjects of the study, however the participation in the study was voluntary and did in no
      way affect the approval of the course.

      Since the primary objective of the study was teaching, the study was confirmed by the
      "Regional Committees for Medical and Health Research Ethics" (REC) to be exempt from REC
      approval.
    

Intervention name(s): NFBDG
Intervention type(s): Other
Intervention description(s): Intervention consists of:
Lecture presenting the NFBDG, Printed booklet containing the NFBDG, Suggested meal plan for a week, Recipes, Access to a restricted website with further information on the NFBDG, A Facebook-group where "Vegetable of the day" was presented with a suggested recipe, text-messages with encouragement to follow the guidelines, follow-up phone-calls, common exercise sessions, Free common meals (1 breakfast, 2 lunches, 1 dinner), Free foods (low-fat dairy products, a juice containing grapes, blueberries, chokeberries, and cherries and fruits)
Intervention model: Single Group Assignment
Masking: Single (Participant)
Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to
      subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea
      or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week
      randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received
      liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both
      combined with OAD treatment.
    


Intervention name(s): liraglutide; exenatide
Intervention type(s): Drug; Drug
Intervention description(s): 1.8 mg once daily for s.c. (under the skin) injection.; 10 mcg twice daily for s.c. (under the skin) injection.
Intervention MeSH terms: Liraglutide; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hepassocin Levels in Patients With Polycystic Ovary Syndrome
Condition: Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1); Polycystic Ovary Syndrome; Obesity; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Observational

Summary: 
      The investigators aimed to investigate hepassocin levels in patients with polycystic ovary
      syndrome (PCOS). There are 3 groups aged between 18 and 35 years as non-obese healthy women,
      non-obese women with PCOS, and obese women (BMI>30) with PCOS.
    

Detailed description: 
      Hepassocin, also known as Fibrinogen-like-protein or hepatocyte-derived fibrinogen-related
      protein 1, is a new marker for obesity and insulin resistance. In hepatic injury, it protects
      liver cells and promotes regeneration. High levels of hepassocin was shown to be
      independently associated with HOMA-IR and diabetes. Since insulin resistance is known to be
      seen in patients with PCOS, it may be expected that hepassocin levels may be higher in this
      group of patients.
    

Intervention name(s): hepassocin
Intervention type(s): Other
Intervention description(s): hepassocin levels in polycystic ovary syndrome
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 60 patients with PCOS aged between 18 and 35 and age matched 30 healthy women
        with BMI < 30 were enrolled to the study.
      
Biospecimen description: 
      Early follicular phase day 3 in case of menstruating and random day for amenorrheic patients
      was chosen for blood sampling after 8 hour of fasting. The blood samples were obtained from
      the antecubital vein via a vacutainer. Process of samples was achieved within maximum 1 hour
      and serum sample was stored in -80 for hepassocin work-up after 5 minutes of centrifuge.
Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to identify neural signatures, behavioral and phenomenological
      expressions of self-related processes including: sense of agency, semantic distinction
      between self and other, selflessness (altruism), social agency, embodied self
      (interoception), perceptual functioning of dissolved self including hallucinations and
      crossmodal processing, and finally the mystical type dissolution of the self.
    

Detailed description: 
      Four placebo-controlled, double blind sets of procedures using psilocybin with four
      independent study groups will be conducted. The number of subjects, testing procedures and
      dose of psilocybin for each group are as follows: group 1 (20 subjects, EEG, questionnaires,
      0.200 mg/Kg body weight), group 2 (30 subjects, functional magnetic resonance imaging (fMRI),
      questionnaires, 0.200 mg/Kg body weight), group 3 (10 subjects, fMRI, questionnaires, 0.215
      mg/Kg body weight), study group 4 (80 subjects, blood serum and saliva parameters,
      questionnaires, fMRI (only in 20 subjects from this group), 0.315 mg/Kg body weight). The
      groups 1, 2 and 3 involve healthy volunteers. The group 4 involves healthy volunteer
      long-term and short-term meditators during a 5-day group meditation retreat. Together, 140
      subjects will participate in the study.
    

Intervention name(s): Placebo; Psilocybine
Intervention type(s): Drug; Drug
Intervention description(s): 100% lactose; Study Group 1: 0.250 mg/Kg weight Study Group 2: 0.200 mg/Kg body weight Study Group 3: 0.215 mg/Kg body weight Study Group 4: 0.315 mg/Kg body weight
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Four independent study groups
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD
Condition: PTSD, Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to compare two slightly different methods of transcranial
      magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)
    

Detailed description: 
      This is a randomized single-blind pilot study investigating the efficacy of high-frequency
      repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral
      prefrontal cortex at either 10 Hz or 20 Hz as compared to a treatment as usual group for the
      treatment of Post Traumatic Stress Disorder (PTSD) symptoms.
    

Intervention name(s): 10 Hz rTMS of the right dorsolateral prefrontal cortex; 20 Hz rTMS of the right dorsolateral prefrontal cortex
Intervention type(s): Other; Other
Intervention description(s): Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex; Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD, Post Traumatic Stress Disorder
Asthma Surveillance and Education in Preschool Settings
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to test the effectiveness of a bilingual intervention in
      improving asthma care for low-income inner-city children enrolled in subsidized preschool
      childcare programs.
    

Detailed description: 
      BACKGROUND:

      Proposed is a non-randomized, controlled, prospective trial to test the efficacy of a
      bilingual intervention to improve asthma care for low-income inner-city children enrolled in
      subsidized preschool childcare programs. Because of high rates of asthma prevalence,
      subsidized preschool childcare programs offer ideal settings to test innovative strategies to
      improve asthma care within communities at highest risk of morbidity.

      DESIGN NARRATIVE:

      The study will comprise three arms. Arm 1 is surveillance, in which children with asthma are
      identified. In Arm 2, children with asthma are identified and given written Asthma Action
      Plans (monitoring). Arm 3 consists of surveillance, monitoring, and education.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We formed collaborative agreements with subsidized day care providers in three New York
        City communities with high asthma prevalence. These three communities - Harlem, the South
        Bronx and the Lower East Side - are economically disadvantaged communities of color.
        Participants were parents or guardians of children with asthma enrolled in subsidized day
        care center. 95% of participants were female, 64% were Hispanic, 25% were Black, 1% were
        White and 10% were Other. 70% were born in the continental USA, 70% spoke English as their
        primary language. 30% had earned less than a HS degree, 32% had received a HS diploma or a
        GED, 37% had attended som college, and 1% had completed college. 33% of participants had
        family incomes of less than $1,000 per month, 35% had incomes of $1,000 to $1,999 and 32%
        had incomes over $2,000.