bioihbjkbjnl/mcl2 huggingface dataset:
Skin Diseases and Pregnancy: Which Heathcare Professionals ?
Condition: Skin Abnormalities; Pregnancy
MeSH terms: Skin Abnormalities; Skin Diseases
Study type: Observational

Summary: 
      Pregnancy-induced physiological dermatological changes are common. In 2016, they represented
      between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological
      changes require medical advice to identify a possible pathological rash.

      These pathological rashes can be dangerous for the mother or the fetus.

      The aim of this study is to assess the prevalence of skin diseases during pregnancy and to
      evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?
    

Detailed description: 
      Pregnancy-induced physiological dermatological changes are common. In 2016, they represented
      between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological
      changes require medical advice to identify a possible pathological rash.

      These pathological rashes can be dangerous for the mother or the fetus. It is therefore
      essential to recognize them for a quick specialized treatment. They include: intrahepatic
      cholestasis of pregnancy, pemphigoid gestationis, polymorphic eruption during pregnancy,
      atopic eczema, generalized pustular psoriasis in pregnancy.

      In view of the demography of dermatologists in the Vendee, 18 dermatologists in 2020 in all
      establishments (hospitals, clinics, practices), the general practitioner is at the center of
      these considerations.

      The aim of this study is to assess the situation of skin disease during pregnancy and to
      evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?
    

Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): Self-questionnaire on skin diseases reported during pregnancy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective collection of data from a questionnaire answered by patients giving birth at
        the Departmental Hospital Center of Vendee during the postpartum period.
Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques
Condition: Catheterization; Peripheral Phlebotomy
Study type: Interventional
Phase: Phase 4

Summary: 
      Children fear having an intravenous (IV) needle placed because of the pain that they will
      experience. The more needle punctures that a child has to endure before the IV is
      successfully placed, the greater the pain experienced and anxiety suffered. In addition,
      false starts increase the demands on medical staff and can increase the length of the
      emergency department stay. Often, veins are difficult to see or feel, particularly in an
      unwell, dehydrated child or in young infants who have more fat below the skin surface. Also,
      the venous pattern below the skin surface naturally varies from person to person and
      therefore success in placing IVs leaves room for improvement. Technology may be able to play
      an important role is improving the rates of success. The investigators wish to investigate
      whether the use of either an Ultrasound machine or a VeinViewer machine can improve the rate
      of success of the initial attempt (skin puncture) at peripheral IV placement in comparison to
      the current standard approach.
    

Detailed description: 
      Peripheral IV line placement is one of the most common and challenging painful procedures
      performed in the pediatric emergency department (PED). The lack of a clear visual guide for
      IV placement often leads to multiple painful attempts; delays in urgent treatment; increased
      use of human resources; increased costs; and increased anxiety in the patient, the parents
      and the staff. The research plan is a randomized controlled trial (RCT) to compare the use of
      two new technologies with the current standard method for vein location and IV placement in
      children.We would like to know if either of these technologies improve rates of successful IV
      placement on first attempt. Furthermore we would like to know if either technology leads to
      decreased time spent by staff on the procedure or decreased overall number of painful
      attempts. Information on nursing satisfaction, parental satisfaction and cost analysis will
      also be obtained.
    

Intervention name(s): Veinviewer; Ultrasound; Conventional technique
Intervention type(s): Device; Device; Other
Intervention description(s): Veinviewer machine; Ultrasound; Conventional IV placement by nurses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Venipuncture; Randomized Controlled Trial; Intravenous access; Children; Pediatric Emergency Department; Peripheral intravenous catheterization; Catheterization, Peripheral Phlebotomy
Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      This study aims to evaluate the clinical efficacy and safety in obese patients with
      Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy.
    

Detailed description: 
      This study aims to evaluate the clinical efficacy and safety of laparoscopic sleeve
      gastrectomy in obese patients with Polycystic Ovary Syndrome（PCOS). About 100 obese patients
      with PCOS and 100 simple obese patients (without complications) were enrolled.

      All PCOS patients with obesity underwent LSG. A multidisciplinary team evaluated participants
      with obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics,
      Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic
      steatosis were measured baseline and postoperative.
    

Intervention name(s): Laparoscopic sleeve Gastrectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic sleeve Gastrectomy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; Laparoscopic sleeve gastrectomy; Obesity; menstrual cycle
Behavioural Economics-based Incentives in Adults With Type 2 Diabetes Pilot Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      A feasibility pilot study of a randomised control trial of adults newly diagnosed with type 2
      diabetes to compare the effectiveness of financial and social incentives on healthy lifestyle
      behaviour.
    

Detailed description: 
      This is a pilot study of testing the feasibility of the interventions being implemented in
      our main trial in local settings. Adults newly diagnosed with type 2 diabetes without
      receiving any anti-diabetic medication in Hong Kong are randomised to compare the
      effectiveness of financial and social incentives against a control group receiving standard
      care. The investigators follow participants for 9-months (6-month intervention period and a
      3-month post-intervention follow-up period) to assess glycemic control and other health
      indicators. Participants will be randomly assigned to one of two groups (in ratio 3:1): arm A
      (financial and social incentives in addition to standard care), and arm B (control arm
      receiving standard care). Financial incentives will be framed around loss aversion and the
      endowment effect. Social incentives will include peer competition, and social support.
      Financial and social incentives are to encourage increased physical activity and participants
      will use a pedometer to track activity. Participants are followed for an additional 3-months
      after the cessation of incentives to assess the sustainability of lifestyle changes.
    

Intervention name(s): Financial and social incentives
Intervention type(s): Behavioral
Intervention description(s): Participants will be credited with HK$1000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, participants will lose HK$40 for each subsequent week that they do not meet their personal weekly step target.
The social incentives are peer comparison and social support. Participants receive feedback of their physical activity performance by assessing whether they met or exceeded their step count target, followed by positive messages for encouragement. Nominated supporters will be informed of participants' performance for social support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different
      commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged
      10-17 years, determined by ELISA. Absence in significant variation for both parameters among
      the tested lots was hypothesized.
    

Detailed description: 
      At month 0, 1 and 6, 3 groups of 184 subjects received each 3 doses of herpes simplex vaccine
      lot A, B or C, respectively. The study took 14 months to complete, including screening, and 6
      visits were required. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Intervention name(s): GSK208141 vaccine
Intervention type(s): Biological
Intervention description(s): 3 IM doses
Other intervention name(s): Herpes simplex vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Adolescents; Immunogenicity; Safety; Herpes Simplex vaccine
Induced Gingivitis & Intra-oral Imaging
Condition: Plaque Induced Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Using an experimental, non-invasive intra-oral imaging device, this study evaluates the
      effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two
      weeks and gingivitis develops. The effects on the gingival tissue continues to be evaluated
      as oral hygiene is resumed and the gingival tissue returns to health.
    

Detailed description: 
      The study will include the following phases - 1) Hygiene phase of 2 weeks; 2) Gingivitis
      induction phase with stent lasting up to 2 weeks; and 3) Resolution phase of 2 weeks.

      The intervention will consist of cessation of oral hygiene versus an active control of oral
      hygiene with a fluoridated toothpaste. This study is a modification of classical experimental
      gingivitis model. The study will prospectively enroll subjects and assign a maxillary sextant
      to the intervention, while the other sextant will serve as control in a split-mouth design of
      localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model
      (SIBO). The intervention, i.e. oral hygiene cessation will manipulate the participants' oral
      environment by leading to reversible inflammation of the gingival tissues. The purpose of
      this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an
      innovative non-invasive microimaging technique, i.e. Optical coherence tomography (OCT).
    

Intervention name(s): Plaque induced gingivitis; Oral hygiene maintenance
Intervention type(s): Device; Device
Intervention description(s): Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.; Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
Other intervention name(s): Cessation of oral hygiene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth
Masking: None (Open Label)
Primary purpose: Diagnostic
Child STEPS for Youth Mental Health in Maine Sustainability
Condition: Anxiety; Depression; Trauma; Behavior Problems
MeSH terms: Depression; Problem Behavior
Study type: Interventional

Summary: 
      The overarching goal of this project is to study the sustainability of MATCH-ADTC within
      community mental health clinics, to learn what is needed for evidence-based practices (EBPs)
      to take root and thrive within a public system.
    

Detailed description: 
      In this project, the investigators are randomizing children to Wave 1 (previously MATCH
      trained) or Wave 2 (newly MATCH trained) and using a clinical monitoring system (TRAC) to
      measure youth outcomes over time. Participating therapists receive weekly MATCH consultation
      provided by the Judge Baker Children's Center/Harvard University research team or by Maine
      clinic supervisors who are MATCH Associate Consultants. The investigators are also developing
      and testing new low-cost measures of MATCH treatment and consultation fidelity to explore the
      feasibility of more sustainable measures of MATCH adherence. Study data will be used to
      answer questions about the sustainability of MATCH in the public sector.
    

Intervention name(s): MATCH-ADTC; TRAC
Intervention type(s): Behavioral; Other
Intervention description(s): MATCH - ADTC (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems; Chorpita & Weisz, 2009) is a psychosocial intervention designed to treat children with multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. It is recommended for children aged 6-15. MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.; TRAC (Treatment Response Assessment for Children) is a web-based system that provides weekly monitoring of the MATCH modules used and the child's response to treatment. Child's response to treatment is based on caregiver and child reports of (a) changes in problem severity on the standardized Brief Problem Checklist, and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, TRAC provides a complete record of modules used, and child treatment response, across all the weeks of treatment, as illustrated in the "client dashboard."
Other intervention name(s): MATCH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children; youth; adolescents; anxiety; depression; trauma; behavior problems; evidence-based treatments; manualized; cognitive-behavioral therapy; mental health
The Impact of Food on Blood Sugar in People With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study will record the impact of food on blood glucose levels using continuous glucose
      monitoring (CGM).

      The investigators think the impact will improve as medication doses are adjusted. The
      investigators also think that the impact will differ depending on the type of medication
      taken.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in Clinical Trials Study NCT01089569
      
Keywords: type 2 diabetes; metformin; glargine; exenatide; glycemic impact of food; continuous glucose monitoring
High-intensity Focused Ultrasound in Treatment of Uterine Fibroid
Condition: Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual
      bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the
      definitive treatment, some women prefer to have their uterus preserved. High-intensity
      focused ultrasound (HIFU) therapy is receiving increasing interest in the management of
      uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by
      various research groups have shown that HIFU treatment is safe, effective and is highly
      acceptable to patients. The main objective of this study is to evaluate the therapeutic
      efficacy of HIFU in the treatment of uterine fibroids.

      In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study
      inclusion criteria will be invited to participate in the study which involves the use of HIFU
      in the management of the fibroid. Background information of the patients such as age, body
      mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical
      disease will be collected. Subjects will also be asked to complete an eight-item section of a
      Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which evaluate the effect
      of the fibroid on the quality of life of women.
    


Intervention name(s): HIFU treatment
Intervention type(s): Procedure
Intervention description(s): High intensity focused ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uterine fibroid
Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery
Condition: Postoperative Ocular Pain After PRK Surgery
MeSH terms: Eye Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if SAF312 eye drops have an adequate safety and
      efficacy profile to justify further clinical development for the treatment of ocular pain
      associated with corneal epithelial defect such as after photorefractive keratectomy (PRK)
      surgery
    


Intervention name(s): SAF312; Placebo
Intervention type(s): Drug; Drug
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ocular pain; photorefractive keratectomy (PRK); SAF312; corneal epithelial defect
A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects
Condition: Alzheimer's Disease; Huntington's Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to characterize the pharmacokinetics of single and multiple oral doses of
      Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and
      tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The
      secondary objective of this study is to compare the pharmacokinetics, safety and tolerability
      of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.
    


Intervention name(s): Dimebon; Dimebon; Dimebon; Dimebon
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): dose escalation of single oral doses of 5, 10 and 20 mg; dose escalation of single oral doses of 5, 10 and 20 mg; 10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days; 10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dimebon, Japanese and Western population, pharmacokinetics
Fever Tracking Study
Condition: Core Body Temperature in Healthy Subjects; Immune Response to mRNA COVID-19 Vaccination
MeSH terms: COVID-19; Fever
Study type: Observational

Summary: 
      The aim of this study is to investigate the feasibility of continuous fever tracking of
      participants having fever symptoms in a home setting, using a core body temperature (CBT)
      sensor. CBT as measured by the wearable sensors will be coampared with CBT as measured by
      ingestible electronc pills (reference).

      A secondary research question is, if the CBT behavior of the the participants in a home
      setting can be compared to previously described CBT profiles in the literature, and if
      special patterns can be identified.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects testing for COVID-19 at the University Hospital Basel and having acute fever
        symptoms, or individuals receiving the second shot or the booster of an mRNA COVID 19
        vaccination, will be informed about the possibility to participate in this study by study
        personnel on-site.
      
Keywords: Fever Tracking; Core body temperature CBT; mRNA COVID-19 vaccination; Wearable sensors; Wearables
Domiciliary Physiotherapy During Breast Cancer Radiation
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Background: Breast cancer is the most common type of cancer among women. Its treatment,
      including radiotherapy (RT), can cause potential complications to be treated by the
      physiotherapy. Objective: To evaluate the effect of domiciliary physiotherapy on the upper
      limb applied during the period of radiotherapy in women submitted to surgical and
      radiotherapy for breast cancer. Study design: This is a prospective randomized controlled
      clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March
      2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after the
      end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm
      circumference. They were divided into two groups: CG) control group, submitted only to the
      assessments and SG) study group, submitted to domiciliary physiotherapy.
    


Intervention name(s): Domiciliary exercises for the upper limbs
Intervention type(s): Other
Intervention description(s): Study group (SG) instructed to perform domiciliary exercises for the upper limbs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer; physiotherapy; radiotherapy