bioihbjkbjnl/mcl2 huggingface dataset:
Effects of HIA and PCE in Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      The main purpose of study is to manage the unpleasant pain suffered by females during
      Mensturation. The aim of this study is to guide physiotherapist that how to apply these
      exercises to manage dysmenorrhea.
    

Detailed description: 
      There are less research on effectiveness of pelvic clock exercises in dysmenorrhea they are
      very less evidence and less documented in literature.. Although there are many researches on
      high intensity aerobics.Previous researches only have lierature about aerobics.So to address
      this literature gap, conduct a prospective randomized controlled trial to investigate the
      effects of high intensity aerobics and pelvic clock exercises in primary dysmenorrhea.
    

Intervention name(s): High intensity aerobics; Pelvic clock exercises
Intervention type(s): Other; Other
Intervention description(s): "London bridges (8mins)" "Jumping lunges(8mins)" "Mountain climbers(8mins)" "Quadruped bent knee hip extension (8mins)"; Lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Subject begin with gentle movements from 12 to 6 o'clock, as instructed to move from 3 o'clock to 9 o'clock. Then move in a clockwise manner from 12 to 3 to 6 to 9 and then back to 12 o' clock.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: high intensity aerobics; primary dysmenorrhea; aerobics; painful menstruation
A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability, and efficacy of the addition
      of canagliflozin relative to the addition of placebo in patients with inadequate glycemic
      control on metformin alone or in combination with a sulphonylurea.
    

Detailed description: 
      This is a double-blind (neither study staff or the patient will know the identity of the
      treatment assigned) study of canagliflozin where Chinese and other Asian adult patients with
      Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control on metformin alone or in
      combination with a sulphonylurea (SU) will be randomized (assigned to 1 of 3 treatments by
      chance) to receive the addition of treatment with canagliflozin 100 mg once daily,
      canagliflozin 300 mg once daily, or matching placebo capsules (placebo is a treatment
      identical in appearance to canagliflozin but does not contain active drug). All patients will
      take orally (by mouth) 1 single-blind placebo capsule once daily before the first meal of the
      day for up to 2 weeks (last dose of single-blind placebo to be taken the day before the
      baseline (Day 1) visit. On Day 1, patients will take orally, once daily 1 capsule of
      canagliflozin 100 mg, canagliflozin 300 mg, or placebo before the first meal of the day for
      up to 18 weeks.
    

Intervention name(s): Placebo; Canagliflozin 100mg; Canagliflozin 300mg; Metformin; Sulphonylurea
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).; Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).; Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).; The participant's stable dose of background therapy of metformin should be continued throughout the study.; The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Canagliflozin; Placebo; Type 2 diabetes mellitus
Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Men who have Prostate Specific Antigen (PSA) recurrence with low PSA levels and long doubling
      times do not require immediate treatment with androgen deprivation therapy and may be safely
      observed. In these situations where current treatment options may cause more unnecessary side
      effects than anticipated benefit, it is reasonable to use a low-risk natural product such as
      Acai Juice Product with antioxidant properties to evaluate whether there are any anti-cancer
      effects.
    

Detailed description: 
      In this study, patients who meet eligibility criteria will take Acai Juice 2 ounces by mouth
      twice daily on a continuous basis.
    

Intervention name(s): Acai Juice Product
Intervention type(s): Drug
Intervention description(s): 2 ounces of Acai Juice Product twice daily.
Other intervention name(s): Acai Juice
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer; Nutraceutical; Acai Juice
Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug
      interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.
    


Intervention name(s): Sevikar(amlodipne/olmesartan); crestor(Rosuvastatin)
Intervention type(s): Drug; Drug
Intervention description(s): Treatment AB; Treatment AB/Treatment C
Intervention MeSH terms: Olmesartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects were previously vaccinated at 12 to 23 months of age. This extension study starts 24
      months after vaccination and the subjects who were vaccinated in the primary study will be
      enrolled in this extension phase. No new subjects will be enrolled.
    

Detailed description: 
      This study will assess the long-term protection offered by the new meningococcal vaccine GSK
      134612 compared to Meningitec™ up to 4 years after vaccination of toddlers. Subjects were
      previously vaccinated at 12 to 23 months of age with GSK Biologicals' meningococcal vaccine
      GSK 134612 or Meningitec™. All subjects received at least one dose of Priorix-Tetra™. This
      extension phase starts 24 months after vaccination and the subjects who were vaccinated in
      the primary study will be enrolled in this extension study. No new subjects will be enrolled.
      The subjects will have a blood sample taken at 24, 36 and 48 months after primary
      vaccination.

      At Year 4 subjects will be boosted with the same meningococcal vaccine as given in the
      primary study, i.e. either the new meningococcal vaccine GSK 134612 or Meningitec™. Blood
      samples will be taken 1 and 12 months after the booster vaccination.
    

Intervention name(s): Meningococcal vaccine GSK134612; Meningitec™
Intervention type(s): Biological; Biological
Intervention description(s): One intramuscular dose (Booster); One intramuscular dose (Booster)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal vaccine GSK134612
Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment
      as long-term treatment in paediatric patients with atopic dermatitis.
    

Detailed description: 
      This is a long-term, multi-centre, non-comparative phase II study. All centres participating
      in the FG-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. Only
      patients enrolled by those centres for the above mentioned study, who applied at least one
      dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be
      enrolled.

      During episodes of active disease, a thin coat of ointment is applied on each lesion. In the
      first three weeks, frequency of application is twice a day; after three weeks treatment is
      continued once a day. All atopic dermatitis lesions are treated until clearance (i.e. itch
      has gone). In case of a flare-up or worsening treatment twice daily treatment is re-started
      for three weeks and thereafter reduced to once daily.

      Safety is assessed from adverse events reported by the patient and/or his parents or observed
      by the investigator at the site of application and elsewhere. The safety evaluation includes
      monitoring of routine haematology and serum chemistry parameters. Blood samples are analysed
      by local laboratories. Blood samples are taken to determine concentrations of tacrolimus.

      Height, weight and pulse of the patient are recorded at each visit.

      Efficacy is assessed by physician's global evaluation of clinical response, patient's
      parent/guardian's assessment of global response, physician's assessment of individual signs
      and the affected area assessment.
    

Intervention name(s): Tacrolimus Ointment 0.03%
Intervention type(s): Drug
Intervention description(s): Once or twice daily topical application
Other intervention name(s): Protopic 0.03%
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paediatric patients; Tacrolimus; Dermatitis, Atopic
Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the
      5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the
      treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and
      antipsychotics.
    

Detailed description: 
      METHOD: Fourteen patients with a DSM-IV diagnosis of treatment resistant OCD, under stable
      treatment with SSRI's and neuroleptic augmentation will enter an 12-week single blind trial
      of ondansetron initiated at a dose of 0.25 mg twice daily for 6 weeks, that will be titrated
      to 0.5 mg twice daily for 6 weeks.
    

Intervention name(s): ondansetron
Intervention type(s): Drug
Intervention description(s): ondansetron hydrochloride (oral solution) dosage of 0.25 mg twice a day for 6 weeks followed by 0,5 mg twice a day for 6 weeks for a total observation period of 12 weeks.
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder; 5-ht3; ondansetron
Effect of Magnesium Sulphate on Coagulation
Condition: Myoma
Study type: Interventional

Summary: 
      Arterial and venous thrombotic events are the clinical manifestation of postoperative
      hypercoagulability. Altered serum magnesium may play a role in the balance of coagulation. In
      this study, the investigators investigated the effect of magnesium sulphate on the
      postoperative coagulation change in total intravenous anesthesia (TIVA).
    


Intervention name(s): Magnesium Sulfate; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Group M received 50 mg/kg of magnesium sulphate on 100 ml of isotonic saline over 10 minutes during the anesthesia induction, followed by the 15 mg/kg/h by continuous infusion during the operation; Group S received the same volume of isotonic saline as same method.
Other intervention name(s): magnesium sulphate; isotonic saline
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Hull Airway Reflux Questionnaire Scores Following Cough Treatment
Condition: Cough
MeSH terms: Cough
Study type: Observational

Summary: 
      The aim of this study is to have those patients taking part in the Clinical trial-: A
      Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of
      Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire
      (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment
      period. The investigators hope to demonstrate a clinically significant change in HARQ scores
      of at least 16 points from before and after treatment. Furthermore the investigators would
      hope to show a significantly improved HARQ score in patients on the BC036 arm of the study
      compared to the placebo arm.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patients attending chronic cough clinics
      
Keywords: chronic cough
Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity
Condition: Abdominal Obesity Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal
Study type: Interventional

Summary: 
      A growing body of evidence demonstrates that increased adipose mass, especially visceral
      adipose tissue, contributes directly towards an increase in systemic inflammation,
      (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin
      resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a
      heterogeneous family of unavoidable by-products, which are formed by reactive metabolic
      intermediates derived from glucose and lipid oxidation. In addition to the overwhelming
      amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular
      dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue
      contributes to the dysregulation of adipokines and the development of insulin resistance.

      The investigators want to examine, in a double-blind randomized placebo controlled parallel
      study, the physiological effect of a dietary intervention with pyridoxamine in abdominally
      obese persons.

      A sub-study is implemented next to the clinical trial. The objective of the sub-study is to
      measure the metabolization and kinetics of pyridoxamine in plasma and urine with UPLC-MS/MS.
      The sub-study comprises of 5 additional healthy volunteers, with pyridoxamine as an oral
      supplement.
    


Intervention name(s): Pyridoxamine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Pyridoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
Condition: Sleep-Wake Disorders; Healthy
MeSH terms: Sleep Wake Disorders
Study type: Interventional

Summary: 
      Validation of two devices with optical sensor in healthy participants and patients with sleep
      wake disorders.
    

Detailed description: 
      The objective of this study is to evaluate and optimize a method of detecting sleep and sleep
      stages based on a new algorithm combining actigraphy and heart rate variability (measured by
      optical analysis of the pulse wave) to determine sleep architecture (segmented into three
      phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.
    

Intervention name(s): OHR Tracker and PulseWatch
Intervention type(s): Device
Intervention description(s): Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Sleep apnea; Hypersomnia; Parasomnia
Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients undergoing multivessel off-pump coronary bypass surgery (OPCAB) inevitably
      experience cumulative ischemia-reperfusion injury at myocardium. Glucose-insulin-potassium
      (GIK) is a potentially useful adjunct to myocardial protection. This study was designed to
      evaluate the effects of GIK infusion on myocardium in patients undergoing OPCAB. Patients
      undergoing OPCAB with acute coronary syndrome are randomly assigned to GIK or Control group.
      The trial is double-blind and conducted at a single center.
    


Intervention name(s): GIK solution
Intervention type(s): Drug
Intervention description(s): Patients receive 0.3 ml/kg/hr GIK solution or the same volume of normal saline depending on the group during off-pump coronary bypass surgery. GIK solution consist of 50% glucose, potassium 80 mEq, and regular insulin 325 IU/500ml.
Other intervention name(s): glucose-insulin-potassium(GIK) solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Akathisia in Post Operative Outpatients Surgery
Condition: Akathisia
MeSH terms: Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to evaluate the incidence of akathisia with Droperidol,
      the prophylactic treatment of post operative nausea and vomiting, used at two different
      doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to
      compare the number of observed akathisia (Barnes score > 1) in the Droperidol arms (0,625 mg
      and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that
      there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO,
      that among patients taking Ondansetron.
    


Intervention name(s): Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration
Intervention type(s): Drug
Intervention MeSH terms: Droperidol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency and vitamin D deficiencies are common in menstruating women. The present
      assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron
      pyrophosphate) or with iron and vitamin D3 in iron deficient women on:

        -  Iron metabolism

        -  Biomarkers of bone remodelling

        -  Cardiovascular risk indexes
    


Intervention name(s): Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women
Intervention type(s): Other
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Iron deficiency; Menstruating women; Vitamin D; Functional food
Effect of HICT and LIIT on Functional Strength and Weight Efficacy in Overweight and Obese Females
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is aimed at determining the effects of high-intensity circuit training versus
      low-intensity circuit training on functional strength and weight efficacy in overweight and
      obese females.
    

Detailed description: 
      A high-intensity circuit promotes muscle mass and as a result, potentially reduces the
      incidence of cardiovascular disease and reduces the risk of death in the young population.
      Low-intensity interval training increases muscle circulation and improving the uptake of
      oxygen. Both high-intensity circuit training and low-intensity interval training enhance body
      composition, quality of life, functional fitness and decrease body mass index. These
      trainings also motivate participants to continue their exercise. This study will help us
      determine whether high intensity or low-intensity training is more helpful in improving the
      functional strength and weight efficacy in overweight and obese females. As obesity is on the
      rise in modern society, our results will help improve the quality of life of obese and
      overweight females.
    

Intervention name(s): High intensity circuit training; Low intensity interval training
Intervention type(s): Other; Other
Intervention description(s): 6 series with 3 minutes rest between the series. each series will consist of 30 seconds each of burpees, skipping, lunges, 1- legged squat, leg levers, and push-ups with 30 seconds rest in between. the volume of exercise will be increased progressively over a period of 8 weeks.; 4 series with 3 minutes rest in between. each series will consist of 10 minutes of jogging and 5 minutes walking with 30 seconds recovery in between. the volume of exercise will be increased progressively over a period of 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: female; Quality of life; overweight; obesity; Exercise