bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, crossover, randomized-controlled, dispensing clinical trial. A total
      of approximately 70 myopic eligible subjects will be targeted to complete the study.
    


Intervention name(s): JJVC Investigational Multifocal Contact Lens (senofilcon A c3); Dailies Total 1® Multifocal Contact Lens
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Peg interferon and ribavirin currently represent the standard approved association for
      treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is
      expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50
      % of the patients remain relapsers or virological non responders. The main predictive factors
      of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological
      properties, particularly those of ribavirin requires complementary studies. This drug has a
      large distribution volume and its concentrations display large inter-individual variability.
      Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on
      BW and a single ribavirin time point serum concentration at steady state.

      The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of
      ribavirin in hepatitis C patient
    

Detailed description: 
      The study is conducted in naive patients infected with genotype non 2 non 3 administered
      peginterferon alpha 2-a (40KD) weekly, and ribavirin with dose adjusted on BW (< 75 kg 1000
      mg/day, >75 kg 1200 mg/day) for the first three months with adjunction of amantadine 200 mg
      daily for the following 9 months.

      Plasma concentration profiles of ribavirin were studied after the first dose (D0) and at W12.
      At each period, blood samples were collected pre-dose and 30 minutes, 1, 1.5, 2, 3, 4, 6, 8,
      and 10 hours post-dosing. Ribavirin concentrations were measured using liquid
      chromatography-tandem mass spectrometry and ribavirin area under the concentration-timcurves
      (AUC0-10h) were derived from plasma concentrations profiles using the linear trapezoidal
      rule.

      Virological follow-up was performed at W2, W4, W6, W8, W12, W24 and W72. Early virological
      response was defined by undetectable viral load at W12.
    

Intervention name(s): Ribavirine
Intervention type(s): Drug
Intervention MeSH terms: Ribavirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug monitoring; ribavirin-pharmacokinetic; pharmacodynamics; chronic hepatitis C; non 2 non 3 genotype
The Evaluation of Cow's Milk Formula - Study B
Condition: Healthy Term Infants
Study type: Interventional

Summary: 
      A study to evaluate the growth and development of term infants fed either a marketed cow's
      milk formula, or an experimental cow's milk formula with prebiotics + a different calcium
      source + a different level of fatty acids and fat, or an experimental cow's milk formula with
      prebiotic + a different calcium source + a different level of fatty acids and fat
    


Intervention name(s): Infant formula; Infant formula; Cow's milk infant formula
Intervention type(s): Other; Other; Other
Intervention description(s): Marketed cow's milk base infant formula 20 kcal/oz; cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source; Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
Other intervention name(s): Similar to Enfamil LIPIL with iron; No other similar brand names; experimental formula; No other similar brand names; experimental product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Term; Infant; Formula
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias; Dyssomnias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to establish the efficacy and safety of Circadin in children
      with neurodevelopmental disorders and to determine the dose, this randomized,
      placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week
      treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and
      additional parameters in children with neurodevelopmental disabilities. The efficacy and
      safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period
      of 13 weeks.
    


Intervention name(s): Circadin 2/5/10 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active arm
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleep disturbance; Circadian; Prolong release melatonin; Autism Spectrum Disorder; Smith-Magenis Syndrome; Angelman Syndrome; tuberous sclerosis
Adjuvant Acupuncture for Severe Head Injury
Condition: Head Injury
MeSH terms: Craniocerebral Trauma; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine the therapeutic effect of acupuncture on severe
      head injury under conventional treatment. A double-blind clinical trial is conducted up to 6
      weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.
    

Detailed description: 
      Objective: To investigate the therapeutic effect of acupuncture on severe head injury under
      conventional treatment.

      Methods: 90 subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8
      or less) are randomly divided into acupuncture, laser acupuncture and control group. We use
      restoring consciousness acupuncture (GV26 and 12 Well points) to treat the subjects 3
      sessions per week under conventional treatment at Department of Neurosurgery. A double-blind
      clinical trial is conducted up to 6 weeks and the change of subjects' GCS and muscle power is
      measured.
    

Intervention name(s): acupuncture; laser acupuncture; control
Intervention type(s): Other; Other; Other
Intervention description(s): acupuncture on GV26 and 12 Well points; laser acupuncture on GV26 and 12 Well points; sham laser acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; laser acupuncture; traumatic brain injury
Determining the Effects of an Evidence-Based Practice Education Intervention Program Applied to Nursing Students
Condition: Evidence-Based Practice
Study type: Interventional

Summary: 
      It was planned to evaluate the effectiveness of the evidence-based practice education
      intervention program in 3rd year students of the Faculty of Nursing on their knowledge,
      attitude, behavior and future use of evidence-based practice, and their awareness and
      attitudes towards research and developments.

      The study was parallel group (experimental-control), randomized controlled experimental
      design with pretest-posttest design.

      It was carried out in 3rd year students of nursing department of Selçuk University Faculty of
      Nursing in Konya province.

      Study data were collected from 108 students between February 2023 and June 2023. Nursing
      students in the intervention (n = 54) and control groups (n = 54) were determined by
      randomization method.
    

Detailed description: 
      A total of 12 hours of Evidence-Based Education intervention was applied to students in the
      intervention group, spread over 7 sessions. The educational intervention was created in line
      with the literature. No application was given to the students in the control group. Data were
      collected using the Students' Knowledge, Attitudes and Behavior Towards Evidence-Based
      Nursing Scale and the Nursing Students' Awareness and Attitudes Towards Research and
      Developments in Nursing Scale.

      Paired Sample T test and Wilcoxon test will be used in pre-test and post-test comparisons.
      Mann Whitney U, Kruskal Wallis, One Way Anova test will be applied to determine the
      difference between groups. Statistical significance level was accepted as p˂0.05.
    

Intervention name(s): Evidence-Based Education intervention
Intervention type(s): Other
Intervention description(s): A total of 12 hours of Evidence-Based Education intervention was applied to students in the intervention group, spread over 7 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel group (experimental-control)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Evidence; Nursing Student; Evidence-Based Education
Contingency Management to Promote Weight Loss in Low Income Adults
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the feasibility and provide preliminary evidence for
      efficacy of a 12-week contingency management intervention to promote weight loss in
      overweight and obese low income adults in a community-based clinic. The study has three
      primary goals: (a) to determine if the contingency management treatment can be effectively
      applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency
      management's efficacy in promoting weight loss and improving treatment retention, diet
      quality, physical activity levels, and self efficacy; and (c) to identify barriers and
      challenges to implementing contingency management for weight loss among low income patients.
    


Intervention name(s): contingency management; weight loss manual-guided individual therapy sessions
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Prize-based contingency management for weight loss; once weekly counseling session with research staff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Contingency Management
The Effect of Green Tea and Vitamin C on Skin Health
Condition: Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      There is little information on the effect of oral bioactive compounds on human skin
      clinically despite evidence of a beneficial effect from laboratory studies. The aim of this
      study is to examine the effect of oral bioactive compounds (green tea and vitamin C) on the
      health of human skin by measuring markers of skin health directly and skin nutrient uptake.
    

Detailed description: 
      There is little information on the effect of oral catechin, a nutritionally relevant
      bioactive compound, on skin health in humans in vivo despite considerable evidence for
      protective effects in experimental studies. Vitamin C is essential for skin health and
      stabilises catechins in the gut lumen. Ultraviolet radiation (UVR) in sunlight is a key
      environmental stressor impacting on skin health. Effects include acute inflammation and
      longer term photodamage.

      OBJECTIVE: To examine the protective effect of catechin and vitamin C on UVR-induced
      inflammation.

      STUDY DESIGN

      (1) A double-blind randomised controlled nutritional study in 50 healthy volunteers.
      Volunteers will receive 3 months dietary supplement with high dose bioactive (n=25),or
      placebo (n=25).

      The aim is to quantify the influence of catechin/vitamin C on:

        1. UVR-induced inflammation

        2. Leukocyte infiltration

        3. Inflammatory mediators

        4. Markers of photoageing

        5. DNA damage

        6. Bioavailability will also be assessed

      (2) Bioavailability of catechin and vitamin C in skin and blood. Volunteers will receive
      active dietary supplement. Blood and urine samples will be taken over a period of 6 hours to
      determine blood bioavailability. Skin biopsies will also be taken to assess skin
      bioavailability. Volunteers will then receive 3 months of active dietary supplement followed
      by repeated sampling.
    

Intervention name(s): Green tea + vitamin C high dose; Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months; One capsule daily for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Green tea; Vitamin C; Ultraviolet radiation; Inflammation; Photoageing
Implementation of Transdx Group for POTS
Condition: Dysautonomia; Anxiety; Depression
MeSH terms: Primary Dysautonomias; Autonomic Nervous System Diseases
Study type: Interventional

Summary: 
      The proposed intervention is focused on developing and implementing a psychological approach
      incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction.
      The investigators hypothesize that their intervention will result in improvements in the
      transdiagnostic mechanisms specifically targeted by components of their intervention
      including sleep, information processing, and youth/parent experiential avoidance.
    


Intervention name(s): Transdiagnostic Group-Based Treatment
Intervention type(s): Behavioral
Intervention description(s): 10 week 90-minute weekly therapy sessions including both the adolescent and caregiver. Treatment will consist of psychoeducation about dysautonomia, motivational interviewing techniques to promote readiness for change, support around lifestyle and behavioral changes, core CBT components (e.g., relaxation training, linking thoughts, feelings, and behaviors, minimizing catastrophizing thoughts, cognitive coping, and exposure), and components of ACT aiming to increase cognitive flexibility (e.g., mindfulness, experiential avoidance, values, cognitive defusion, committed action), and relapse prevention and maintenance. Most sessions will involve homework assigned to the adolescent and their parent/legal guardian(s) to encourage practice at home.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transdiagnostic; POTS (Postural Orthostatic Tachycardia Syndrome); Therapy
Intrabone Infusion of Umbilical Cord Blood Stem Cells
Condition: Hematopoietic Stem Cell Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the method of intrabone infusion of hematologic
      stem cells can increase and accelerate hematopoietic reconstitution after umbilical cord
      blood transplantation in pediatric patients.
    

Detailed description: 
      Umbilical cord blood transplantation (UCBT) has been increasingly used to treat malignant and
      non-malignant haematological, immunodeficiency and some metabolic diseases. UCBT offers the
      advantages of easy procurement, no risk to donors, a reduced risk of transmitting infections,
      immediate availability of cryopreserved units, and acceptable partial HLA mismatches.
      However, patients treated with UCBT show delayed hematopoietic and immunological recoveries,
      have higher rates of infection, and relapse from the original malignant disease, which can
      all lead to life threatening problems. UCBT can also result in a higher rate of graft failure
      compared to other hematopoietic stem cell transplantation (HSCT) sources. The problem of a
      slower hematopoietic recovery post-UCBT has been addressed using a number of different
      approaches in adult patients.In adults, use of intrabone injection of cord blood results in a
      faster hematopoietic recovery in a phase II study. However, there is no clinical trial in
      pediatric patients.

      This study is addressed to determine if a change in the cord blood stem cell infusion method
      can increase and accelerate hematopoietic reconstitution after UCBT in pediatric patients.
    

Intervention name(s): Intrabone infusion of umbilical cord blood stem cells
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematopoietic stem cells; Umbilical cord blood transplantation; Intrabone infusion; Platelet recovery; Neutrophil recovery; Pediatric patients
Short Term Effects of Anodal Cerebellar vs Anodal Cerebral Transcranial Direct Current Stimulation in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To compare the effect of anodal cerebellar Transcranial Direct Current Stimulation (tDCS) vs
      anodal cerebral tDCS on balance, mobility and cognition in stroke patients in stroke patients
    


Intervention name(s): Anodal tDCS cerebellar stimulation group; Anodal tDCS cerebral (M1) stimulation group; Sham Group
Intervention type(s): Other; Other; Other
Intervention description(s): three-session ctDCS (2 mA, 20 min). The active (anode) and the returning (cathode) electrodes will be placed bilaterally over the cerebellum (1 -2 cm below inion of occipital bone) and the right buccinator muscle, respectively xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.; three-session a-tDCS (2 mA, 20 min), the anode will be positioned over the lesioned M1 (C3, International 10-20 system) and the cathode would be located over the supraorbital area. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.; three-session a-tDCS (2 mA, 20 min), Sham tDCS followed a similar protocol as Anodal tDCS cerebral (M1) stimulation and arrangement but stimulation for 30 s, after which the current was ramped-down and turned off for the rest of the treatment. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anodal Cerebral; Anodal Cerebellar
Treating the Partners of Drug Using Pregnant Women: Stage II
Condition: Drug Addiction
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a two group randomized design that will compare a novel therapy package (i.e.,
      Research supported treatment intervention, Contingency-based voucher incentives for the male
      partner's drug abstinence, Specialized MI couples counseling) to standard care for helping
      drug using partners of drug dependent pregnant women obtain and maintain drug abstinence.
      Participants will be followed for 22 weeks and have scheduled twice weekly urine sample
      collection and all participants will have follow-up interviews post-study entry.
    


Intervention name(s): Enhanced care; control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): this group received counseling, contingency management and methadone or detoxification; this group receives the opportunity to participate in a support group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: male; female; couple; cocaine; opiate; methadone; detoxification; pregnancy
Anxiety Symptoms in Relation to Use of Hemp-derived, Full Spectrum Cannabidiol (CBD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Generalized anxiety disorder affects about 6.8 million adults in the United States, therefore
      its treatment is of major public health interest. Cannabidiol (CBD) has shown promise as an
      effective treatment for anxiety-related symptoms while lacking the severity of adverse
      effects seen with other medications. Given the wide availability of products containing CBD
      on the market today, from tinctures to coffee additives, and the undetermined potential for
      drug-to-drug interactions, medical supervision of CBD intake and formulation-specific
      clinical research is necessary. Therefore this study aimed to observe the effects of a
      specific hemp-derived full spectrum CBD formula on anxiety-related symptoms in a group of
      volunteers. The investigators will examine the self-reported anxiety symptoms in relation to
      use of a specific CBD formulation (25mg solvent-free full spectrum CBD capsules) in a cohort
      of adults diagnosed with generalized anxiety disorder. This open-label, cohort study will be
      conducted at six clinic sites in the United States (including Puerto Rico) from June 2020
      through October 2020. The six physicians recruited to participate in the study were each
      actively prescribing CBD in their practices and were actively caring for patients with
      anxiety symptoms. Anxiety levels will be measured in enrolled participants diagnosed with
      generalized anxiety disorder each week for a period of eight weeks using the Generalized
      Anxiety Disorder 7-Item Scale (GAD7). Participants will also be instructed to take a daily
      25mg capsule of CBD. The investigators hypothesize that this formula, when carefully
      developed and administered by a healthcare professional, will significantly reduce anxiety
      symptoms.
    


Intervention name(s): Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules
Intervention type(s): Dietary Supplement
Intervention description(s): Formula30A Full Spectrum Hemp-Derived Cannabidiol (CBD) 25mg Capsules taken once daily for 8 weeks.
Intervention MeSH terms: Cannabidiol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study conducted at six clinic sites in the United States, primarily Texas and Puerto Rico,
        from June 2020 through October 2020. Patients with a varying range of anxiety symptoms, who
        are current patients of the participating clinics and are who diagnosed with generalized
        anxiety disorder, will be eligible to enroll in the study.
      
Keywords: cannabidiol; endocannabinoid system; CBD; cannabis; anxiety; generalized anxiety disorder; cannabinoids; endocannabinoids; GAD7