bioihbjkbjnl/mcl2 huggingface dataset:
The CANabidiol Use for RElief of Short Term Insomnia
Condition: Sleep Disturbance; Insomnia; Insomnia Type; Sleep Disorder; Insomnia, Transient; Insomnia Due to Anxiety and Fear; Insomnia Due to Other Mental Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to investigate the effect of 50 mg and 100 mg per day oral CBD product versus
      a placebo over 8 weeks on insomnia severity in adults aged 18-65 years old with insomnia
      symptoms.
    

Detailed description: 
      This is a double-blind, randomised, parallel-group, placebo-controlled study of 8 weeks of
      oral CBD at 50 or 100 mg per day versus placebo in 198 participants with insomnia symptoms as
      classified by an Insomnia Severity Index (ISI) score of 8-21. Participants will be recruited
      voluntarily and are able to withdraw at any time. The study will be conducted online with
      telehealth consults where required.
    

Intervention name(s): 50 mg Cannabidiol (CBD); Placebo; 100 mg Cannabidiol (CBD)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): For the study arm, '50 mg CBD' participants take two (2) CBD capsules and two (2) placebo capsules.; Participants take four (4) placebo capsules.; For the study arm, '100 mg CBD' participants take four (4) CBD capsules.
Other intervention name(s): BodECS BioAbsorb(TM) capsule; BodECS BioAbsorb(TM) capsule
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, placebo-controlled, double-blind, parallel trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia; sleep; fatigue; cannabidiol; CBD; mental health; anxiety
The Effect of DASH Diet on the Cardiometabolic Risks and Hepatic Function Among Type 2 Diabetic Patients
Condition: Type 2 Diabetic Patients
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators are not aware of any study regarding the effect of DASH eating pattern on
      different cardiovascular risks among type 2 diabetic patients. The investigators assumed that
      DASH eating pattern could reduce the cardio-metabolic risks and improve the hepatic function
      among type 2 diabetes.
    


Intervention name(s): DASH diet; a usual diabetic diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Dietary aproaches to stop hypertension
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dietary Approach to Stop Hypertension; weight; coagulation; DASH eating pattern.
Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae
Condition: Recurrent Aphthous Stomatitis
MeSH terms: Stomatitis; Stomatitis, Aphthous
Study type: Interventional
Phase: Phase 1

Summary: 
      Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory
      disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's
      safety and effectiveness in treatment of aphthous stomatitis .
    


Intervention name(s): chamomilla tincture mouthwash; placebo mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): The patient is directed to mouth wash chamomilla tincture lightly three times a day,ten drops for each time,until ulcers completely heal; The patient is directed to use placebo mouthwash three times a day, ten drops for each time,until the ulcers completely heal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla
Augmented CBGT for Perinatal Anxiety During a Global Pandemic (COVID-19)
Condition: Perinatal Anxiety; Covid19
MeSH terms: COVID-19; Anxiety Disorders
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of an augmented version of our current
      evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with
      cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and
      impact content.
    


Intervention name(s): Cognitive Behavioural Group Therapy for Perinatal Anxiety
Intervention type(s): Other
Intervention description(s): The treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population. Additional strategies for COVID-19 specific worry content have been included.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a
      live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan
    


Intervention name(s): TV003; Placebo for TV003
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated virus vaccine-TetraVax-DV; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Vaccine
Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This is a prospective, multicenter pilot study to investigate the feasibility and preliminary
      effectiveness of a tailored tele-coaching intervention to enhance medical adherence in
      patients with CF.
    

Detailed description: 
      This is a prospective, multicenter pilot study to test the feasibility and acceptability of a
      tele-coaching intervention and its implementation in patients with CF (ages 14-25 years), and
      to obtain estimates of treatment effects across a range of key outcome measures (e.g., global
      adherence, change in treatment barriers, specific improvement in adherence, etc.)
    

Intervention name(s): Tele-coaching
Intervention type(s): Behavioral
Intervention description(s): Patients will meet with a "tele-coach," who is a care team member, via video-calling, on a regular basis for six months to identify and address treatment adherence concern(s).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Patient Care; Tele-health; Behavioral intervention
Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods
Condition: Healthy Volunteer
Study type: Observational

Summary: 
      The main objective of this study is to describe for the first time the expansion reserve of
      the pelvic area (measurements using the EOS system) for each of the four morphotypes
      (Roussouly classification) commonly found in a population of healthy volunteers.
    

Detailed description: 
      Secondary objectives:

      A. The intra-judge reproducibility and the interrater reliability for the different tools
      used to measure hip extension will be evaluated. Intra-judge reproducibility (photography)
      and interrater reliability (goniometry and photography) for the different tools used for
      measuring hip extension will be evaluated.

      B. The concordance between EOS measurements and measurements acquired via goniometry and
      photography will be evaluated.

      C. Describe certain radiographic measurements via the EOS system for the four morphotypes
    

Intervention name(s): Goniometric measure of pelvic extension reserve.; Photographic measure of pelvic extension reserve.; EOS measure of pelvic extension reserve.
Intervention type(s): Other; Other; Other
Intervention description(s): The pelvic extension reserve (°) is measured via goniometry.
The goniometric measurements will be taken once by an investigator on all subjects and once by a different investigator on half of the subjects (with balanced distribution of morphotypes).; The pelvic extension reserve (°) is measured using photography.
Photographic measurements will be performed twice one investigator and 1 time by a different investigator (total of three measurements).; The pelvic extension reserve (°) is measured using the imaging system EOS.
Five X-rays will be made for each volunteer on the EOS system. The first is a frontal shot in a bipedal position, reference snapshot for verifying the absence of spinal deformity or hip pathology. The second and third are profile shots, one on the left and one on the right, whole body, bipedal position; serving as a reference picture. The fourth is profile shot, whole body, with the left hip in hyperextension. For maximum left hip hyperextension, the right leg rests on a step of varying height, and the hip is maximally flexed. The fifth is a profile shot, full body, with the right hip in hyperextension. For a maximum right hip hyperextension, the left leg rests on a step of varying height, and the hip is maximally flexed.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers 20 to 30 years of age.
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
Condition: Treatment-resistant Depression
MeSH terms: Depressive Disorder, Treatment-Resistant
Study type: Observational

Summary: 
      This observational study will allow data to be collected to demonstrate changes in brain
      activity following administration of standard of care (SOC) Ketamine. By comparing genetic
      markers across participants, data on impact of genetic markers and response to Ketamine will
      also be analysed. This data will contribute to the design of future studies utilizing
      Ketamine for various psychiatric disorders. This study will focus on treatment-resistant
      Major Depressive Disorder (MDD).
    

Detailed description: 
      This is an Open Label Observational Study with the primary objective to assess brain activity
      in patients prior to, during and after Ketamine treatment and to assess genetic markers prior
      to Ketamine treatment. This is a non-interventional study that will observe the
      Electroencephalogram (EEG) pattern of participants who, per standard of care, are treated
      with intramuscular Ketamine. The administration of the Ketamine during this study is not
      considered investigational. The experimental intervention, measurements via EEG, will be
      offered to patients of the study site presenting for intramuscular (IM) ketamine treatment
      per the site's established and evidence-based protocol as part of their regular clinical
      care. Participants in this study have already been determined to have a medically appropriate
      indication for IM Ketamine treatment, independent of enrollment in this study. Given the
      requirement, per study protocol, to wear an EEG headset and complete study measures,
      participants will be compensated by having treatment costs paid by the study sponsor. There
      will be 36 participants enrolled at one study site.
    

Intervention name(s): Observational - no intervention
Intervention type(s): Other
Intervention description(s): This is an observational study with no intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male or female participants with treatment-resistant Major Depressive Disorder aged 21-60
        interested in receiving intra-muscular injections of ketamine over 10 sessions in the
        clinic and willing to wear an electroencephalogram (EEG) headset to measure their brain
        wave patterns.
The Effects of Hesperidin and Flaxseed in Prediabetes
Condition: PreDiabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      To study the effects of Hesperidin and flaxseed supplement in patients with prediabetes, 50
      patients will be randomly allocated to control group or 2 capsules Hesperidin and 30 gram
      flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and
      exercise program too. At the first and the end of the intervention, lipid profiles, blood
      pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared
      between groups.
    


Intervention name(s): hesperidin and flaxseed; control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 capsuls hesperidin and 30 g flaxseed; no supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Asthma Patient Survey Study to Assess Asthma Effect and Medication in Finland
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study was aimed at clarifying how the asthma medication is used in practice and how
      asthma affects everyday life. Total of 106 GPs were asked to recruit patients using inhaled
      steroid as maintenance treatment for asthma to take part in a telephone survey. Altogether
      142 patients were interviewed.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Asthma; use of asthma medication; asthma control; telephone survey; patient's perception
A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I，randomized, double-blind, placebo controlled,dose escalated,single
      administrated clinical trial in Chinese healthy adult's volunteers.

      In the trial, it is planned to enroll 50 subjects, randomized to 5 dosage groups to receive
      the test drug and the placebo control.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, dose-escalation, single-dose
      phase I clinical study, including safety tolerability assessment, pharmacokinetic studies and
      immunogenicity studies, to evaluate the expression level of mRNA in whole blood of
      2',5'-oligoadenylate synthetase, as well as the level of Neopterin (NTP) in serum.
    

Intervention name(s): PEGIFNα1b; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100μg/vial; 0.5ml/vial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peginterferon α1b for Injection
Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in
      breast milk of healthy lactating women after an oral administration of 10 mg once daily over
      a period of 8 days.
    


Intervention name(s): Bisacodyl; Sodium picosulfate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bisacodyl; Picosulfate sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles
Condition: Facial Wrinkles
MeSH terms: Facies
Study type: Interventional

Summary: 
      The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation
      and resurfacing of the skin, and for the treatment of facial wrinkles. This study was
      designed in order to evaluate the safety and efficacy of the A3F for treatment of facial
      wrinkles.
    

Detailed description: 
      The need for cosmetic facial enhancement procedures with minimal down time and low risk has
      led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers
      were developed, which remove the full skin surface in a controlled manner1,2. However, the
      prolonged recovery and the significant risks prompted the development of fractional lasers
      which ablate the skin in a fractional manner, leaving untreated areas to improve healing
      process3. In the past few years, fractional RF systems have been introduced that enable
      controlled skin resurfacing accompanied with dermal collagen remodeling4,5,6. The new 3F
      Applicator (A3F, trade name TriFractional) from Pollogen™ is designed to enable skin
      resurfacing and treatment of wrinkles using radiofrequency energy.

      The 3F Applicator (A3F) is indicated for use in dermatological procedures requiring ablation
      and resurfacing of the skin, and for the treatment of facial wrinkles. This study was
      designed in order to evaluate the safety and efficacy of the A3F for treatment of facial
      wrinkles.
    

Intervention name(s): A3F
Intervention type(s): Device
Intervention description(s): A3F fractional RF treatments for facial wrinkles
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fractional,; RF,; Wrinkles; Safety; Efficacy; treatment
Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
Condition: Heart Valve Disease
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to study the effect of remote ischemic preconditioning on acute
      kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary
      bypass.
    

Detailed description: 
      Hypothesis : RIPC using tourniquet might be a simple technique with the benefit to provide
      renal protection without disturbing operating procedure and prolongation of total operating
      time.
    

Intervention name(s): Automated cuff-inflator
Intervention type(s): Procedure
Intervention description(s): RIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated.
Intervention model: Parallel Assignment
Primary purpose: Prevention
Efficacy of Platelet Rich Plasma in Plantar Fasciitis
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      Plantar fasciitis is a common pathology among podiatry moreover the healing time takes
      several months.

      The main aim of this study is to evaluate the efficacy of a injection of Platelet-Rich Plasma
      (PRP) versus corticosteroid injection.
    


Intervention name(s): Injection of autologous platelet rich plasma; Injection of cortivazol : Altim®
Intervention type(s): Biological; Drug
Intervention description(s): Corticosteroids
Intervention MeSH terms: Cortivazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Mental Health Promotion Interventions Among Migrant Workers in China
Condition: Depression; Anxiety
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The goals of this research were to conduct a mental health intervention study for reducing
      self-reported depression and anxiety among migrant workers in a labor-intensive industry in
      China and to assess the effectiveness of the integrated mental health interventions aimed at
      promoting the mental health of migrant workers in labor-intensive industries in China.
    


Intervention name(s): mental health promotion
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: mental health promotion; depression; migrant workers; China
Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of
      ONO-5129 in patients with type 2 diabetes mellitus.
    


Intervention name(s): ONO-5129
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ONO-5129; type 2 diabetes mellitus
Breathing and Attention Training for Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to see if breathing and attention training (BAT)
      treatments improve pain symptoms and well-being in people who have chronic low back pain
      (cLBP). For this breathing intervention, you will be randomly assigned to either standard or
      focused BAT. The standard BAT includes instructions on deep breathing and relaxation. The
      focused BAT is similar to the standard BAT in most ways but includes extra instructions to
      help you focus and alter your breathing patterns.
    

Detailed description: 
      The primary objective of the proposed pilot randomized controlled trial (RCT) is to examine
      the safety, feasibility, and acceptability of a 5-day breathing and attention training (BAT)
      in a sample of 30 adults with cLBP. The secondary objective is to explore preliminary
      clinical efficacy and potential mechanisms of the breathing interventions (focused-BAT and
      standard-BAT), by examining changes in clinical pain outcomes and potential pain-related
      psychological, physiological, and behavioral mediating variables. Both interventions will be
      delivered via an audio recording in order to standardize the interventions across
      participants and to enhance treatment fidelity. Results from this study will inform the
      successful design and implementation of a larger RCT and provide preliminary evidence
      regarding the potential efficacy of this breathing intervention for people with cLBP.
    

Intervention name(s): Breathing and Attention Training
Intervention type(s): Behavioral
Intervention description(s): A guided audio recording will instruct participants to alter their breathing and pay attention in specific ways.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic Pain; Low Back Pain; Breathing
Effect of Mat Pilates Training on Blood Pressure of Hypertensive Individuals
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The study aimed to evaluate the chronic effects of Mat Pilates Training on blood pressure,
      heart rate, double product and psychobiological factors in hypertensive medicated women and
      acute effects of Mat Pilates Exercise on blood pressure of such individuals.
    


Intervention name(s): Mat Pilates Training
Intervention type(s): Behavioral
Intervention description(s): Mat Pilates training performed two times at week for 16 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment