bioihbjkbjnl/mcl2 huggingface dataset:
Motivation and Barriers for Exercise in Patients With Anxiety or Posttraumatic Stress Disorder
Condition: Exercise; Motivation
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      Relevance and Aim: There has been increasing research interest in sport preferences and
      motivational factors as well as barriers that restrain from engaging in sport activities in
      people suffering from mental illnesses. Anxiety disorders are one of the leading mental
      disorders worldwide. Exercise has previously shown anxiolytic effects and is discussed as an
      adjunctive treatment option in clinical practice. This study aims to depict motivation and
      barriers in patients with anxiety or posttraumatic stress disorders.

      Design and Participants: Observational study of patients diagnosed with anxiety disorder or
      posttraumatic stress disorder (ICD-10)

      Measurements: Structured questionnaire compounded of validated scales for current physical
      activity, sport motivation, exercise preferences, perceived barriers , self-efficacy, social
      support for physical activity, motivation,enjoyment, quality of life as well as
      sociodemographic data.

      Duration: The questionnaire will require approximately 20 minutes, the overall duration is 3
      months. Personal assistance for completing the questionnaire will be provided if necessary.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients of outpatient department and inpatients of the Medical Hospital Innsbruck,
        Department of Psychiatry and Psychosomatic will be selected by clinical professionals
        according to inclusion and exclusion criteria.
      
Keywords: Anxiety; Posttraumatic Stress Disorder
Hemosonics- VCU Cardiac Surgery Clinical Study
Condition: Cardiopulmonary Bypass
Study type: Observational

Summary: 
      This study compares the results of current standard coagulation measurement devices to the
      Quantra System, a new device, using small amount of extra blood obtained during routine blood
      draws in cardiac surgery patients.
    

Detailed description: 
      HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole
      blood coagulation analysis and which is suitable for use in surgical and intensive care
      settings. The Quantra System employs a patented technology named sonorheometry, which was
      invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize
      the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot
      lysis. The initial assay performed on the Quantra System will be the surgical assay for
      monitoring hemostasis during major surgical procedures in adult patients.

      A clinical study will be conducted to evaluate the analytical performance as well as provide
      a preliminary evaluation of the performance comparability of the HemoSonics' device as
      compared to existing coagulation monitoring technology in heart surgery. This study will be
      performed at HemoSonics and the Virginia Commonwealth University Medical Center and will
      involve patients undergoing cardiac surgery requiring bypass.
    

Intervention name(s): Coagulation function
Intervention type(s): Device
Intervention description(s): Coagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device)
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants for this study will be recruited at the Virginia Commonwealth University
        Medical Center. The subject population will be representative of the local racial and
        ethnic population.
Increasing Hepatitis B Screening Among Korean Church Attendees
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to design an intervention to increase hepatitis B (HBV)
      screening among Korean Americans.

      The investigators will design a culturally specific intervention (educational sessions) and
      test the effect of the intervention on 1200 Korean Americans.

      All subjects will be interviewed before the intervention/control sessions and 6 months after
      the sessions to assess HBV screening levels in the two groups. Self-reported HBV screening
      will be verified by a review of subjects' medical records.

      The primary study hypothesis is that the intervention group will have a higher rate of HBV
      serologic testing at follow-up compared to the control group.
    

Detailed description: 
      The purpose of this study is to design an intervention to increase hepatitis B (HBV)
      screening among Korean Americans.

      The investigators will design a culturally specific intervention; an educational small group
      discussion led by a trained Korean leader. The effect of the intervention will be tested on
      1200 Korean Americans.

      Subjects will be recruited at Korean churches and invited to join a one-hour discussion of
      health issues with other members of their church. One half of the subjects will participate
      in the intervention group. These subjects will discuss HBV and will receive resources related
      to HBV and where to obtain screening. The other half of the subjects will participate in the
      control group. These subjects will discuss nutrition and physical activity and will receive
      resources related to these topics, but not related to HBV and where to obtain screening.

      All subjects will be interviewed before the sessions and 6 months after the sessions to
      assess HBV screening levels in the two groups. Self-reported HBV screening will be verified
      by a review of subjects' medical records.

      The primary study hypothesis is that the intervention group will have a higher rate of HBV
      serologic testing at follow-up compared to the control group.

      Secondary hypotheses are:

      The intervention group will have a higher level of knowledge of hepatitis B and liver cancer
      at follow-up compared to the control group.

      The effect of the intervention on hepatitis B serologic testing will be mediated by knowledge
      of hepatitis B and liver cancer.
    

Intervention name(s): Educational Small Group Session
Intervention type(s): Behavioral
Intervention description(s): 1 hour small group health-related discussion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Hepatitis B Screening; Korean Americans
Core Stabilization Training in Elite Athletes
Condition: Athlete
Study type: Interventional

Summary: 
      The studies in the literature have not sufficiently investigated the effects of core
      stabilization training on anaerobic performance. Therefore, this study was planned to
      comparatively investigate effects of progressive core stabilization training applied to elite
      athletes on anaerobic capacity, anaerobic performance, and fatigue.
    

Detailed description: 
      In taekwondo, weightlifting, badminton, and volleyball sports branches, strong relationships
      between sports performance, anaerobic strength and fatigue parameters have been also shown.
      It is clear of the necessity of developing anaerobic capacity using various exercises in
      these elite athletes. However, the studies conducted to date have not sufficiently
      investigated the effects of core stabilization training on anaerobic performance and fatigue
      with more objective methods and enough sample sizes. This study was planned to comparatively
      investigate effects of progressive core stabilization training applied to elite athletes on
      anaerobic capacity, anaerobic performance, and fatigue.
    

Intervention name(s): Progressive Core Stabilization Training; Standard Core Strengthening Exercises
Intervention type(s): Other; Other
Intervention description(s): The Progressive Core Stabilization Training was applied to study group as a group exercise with 5-10 athletes which was planned in the form of 3 days/week for a total of 9 weeks and 27 sessions. A session consisted of warm-up, core stabilization (30-40 min.), and cool-down exercises. During the training period, exercise volume, degree of difficulty, additional weight, and level of instability (contralateral limb movements and reduction of the support surface, etc.) for each exercise were incrementally increased in four steps.; The athletes included in the CG performed only Standard Core Strengthening Exercises which is the first phase of the Progressive Core Stabilization Training on fixed surfaces (i.e. without pads and balls, with a flat floor and a bench) for 3 days/week and totally 9-week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: athlete; weightlifting; volleyball; racquet sports; core stability
Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Condition: Cutaneous Malignant Melanoma
MeSH terms: Melanoma; Skin Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess whether vitamin D supplementation after surgery of a first cutaneous malignant
      melanoma protects against relapse of the disease.
    

Detailed description: 
      To assess whether vitamin D supplementation, in the follow up period after diagnosis and
      surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of
      cutaneous malignant melanoma and whether this protective effect correlates with vitamin D
      levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.
    

Intervention name(s): Vitamin D; arachides oleum raffinatum
Intervention type(s): Drug; Drug
Intervention description(s): prospective interventional randomized double blind placebo controlled trail
clinical setting (tertiary university hospital)
investigator driven, no pharmaceutical sponsor
cutaneous malignant melanoma patients
add- on study (placebo or vitamin D) on top of optimal standard care
1:1 inclusion ratio (placebo:Vitamin D)
randomisation after informed consent and screening
Other intervention name(s): D-Cure; Cholecalciferol; Placebo
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cutaneous malignant melanoma; Vitamin D; Cholecalciferol
Study of Assisted Hatching of Cleavage Stage Embryos
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study was to determine if assisted embryo hatching can improve pregnancy
      rates for good prognosis patients undergoing in vitro fertilization (IVF) with day 3 embryo
      transfer.
    

Detailed description: 
      Assisted hatching is a procedure in which a hole is made in the hard covering of a developing
      embryo to allow the embryo to hatch more easily from this shell. This procedure is sometimes
      used before transferring embryos to patients after in vitro fertilization (IVF) in an attempt
      to improve resulting pregnancy rates. Assisted hatching has been shown to improve outcomes
      among certain groups of patients, such as older patients or patients with a history of IVF
      treatment and embryo transfer without success. Whether this procedure could benefit the
      broader patient population remains unclear. The purpose of this study was to evaluate
      potential benefits of assisted hatching for good prognosis patients who would not typically
      be treated with assisted hatching under current standard protocols. Pregnancy rates were
      compared between good prognosis patients undergoing IVF with day-3 embryo transfer with or
      without assisted hatching of the transferred embryos.
    

Intervention name(s): Assisted embryo hatching
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Assisted Hatching; Cleavage Stage, Ovum; Embryo Transfer; Pregnancy; Embryo Implantation
AZD5672 Absolute Bioavailability Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to estimate the absolute bioavailability at steady state of 2
      doses of AZD5672 (50 mg and 150 mg administered orally once daily)
    


Intervention name(s): AZD5672; AZD5672; AZD5672
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period; 50 mg od, 12 days; 150mg od, 12 days
Intervention MeSH terms: N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: AZD5672
Fluoride Varnish For Childsmile Nursery School Attenders
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any
      further dental decay among 3-4 year old children in nursery schools.

      It is important to ascertain the additional preventive value that fluoride varnish may
      provide when applied in conjunction with other preventive measures which form part of a
      national dental health improvement programme targeting children at risk from dental decay.
      1600 children will be recruited into the study for 2 years.
    

Detailed description: 
      The objective of this study is to compare the effectiveness of Duraphat® fluoride varnish
      plus treatment as usual (TAU) with TAU only in preventing any further dental decay.

      Thus the study is a clinical trial of treatment as usual (TAU) versus TAU plus fluoride
      varnish in the nursery school setting. TAU is the core Childsmile Nursery intervention
      (supervised daily toothbrushing with fluoride toothpaste, free dental packs of fluoride
      toothpaste, toothbrushes and advice).

      Children will be screened by asking parents whether or not the child has previously been
      hospitalised with asthma or diagnosed with any allergies. Provided that a child has no
      contraindications to fluoride varnish then the child can proceed to study inclusion. On the
      day of the planned application, the dental nurse will carry out a risk assessment to reduce
      the possibility of children with oral/facial infections being included. After excluding
      non-eligible children, a baseline dental examination will take place, followed by
      randomisation into treatment as usual or treatment as usual plus fluoride varnish. This
      second group will receive up to four fluoride varnish applications at 6 month intervals.
      After two years, all study children will be offered a final dental examination.
    

Intervention name(s): Duraphat® Fluoride Varnish; treatment as usual
Intervention type(s): Drug; Behavioral
Intervention description(s): 0.25 ml per application will be painted on tooth surfaces by a Childsmile trained Extended Duties Dental Nurse, currently registered with the UK General Dental Council; includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.
Other intervention name(s): Duraphat® Fluoride Varnish (Colgate-Palmolive).
Intervention MeSH terms: Listerine; Fluorides; Fluorides, Topical; Sodium fluoride topical preparation; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dental; prevention; caries; oral; children
A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
Condition: Alzheimer's Disease; Huntington's Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the potential drug-drug interaction of Dimebon with the
      FDA-recommended CYP2C9 substrate warfarin in healthy subjects. Conformance with the guidance
      includes general study design using a randomized, open label, single-dose warfarin,
      steady-state Dimebon, 2-sequence, 2-treatment, 2-period crossover design with a minimum 7-day
      washout period between treatments.
    


Intervention name(s): Warfarin; Dimebon; Warfarin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A: a single oral dose of warfarin 25 mg administered on Day 1 of the relevant dosing period, as tablets.; B is oral doses of Dimebon 10 mg TID on Days 1 7 and Dimebon 20 mg TID on Days 8 17, with co administration of a single oral dose of warfarin 25 mg on Day 12 of the relevant dosing period, both as tablets; B is oral doses of Dimebon 10 mg TID on Days 1 7 and Dimebon 20 mg TID on Days 8 17, with co administration of a single oral dose of warfarin 25 mg on Day 12 of the relevant dosing period, both as tablets
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dimebon Warfarin Drug-Drug Interaction
Association Between Clinical Effect of Morphine With PCA After Surgery and Pharmacogenetics
Condition: Anesthesia; Surgery
Study type: Observational

Summary: 
      Identification of the genetic polymorphisms that could be correlated either with a better
      clinical response or with a major predisposition of patients to develop tolerance and/or side
      effects to the treatment with morphine.
    

Detailed description: 
      Valuation of the medium morphine dose (mg/kg/die) necessary to maintain NRS<4 in the first 24
      hours post-surgery in the two groups of patients, A e B. Group A: homozygous patients for the
      more frequent allele of the polymorphism A118G of OPRM1 gene (about 80%); group B: both
      homozygous and heterozygous patients for the less frequent allele (about 20%).

      In order to avoid the bias related to alterations in metabolism, patients with Cmax and AUC
      of morphine (and metabolites M6G and M3G) >2 standard deviation higher than expected
      population curve ("outliers") will be excluded for the primary purpose.
    

Intervention name(s): morphine chlorhydrate
Intervention type(s): Drug
Intervention description(s): The drug will be administrated by a bolus 45 minutes before the end of the surgery, with the following modalities: bolus with morphine chlorhydrate 0.15 mg/kg ± 20%. Also acetaminophene 1g and ketoprofen 160 mg (ketorolac 30mg) will be administrated during the operation.
At the exit of the operative compartment patients will have an electronic pump (PCA) for 48h with morphine chlorhydrate to be used in boluses by 1 mg with a lock out of 5 mins, max dose 20 mg in 4 hours.
Moreover, ketoprofen will be prescribed 160 mg x 2 per day (ketorolac 30mg x 2) (in case of allergy acetaminophene 1g x 3 daily).
Postoperative analgesic treatment is lasting 48h for each patient (between starting of the PCA infusion (T0) and the following 48h).
Other intervention name(s): morfina cloridrato
Intervention MeSH terms: Morphine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pazients scheduled for major abdominal or urological surgery with postoperative pain
        control by PCA morphine administration
      
Biospecimen description: 
      genes OPRM1, COMT, UGTs, ESR1
    
Keywords: systemic morphine analgesia; pharmacogenetics; pharmacokinetics
The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients
Condition: Major Depressive Disorder; Depression; Depressive Symptoms
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be an 8-week open-label pilot study examining subjective and objective
      changes in mood, anxiety, cognition, and sleep before and after the introduction of a
      probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10
      treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to
      examine the full composition of the micro biome, the investigators will also be collecting
      and analyzing fecal samples as well as blood samples to examine changes in plasma levels of
      inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms
      of any changes seen.
    


Intervention name(s): Probio'Stick
Intervention type(s): Dietary Supplement
Intervention description(s): A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Smart Walk: A Physical Activity Program for African American Women
Condition: Physical Activity
Study type: Interventional

Summary: 
      The purpose of this project is to test an 8-month, culturally relevant, Smartphone-delivered
      PA program to improve and maintain high physical levels and reduce cardiometabolic disease
      risk among obese AA women.
    

Detailed description: 
      A three-phase study will be used to refine and implement an established theory-based
      culturally relevant physical activity promotion intervention for obese African American
      women. Phase 1 (Aim 1a) will include formative research where 25 African American women
      provide feedback (via 9 focus groups) to further refine the physical activity intervention by
      specifying the deep structure cultural relevance of the theoretical mediators of
      self-regulation, self-efficacy, social support, behavioral capability, and outcome
      expectations.5 Phase 2 will focus on technical development of the refined culturally tailored
      intervention and 1-month demonstration trial of the Smartphone-delivered physical activity
      promotion program. Phase 3 (Aims 1b and 1c) will test the intervention and delivery strategy
      in a two-arm randomized trial where 60 sedentary, obese African American women will receive
      either the 8-month culturally relevant smartphone-delivered physical activity intervention or
      a 8-month wellness contact control condition
    

Intervention name(s): Physical Activity; Wellness
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A Smartphone delivered physical activity program; A Smartphone delivered wellness intervention focused on topics other than physical activity (e.g., skin care, oral health, and breast exams).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; overweight; obese; exercise; women; African American; Smartphone; cardiovascular disease risk