bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Aromatherapy on the Incidence and Severity of Acute Pain
Condition: Venipuncture
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The purpose of this research was to estimate feasibility of an aromatherapy pain management
      intervention to reduce pain and distress caused by venipunctures in a pediatric population.
      The feasibility of the use of aromatherapy essential oil lavandula angustifolia for pain
      management intervention (Treatment Group) was compared to placebo aromatherapy with jojoba
      oil (Placebo Control Group) and to the current standard of care, which is no oil during a
      venipuncture (Standard of Care Control Group). Primary measured outcomes were assessed using
      a double-blind randomized design. The physiological measure of heart rate was taken over the
      course of four minutes at three different intervals to note the pattern of change that occurs
      during anticipatory anxiety resulting from the impending procedure, the procedural pain
      experienced during the venipuncture, and the residual fear common after completion of the
      venipuncture procedure. The Visual Analogue Scale (VAS) for pain and the Hospital Fears
      Rating Scale (HFRS) were administered to measure subjective pain and anxiety. Participants
      (N=21) were recruited from the Laboratory Medicine Unit of Children's National Health System.
      Feasibility was estimated based on the ability to inhale the full dose of oil without adverse
      effects and and ability to inhale the full dose within the ten-minute time frame. This study
      analyzed the effect of the aromatherapy pain management intervention, lavandula angustifolia
      aromatherapy, on the stress response of a pediatric population through observation of
      physiological and psychological indicators of pain and distress, in order to learn more about
      the pain and anxiety experienced during venipuncture and the use of aromatherapy to decrease
      pain and anxiety during venipuncture.
    


Intervention name(s): Lavender Aromatherapy; Jojoba Aromatherapy
Intervention type(s): Other; Other
Intervention description(s): 100% pure lavender aromatherapy was administered using person essential oil diffusor sachets, consisting of three drops of oil on a surgical sponge covered in a sealed plastic packet.; 100% pure jojoba aromatherapy was administered using person essential oil diffusor sachets, consisting of three drops of oil on a surgical sponge covered in a sealed plastic packet. This colorless, odorless oil was used as a placebo comparator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aromatherapy; pediatric; venipuncture; lavender; pain management
Role of Vitamin E in Gaucher Disease Patients
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      gaucher disease (GD) can be classified into three clinical types .type 1,the most common type
      ,is the chronic non neuronpathic form of the disease,which shows gighly variable signs and
      symptoms and variable course,with visceral,skeletal and hematologic involvement among
      others.the neurologocal involvement can be observed in types 2 and 3
    

Detailed description: 
      enzymatic defeciency in gaucher disease patients may induce a cascade of events that result
      in side effects, such as the production of reactive oxygen species(ROS) and reactive nitrogen
      species(RNS) that can then generate the oxidative stress whereas in body of healthy
      individuals,the production and degradation of ROS and RNS are generally balanced.

      neurochemical abnormalities in patients with gaucher disease might be related to oxidative
      stress and inflammation in the brain.

      oxidative stress induces peroxiredoxin-2 as cytoprotective response against RNS .it is able
      to detoxify a vast range of organic peroxides.

      vitamin E well accepted nature most effective lipid soluble chain breaking antioxidant .
    

Intervention name(s): Vitamin E
Intervention type(s): Drug
Intervention description(s): Vitamin E will be taken for 6 months for gaucher disease patients who have oxidative stress and vitamin E defecient
Other intervention name(s): No other alternatives
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis
Condition: Glucose Tolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial is designed to study the effects of rifampicin on the glucose, lipid and
      hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin lowers
      fasting glucose and enhances insulin sensitivity. The study is a randomized,
      placebo-controlled, open-label cross-over trial. Twelve subjects will be given 600 mg of
      rifampicin a day for a week compared to a one-week placebo arm. There is at least a 4-week
      wash-out between the arms. The main outcome measures are the changes in the fasting glucose
      and HOMA-IR-index (calculated based on fasting glucose and insulin).
    


Intervention name(s): Rifampicin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Rimapen, ATC J04AB02
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to determine wether autologous bone graft from iliac crest
      enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.
    

Detailed description: 
      Opening-Wedge High Tibial Osteotomy is a classic procedure,but the use of autologous bone
      graft from iliac crest causes pain and bleeding. Bone union occur even without bone graft,
      but no clinical trials compared results of the twoo procedures.
    

Intervention name(s): high tibial osteotomy; higi tibial osteotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): addition of bone graft to fill the osteotomy gap; the gap of the tibia is unfilled
Other intervention name(s): opening-wedge higi tibial osteotomy; opening-wedge higi tibial osteotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteotomy; knee; varus deformity; bone graft
Effectiveness of a Cognitive-functional (Cog-Fun) Intervention for Children With ADHD
Condition: ADHD
Study type: Observational

Summary: 
      Scientific Rationale: Many children with ADHD have serious difficulties in participation in
      daily occupations in their ecological settings. These difficulties have a pervasive negative
      impact on their everyday functioning and quality of life (QoL). Although pharmacological
      treatment has been proven effective in treating ADHD symptoms in many children, as have
      psychosocial interventions such as parent training, there is little evidence for integrative
      approaches that address the cognitive, volitional and social-environmental barriers to
      participation with this population. Although preliminary positive effects of a
      cognitive-function (Cog-Fun) treatment in occupational therapy on this population have been
      demonstrated, additional evidence is needed to confirm these initial findings. Methods:
      Initial results of our pilot study (N=17 children with ADHD) demonstrated significant
      moderate to large effects of Cog-Fun treatment, which targeted participation and executive
      functions in daily life. Significant effects were also found for a measure of self-efficacy
      and neuropsychological measures of attention, planning and organization. Parent ratings
      showed significant reduction of ADHD symptoms and improved QoL. The purpose of the current
      study is to replicate the pilot study findings in a randomized controlled trial. The study
      will be a randomized controlled trial with a crossover design, including 2 groups of children
      with ADHD attending elementary school and their parents. The research group (Group A, n=50)
      will receive three months of the Cog-Fun treatment, designed for a parent/child dyad and the
      control group (Group B, n=50) will be wait-listed and receive treatment after three months.
      Outcomes will include measures of participation, executive functions in daily life, child and
      parental self-efficacy, ADHD symptoms and QoL. The investigators expect to find a significant
      main effect of time (pre-post intervention), group (research vs. control) and a significant
      interaction effect (group x time) on executive and occupational outcome measures.
    


Intervention name(s): COG - FUN
Intervention type(s): Behavioral
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children age 7-10 years diagnosed with ADHD
      
Keywords: Age 7-10 years old; regular education system; no moderate or severe neurological and/or psychiatric disorders
Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
Condition: Chronic Kidney Failure; Renal Dialysis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Observational

Summary: 
      The purpose of this study is to assess health related quality of life and its predictors
      among chronic dialysis patients and to assess cognitive function using 3 different tests.

      (undergraduate medical student research project; not published)
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with end-stage renal disease and in active dialysis treatment in the Norwegian
        county of Sør-Trøndelag.
Continuous Treatment Study of Topiramate in Migraine Participants
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of topiramate in
      participants with migraine (type of severe headache that occurs periodically and is often
      associated with nausea, vomiting and constipation or diarrhea) who completed the
      JNS019-JPN-02 study.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multicenter
      (conducted in more than one center), dose-titration (dose escalation/reduction) study of
      topiramate in participants with migraine. This study is a continuous study for the
      participants who were enrolled in the JNS019-JPN-02 study. Participants who completed the
      JNS019-JPN-02 study will receive treatment for 52 weeks starting at Visit 4 of the
      JNS019-JPN-02 study. The present study will consist of 3 weeks of Transfer period (during
      this period the dose titration will take place and along with dose titration the new
      treatment will be initiated at 25 milligram per day [25mg/day]), Continuous treatment period
      (32 weeks), Exit period (up to 3 weeks) and Follow-up period (4 weeks). Participants in the
      Continuous treatment period will receive topiramate tablets orally in the dose range of 50
      mg/day to 100 mg/day. Dose can be increased or decreased as per Investigator's discretion.
      The maximum daily dose will be 200 mg/day. Efficacy will be primarily evaluated by change
      from Baseline in the number of monthly migraine attacks in Continuous treatment period.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.
Other intervention name(s): JNS019
Intervention MeSH terms: Topiramate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Topiramate
Comparative Efficacy and Safety of Fenoverine
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine
      maleate in the efficacy and safety.

      Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and
      safety.
    

Detailed description: 
      For subjects with IBS, Fenoverine and Trimebutine will be administered orally for 8 weeks;
      Fenoverine 100mg capsule three times a day and Trimebutine 150mg tablet three times a day.
      Because one is capsule and the other is tablet, double dummy design will be used. Efficacy is
      evaluated at the end of 8 weeks and safety will be followed for 4 more weeks after the end of
      the scheduled medication.
    

Intervention name(s): Fenoverine; Timebutine
Intervention type(s): Drug; Drug
Intervention description(s): Fenoverine 100mg three times a day for 8 weeks; Timebutine maleate 150mg three times a day for 8 weeks
Other intervention name(s): Fexadin; Polybutin
Intervention MeSH terms: Fenoverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fenoverine; Irritable Bowel Syndrome; Abdominal pain; BSS
Assessment of Hypotonia in Children With Down Syndrome
Condition: Muscle Hypotonia; Down Syndrome; Muscle, Floppy; CHILD Syndrome; Infant Floppy
MeSH terms: Down Syndrome; Muscle Hypotonia; Syndrome
Study type: Observational

Summary: 
      Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and
      delays in gaining basic motor skills. There are no screenings available to aid in early
      diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in
      children with Down syndrome.
    

Detailed description: 
      Hypotonia is usually diagnosed by observation and clinical assessment. Aiming to develop an
      instrument for early diagnosis, a systematic review was carried out which compiled
      characteristics and testing that are attributed to or used in the diagnosis of hypotonia.
      They were presented as an item group and a first stage was created and administered to 50
      children with Down's Syndrome between the ages of 7 months to 8 years old. The study of the
      results showed which characteristics were really related to the convention and which were
      more affected by changing factors. Then a final scale was developed that met the expected
      requirements of validity and reliability.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Down Syndrome
Philadelphia Preterm Prevention Project
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This is a randomized clinical trial in which all Philadelphia resident women experiencing a
      pre-term birth (PTB) at <34 weeks of gestation (GA) over an 18 month period will be
      approached at the time of the postpartum hospital stay. Consenting women will be randomized
      into a usual care group or an interconceptional intervention targeting five risk conditions,
      all of which increase systemic inflammation. Our primary objective in this study is to assess
      the efficacy of our interconceptional intervention on the rate of repeat PTB.
    

Detailed description: 
      This is a randomized clinical trial in which all Philadelphia resident women experiencing a
      pre-term birth (PTB) at <34 weeks of gestation (GA) over an 18 month period will be
      approached at the time of the postpartum hospital stay. Consenting women will be randomized
      into a usual care group or an interconceptional intervention targeting five risk conditions,
      all of which increase systemic inflammation. Our primary objective in this study is to assess
      the efficacy of our interconceptional intervention on the rate of repeat PTB.

      Participants will be randomized into one of two groups: usual care of interconceptional
      intervention. Those who are randomized into the interconceptional intervention group will be
      targeted for five risk conditions, including smoking, depression, infectious disease burden
      and maternal stress, and achieving an appropriate BMI. It is hoped that by reducing these
      seemingly disparate yet well-known risk conditions, we can reduce PTB and the subsequent
      race/ethnic disparities.
    

Intervention name(s): Psychological intervention; Usual Care Group
Intervention type(s): Other; Other
Intervention description(s): Subjects will be randomized into either usual care or interconceptional intervention groups. If the subject is randomized into the intervention group, she will receive targeted interventions to reduce one of several risk factors: smoking, depression, infectious disease burden and maternal stress, and achieving an appropriate BMI. A woman who is randomized to the intervention group may receive interventions on one, two, three, four, or five of the targeted intervention methods, depending on her needs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preterm birth; interconceptional intervention; pregnancy outcomes
The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial
Condition: Osteoarthritis, Knee; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Treatment options for individuals who have advanced knee osteoarthritis (OA) and a body mass
      index (BMI) ≥35 kg/m2 are limited, and this patient population may be neglected in current
      clinical care pathways for OA management. These individuals are considered to be at high risk
      for complications with total knee arthroplasty (TKA), and as a result may not be eligible for
      this procedure unless they lose significant weight. However, there is limited evidence for
      endorsing weight loss as beneficial prior to TKA. Further, unsupervised weight loss could put
      patients at risk for muscle loss and development of sarcopenic obesity, a health condition
      that negatively impacts mobility and mortality. This suggests that weight loss might not be
      the primary treatment goal for this patient population. Integrated non-surgical treatment
      approaches are needed that can target the specific needs of this knee OA patient group. This
      study will examine the feasibility and acceptability of a personalized, multicomponent
      intervention, and its effects on body composition and physical function compared to usual
      care.
    

Detailed description: 
      The primary objectives of the POMELO study are to determine if a multicomponent behavioural
      intervention that includes personalized nutrition recommendations, progressive resistance
      training exercise, and chronic disease self-management support is feasible and acceptable for
      individuals living with advanced knee OA and a BMI ≥35 kg/m2. The secondary objectives are to
      assess potential effects of the intervention on muscle mass and physical function compared to
      usual care. The intervention is delivered over three months, followed by six months of
      ongoing maintenance support. Assessments are completed at baseline, interim (after the 3
      month intervention phase), and at study end (after the 6 month maintenance phase) [for a
      total study period of 10 months]. This project will inform and influence the future
      development and implementation of more personalized knee OA treatment approaches for adults
      with a BMI ≥35 kg/m2 and reduce health disparities in access to effective care. Findings will
      also contribute to improved health outcomes for this vulnerable patient population, and
      enhanced delivery of health services by offering an alternative treatment pathway targeted to
      patient needs.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Targeted nutrition advice, progressive resistance training exercise, and self-management support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
SAD Study of APR002 Investigating the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics in Healthy Subjects
Condition: COVID-19
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics
      of single ascending doses of APR002 in healthy subjects.
    

Detailed description: 
      A Phase 1, Randomized, Blinded, Placebo-Controlled, First-in-Human, Single Ascending Dose
      Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APR002
      Administered by Inhalation in Healthy Volunteers
    

Intervention name(s): APR002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Investigational Product; Placebo
Other intervention name(s): TLR7 agonist; 0.9% Sodium Chloride; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
Condition: Osteoarthritis; Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study
      to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of iN1011-N17 after Oral
      Administration in Healthy Volunteers.
    


Intervention name(s): iN1011-N17; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This study will be conducted in approximately 104 healthy subjects in up to 13 sequential dose cohorts. Thirteen cohorts will consist of up to 8 subjects, including 2 subjects receiving placebo and 6 subjects receiving iN1011-N17.
Each subsequent cohort will continue to be randomized and dosed until maximum exposure is attained or a stopping criterion has been reached.; Matching Placebo for each formulations
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nav1.7 Inhibitor; Neuropathic pain; Postoperative pain; Chemotherapy-induced neuropathic pain; Nav 1.7; Pain