bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Mobile Application Intervention in Day Surgery
Condition: Pain; Fear; Stress; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      In Finland about 50% of surgical operations for all under 16 years of age are made as day
      surgery which means that the patient comes to the hospital and is discharged on the day of
      the operation. Day surgery will continue to grow in the next few years. Its benefits include
      shorter hospitalization, family reunion and rapid recovery. The preschool children and their
      parents who come in for day surgery feel fear, anxiety and stress, which depend on the amount
      of knowledge and its quality. By developing the preparation of preschool children and their
      parents for day surgery, and by testing new methods more attention can be paid to the special
      features of day surgery, supporting the families, and increasing family involvement in the
      whole process.

      The purpose of this study is to describe and evaluate the effectiveness of a new mobile
      application intervention compared to the effectiveness of the traditional preparing method
      when measuring preschool children's fear and pain and their parents' anxiety and stress. The
      aim is to produce new information and to develop day surgery of preschool children.

      The study consist of two phases. The first phase of the research is a systematic literature
      review and meta-analysis. The purpose of the review is to assess and describe the methods
      previously used in the preparation of parental day surgery and their effectiveness for
      preschool children fear and pain and parents' anxiety and stress. The second phase of the
      study is carried out as a randomized controlled trial (=RCT). The parents of the preschool
      children are randomized to the mobile application group (n = 50-60) and the control group (n
      = 50-60). The sample size is based on power-analysis, with anxiety as the primary outcome.
      The material for the second phase of the study is collected at the day surgery department of
      the Oulu University Hospital. The study group is prepared for day surgery with a new mobile
      application and the control group according to the traditional preparing method. The study
      examines the effectiveness of a new intervention compared to the effectiveness of the
      traditional preparing method when measuring preschool children's fear and pain and their
      parents' anxiety and stress. The collected data are analyzed using the Mann-Whitney, t-test,
      Khi square test, and Fisher's accurate test.
    


Intervention name(s): Mobile application; current practice
Intervention type(s): Other; Other
Intervention description(s): A mobile application that will be used to prepare families for day surgery; the current practice used to prepare families for day surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: None (Open Label)
Primary purpose: Other
A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The current study is designed to evaluate the safety and efficacy, including MRI imaging,
      across a range of VX-509 doses in subjects with active rheumatoid arthritis (RA) who have had
      an inadequate response to disease-modifying antirheumatic drugs (DMARDs).
    

Detailed description: 
      VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In
      autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This
      cascade ultimately contributes to abnormal immune response that results in chronic
      inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage
      and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the
      treatment of RA, and a broad range of other autoimmune diseases.
    

Intervention name(s): VX-509; VX-509 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg oral tablet; 0 mg oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
UVB Model Validation Study
Condition: Pain; Inflammation; Healthy Volunteers
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, subject and observer blinded, placebo controlled, cross-over study of the
      effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR)
      induced pain and inflammation in healthy volunteers conducted in two segments and using an
      intra-individual comparison of application areas.
    

Detailed description: 
      Single centre, subject and observer blinded, placebo controlled, cross-over study of the
      effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR)
      induced pain and inflammation in healthy volunteers conducted in two segments and using an
      intra-individual comparison of application areas.

      Subjects that signed the informed consent and are eligible to the study will be irradiated on
      the back to evaluate their individual minimal erythema doses (MEDs). Read out to determine
      MED will be done within 24 h after UVR.

      A training session (without study medication) using the MED definition areas will be
      performed in order to introduce subjects to the testing and rating procedures.

      Subjects will come in within 14 days of screening to start the first Segment of the study.
      Eligible subjects will be randomised to receive either:

        1. IB 600 mg, applied orally b.i.d., or

        2. OP, applied orally b.i.d.

      Allocation of topical treatment to these areas will be randomly assigned to:

        1. PG, 15 μl/cm2 applied topically b.i.d., or

        2. HC, 15 μl/cm2 applied topically b.i.d.

      Defined areas will be irradiated with defined dosages of UVR. Assessment of hyperalgesia to
      heat and signs of inflammation (erythema, skin temperature) for all areas will be performed.

      Subjects return within 4 to 11 days to the study site for the second segment of the study.
      Treatment allocation will be crossed-over and new treatment areas will be selected on the
      back.
    

Intervention name(s): Ibuprofen, Hydrocortisone; Hydrocortisone
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.; Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
Intervention MeSH terms: Ibuprofen; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: UVB; pain; inflammation; model; healthy volunteers; Ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers
Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and
      axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of
      Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.
    

Detailed description: 
      Introduction: Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of
      palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low
      doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

      Purpose: The objective of this study is to evaluate the effectiveness and patient
      satisfaction with the use of oxybutynin at low doses comparing to placebo for treating palmar
      hyperhidrosis.

      Methods: This is a prospective, randomized and controlled study. From December 2010 to
      february 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin
      or placebo. Data were collected from 50 patients, and 5 (10,0%) patients were lost to
      follow-up. During the first week, patients received 2.5 mg of oxybutynin once a day in the
      evening. From the 8th to the 42nd day, they received 2.5 mg twice a day, and from the 43rd
      day to the end of the 12th week, they received 5 mg twice a day. All of the patients
      underwent 2 evaluations: before and after (12 weeks) the oxybutynin treatment, using a
      clinical questionnaire; and a clinical protocol for quality of life (QOL).
    

Intervention name(s): Oxybutynin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg every 12 hours for 6 weeks; placebo twice a day for 42 days.
Intervention MeSH terms: Oxybutynin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hyperhidrosis; oxybutynin
Utilizing GI: Exploring an Optimum Glycaemic Profile for Cognitive Function Across the Day
Condition: Cognitive Performance; Glucose, Low Blood; Glucose, High Blood; Mood
Study type: Interventional

Summary: 
      This study provides participants with two diets that vary in their glycaemic index values
      (low vs. high), whilst also measuring cognitive performance and mood.
    

Detailed description: 
      Therefore, the current study introduces cognitive testing into study procedures. Participants
      will consume the favourable and unfavourable conditions (each containing three meals) on
      separate days following a crossover, randomised, couterbalanced design. The primary dependent
      variable is cognitive function, whilst secondary measures include glucose and mood. It is
      hypothesised that the favourable meal profile will be associated with cognitive and
      physiological benefits relative to the unfavourable meal profile.
    

Intervention name(s): Low Glycaemic Diet; High Glycaemic Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This intervention was a diet that provided participants with three meals with a low GI value. These meals were breakfast (9am), lunch (midday) and a snack (3pm).; This intervention was a diet that provided participants with three meals with a high GI value. These meals were breakfast (9am), lunch (midday) and a snack (3pm).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants took part in both conditions.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: cognition; glycaemic; mood; diet
Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
Condition: Infertility, Female; Endometrial Hyperplasia; PCOS
MeSH terms: Infertility; Infertility, Female; Endometrial Hyperplasia; Hyperplasia
Study type: Observational

Summary: 
      To assess the prevalence of endometrial hyperplasia (EH), endometrial intraepithelial
      neoplasia (EIN) and endometrial carcinoma between obese and not obese women undergoing IVF
      techniques for primary or secondary infertility.
    

Detailed description: 
      Endometrial cancer and pre-neoplastic diseases represent the most incident gynecologic
      malignant pathologies found in women.1 Although diagnosed in postmenopausal patients, it can
      be also found in younger patients, especially when associated with some risk factors. Those
      include weight gain and lifestyle habits, such as consumption of fatty foods that increase
      estrogen levels. The positive association be- tween infertility and EC is well established.
      Infertile women with irregular menstrual periods, oligomenorrhea, or chronic anovulation have
      a risk of developing

      A prospective cohort study conducted at "Fertility Center, OB/GYN Unit, Department of Woman,
      Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples,
      Italy".
    

Intervention name(s): in-office hysteroscopy
Intervention type(s): Procedure
Intervention description(s): in-office hysteroscopy with miniaturized instruments
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Southern Italian women eager for children who are set for infertility work-up at a tertiary
        university hospital
Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to test an adaptive adherence intervention, which utilizes two
      mobile health (mHealth) intervention designs, in an effort to promote adherence to
      antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth
      living with HIV (YLH) while increasing understanding of the context for wide-scale
      implementation of cell phone support (CPS) and text messaging support (SMS), with and without
      incentives.
    

Detailed description: 
      The study will consist of two points of randomization. The first step involves randomization
      of participants to receive either CPS or SMS using a 1:1 allocation ratio. Both intervention
      conditions will receive 3 months of intervention (i.e., 12 weeks of CPS or SMS).

      The second step involves a stratified randomization in blocks with 8 possible intervention
      trajectories. Within each condition, participants are categorized into two groups -
      responders with VL<200 (Rsp) and non-responders with VL ≥200 (NRsp). Responders in the CPS
      condition will be randomly assigned to receive either 3 months of CPS tapered (CPS-T)
      intervention followed by standard care (SC) or only SC. Similarly, responders in the
      SMScondition will be randomly assigned to receive either 3 months of SMS tapered (SMS-T)
      intervention followed by SC or only SC. Non-responders in both CPS and SMS conditions will be
      randomly assigned to receive either 3 months of incentivized CPS (CPS-I) followed by 3 months
      of CPS-T and 3 months of SC or 3 months of incentivized SMS (SMS-I) followed by 3 months of
      SMS-T and 3 months of SC.
    

Intervention name(s): CPS; SMS
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Assessment of participant's medication adherence and barrier problem solving via phone conversation; Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Multiple Assignment Randomized Trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Interventions; youth living with HIV; mHealth; ART adherence; adaptive intervention; cell phone; text messaging
A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      This study will aim to identify genetic, medical, dietary and environmental factors
      associated with the development of endometrioma and/or deep infiltrating endometriosis in
      order to move towards early diagnosis and implementation of potential preventative measures.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Women who have undergone a laparoscopy/laparatomy for a benign gynaecological indication
        excluding pregnancy in the last 3 months.
Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
Condition: Kidney Disease; Hypercalcemia
MeSH terms: Kidney Diseases; Hypercalcemia
Study type: Interventional

Summary: 
      Renal patients have an increased risk for cardiovascular complications. There is also
      increased vascular calcification and bone metabolism is similarly abnormal in patients with
      chronic kidney disease.

      In dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure
      those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering
      capacity in dialysis patients can be a mechanism for vascular calcifications.
    

Detailed description: 
      Study hypothesis.

      Patient with a higher ∆ Calcium (Calcium post - Calcium pre) have a diminished bone buffering
      capacity indicative for adynamic bone disease compared with patients with smaller ∆ Calcium.

      This may result in higher extraosseous calcification and higher pulse wave velocity

      ∆ PTH/∆ Calcium may reflect the sensitivity and density of the calcium receptors; this may
      reflect parathyroid "health"
    

Intervention name(s): high calcium dialysate
Intervention type(s): Procedure
Intervention MeSH terms: Dialysis Solutions; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: dialysis; vascular calcification; bone mineralism; arterial stiffness; bone metabolism; chronic kidney disease
Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic
      effects of accurate blood sugar results and education. A systematic approach in
      self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients.
      Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in
      a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9
      months.
    

Detailed description: 
      -  Written informed consent 130 patients with type 1 diabetes to be included

        -  age 18-70

        -  HbA1c of 8% or higher, variation in HbA1c over the last 18 months sholuld be <1,5%

        -  Treated with multiple insulin injections or insulin pumps

        -  Variation in weight less than 5kg within last year

        -  Using SMBG on a daily basis

        -  Mental capacity and stability to participate

        -  No hypoglycemia unawareness

        -  No likelihood that patient will drop out or not perform according to protocol

        -  Continious recruitment from the outpatient clinic at Stavanger University Hospital from
           October 2004-October 2005

        -  9 months follow-up

        -  Possible 12 month extension after initial

        -  Intervention group receives new SMBG instrument, education and advice on treatment
           changes at baseline, 1,2,3,6 and 9 months. Control group continues regular care
           following national guidelines of Norway. This includes visits usually every 3-6 months
           at the outpatient clinic and possibly with their GP in addition.
    

Intervention name(s): Use and interpretation of blood glucose results; Insulin dosing based on SMBG chart and education
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: HbA1c; Self-monitoring blood glucose (SMBG); Diabetes treatment; quality of care
Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast Induced-acute Kidney Injury
Condition: X-ray Contrast Media Adverse Reaction
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      Bioelectrical impedance analysis guided volume expansion for the prevention of contrast
      induced-acute kidney injury
    

Detailed description: 
      Compared bioelectrical impedance analysis guided hydration therapy versus standard hydration
      for the prevention of contrast induced-acute kidney injury
    

Intervention name(s): Bioimpedance guided; standard hydration
Intervention type(s): Other; Other
Intervention description(s): bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water
extracellular water/total body water < 0.36 : 4 ml/kg/hr
extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr
extracellular water/total body water > 0.4 : 1 ml/kg/hr; standard hydration : 7.5%Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: contrast induced acute kidney injury; bioimpedance
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
Condition: Antipsychotic-induced Weight Gain (AIWG)
MeSH terms: Weight Gain; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety and
      efficacy of miricorilant (CORT118335) in obese patients with schizophrenia treated with
      antipsychotic medications.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study that will assess the safety,
      efficacy, and pharmacokinetics (PK) of miricorilant in obese patients with schizophrenia who
      are currently taking olanzapine, risperidone, paliperidone, or quetiapine.

      Patients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to
      receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.
    

Intervention name(s): Miricorlilant; Miricorlilant; Miricorlilant
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Miricorilant 600mg for oral dosing; Miricorilant 900mg for oral dosing; Placebo for oral dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antipsychotic-induced weight gain (AIWG); Obesity; Weight Gain; Mental disorders; Schizophrenia; Risperidone; Paliperidone; Quetiapine; Olanzapine
MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The multiple dose study to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.
    


Intervention name(s): Placebo; MK-0941
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablets before every meal (q.a.c) Treatment period is 5 days.; MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment