bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Plant-based Polar Lipids on Acute and Second Meal Glucose Tolerance and Appetite Sensations
Condition: Healthy Subjects; Diet Intervention
Study type: Interventional

Summary: 
      The overall goal of the project is to increase knowledge which can be used for the
      development of food products with anti-diabetic properties, with the purpose to facilitate
      healthier food choices for people. More specifically the primary purpose is to evaluate
      effects on cardiometabolic test markers of bioactive compounds in healthy humans. Previously
      the investigators reported beneficial effects of oat polar lipids on cardiometabolic risk
      markers. In this study the effects previously observed will be compared with cardiometabolic
      effects of another plant based lipid.
    


Intervention name(s): Non-polar lipids; No lipids; Polar lipids low; Polar lipids high
Intervention type(s): Other; Other; Dietary Supplement; Dietary Supplement
Intervention description(s): The shame comparator lipid intervention product contains no polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of lipids are15g, and the total amounts of available carbohydrates are 50 g.; The placebo comparator contains no added lipids. The product contains a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g.; The experimental intervention product contains 7,5 g plant based lipids polar lipids and 7.5 g plant based lipids non polarlipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. TThe total amounts of available carbohydrates are 50 g.; The experimental intervention product contains15 g plant based polar lipids. The lipids are mixed with a defined amount of glucose and a flavor enhancer and formulated as a spread. The topping is spread on a defined amount of white wheat bread. The total amounts of available carbohydrates are 50 g.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, controlled, crossover trial
Masking: Single (Participant)
Primary purpose: Prevention
A Prospective Study on Diabetes Management Through an Integrated Delivery System
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      1. To demonstrate a feasible hospital-based diabetic shared care model in Taiwan.

        2. To compare effectiveness of diabetes control between patients receiving case management
           provided by a health manager and patients receiving usual care.

        3. To determine the optimal level of glucose, blood pressure and lipids in control of
           diabetes in Taiwan.
    

Detailed description: 
      Five general hospitals, including both public and private, are chosen as regional
      coordinating centers in this project. Collaborating with community physicians, project
      coordinating-centers randomize diabetic patients, who have signed informed consent, into
      either intervention or control group. While two annual comprehensive lab tests are offered to
      the control group, an additional package of consultations and coordinating services provided
      by health managers is appended to the intervention group. Qualified health managers are
      cultivated in five selected medical institutes to support primary care physicians in managing
      diabetic patients. Responsibilities of health managers include tracking and updating enrolled
      patients' information, providing adequate and scheduled consultations, arranging specialty
      referrals for patients in needs, and transferring stable patients back to their original
      physicians. The feasibility phase of the project implementation will last for three years and
      it will be followed by a phase of full-scale implementation for another two years. Glycemic
      control as well as health status of participants will be the indicators to evaluate outcome
      of the project. At the same time, the periodic measurements on glucose, blood pressures,
      lipids and the incidence of complications will also be analyzed to set up an optimal target
      for diabetic control in Taiwan.
    

Intervention name(s): Health Education
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Diabetic shared care; Health manager; Prospective Study; Health Care Quality, Access, and Evaluation
Irritation and Sensitization Study of HP-5000 Topical System
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess skin irritation and sensitization for HP-5000 patch in healthy
      subjects.
    

Detailed description: 
      This is an evaluator-blinded, randomized phase 1 study evaluating skin irritation and
      sensitization of HP-5000 topical system in comparison to control patches. The study will
      consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist
      of the following periods: an Induction Period, a Rest Period followed by a Challenge Period
      and if needed, a Re-Challenge Period.
    

Intervention name(s): HP-5000 Topical Patch; HP-5000 Placebo Patch; Saline Patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HP-5000, placebo and saline will be administered simultaneously; HP-5000, placebo and saline will be administered simultaneously; HP-5000, placebo and saline will be administered simultaneously
Other intervention name(s): HP-5000 Patch; Placebo Control; Saline Control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Persistence of Autoantibody Neutralisation by BC 007 in Patients With Chronic HFrEF and Autoantibodies Against the Beta1-Adrenergic Receptor
Condition: Cardiomyopathy, Dilated; Heart Failure; Autoantibodies
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic heart failure (CHF) is one of the major causes of death in Western societies.
      Evidence has accumulated that functionally active autoantibodies directed against the beta1
      adrenergic receptor (β1 AAb) are of pathophysiological relevance for the development and
      progression of cardiomyopathy and associated CHF. BC 007 is under development for targeted
      neutralisation of autoantibodies directed against G protein coupled receptors, including β1
      AAb. This is an open label, three-centre, randomised phase 2a study in participants with
      chronic HFrEF. The study will evaluate whether BC 007 causes a persistent neutralisation of
      the β1 AAb demonstrated by a negative β1 AAb status up to 12 months. Participants will be
      randomised in a 2:1 ratio to the treatment arm (BC 007) or the control arm (untreated).
      Treatment is repeated once up to month 11 if the participant's β1 AAb were not neutralised
      after 1st dosing on day 1 or reoccur.
    

Detailed description: 
      Primary objective is:

      - To compare the efficacy of an intravenous (i.v.) infusion of BC 007 with an untreated
      control arm in removal of β1 AAb at month 12 in participants with chronic heart failure with
      reduced ejection fraction (HFrEF)

      Secondary objectives are:

        -  To evaluate the time to recurrence of β1 AAb after a single i.v. infusion of BC 007

        -  To evaluate the response rate and time to recurrence of β1 AAb after a repeated single
           i.v. infusion of BC 007 after the first recurrence of β1 AAb

        -  To evaluate the safety and tolerability of BC 007 after a single and a repeated single
           i.v. infusion

        -  To determine the pharmacokinetic (PK) plasma and urine profiles of BC 007

        -  To investigate the PK plasma profiles of BC 007 metabolites

        -  To investigate the β aminoisobutyric acid (β-AIBA) plasma and urine, and uric acid serum
           and urine concentration as a marker for BC 007 degradation

        -  To investigate the spontaneous conversion of β1 AAb status from positive to negative in
           untreated participants (control arm)

      Exploratory objective is:

      - To evaluate the change of the left ventricular ejection fraction (LVEF) after a single and
      a repeated single i.v. infusion
    

Intervention name(s): BC 007
Intervention type(s): Drug
Intervention description(s): 1350 mg of BC 007
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Nail fungus, often known as onychomycosis (OM), can attack either the toenails or the
      fingernails. Onychomycosis can affect the matrix, the nail bed, or the nail plate. Though not
      fatal, onychomycosis is a significant condition that can impede a person's mobility and
      ability to work. Onychomycosis's wide-ranging emotional and social impacts can have a serious
      negative impact on patients' well-being.

      White superficial onychomycosis (WSO), proximal subungual onychomycosis (PSO), endonyx
      onychomycosis (EO), and candidal onychomycosis are the most common subtypes of onychomycosis.
      A patient may exhibit characteristics from more than one of these categories. A severe case
      of onychomycosis, regardless of its subtype, is called total dystrophic onychomycosis.

      Different types of onychomycosis have different pathophysiology. The most frequent type of
      onychomycosis, known as distal lateral subungual onychomycosis, occurs when a fungus travels
      from the plantar skin to the nail bed through the hyponychium.

      These sections of the nail apparatus become inflamed, leading to the outward manifestations
      of distal lateral subungual onychomycosis. White superficial onychomycosis, on the other
      hand, is a less common presentation produced by invasion of the nail plate's surface. Fungi
      colonise the deep section of the proximal nail plate in the rare condition known as proximal
      subungual onychomycosis. When the fungi infect the nail through the skin and penetrate the
      nail plate, the result is known as endonyx onychomycosis, a subtype of distal lateral
      onychomycosis.

      Over and over again, terbinafine has been shown to be more effective than other antifungal
      medicines in clinical trials. Mycological cure rates for onychomycosis were 76% with
      terbinafine, 63% with pulse itraconazole, and 48% with fluconazole, according to a
      meta-analysis of 18 studies.

      The aim of this study is to determine the aim of this study is to compare pulse therapy with
      oral itraconazole versus continuous oral terbinafine for treatment of onychomycosis
    


Intervention name(s): itraconazole; terbinafine
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg two capsules of itraconazole were givev twice daily to 50 patients in group A for one week per month . baseline LFTs were also monitered; one 250 mg tablet of terbinafine were given once daily to 50 patients in group B for 12 weeks continously
Other intervention name(s): capsules icon; tablets terbesil
Intervention MeSH terms: Itraconazole; Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The purpose of this study is to examine the dose-response relationship of esketamine in
      combination with propofol for children with Autism Spectrum Disorder undering colonoscopy.
    

Detailed description: 
      Autistic children appear with significant frequency for medical services, lots of which
      requiring procedural sedation or anaesthesia. They have often been described as difficult to
      sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide
      safe and effective sedation during the colonoscopic procedure in autism children. Propofol
      sedation for endoscopic procedures is safe and acceptable for children, especially those who
      express significant anxiety. Propofol-based sedation turned out to be the most effective
      dosage regimens, with effectiveness comparable to general anesthesia. The addition of certain
      dose ketamine to propofol may increase the effectiveness without creating more adverse
      events.
    

Intervention name(s): Esketamine; Esketamine; Propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): esketamine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.; esketamine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.; propofol
Intervention MeSH terms: Propofol; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: colonoscopy; anaesthesia; autism spectrum disorder; propofol; esketamine
A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
Condition: Type2Diabetes
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy
      Volunteers Under Fed Conditions
    

Detailed description: 
      A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic
      profiles and safety of CKD-393(2) in healthy volunteers under fed conditions
    

Intervention name(s): CKD-393(2); CKD-501, D759, D150, D029
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of
      Ortho Tri-Cyclen® in healthy female subjects.
    


Intervention name(s): BMS-790052; Ortho Tri-Cyclen®
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 60 mg, once daily, 10 days; Tablets, Oral, once daily, 78 days
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Reliability and Validity of the Tampa Scale for Kinesiophobia
Condition: Hand Injuries; Forearm Injuries; Trauma
MeSH terms: Wounds and Injuries; Hand Injuries; Forearm Injuries; Kinesiophobia
Study type: Observational

Summary: 
      The aim of this study was to investigate the validity and reliability of the Tampa Scale for
      Kinesiophobia (TSK) in patients with traumatic hand and forearm injuries.

      A total of 170 patients with traumatic hand-forearm injuries with a mean age of 37.57±11.85
      (18-63) years were included in the study. TSK, Pain Catastrophizing Scale (PCS) and Beck
      Anxiety Inventory (BAI) were applied to the patients in the first session. Tampa Scale for
      Kinesiophobia was re-administered 15 days after the first session. Test-retest reliability,
      internal consistency, and construct validity of the TSK were evaluated. In addition,
      exploratory factor analysis was applied.
    


Intervention name(s): conducting questionnaires; assesment of the severity and pain
Intervention type(s): Other; Other
Intervention description(s): The patients were administered TSK, Pain Catastrophizing Scale (PCS), Beck Anxiety Inventory (BAI) by face to face interview technique.; The Modified Hand Injury Scoring System (MHISS) to determine the severity of the injury, and Visual Analog Scale (VAS) to evaluate perceived pain levels were used.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients between the ages of 18-65 who were referred to the hand rehabilitation unit
        due to traumatic hand and forearm injuries, those who did not have any neurological,
        orthopedic, rheumatological disease or surgery history in the relevant extremity and those
        who did not have communication problems were eligible to participate in the study.
      
Keywords: hand injuries; forearm injuries; kinesiophobia; psychometrics
Breath Volatile Organic Compounds Patterns of Lung Transplant Patients With Chronic Lung Allograft Dysfunction
Condition: Chronic Lung Allograft Dysfunction (CLAD)
Study type: Observational

Summary: 
      It's the aim of this study to clarify, whether the non-invasive assessment of breath can
      serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS
      can be discriminated by the level of certain VOCs than there would also be a potential to
      actually predict the development at an early stage and would enable an earlier intervention.
    


Intervention name(s): Collection of exhaled breath volatile organic compounds
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group of transplant patients with and without signs of BOS
Fibromyalgia in Men Suffering From PTSD
Condition: Fibromyalgia; Posttraumatic Stress Disorder; Major Depressive Disorder
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Depressive Disorder; Depressive Disorder, Major; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      Assessing FM and psychiatric state among PTSD, MDD and healthy participants
    


Time perspective: Retrospective
Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males.
Condition: Hypogonadal Males
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of
      testosterone in hypogonadal males.
    

Detailed description: 
      M12-778 is a rising multiple dose, randomized, double blind, placebo controlled single center
      study. It will have 5 dose groups of 20 subjects in dose groups 1,2 and 3 and 24 subjects in
      dose groups 4 and 5; a total of 84 subjects . There will be a 7 day period between dose
      groups 1,2 and 3 to assess the safety of increasing to the next dose. Dose groups of 4 and 5
      will be run in parallel. Subjects will be confined in center for 20 days for dose groups 1,2
      and 3 and 33 days for dose groups 4 and 5.
    

Intervention name(s): ABT-SLV361; placebo
Intervention type(s): Drug; Drug
Intervention description(s): For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.; For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: dose escalating
Echographic Measurement of Skin Thickness in Children
Condition: Skin Thickness
Study type: Observational

Summary: 
      To optimize a medical device for intradermal injection, knowledge concerning the thickness of
      epidermis and dermis at the proximal forearm is required. Since scientific knowledge is
      lacking, the investigators will examine the skin thickness (epidermis and dermis) of children
      (aged 8 weeks to 18 years) using imaging technology (High Frequency Ultrasound). The
      investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to
      a specific combination of parameters age, gender, and BMI.

      Based on these results, the investigators can define which needle type and length is needed
      to correctly perform injections into the dermal layer
    


Intervention name(s): Echographic measurement of skin thickness
Intervention type(s): Other
Intervention description(s): (Epi)Dermal thickness at the proximal forearm, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® & VEVO 3100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate.
The echographic measurement will be performed on the left and right deltoid and medial thigh region, and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants will be recruited in the vicinity of the university and its university
        hospital of Antwerp. Through primary and secundary school in Antwerp, children will be
        recruited after approval of their parents and via some Child and Family (Dutch: Kind&Gezin)
        facilities children aged 8 weeks to 3 years will recruited.

        All recruitement will be done from October 2015 until November 15th 2015.
      
Keywords: skin thickness; high-frequency ultrasound
Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      A feasibility controlled trial of an eight-session group intervention for siblings of
      children who have an Autism Spectrum Disorder (ASD).

      Children will be recruited from a multi-academy trust of nine schools. Due to the on-going
      impact of COVID-19 restrictions, children will be allocated to the intervention condition
      (eight session support group) if they are physically attending school and to the control
      condition (receipt of a booklet) if they remain at home. Pre and post outcome measures will
      be completed by children and their parents in both research arms.
    


Intervention name(s): Sibling support group; None - control condition
Intervention type(s): Other; Other
Intervention description(s): The intervention is a novel, 8 session sibling support group which has been created for the purpose of the study.; The second arm of the study is a control condition in which participants will be given a tailored booklet to complete at home as it was deemed unethical to provide them with nothing.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment