bioihbjkbjnl/mcl2 huggingface dataset:
VR for Preoperative Anxiety in Children
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      All of the tools currently available for preoperative preparation of children either use a
      third person approach (i.e., use media whereby they watch a video or look at pictures of
      another child receiving an anesthetic), provide tours at some time previous to the operation
      date, or are shown the equipment that they will encounter during their anesthetic. No
      preoperative programme currently allows the child to experience the entire chain of events
      from leaving the preoperative preparation area (and their parents), walking to the operating
      area, being initially prepared for and receiving anesthesia and recovering from anesthesia,
      in real time and from a first person perspective. As such the investigators are carrying out
      this study to assess whether virtual reality preoperative preparation is effective in
      reducing anxiety at induction of anesthesia.
    

Detailed description: 
      The investigators' goal in this study is to investigate the effects of virtual reality
      preoperative preparation on anxiety in children at induction of anesthesia. The hypothesis is
      that utilisation of this novel 1st person immersive preparatory method will lead to an
      enhanced understanding of what will happen to the child (in addition to what the environment
      looks and sounds like) when they have their anesthetic. The investigators believe this
      enhanced understanding and preparation will lead to the reduction in anxiety levels before
      and during the induction of anesthesia, and will also lead to a reduction in postoperative
      negative behaviour disorders.
    

Intervention name(s): slideshow; virtual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be shown a slideshow showing a child being prepared for surgery; Participants will be shown an immersive virtual reality preparation for surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Pain and Convalescence After Laparoscopic Groin Hernia Repair
Condition: Inguinal Hernia; Convalescence
MeSH terms: Hernia; Hernia, Inguinal; Convalescence
Study type: Observational

Summary: 
      The investigators want to identify limiting factors for short convalescence after
      laparoscopic groin hernia repair. Before the operation patients are given intensive
      structured information about one day´s convalescence. Patients fill out questionnaire before
      operation about several clinically relevant parameters. This is also done first 3 days after
      operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and
      6 months.
    


Intervention name(s): Information
Intervention type(s): Behavioral
Intervention description(s): Information on short convalescence (1 day). Example: Operated today and getting started with normal activities again tomorrow.
Other intervention name(s): Groin hernia repair; TAPP; Convalescence
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The population are from Region Sjaelland and are planned for laparoscopic inguinal or
        femoral herniorrhaphy. Single university hospital department i Denmark.
      
Keywords: convalescence; pain; nausea; vomiting; sexual dysfunction
Period Tracker at Home Study
Condition: Menstrual Cycles
Study type: Observational

Summary: 
      This study will assess the usability of a Period Tracker product when used by lay users in
      their own homes.
    


Intervention name(s): LH Urine Test
Intervention type(s): Device
Intervention description(s): Test for the qualitative measurement of LH in urine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between the ages of 18 to 45 represent the intended user of the product
Angiotensin II Pathway and Postoperative Hypoxemia
Condition: Aortic Dissection
MeSH terms: Aortic Dissection; Hypoxia
Study type: Observational [Patient Registry]

Summary: 
      Acute type A aortic dissection is often accompanied by postoperative hypoxemia, the cause of
      which is not fully understood. Angiotensin II is an important component of the
      renin-angiotensin system (RAS), which has been suggested to be involved in the development of
      aortic dissection and pulmonary inflammation.The purpose of this study was to investigate the
      role and mechanism of angiotensin II pathway in postoperative hypoxemia after acute type A
      aortic dissection, and to provide reference for clinical application
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing surgical treatment for acute type A aortic dissection in our hospital
        were selected. The age was 18 years ≤ age ≤80years, and gender was not limited. The overall
        study patients were divided into the hypoxemia group and non-hypoxemia group according to
        the presence or lack of hypoxemia after surgery.
EVALUATION OF EFFICACY OF SAMEUP IN SUBJECTS WITH DEPRESSION SYMPTOMS: A RANDOMIZED STUDY
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study is planned to assess the efficacy of SAMEUp versus placebo after six weeks of
      treatment in subjects characterized by depression symptoms according to ICD-10 (International
      Classification of Diseases - 10th revision) diagnostic criteria and confirmed by mean of
      Zung's Self-Rating Depression Scale.
    

Detailed description: 
      Depression is a common condition of low mood and aversion to activity that can affect a
      person's thoughts, behaviour, tendencies, feelings, and sense of well-being.

      Several literature findings suggest that an oral combination of the two food supplements SAMe
      (S-adenosyl-L-methionine) and probiotic Lactobacillus plantarum might be favourable in
      relieving some of symptoms of depression, particularly in the mild to moderate forms of this
      condition. This double blind placebo controlled clinical study aims to evaluate this
      hypothesis. In particular, the primary objective is to assess, versus placebo, the efficacy
      of SAMEUp in improving the overall symptomology of depression after 6 weeks of treatment.
      Subjects with mild to moderate depression were identified according to ICD-10 diagnostic
      criteria and confirmed by mean of Zung's Self-Rating Depression Scale.

      SAMEUp, the investigational food supplement, is an oral formulation (tablet) containing
      S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU, already
      notified to the Ministry of Health as food supplement.

      Placebo is an oral formulation of inert tablet. Placebo and SAMEUp are indistinguishable.
    

Intervention name(s): SAMEUp; Placebo
Intervention type(s): Combination Product; Other
Intervention description(s): One tablet per day of food supplements containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.; One tablet per day identical in shape, size, colour and taste to the SAMEUp tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depression; probiotic; SAMe; Lactobacillus plantarum 299v; anxiety; insomnia; irritable bowel syndrome; randomized controlled study
Effects of Biofunctional Orange Juice on Cardiometabolic Risk Markers
Condition: Overweight and Obesity; Prediabetes; Hypertension; Dyslipidemias
MeSH terms: Overweight; Dyslipidemias
Study type: Interventional

Summary: 
      The effects of orange juice enriched with vitamin D3 and encapsulated probiotics
      (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) compared to
      conventional orange juice on several cardiometabolic and anthropometric parameters in
      individuals at risk of cardiovascular disease.
    

Detailed description: 
      This randomized, double-blind, controlled clinical trial aims to evaluate the effects of the
      consumption of orange juice enriched with vitamin D3 and encapsulated probiotics
      (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) compared to
      conventional orange juice in 50 high cardiometabolic risk volunteers. The participants must
      be overweight/obese with either prediabetes, and/or hypertension, and/or hyperlipidemia, and
      will be divided and randomly assigned into 2 groups of 25 individuals each. Participants will
      consume 250 ml of either orange juice enriched with vitamin D3 and encapsulated probiotics
      (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) or conventional orange
      juice daily for 8 weeks as an addition to their usual dietary intake. Participants will be
      asked to maintain their usual physical activity during the intervention period. At the
      beginning of the study and at 8 weeks, blood samples will be collected after 12 hours of
      fasting. Two-hour oral glucose tolerance test (OGTT) will be performed using a continuous
      glucose monitoring system at the beginning and at 8 weeks. Anthropometric measurements will
      be performed at the beginning and every week for 8 weeks. Basal metabolic rate (BMR) and
      central aortic blood pressure will be measured at the beginning, 4 weeks, and 8 weeks of
      intervention. Fecal samples will be collected and analyzed to study gut microbiome compositob
      at the intervention's beginning and at 8 weeks.
    

Intervention name(s): Orange juice enriched with vitamin D3 and encapsulated probiotics; Conventional orange juice
Intervention type(s): Other; Other
Intervention description(s): 25 high cardiometabolic risk volunteers will be asked to consume 250 ml orange juice enriched with 2000 IU vitamin D3 and 10^8 cfu/ml encapsulated probiotics (Lactocaseibacillus casei shirota and Lactocaseibacillus rhamnosus GG) daily, for 8 weeks, without any other change in their dietary habits and physical activity.; 25 high cardiometabolic risk volunteers will be asked to consume 250 ml conventional orange juice daily, for 8 weeks, without any other change in their dietary habits and physical activity.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: orange juice; vitamin D3; probiotics; cardiometabolic risk factors
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
      parallel-group clinical trial with 12 weeks of study drug therapy.
    

Detailed description: 
      This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
      parallel-group clinical trial with 12 weeks of study drug therapy.

      Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow
      for any necessary diagnostic procedures, allow for required washout of medications and to
      determine study eligibility. If otherwise eligible based on screening criteria, patients will
      undergo a 2-week baseline assessment using an electronic diary where they will record daily
      assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS),
      abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary
      assessment just prior to the randomization visit will be used to confirm IBS-C and study
      eligibility as well as define the patient's baseline from which change will be determined.

      Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three
      blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of
      study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication
      use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will
      return to the clinic to undergo safety and efficacy assessments.

      Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily
      electronic diaries. Patients will then return to the clinical site for a final follow-up
      visit during Week 14 following randomization.

      The planned duration of participation in this study will be at least 116 days from signing of
      informed consent through post-treatment or up to approximately 135 days with visit windows
      considered.
    

Intervention name(s): Plecanatide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Plecanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Polyurethane Foam on the Heel for Prevention in Children
Condition: Flat Foot; Pressure Ulcer
MeSH terms: Flatfoot; Pressure Ulcer
Study type: Interventional

Summary: 
      The post-operative treatment of pediatric patients operated for the correction of flat foot,
      sees today the use of preformed leg-foot splint (Walker) as an alternative to the application
      of plaster casts. The change of the immobilization system has led to the appearance of
      problems of tolerability in particular in the skin. The aim of the study is to assess whether
      by placing a polyurethane foam dress at the heel in the immediate postoperative period until
      removal of the Walker, the rate of skin lesion and pain is reduced.
    


Intervention name(s): polyurethane foam dress
Intervention type(s): Device
Intervention description(s): Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluate Efficacy of Oxyjun on Cardiovascular Health in Healthy Individuals.
Condition: Cardiovascular Health
Study type: Interventional

Summary: 
      Terminalia arjuna, commonly known as arjuna, that belongs to the family of Combretaceae. Most
      clinical and experimental studies for Terminalia arjuna, have suggested that the crude drug
      possesses anti-ischemic, antioxidant, hypolipidemic, and antiatherogenic activities.
    


Intervention name(s): Oxyjun; Placebo
Intervention type(s): Other; Other
Intervention description(s): One capsule to be taken after breakfast with water.; One capsule to be taken after breakfast with water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
Condition: Osteoarthritis Pain; Chronic Low Back Pain; Pain Due to Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Subcutaneous administration of tanezumab can result in changes in the number of nerves around
      the injection site in the thigh.
    


Intervention name(s): placebo; tanezumab
Intervention type(s): Other; Biological
Intervention description(s): single dose of the drug formulation; single dose of the active drug tanezumab at a dose level of 20 mg
Intervention MeSH terms: Tanezumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: intraepidermal nerve fiber density; IENF; tanezumab; subcutaneous; healthy volunteers
AVONEX® Combination Trial - "ACT"
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy and safety of combination therapy with
      AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous
      methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX
      monotherapy.
    


Intervention name(s): Methotrexate; IV methylprednisolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Methotrexate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Keywords: Multiple Sclerosis; Relapsing-Remitting; AVONEX; Combination; Methotrexate; IV Methylprednisolone; IVMP; ACT; MTX
A Randomized Controlled Feasibility Study of Emotional Well-being of Adolescents Undergoing a Mindfulness Training During COVID-19
Condition: Healthy
Study type: Interventional

Summary: 
      The COVID-19 pandemic has been significantly affecting people's lives around the globe.
      Social distancing, self-quarantine, shelter-in-place measures, economic challenges, and
      COVID-19-cased illness and deaths have the potential to significantly impact mental health
      and cause stress, anxiety, and depression. Adolescents may be especially vulnerable to this
      situation, due to their increased vulnerability to the onset of depression and anxiety in
      general.

      One promising approach to reduce anxiety and depression in youth is a neuroscience-based
      mindfulness intervention Training for Awareness Resilience and Action (TARA) (Henje Blom et
      al., 2014). TARA is usually delivered over 12 weeks by two facilitators in groups of 10-15
      adolescents in-person, and it has been shown to reduce symptoms of depression and anxiety in
      depressed adolescents (Henje Blom et al., 2016) and modify brain properties (Yuan et al.,
      2020). The TARA intervention can also be delivered remotely. Other types of therapy delivered
      remotely, such as internet-based cognitive behavioral therapy, have shown comparable
      efficiency to face-to-face delivery (Carlbring et al., 2017).

      The objective of this study is to utilize an individually randomized group treatment,
      open-label, waitlist-controlled clinical trial to test the feasibility of TARA (delivered
      partially over Zoom) in improving the self-reported emotional well-being primary outcome
      (emotional problems measured with the Strengths and Difficulties Questionnaire [SDQ]) in
      healthy adolescents between the ages of 14 to 18 years old during the COVID-19 pandemic.

      Our central hypothesis is that emotional well-being of adolescents in the intervention group
      will improve stronger (or deteriorate less) than in the control group. We will test this
      hypothesis in 21 adolescents randomized to the TARA intervention (partially delivered over
      Zoom) (12 adolescents) or to the waitlist control group (9 adolescents).
    


Intervention name(s): Training for Awareness, Resilience, and Action (TARA)
Intervention type(s): Behavioral
Intervention description(s): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      To Evaluate the Safety, Tolerability and Pharmacokinetics on GST-HG171 Tablets in Randomized,
      Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase Ia Clinical
      Trials in Healthy Subjects
    


Intervention name(s): GST-HG171; placebo of GST-HG171
Intervention type(s): Drug; Drug
Intervention description(s): This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated.; This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral
      dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or
      severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic
      function.
    

Detailed description: 
      Approximately 24 to 28 subjects will be enrolled. Safety and PK assessments will be performed
      at selected time points throughout the study.
    

Intervention name(s): GBT440
Intervention type(s): Drug
Intervention description(s): Oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Multiple-center, nonrandomized, open-label, parallel group study
Masking: None (Open Label)
Primary purpose: Other
Assessment of Suicidality in Epilepsy - Rating Tools
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      This will be a cross-sectional study enrolling 200 outpatients/inpatients with treatment
      resistant partial epilepsy for at least two years, receiving 1-3 AEDS.

      The study will consist of one or two visits, each lasting 1-2 hours. All subjects will
      complete Visit 1. Twenty five percent of the subjects will return for Visit 2. The study will
      assess the prevalence of depression and suicidal thoughts and the feasibility of using the
      proposed psychiatric rating scales in future epilepsy clinical trials. This study will also
      provide an estimate of the proportion of patients with epilepsy (PWE) who may be ineligible
      for future trials.
    

Detailed description: 
      In light of the recent issues regarding antiepileptic drugs and suicidality, The Epilepsy
      Study Consortium is proposing a pilot study. Several scales to assess suicidality and screen
      for depression and anxiety disorders will be administered to a group of epilepsy patients
      with characteristics similar to patients who are usually enrolled in epilepsy clinical
      trials. The study will assess the prevalence of depression, suicidal thoughts, and behavior
      and the feasibility of using the proposed psychiatric rating scales in future epilepsy
      clinical trials. This study will also provide an estimate of the proportion of patients with
      epilepsy who may be ineligible for future trials because they have had active suicidal
      thoughts in the last 6 months, suicidal behavior in the last 2 years or a current major
      depressive episode.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with partial epilepsy for at least two years, who are treatment resistant,
        experience at least 1 seizure/month, and are receiving 1-3 AEDs/month will be selected.