bioihbjkbjnl/mcl2 huggingface dataset:
DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
Condition: Endometrioma; Visual Analogue Pain Scale: Moderate or Severe Pain
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for
      the treatment of pain in patients suspected endometriosis. It is hypothesized that the
      reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of
      study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen,
      is significantly greater than that of Control. In addition, the administration of DLBS1442 at
      higher dose also results in significantly greater reduction than that of DLBS1442 at lower
      dose and of Control.
    

Detailed description: 
      There will be three groups of treatment by dosage regimen in this study. Eligible subjects
      will be randomized to receive any of the following regimens: 1) DLBS1442 at a dose of 3 x 100
      mg daily, or 2) DLBS1442 at a dose of 3 x 200 mg daily; or 3) mefenamic acid at a dose of 3 x
      500 mg daily. DLBS1442 will be taken every day along the study period (8 weeks), while
      mefenamic acid will only be taken for five (5) days during the menstrual period, i.e. day 1st
      to day 5th of menstrual period. Study treatment will be given at a standardized starting
      point for all subjects, i.e. on the first day of their respective menstrual periods. Clinical
      and laboratory examinations to evaluate the investigational drug's efficacy and safety will
      be performed at baseline and every 4-week interval throughout the study period.
    

Intervention name(s): DLBS1442 100; Mefenamic acid; DLBS1442 200
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study treatment will be DLBS1442 capsules at a dose of 3x100 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).; Control will be mefenamic acid 500 mg tablets, administered 3 times daily for 5 days during the menstrual period, i.e. day 1st to day 5th of the menstrual period. The drug will be given within the 8 weeks of study period (2 menstrual cycles).; Study treatment will be DLBS1442 capsules at a dose of 3x200 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).
Other intervention name(s): Dismeno 100; Pondex Forte; Dismeno 200
Intervention MeSH terms: Mefenamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DLBS1442; Endometriosis; Pain; Visual Analogue Scale; Endometriosis Health Profile (EHP-30TM)
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary objective :

        -  To explore the relation between 3 doses of GRASPA and duration of asparagine depletion
           (< 2µmol/l)

      Secondary objective :

        -  Pharmacokinetic / Pharmacodynamic parameters

        -  toxicity

        -  Study duration : 2 years

        -  Study treatment : Red blood cells loaded with L asparaginase versus native L
           asparaginase

        -  Associated treatments : COPRALL chemotherapy

        -  Randomization : centralised randomisation on scratching list
    


Intervention name(s): GRASPA; GRASPA; GRASPA; native L asparaginase
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): 50 UI/Kg; 100 UI/Kg; 150 UI/Kg; 10000UI/m2, 14 infusions during 4 chemotherapy cycle
Intervention MeSH terms: Asparaginase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapse; Lymphoma lymphoblastic
A Study to Evaluate Alzheimer's Disease Conversion Rate Differences Between High-risk Mild Cognitive Impairment (MCI) and Low-risk MCI in a Real World Setting
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      This study will be conducted to evaluate the rate of Alzheimer's disease conversion
      differences between high-risk mild cognitive impairment (MCI) and low-risk MCI.
    


Intervention name(s): Usual care setting
Intervention type(s): Other
Intervention description(s): usual care settings without any intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with mild cognitive impairment
      
Keywords: High-risk; Low-risk; Alzheimer's disease; Observational study
Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)
Condition: Complex Regional Pain Syndrome
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of soticlestat (TAK-935) on calculated
      24-hour average pain intensity by the numeric pain scale (NPS).
    

Detailed description: 
      The drug being tested in this study is called soticlestat (TAK-935). Soticlestat is being
      tested to treat people with chronic complex regional pain syndrome (CRPS). This study will
      look at the efficacy, safety, and tolerability of soticlestat as an adjunctive therapy in
      participants with CRPS.

      The study will enroll approximately 24 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) in 2:1 ratio to one of the two treatment groups-which will
      remain undisclosed to the patient and study doctor during the study (unless there is an
      urgent medical need):

      Soticlestat 100 mg tablets, 100, 200 or 300 mg twice daily (BID) Placebo (dummy inactive
      pill) - this is a tablet that looks like the study drug but has no active ingredient

      Participants will receive 100 mg soticlestat tablets or soticlestat matching placebo tablets,
      BID for Week 1, 2x100 mg soticlestat tablets or soticlestat matching placebo tablets, BID for
      Week 2 and followed by 3x100 mg soticlestat tablets or soticlestat matching placebo tablets,
      BID for Week 3. Dose will be uptitrated based on safety and tolerability in titration period.
      Participants will continue to receive the same dose in maintenance period. Dose adjustments
      during maintenance period may take place due to safety and tolerability.

      Participants will then enter Part B (optional) or taper period. In Part B all participants
      will receive soticlestat 2x100 mg tablets, BID for 1 Week, followed by soticlestat 3x100 mg
      tablets, BID for 1 Week. Dose will be uptitrated/downtitrated based on safety and
      tolerability in titration period (Part B), participants will continue to receive the same
      dose in maintenance period (Part B) and followed by a taper period.

      This multi-center trial will be conducted in United Kingdom. The overall time to participate
      in this study is approximately 36 weeks. Participants will make multiple visits to the clinic
      and will be contacted by telephone 15 days after last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): Soticlestat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Soticlestat tablets; Soticlestat matching placebo tablets
Other intervention name(s): TAK-935
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy; Soticlestat; TAk-935
Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether ORM-12741 is safe and effective in the
      treatment of Alzheimer's disease.
    

Detailed description: 
      The purpose of this study is to determine whether ORM-12741 is safe and effective in the
      treatment of cognitive and behavioral symptoms in patients with Alzheimer's disease.
    

Intervention name(s): ORM-12741; ORM-12741; Placebo for ORM-12741
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 60mg twice a day; 200mg twice a day; Placebo twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions
Condition: Fibromyalgia; Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or
      Chronic Widespread Pain (Wolfe 1990) participate in the study.

      The main objective of the study is to compare the effect of a graded strength training
      program and a low intensive pool exercise program.
    

Detailed description: 
      A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or
      Chronic Widespread Pain (Wolfe 1990) participate in the study.

      40 patients (in the city Uddevalla) are randomised into two groups; low intensive temperate
      pool exercise program, and graded strength training program. The study period is 12 weeks.

      20 patients (in the city Alingsås) make a reference group who is asked to continue their
      normal activities during the study period.

      Primary outcomes are fatigue (using the Multidimensional fatigue inventory and VAS for global
      fatigue)and muscle strength (using Steve Strong, Isobex and the Grippit). Several other
      self-administered instruments was used.
    

Intervention name(s): Graded strength resistance training program; Temperate pool exercise program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Graded strength resistance training, 75 minutes, twice a week for 12 weeks.; Temperate pool low intensive exercise, 50 minutes, twice a week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia; Widespread pain; Fatigue; Physical exercise
Clinical Trial of SARS-CoV-2 mRNA Vaccine in Chinese People
Condition: SARS-CoV-2
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase Ⅱ Clinical Trial to Evaluate the Safety and Immunogenicity of the New Coronavirus mRNA
      Vaccine (LVRNA009) in Chinese People Aged 18~59 Years
    


Intervention name(s): SARS-CoV-2 (LVRNA009) 50μg group; SARS-CoV-2 (LVRNA009) 100μg group; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): 50μg/person; 100μg/person; 0.5ml/person
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis
Condition: Acute Gallstone Pancreatitis
MeSH terms: Pancreatitis; Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Observational

Summary: 
      The purpose of this study was to determine the effect of gallstone characteristics for the
      severity of acute gallstone pancreatitis (GSP)
    

Detailed description: 
      The timing of cholecystectomy is closely related to the severity of acute gallstone
      pancreatitis (GSP). The effect of gallstone characteristics (including stone size, number,
      etc.) for the severity of GSP are currently unknown.
    

Intervention name(s): Gallstone characteristics
Intervention type(s): Other
Intervention description(s): stone size, number, the thickness
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Acute gallstone pancreatitis patients
      
Keywords: Pancreatitis; Gallstone; Severity
The Use of Levonorgestrel-Releasing Device (Metraplant-E) in the Treatment of Dysfunctional Uterine Bleeding
Condition: Dysfunctional Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Metrorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Research hypothesis: Release of levonorgestrel from Metraplant-E levonorgestrel releasing
      intrauterine contraceptive device is inadequate to be used as a medical line of treatment of
      dysfunctional uterine bleeding.

      The investigators aim to evaluate the therapeutic effect of the intrauterine system
      (Metraplant-E) in the treatment of dysfunctional uterine bleeding.
    

Detailed description: 
      Primary outcome : The investigators aim to evaluate the short term release of levonorgestrel
      from the Metraplant-E levonorgestrel releasing intrauterine contraceptive devices (IUCDs).
      This is in a trial to determine to what extent the intrauterine release of levonorgestrel
      would reduce MBL in women with menorrhagia and if the treatment would increase the body iron
      stores and the degree of patient satisfaction and acceptability of treatment for the patients
      with dysfunctional uterine bleeding. This will be conducted through a questionnaire offered
      to the women participating in this study which is designed on Likert scale.

      Secondary outcome:

      1) Endometrial biopsy prior to and 6 months after the insertion of the intrauterine system
      (Metraplant-E).

      3) Haemoglobin level measurement in gm/dl and serum ferritin level on same occasions as when
      endometrial biopsy is done.

      4) The amount of monthly menstrual blood loss after the insertion the Metraplant-E
      levonorgestrel releasing intrauterine contraceptive devices using the following scores:
      bleeding index,total bleeding score and Pictorial blood loss assessment chart (PBAC).

      Inclusion criteria:

        1. Women seeking contraception.

        2. Women with history of menorrhagia.

        3. Pre and perimenopausal women who are married or previously married.

        4. Failure of other medical treatment to control menorrhagia such as hemostatics.

        5. Women who did not tolerate copper IUD (intrauterine device) due to increased amount of
           menstrual blood loss which could lead to anemia.
    

Intervention name(s): Metraplant-E levonorgestrel-releasing intrauterine device
Intervention type(s): Device
Intervention description(s): Metraplant-E insertion and follow up for 6 months
Intervention MeSH terms: Levonorgestrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dysfunctional uterine bleeding; Metraplant-E; Levonorgestrel-releasing intrauterine device; Endometrial decidualization
Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus
Condition: Periodontitis; Diabetes Mellitus
MeSH terms: Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Aim of the current study was to evaluate Endocan biomarker level in gingival crevicular fluid
      of patients with stage 1 or 2 (mild to moderate) periodontitis with controlled type 2
      diabetes mellitus (DM) and compare it to that in DM free periodontitis patients.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with stage 1 or 2 (mild to moderate) periodontitis having ≤ 4 mm attachment loss
        at least in one site were included in the study these were divided into two groups, with
        controlled type 2 diabetes mellitus, and systemically healthy stage 1 or 2 (mild to
        moderate) periodontitis patients
Gait Perturbations to Improve Balance Post-stroke
Condition: Hemiparesis;Poststroke/CVA
MeSH terms: Paresis
Study type: Interventional

Summary: 
      Individuals with stroke have balance and gait deficits. Gait training does improve balance
      and gait abilities, but adding perturbations may have increase these effects. The objective
      was to compare the effect gait training with and without perturbations on balance and gait
      abilities in individuals with hemiparesis due to stroke at a chronic stage.
    


Intervention name(s): Gait training with perturbations; Gait training without perturbation
Intervention type(s): Device; Device
Intervention description(s): Changes in speed of one of the belt of the split belt treadmill during swing phase; Walking on a treadmill with steady belt speed
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Only the experimental intervention was offered in the second phase of the trial, to the participants who received the control intervention in the first phase
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on
      the glucose variability using continuous glucose monitoring (CGM) in Japanese participants
      with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with
      sitagliptin will be superior to treatment with glibenclamide in the change from baseline in
      mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM)
      after 13 days of treatment.
    


Intervention name(s): Sitagliptin; Glibenclamide
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 50 mg orally once a day before breakfast for 14 days; Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days
Other intervention name(s): MK-0431
Intervention MeSH terms: Sitagliptin Phosphate; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers
Condition: Obesity; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of the study is to investigate whether different doses of caffeinated coffee
      consumption has acute effects on subjective appetite feelings, energy intake and biochemical
      markers related to appetite, inflammation and glucose metabolism compared to water
      consumption in normal weight and overweight/obese participants.
    


Intervention name(s): coffee
Intervention type(s): Other
Intervention description(s): Comparison of different amounts of coffee
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: coffee; overweight/obese; appetite; energy intake; inflammation; glucose metabolism; randomized controlled trial
Postural Correction Exercises Effect on Forward Head Posture
Condition: Musculoskeletal Disorder of the Neck
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      To determine the effect of postural correction exercise in universities students regarding
      cervical sagittal posture, head flexion angle in forward head posture.
    

Detailed description: 
      Informed consent will be taken from the participants, then we move further toward their
      demographics which will lead to initial readings after completion of authenticated
      questionnaire, then application of performing technique/exercise protocol by therapist and
      note the measurements again then interpret and analyze the data through data analyzing
      software which will lead to conclude the process.
    

Intervention name(s): Postural correction exercises
Intervention type(s): Other
Intervention description(s): Exercises to improve posture like shoulder shrugging, chin tuckin, neck isometrics
Intervention model: Single Group Assignment
Intervention model description: Quasi-experimental study
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Dietary Fat When Eaten With Fructose Versus Glucose
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      This study is designed to test the effects on liver fat of varying fat intake in the presence
      of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as
      compared to glucose will increase the amount of hepatic lipid as measured by magnetic
      resonance spectroscopy.
    

Detailed description: 
      After 2 screening visits including an exercise test, DEXA and CT scan, qualifiers begin a 7
      day diet with 20% fat, 65% carbohydrate (with 20% glucose) and 15 % protein. Participants
      consume 2 meals per day at PBRC with lunch and weekend meals packed to go. Following a test
      day, participants are randomized to one of 3 diet assignments and then test again:

      1)20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein 2)40% fat, 45%
      carbohydrate (with 20% glucose beverage), 15% protein 3)40% fat, 45% carbohydrate (with 20%
      fructose beverage), 15% protein On Day 7 and again 14 days later participants have labs, an
      oral Glucose tolerance test, hepatic and intramuscular lipid measures by MRS, vital signs and
      waist measurement.
    

Intervention name(s): 40% Fat Diet, 20% Fructose Beverage; 20% Glucose Beverage; 20% Glucose Beverage
Intervention type(s): Other; Other; Other
Intervention description(s): 40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein; 40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein; 20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein
Other intervention name(s): Fructose vs. Glucose; Fructose vs. Glucose; Fructose vs Glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Fructose; Glucose
Cognoa ASD Diagnosis Aid Validation Study
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The primary objective of this study is to collect data to ascertain the Positive Predictive
      Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa
      diagnostic device.
    

Detailed description: 
      To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing
      its diagnostic output with the clinical reference standard, consisting of a diagnosis made by
      a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing
      specialist clinicians
    

Intervention name(s): Cognoa ASD diagnostic device
Intervention type(s): Diagnostic Test
Intervention description(s): Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
Intervention model: Single Group Assignment
Intervention model description: All subjects will undergo both investigational and comparator diagnosis for ASD.
Masking: None (Open Label)
Primary purpose: Diagnostic