bioihbjkbjnl/mcl2 huggingface dataset:
The Effect Of Reiki And Massage With Sage Oil On Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      This study was a randomized controlled trial. It included young girls with primary
      dysmenorrhea in a district located in the south of Turkey and was conducted between March 01,
      2021 and June 30, 2021. The sample size of this research was decided by performing a power
      analysis in the power statistical program. Considering the parameters of the groups, the
      effect size was calculated to be 0.5003604. Since α was found to be 0.05 and power (1 - β)
      was 0.95, a total number of 66 participants were distributed into three equal groups (sage
      oil massage: 22, Reiki: 22, control: 22). Considering the possibility of case losses, 30
      participants were included in each group; finally, a total of 90 people were included in the
      study. For data collection, a questionnaire regarding sociodemographic characteristics and
      the visual analog scale (VAS) were used. Reiki and massage with sage oil were applied for 30
      minutes, and no application was performed on the control group.
    


Intervention name(s): Sage oil group; Reiki group
Intervention type(s): Other; Behavioral
Intervention description(s): Sometimes called muscatel. Made by steam or water distillation of Salvia sclarea flowering tops and foliage. Yields range from 0.7 to 1.5%. A pale yellow to yellow liquid with a herbaceous odor and a winelike bouquet. Produced in large quantities in France, Russia and Morocco. The oil contains linalyl acetate, linalool and other terpene alcohols (sclareol), as well as their acetates.; Within complementary and integrative health practices, Reiki is an ancient practice of Japanese origin widely used worldwide. Through the touch or approximation of the hands, an enabled therapist applies this technique to eliminate toxins, to balance the organism, and to favor the full functioning of the organism, to reestablish the flow of vital energy. Reiki as bioenergy therapy works with the energy that leads the human body to a calmer state that is linked to health and cure. Reiki therapists conduct the curing energy that enters the top of the head and leaves through the hands.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups with alternative therapy is a randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: midwifery, nurse, alternative therapies
Laser 360iQ: Optimal Light-laser Combination Therapy
Condition: Photodamage
Study type: Interventional

Summary: 
      To assess the safety and efficacy of light-laser combination therapy for the improvement of
      skin color, tone, texture and laxity
    

Detailed description: 
      This is a prospective study to test the safety and efficacy of a three different light and
      laser handpieces for the improvement of skin color, tone, texture and laxity. All subjects
      will receive up to four treatments, administered in intervals of 28 +/- 2 days. Each full
      face treatment duration will be approximately 60 minutes. The initial power and number of
      passes parameters shall be set according to the clinical indication and skin type of the
      subject treated. The treatment area will be cleaned and photographed before each treatment.
      Photographs will be taken at baseline, prior to each treatment and during each follow-up
      visit. Before the initiation of the first treatment each subject will undergo clinical
      evaluation.

      Clinical improvement will be assessed by the investigator from the visual appearance of the
      treated area and from the fixed magnification clinical photographs according to the following
      scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement,
      3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored
      by clinical evaluation of erythema, edema, and burns. Treatments and results will be
      documented in a Case Report Form at each treatment session and follow-up session (1 month and
      3 months after the last treatment). In case of adverse side effects and symptoms other than
      erythema or edema appear during or following a treatment, the next treatment may be skipped
      by two weeks or treatment parameters reduced until symptoms resolve. If adverse side effects
      are observed, the investigator should provide the subject with the proper care and remedy and
      will document it in the Case Report Form.
    

Intervention name(s): Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperpigmentation; telangiectasias
Effectiveness of Nurse-led Physical Therapy in Terms of Patient Competency, Patient Engagement and Physical Performance.
Condition: Chronic Liver Disease and Cirrhosis
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      Due to Prolonged diseased Condition, Patients are not able to care for themselves and even
      avoid movement their range of motion is limited which may develop frailty among Liver disease
      Patients.

      This Study aims at assessing Engagement, Competency and Physical Performance of Physical
      Frail Chronic Liver disease Patients before and after Nurse led Physical therapy.

      Besides these Parameters effect of Intervention on Physical frailty will also be assessed.
    

Detailed description: 
      Research Approach: Quantitative Study Research design: Quasi Experimental Research design (
      Pre-test - Post test Control group design) Setting: Study is planned on OPD patients of ILBS,
      New Delhi. Sampling Technique: Random Allocation in Experiment and Control group after
      matching for age and gender Sample size: 80 Patients Variables: Independent variable-
      Nurse-led Physical therapy Dependent Variable- Patient Competency, Patient Engagement,
      Physical Performance.
    

Intervention name(s): Nurse Led Physical Therapy
Intervention type(s): Behavioral
Intervention description(s): Nurse Led Physical Therapy in Form of Range of Motion Exercises
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pre-test - Post test Control group design
Masking: None (Open Label)
Primary purpose: Other
Keywords: Patient Competency; Patient engagement; Physical Performance; CLD; MELD
An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Follow-on study to the VIAject™-08J study to evaluate the long-term safety and efficacy of
      VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 2
      diabetes mellitus.

      The VIAject™-08J study is the efficacy and safety study for insulin VIAject™ to demonstrate
      equivalent blood glucose control in patients with type 2 diabetes mellitus with VIAject™
      insulin or regular human insulin as prandial insulin and to demonstrate an equivalent safety
      profile for VIAject™ in comparison to human insulin.
    


Intervention name(s): VIAject™
Intervention type(s): Drug
Intervention description(s): Subcutaneous injection 25 IU/mL
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Comparing Bioavailability of Oral Formulations of Vabicaserin
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the absorption rate of four oral formulations of
      vabicaserin.
    


Intervention name(s): vabicaserin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To compare the pharmacokinetics of Abcertin to the reference product, EU-sourced Cerezyme,
      after single intravenous administration of 60 IU/kg.

      Secondary Objective:

      To compare the safety, tolerability and immunogenicity of Abcertin to the reference
      formulation, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.
    

Detailed description: 
      This is a phase 1, single-center, randomized, double-blind, two-way crossover study employing
      Abcertin and EU-sourced Cerezyme in healthy volunteers between the ages of 18 and 45 years
      (inclusive). The study aimed to evaluate the PK, safety, tolerability and immunogenicity of
      Abcertin compared with EU-sourced Cerezyme when administered as a single dose.
    

Intervention name(s): Abcertin; EU-sourced Cerezyme
Intervention type(s): Drug; Drug
Intervention description(s): 60IU/kg Single Intravenous Administration; 60IU/kg Single Intravenous Administration
Other intervention name(s): Imiglucerase; Imiglucerase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gaucher Disease; ISU ABXIS Co., Ltd.; ISU302
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
Condition: Patient Under Going Colorectal and Stomach Cancer Surgery
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the
      incidence of bowel obstruction and to evaluate the incidence of all serious adverse events
      (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days
      postoperatively.
    


Intervention name(s): Guardix; Seprafilm
Intervention type(s): Procedure; Procedure
Intervention description(s): Applying 6g of guardix during abdominal surgery; Applying 1 sheet of seprafilm during abdominal surgery
Other intervention name(s): Guardix, Sami pharmaceutical company; Seprafilm
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation
Condition: Infertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Male from infertile couples are tested for semen analysis and sperm DNA fragmentation. Any
      case with high DNA fragmentation index (DFI) will be randomized indicated for multi-micro
      nutrient supplement (PROfortil™) in 3 months and then checked again post-treatment for (DFI).
      The IVF/ICSI cycles will be analyzed for pregnancy outcomes
    

Detailed description: 
      Higher DFI is correlated with poor embryo development, lower implantation rate in
      intracytoplasmic sperm injection (ICSI) cycles and higher miscarriage rate.

      The effectiveness of micro nutrients (PROfortil™) has been proven in improving sperm quality
      including sperm cell density, progressive motility and normal morphology.

      This randomized controlled trial includes male from infertile couples treated at the Center
      for Reproductive Endocrinology and Infertility, Hue University hospital, Vietnam from
      November 2019 to November 2020.

      The semen samples were collected from the husband after 3-5 days of abstinence and then
      evaluated for sperm motility, vitality, concentration and morphology by the guideline of
      World Health Organization (WHO) 2010.

      Sperm DNA fragmentation (SDF) was measured using a sperm chromatin dispersion (SCD) test
      (Halosperm® kit, Halotech, Madrid, Spain). A total of 500 sperms were examined by only one
      highly trained technician to decrease variability. DFI was expressed as the percentage of
      sperms with small halo, without halo and degraded sperms over total of 500 sperms.

      Any case with high DNA fragmentation index (DFI >=30%) will be randomized indicated for
      (group 1) micro nutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once
      per day) in 3 months and (group 2) only Vitamin E (Enat 400 once per day) then checked again
      post-treatment for (DFI).

      The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including
      biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.
    

Intervention name(s): PROFortil; Vitamin E
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months; Only Vitamin E (Enat 400, once per day) in 3 months
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Men from infertile couples with increased sperm DNA fragmentation will be randomized devided into 2 groups: (1) with multi-micronutrient supplements (PROFortilTM) plus Vitamin E and (2) with Vitamin E only.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sperm DNA fragmentation; micronutrient; In vitro fertilization
Acupuncture for Chemotherapy-Induced Nausea and Vomiting
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The purpose of this study is to clarify whether the matching acupoints is more effective than
      a single point by electroacupuncture in the management of chemotherapy-induced nausea and
      vomiting .
    

Detailed description: 
      Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36,
      CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and
      Adverse Eventswill be assessed.
    

Intervention name(s): single point Zhongwan(CV12) plus antiemetic drug; single point Zusanli(ST36) plus antiemetic drug; Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug; only antiemetic drug
Intervention type(s): Other; Other; Other; Drug
Intervention description(s): All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.; A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.; Stimulating both Zusanli(ST36)and Zhongwan(CV12); received routine antiemetic treatment
Intervention MeSH terms: Antiemetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
An Open-label, Single-centre Study Evaluating the Pharmacokinetics of Digoxin Alone and When Administered at Various Doses of Ezogabine/Retigabine in Healthy Adults. The Pharmacokinetics of Ezogabine/Retigabine and the N-acetyl Metabolite of Ezogabine/Retigabine (NAMR) Will Also be Assessed
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite
      NAMR on the pharmacokinetics of digoxin in healthy volunteers
    

Detailed description: 
      This is an open-label, single-centre study to evaluate the pharmacokinetics of single-dose
      digoxin alone and when administered at various up titration doses of ezogabine/retigabine in
      healthy adult subjects. The pharmacokinetics of ezogabine/retigabine and the n-acetyl
      metabolite of ezogabine/retigabine (NAMR) will also be assessed.
    

Intervention name(s): Digoxin Alone; Digoxin + Retigabine
Intervention type(s): Drug; Drug
Intervention description(s): Single administration of digoxin 0.25mg; Increasing doses of retigabine (300mg, 450mg, 600mg, 750mg, 900mg, 1050mg and 1200mg) administered as TID doses over 44 days. Co-administration with digoxin (0.25mg) on days 10, 24 and 38.
Intervention MeSH terms: Digoxin; Ezogabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-center study of subjects undergoing clinically indicated heart scans for
      evaluation of known or suspected heart disease. We will also include 10 healthy subjects
      without known heart disease. We would like to study stress testing of the heart using
      exercise and a medication called regadenoson. Imaging of the heart will be performed.
    

Detailed description: 
      Regadenoson is stress agent approved by the FDA for use with myocardial perfusion imaging
      with technetium-99m single photon emission computed tomography (SPECT) in patients that are
      unable to exercise adequately. We would like to study Regadenoson in conjunction with
      Exercise Rubidium-82 positron emission tomography myocardial perfusion imaging (PET MPI).
      Regadenoson is not approved by FDA for use with Rubidium-82 PET MPI. Also, we would like to
      study a novel stress protocol of Regadenoson combined with symptom limited exercise stress
      (not FDA approved).

      The objectives of this study are to assess the tolerability and safety of combined symptom
      limited exercise stress test with Lexiscan (Lexercise PET) compared to Lexiscan alone
      (Lexiscan PET), to assess image quality of Lexercise compared to Lexiscan PET and to compare
      relative and absolute myocardial perfusion imaging with Lexercise compared to Lexiscan PET to
      identify CAD.
    

Intervention name(s): Exercise plus Regadenoson (Lexercise); Regadenoson (Lexiscan)
Intervention type(s): Drug; Drug
Intervention description(s): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography; Regadenoson Rubidium-82 Positron Emission Tomography
Other intervention name(s): Exercise plus Lexiscan
Intervention MeSH terms: Regadenoson
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery disease; exercise; regadenoson; positron emission tomography
Long Term Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
Condition: Aortic Intramural Hematoma
MeSH terms: Aortic Intramural Hematoma; Hematoma
Study type: Observational

Summary: 
      The study evaluates outcomes of intramural hematomas after long-term follow up and establish
      predictive factors in Chinese population.
    

Detailed description: 
      270 intramural hematoma patients with clinical and imaging follow up were retrospectively
      studied in present study. The primary endpoint was consisted of aortic disease-related death,
      aortic dissection, penetrating atherosclerotic aortic ulcer , thickening of aorta hematoma
      and aortic complications requiring surgical or endovascular treatment.
    

Intervention name(s): drug, stent, surgical treatment
Intervention type(s): Other
Intervention description(s): drug, stent, surgical treatment
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        From February 2003 to May 2017, 1770 consecutive patients were diagnosed with AAS at the
        General Hospital of Shenyang Military Region, including 270 IMH patients, of which 123
        patients were retrospectively examined. Thirty-nine patients presented with type A aortic
        IMH, and 84 presented with type B aortic IMH
      
Biospecimen description: 
      Imaging Samples
    
Keywords: Aortic intramural hematoma; Chinese patients; Clinical outcomes
The Effects of a Group-based Gaze Training Intervention for Children With Developmental Coordination Disorder
Condition: Developmental Coordination Disorder
MeSH terms: Motor Skills Disorders
Study type: Interventional

Summary: 
      The aim of this study was to integrate a gaze training intervention (i.e., quiet eye
      training; QET) that has been shown to improve the throwing and catching skill of children
      with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that
      might alleviate the psychosocial influence of these motor skill deficits.
    

Detailed description: 
      Children with DCD will be randomly split into either QET group or a technical training (TT).
      The TT group will be given movement-related instructions via video, relating to the throw and
      catch phases, while the QET group will also be taught to fixate a target location on the wall
      prior to the throw (QE1) and to track the ball prior to the catch (QE2). Each group will take
      part in a 4- week, group therapy intervention and measurements of QE duration obtained from a
      mobile eye tracking system and catching performance are to be taken before and after
      training, and at a 6-week delayed retention test. Parental feedback on psychosocial and motor
      skill outcomes will also be collected at delayed retention.
    

Intervention name(s): Technical Training; Quiet Eye Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children will watch an instructional video focused on movement related instructions regarding the throwing and catching task.; Children will watch the same video as the TT group but will also receive instructions designed to optimise their quiet eye durations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Quiet eye training; Visual Attention